Trial Outcomes & Findings for Safety and Efficacy of EndoBarrier in Subjects With Type 2 Diabetes Who Are Obese (NCT NCT01728116)
NCT ID: NCT01728116
Last Updated: 2017-02-01
Results Overview
Mean Change in HbA1c from Baseline to 12 Months in the mITT population with Bayesian Imputation
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
325 participants
Primary outcome timeframe
Baseline and12 months
Results posted on
2017-02-01
Participant Flow
Up to 500 subjects were planned to be randomized into either the EndoBarrier or the sham control arm at a 2:1 ratio, respectively. Due to early termination of the trial, only 325 subjects were randomized with 216 EndoBarrier subjects and 109 sham control subjects.
The mITT population for the primary analyses includes 213 EndoBarrier subjects and 107 sham control subjects. The remaining five (5) subjects (n=3 randomized to device; n=2 randomized to sham) were deemed ineligible before an attempted device placement due to findings identified during the upper endoscopy.
Participant milestones
| Measure |
EndoBarrier Group
Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. Subjects also received a prophylactic dose of antibiotics on Procedure Day. Fluoroscopy was also used in conjunction with endoscopy to aid implantation of the EndoBarrier device. Medical Nutritional Therapy (MNT) counseling (as defined by the 2012 American Diabetes Association guidelines) was to be conducted at Baseline then Weeks 13, 26, 39, and 52 for both groups, and additionally at Week 65 for the EndoBarrier group.
|
Sham Control Group
Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.Medical Nutritional Therapy (MNT) counseling (as defined by the 2012 American Diabetes Association guidelines) was to be conducted at Baseline then Weeks 13, 26, 39, and 52.
|
|---|---|---|
|
Overall Study
STARTED
|
213
|
107
|
|
Overall Study
COMPLETED
|
52
|
60
|
|
Overall Study
NOT COMPLETED
|
161
|
47
|
Reasons for withdrawal
| Measure |
EndoBarrier Group
Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. Subjects also received a prophylactic dose of antibiotics on Procedure Day. Fluoroscopy was also used in conjunction with endoscopy to aid implantation of the EndoBarrier device. Medical Nutritional Therapy (MNT) counseling (as defined by the 2012 American Diabetes Association guidelines) was to be conducted at Baseline then Weeks 13, 26, 39, and 52 for both groups, and additionally at Week 65 for the EndoBarrier group.
|
Sham Control Group
Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.Medical Nutritional Therapy (MNT) counseling (as defined by the 2012 American Diabetes Association guidelines) was to be conducted at Baseline then Weeks 13, 26, 39, and 52.
|
|---|---|---|
|
Overall Study
Sponsor Terminated Study
|
106
|
35
|
|
Overall Study
Withdrawal by Subject
|
16
|
9
|
|
Overall Study
Adverse Event
|
13
|
0
|
|
Overall Study
Procedure/device failure
|
7
|
0
|
|
Overall Study
Lost to Follow-up
|
9
|
2
|
|
Overall Study
Physician Decision
|
2
|
0
|
|
Overall Study
Subject Non-Compliance
|
2
|
0
|
|
Overall Study
Inter-current finding at procedure
|
1
|
0
|
|
Overall Study
Incorrectly enrolled in Study
|
0
|
1
|
|
Overall Study
various not noted previously
|
5
|
0
|
Baseline Characteristics
Safety and Efficacy of EndoBarrier in Subjects With Type 2 Diabetes Who Are Obese
Baseline characteristics by cohort
| Measure |
EndoBarrier Group
n=213 Participants
Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. Subjects also received a prophylactic dose of antibiotics on Procedure Day. Fluoroscopy was also used in conjunction with endoscopy to aid implantation of the EndoBarrier device.
|
Sham Control Group
n=107 Participants
Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.
|
Total
n=320 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.9 years
STANDARD_DEVIATION 8.19 • n=99 Participants
|
51.8 years
STANDARD_DEVIATION 8.21 • n=107 Participants
|
52.5 years
STANDARD_DEVIATION 8.20 • n=206 Participants
|
|
Gender
Female
|
127 Participants
n=99 Participants
|
69 Participants
n=107 Participants
|
196 Participants
n=206 Participants
|
|
Gender
Male
|
86 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
124 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
19 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
194 Participants
n=99 Participants
|
93 Participants
n=107 Participants
|
287 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
6 participants
n=99 Participants
|
3 participants
n=107 Participants
|
9 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
0 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
44 participants
n=99 Participants
|
22 participants
n=107 Participants
|
66 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
165 participants
n=99 Participants
|
80 participants
n=107 Participants
|
245 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Baseline Weight (lbs)
|
245.0 lbs
STANDARD_DEVIATION 47.46 • n=99 Participants
|
245.6 lbs
STANDARD_DEVIATION 44.20 • n=107 Participants
|
245.2 lbs
STANDARD_DEVIATION 46.32 • n=206 Participants
|
|
Baseline BMI
|
38.4 kg/m2
STANDARD_DEVIATION 5.74 • n=99 Participants
|
38.3 kg/m2
STANDARD_DEVIATION 5.33 • n=107 Participants
|
38.4 kg/m2
STANDARD_DEVIATION 5.60 • n=206 Participants
|
|
HbA1c (%) fasting bloodwork
|
8.8 percent
STANDARD_DEVIATION 0.92 • n=99 Participants
|
8.9 percent
STANDARD_DEVIATION 0.89 • n=107 Participants
|
8.8 percent
STANDARD_DEVIATION 0.91 • n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and12 monthsPopulation: All randomized subjects who at their baseline endoscopy are judged to be potential recipients of the device (meaning no abnormal pathologies and/or conditions are present). Any subject who has a device enter their body, regardless of eligibility or randomization assignment, is also included in the treatment arm of the mITT population.
Mean Change in HbA1c from Baseline to 12 Months in the mITT population with Bayesian Imputation
Outcome measures
| Measure |
EndoBarrier Group
n=213 Participants
Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. Subjects also received a prophylactic dose of antibiotics on Procedure Day. Fluoroscopy was also used in conjunction with endoscopy to aid implantation of the EndoBarrier device.
|
Sham Control Group
n=107 Participants
Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.
|
|---|---|---|
|
Primary Efficacy Endpoint: Improvement in HbA1c
|
-1.07 Percentage of HbA1c
Standard Deviation 1.5
|
-0.31 Percentage of HbA1c
Standard Deviation 1.59
|
PRIMARY outcome
Timeframe: Baseline and 12 MonthsPopulation: mITT without Imputation
Of the 161 subjects for whom data were available at 12 Months, 19 (11.8%) subjects experienced device-related SAEs that required an early device removal.
Outcome measures
| Measure |
EndoBarrier Group
n=161 Participants
Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. Subjects also received a prophylactic dose of antibiotics on Procedure Day. Fluoroscopy was also used in conjunction with endoscopy to aid implantation of the EndoBarrier device.
|
Sham Control Group
Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.
|
|---|---|---|
|
Primary Safety Endpoint: Early Device Removal Due to Device-Related SAE
|
11.8 percentage of participants
Interval 7.8 to 17.7
|
—
|
SECONDARY outcome
Timeframe: Baseline and 12 MonthsPopulation: mITT population without imputation
Outcome measures
| Measure |
EndoBarrier Group
n=135 Participants
Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. Subjects also received a prophylactic dose of antibiotics on Procedure Day. Fluoroscopy was also used in conjunction with endoscopy to aid implantation of the EndoBarrier device.
|
Sham Control Group
n=61 Participants
Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.
|
|---|---|---|
|
Assessment of Total Cholesterol Change at 12 Months Compared to Baseline
|
-11.30 mg/dL
Standard Deviation 34.39
|
-4.16 mg/dL
Standard Deviation 47.14
|
SECONDARY outcome
Timeframe: Baseline and 12 MonthsPopulation: mITT population without imputation
Outcome measures
| Measure |
EndoBarrier Group
n=135 Participants
Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. Subjects also received a prophylactic dose of antibiotics on Procedure Day. Fluoroscopy was also used in conjunction with endoscopy to aid implantation of the EndoBarrier device.
|
Sham Control Group
n=61 Participants
Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.
|
|---|---|---|
|
Percentage of Subjects Who Achieve HbA1c Less Than or Equal to 7.0% at 12 Months
|
34.81 percentage of participants
|
9.84 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and 12 MonthsPopulation: mITT without imputation
Outcome measures
| Measure |
EndoBarrier Group
n=133 Participants
Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. Subjects also received a prophylactic dose of antibiotics on Procedure Day. Fluoroscopy was also used in conjunction with endoscopy to aid implantation of the EndoBarrier device.
|
Sham Control Group
n=59 Participants
Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.
|
|---|---|---|
|
LDL Change From Baseline
|
-10.76 mg/dL
Standard Deviation 31.42
|
-10.54 mg/dL
Standard Deviation 40.35
|
SECONDARY outcome
Timeframe: Baseline and 12 MonthsPopulation: mITT population without imputation
Outcome measures
| Measure |
EndoBarrier Group
n=135 Participants
Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. Subjects also received a prophylactic dose of antibiotics on Procedure Day. Fluoroscopy was also used in conjunction with endoscopy to aid implantation of the EndoBarrier device.
|
Sham Control Group
n=61 Participants
Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.
|
|---|---|---|
|
Triglycerides Change From Baseline
|
-41.50 mg/dL
Standard Deviation 105.76
|
2.26 mg/dL
Standard Deviation 96.04
|
SECONDARY outcome
Timeframe: Baseline and 12 MonthsPopulation: mITT population without imputation
Outcome measures
| Measure |
EndoBarrier Group
n=135 Participants
Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. Subjects also received a prophylactic dose of antibiotics on Procedure Day. Fluoroscopy was also used in conjunction with endoscopy to aid implantation of the EndoBarrier device.
|
Sham Control Group
n=61 Participants
Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.
|
|---|---|---|
|
Fasting Glucose Change From Baseline
|
-38.90 mg/dL
Standard Deviation 66.08
|
5.31 mg/dL
Standard Deviation 73.65
|
SECONDARY outcome
Timeframe: Baseline and 12 MonthsPopulation: mITT population without imputation
Outcome measures
| Measure |
EndoBarrier Group
n=134 Participants
Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. Subjects also received a prophylactic dose of antibiotics on Procedure Day. Fluoroscopy was also used in conjunction with endoscopy to aid implantation of the EndoBarrier device.
|
Sham Control Group
n=59 Participants
Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.
|
|---|---|---|
|
Systolic BP Change From Baseline
|
-2.76 mmHg
Standard Deviation 17.07
|
1.22 mmHg
Standard Deviation 16.47
|
SECONDARY outcome
Timeframe: Baseline and 12 MonthsPopulation: mITT population without imputation
Outcome measures
| Measure |
EndoBarrier Group
n=134 Participants
Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. Subjects also received a prophylactic dose of antibiotics on Procedure Day. Fluoroscopy was also used in conjunction with endoscopy to aid implantation of the EndoBarrier device.
|
Sham Control Group
n=59 Participants
Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.
|
|---|---|---|
|
Diastolic BP Change From Baseline
|
-2.02 mmHg
Standard Deviation 9.91
|
1.51 mmHg
Standard Deviation 11.19
|
SECONDARY outcome
Timeframe: Baseline and 12 MonthsPopulation: mITT population without imputation
Outcome measures
| Measure |
EndoBarrier Group
n=135 Participants
Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. Subjects also received a prophylactic dose of antibiotics on Procedure Day. Fluoroscopy was also used in conjunction with endoscopy to aid implantation of the EndoBarrier device.
|
Sham Control Group
n=60 Participants
Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.
|
|---|---|---|
|
Percentage of Subjects Who Achieve % Total Body Weight Loss Greater Than or Equal to 5% at 12 Months
|
60.74 percentage of participants
|
20.00 percentage of participants
|
Adverse Events
EndoBarrier Group
Serious events: 53 serious events
Other events: 206 other events
Deaths: 0 deaths
Sham Control Group
Serious events: 5 serious events
Other events: 96 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
EndoBarrier Group
n=212 participants at risk
Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. Subjects also received a prophylactic dose of antibiotics on Procedure Day. Fluoroscopy was also used in conjunction with endoscopy to aid implantation of the EndoBarrier device.
|
Sham Control Group
n=108 participants at risk
Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Cardiac disorders
Atrial fibrillation
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Cardiac disorders
Atrioventricular block complete
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Gastrointestinal disorders
Abdominal pain
|
3.8%
8/212 • Number of events 9 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Gastrointestinal disorders
Esophageal rupture
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Gastrointestinal disorders
Gastrointestinal hemorrhage
|
3.8%
8/212 • Number of events 9 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Gastrointestinal disorders
Nausea
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Gastrointestinal disorders
Pancreatitis
|
0.94%
2/212 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.94%
2/212 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Gastrointestinal disorders
Vomiting
|
1.4%
3/212 • Number of events 3 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
General disorders
Adhesion
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
General disorders
Chest Pain
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
General disorders
Complication of device removal
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
General disorders
Obstruction
|
1.9%
4/212 • Number of events 4 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
General disorders
Pseudopolyp
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Hepatobiliary disorders
Cholecystitis
|
1.9%
4/212 • Number of events 4 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Hepatobiliary disorders
Cholecystitis acute
|
1.4%
3/212 • Number of events 3 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Gastrointestinal disorders
Cholelithiasis
|
0.94%
2/212 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Infections and infestations
Abscess
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Infections and infestations
Appendicitis
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Infections and infestations
Cellulitis
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Infections and infestations
Emphysematous pyelonephritis
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Infections and infestations
Incision site cellulitis
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Infections and infestations
Liver abscess
|
3.3%
7/212 • Number of events 7 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Infections and infestations
Pneumonia
|
1.4%
3/212 • Number of events 4 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Infections and infestations
Scrotal infection
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Infections and infestations
Sepsis
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Infections and infestations
Staphylococcal bacteremia
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/212 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Injury, poisoning and procedural complications
Esophageal injury
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Investigations
Transaminases increased
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/212 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/212 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Nervous system disorders
Syncope
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Psychiatric disorders
Mental status changes
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Psychiatric disorders
Suicidal ideation
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Renal and urinary disorders
Renal failure acute
|
0.94%
2/212 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Surgical and medical procedures
Cholecystectomy
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
Other adverse events
| Measure |
EndoBarrier Group
n=212 participants at risk
Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. Subjects also received a prophylactic dose of antibiotics on Procedure Day. Fluoroscopy was also used in conjunction with endoscopy to aid implantation of the EndoBarrier device.
|
Sham Control Group
n=108 participants at risk
Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.
|
|---|---|---|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/212 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Cardiac disorders
Tachycardia
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Blood and lymphatic system disorders
Anaemia
|
4.2%
9/212 • Number of events 10 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
2.8%
3/108 • Number of events 3 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/212 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Blood and lymphatic system disorders
Splenomegaly
|
1.4%
3/212 • Number of events 3 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Cardiac disorders
Atrioventricular block complete
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Cardiac disorders
Coronary artery disease
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Cardiac disorders
Palpitations
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.00%
0/212 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/212 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Endocrine disorders
Hypothyroidism
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Eye disorders
Chalazion
|
0.47%
1/212 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Eye disorders
Conjunctivitis
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Eye disorders
Corneal lesion
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Eye disorders
Eye haemorrhage
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Eye disorders
Eye swelling
|
0.00%
0/212 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Eye disorders
Keratitis
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Eye disorders
Mydriasis
|
0.00%
0/212 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Eye disorders
Ocular hyperaemia
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/212 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Eye disorders
Vision blurred
|
1.4%
3/212 • Number of events 3 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Eye disorders
Visual impairment
|
1.4%
3/212 • Number of events 3 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Eye disorders
Vitreous detachment
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Gastrointestinal disorders
Abdominal discomfort
|
35.4%
75/212 • Number of events 96 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
13.0%
14/108 • Number of events 17 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Gastrointestinal disorders
Abdominal distension
|
21.2%
45/212 • Number of events 55 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
12.0%
13/108 • Number of events 13 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Gastrointestinal disorders
Abdominal mass
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Gastrointestinal disorders
Abdominal pain
|
59.0%
125/212 • Number of events 223 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
20.4%
22/108 • Number of events 29 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.3%
7/212 • Number of events 9 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Gastrointestinal disorders
Abdominal rigidity
|
1.4%
3/212 • Number of events 3 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.94%
2/212 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Gastrointestinal disorders
Abnormal faeces
|
3.3%
7/212 • Number of events 7 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
2.8%
3/108 • Number of events 4 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Gastrointestinal disorders
Barrett's oesophagus
|
0.94%
2/212 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
1.9%
2/108 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Gastrointestinal disorders
Bezoar
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Gastrointestinal disorders
Breath odour
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Gastrointestinal disorders
Cheilitis
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Gastrointestinal disorders
Constipation
|
26.9%
57/212 • Number of events 62 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
13.0%
14/108 • Number of events 16 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Gastrointestinal disorders
Diarrhoea
|
26.9%
57/212 • Number of events 74 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
36.1%
39/108 • Number of events 49 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Gastrointestinal disorders
Diverticulum
|
1.4%
3/212 • Number of events 3 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Gastrointestinal disorders
Dry mouth
|
0.94%
2/212 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Gastrointestinal disorders
Duodenal stenosis
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Gastrointestinal disorders
Duodenal ulcer
|
4.2%
9/212 • Number of events 9 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Gastrointestinal disorders
Duodenitis
|
0.94%
2/212 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/212 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Gastrointestinal disorders
Erosive oesophagitis
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Gastrointestinal disorders
Eructation
|
7.1%
15/212 • Number of events 17 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
2.8%
3/108 • Number of events 3 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Gastrointestinal disorders
Faecal incontinence
|
1.4%
3/212 • Number of events 3 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.94%
2/212 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Gastrointestinal disorders
Flatulence
|
13.7%
29/212 • Number of events 33 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
5.6%
6/108 • Number of events 6 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Gastrointestinal disorders
Frequent bowel movements
|
1.4%
3/212 • Number of events 3 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
1.9%
2/108 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Gastrointestinal disorders
Gastric polyps
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
1.9%
2/108 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Gastrointestinal disorders
Gastritis
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.94%
2/212 • Number of events 4 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
7.1%
15/212 • Number of events 18 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
8.3%
9/108 • Number of events 9 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Gastrointestinal disorders
Gingival pain
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Gastrointestinal disorders
Glossodynia
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Gastrointestinal disorders
Haematochezia
|
1.4%
3/212 • Number of events 3 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
1.9%
2/108 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Gastrointestinal disorders
Haemorrhoids
|
1.9%
4/212 • Number of events 4 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
1.9%
2/108 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/212 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Gastrointestinal disorders
Infrequent bowel movements
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Gastrointestinal disorders
Lip pain
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Gastrointestinal disorders
Lip swelling
|
1.9%
4/212 • Number of events 4 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Gastrointestinal disorders
Nausea
|
52.4%
111/212 • Number of events 164 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
22.2%
24/108 • Number of events 27 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Gastrointestinal disorders
Odynophagia
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Gastrointestinal disorders
Oesophageal discomfort
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Gastrointestinal disorders
Oesophageal rupture
|
1.4%
3/212 • Number of events 5 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.94%
2/212 • Number of events 3 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/212 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Gastrointestinal disorders
Oral pain
|
0.94%
2/212 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Gastrointestinal disorders
Pancreatic mass
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Gastrointestinal disorders
Retching
|
0.94%
2/212 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Gastrointestinal disorders
Stomatitis
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Gastrointestinal disorders
Tongue cyst
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Gastrointestinal disorders
Tooth loss
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Gastrointestinal disorders
Toothache
|
1.4%
3/212 • Number of events 3 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Gastrointestinal disorders
Vomiting
|
32.1%
68/212 • Number of events 85 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
8.3%
9/108 • Number of events 9 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
General disorders
Adverse drug reaction
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
General disorders
Asthenia
|
3.3%
7/212 • Number of events 7 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
General disorders
Chest discomfort
|
1.4%
3/212 • Number of events 3 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
General disorders
Chest pain
|
1.4%
3/212 • Number of events 3 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
General disorders
Chills
|
2.4%
5/212 • Number of events 5 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
General disorders
Device dislocation
|
0.94%
2/212 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
General disorders
Fatigue
|
12.7%
27/212 • Number of events 28 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
7.4%
8/108 • Number of events 9 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
General disorders
Feeling cold
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
1.9%
2/108 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
General disorders
Feeling hot
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
General disorders
Feeling jittery
|
0.00%
0/212 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
General disorders
Irritability
|
0.00%
0/212 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
General disorders
Local swelling
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
General disorders
Obstruction
|
0.94%
2/212 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
General disorders
Oedema mucosal
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
General disorders
Oedema peripheral
|
0.94%
2/212 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
2.8%
3/108 • Number of events 4 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
General disorders
Pseudopolyp
|
0.94%
2/212 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
General disorders
Pyrexia
|
4.7%
10/212 • Number of events 13 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
3.7%
4/108 • Number of events 5 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
General disorders
Temperature intolerance
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
General disorders
Thirst
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Hepatobiliary disorders
Biliary colic
|
0.94%
2/212 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Hepatobiliary disorders
Biliary dilatation
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Hepatobiliary disorders
Biliary dyskinesia
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Hepatobiliary disorders
Cholecystitis
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Hepatobiliary disorders
Cholelithiasis
|
4.2%
9/212 • Number of events 9 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Hepatobiliary disorders
Gallbladder polyp
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.94%
2/212 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Hepatobiliary disorders
Hepatic lesion
|
0.94%
2/212 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Hepatobiliary disorders
Hepatic steatosis
|
4.2%
9/212 • Number of events 9 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Hepatobiliary disorders
Liver injury
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Immune system disorders
Food allergy
|
0.00%
0/212 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Immune system disorders
Hypersensitivity
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
2.8%
3/108 • Number of events 3 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Immune system disorders
Multiple allergies
|
0.00%
0/212 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Immune system disorders
Seasonal allergy
|
1.4%
3/212 • Number of events 3 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
1.9%
2/108 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/212 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Infections and infestations
Bronchitis
|
1.4%
3/212 • Number of events 5 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
4.6%
5/108 • Number of events 7 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Infections and infestations
Carbuncle
|
0.00%
0/212 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Infections and infestations
Cellulitis
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Infections and infestations
Cystitis
|
0.00%
0/212 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Infections and infestations
Diverticulitis
|
0.94%
2/212 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Infections and infestations
Ear infection
|
0.94%
2/212 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
1.9%
2/108 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Infections and infestations
Fungal infection
|
0.94%
2/212 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/212 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Infections and infestations
Gastroenteritis
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.00%
0/212 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/212 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
1.9%
2/108 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Infections and infestations
Gastrointestinal viral infection
|
1.4%
3/212 • Number of events 3 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
1.9%
2/108 • Number of events 3 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Infections and infestations
Gingival infection
|
0.47%
1/212 • Number of events 3 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Infections and infestations
Helicobacter infection
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Infections and infestations
Herpes zoster
|
1.4%
3/212 • Number of events 4 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Infections and infestations
Infection
|
0.94%
2/212 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Infections and infestations
Influenza
|
4.7%
10/212 • Number of events 10 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
4.6%
5/108 • Number of events 5 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Infections and infestations
Nasopharyngitis
|
9.4%
20/212 • Number of events 20 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
12.0%
13/108 • Number of events 16 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Infections and infestations
Pneumonia
|
2.8%
6/212 • Number of events 6 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
2.8%
3/108 • Number of events 3 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Infections and infestations
Respiratory tract infection
|
2.4%
5/212 • Number of events 5 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Infections and infestations
Sialoadenitis
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Infections and infestations
Sinusitis
|
2.8%
6/212 • Number of events 8 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
4.6%
5/108 • Number of events 5 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Infections and infestations
Skin infection
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Infections and infestations
Tinea cruris
|
0.00%
0/212 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Infections and infestations
Tooth abscess
|
0.94%
2/212 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Infections and infestations
Tooth infection
|
0.94%
2/212 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
1.9%
2/108 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Infections and infestations
Trichomoniasis
|
0.00%
0/212 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Infections and infestations
Upper respiratory tract infection
|
7.5%
16/212 • Number of events 17 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
6.5%
7/108 • Number of events 7 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Infections and infestations
Urinary tract infection
|
4.2%
9/212 • Number of events 10 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
1.9%
2/108 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Infections and infestations
Vaginitis bacterial
|
0.94%
2/212 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
1.4%
3/212 • Number of events 3 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
1.9%
2/108 • Number of events 4 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/212 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
1.9%
2/108 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Injury, poisoning and procedural complications
Contusion
|
1.4%
3/212 • Number of events 3 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Injury, poisoning and procedural complications
Fall
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
2.8%
3/108 • Number of events 3 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/212 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
2.8%
3/108 • Number of events 4 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Injury, poisoning and procedural complications
Laceration
|
0.94%
2/212 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
1.9%
4/212 • Number of events 4 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Injury, poisoning and procedural complications
Lip injury
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Injury, poisoning and procedural complications
Mouth injury
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Injury, poisoning and procedural complications
Oesophageal injury
|
3.8%
8/212 • Number of events 8 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Injury, poisoning and procedural complications
Post-traumatic neck syndrome
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.00%
0/212 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/212 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/212 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/212 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Investigations
Amylase decreased
|
1.4%
3/212 • Number of events 4 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Investigations
Blood albumin abnormal
|
0.00%
0/212 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Investigations
Blood alkaline phosphatase increased
|
2.4%
5/212 • Number of events 6 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
1.9%
2/108 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Investigations
Blood bilirubin increased
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Investigations
Blood calcium decreased
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Investigations
Blood calcium increased
|
0.94%
2/212 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Investigations
Blood chloride decreased
|
1.4%
3/212 • Number of events 3 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Investigations
Blood cholesterol decreased
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Investigations
Blood cholesterol increased
|
2.8%
6/212 • Number of events 6 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
1.9%
2/108 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Investigations
Blood creatinine decreased
|
1.4%
3/212 • Number of events 4 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Investigations
Blood creatinine increased
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
1.9%
2/108 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Investigations
Blood electrolytes decreased
|
0.00%
0/212 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Investigations
Blood glucose increased
|
1.4%
3/212 • Number of events 3 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
1.9%
2/108 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Investigations
Blood iron decreased
|
11.3%
24/212 • Number of events 27 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
8.3%
9/108 • Number of events 10 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Investigations
Blood iron increased
|
0.47%
1/212 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Investigations
Blood magnesium decreased
|
4.2%
9/212 • Number of events 9 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
6.5%
7/108 • Number of events 7 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Investigations
Blood potassium decreased
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Investigations
Blood potassium increased
|
0.94%
2/212 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Investigations
Blood pressure increased
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Investigations
Blood sodium decreased
|
1.9%
4/212 • Number of events 4 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
1.9%
2/108 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Investigations
Blood triglycerides increased
|
2.4%
5/212 • Number of events 5 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
3.7%
4/108 • Number of events 4 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Investigations
Blood urea increased
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
2.8%
3/108 • Number of events 3 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Investigations
Carbon dioxide decreased
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
1.9%
2/108 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Investigations
Electrocardiogram abnormal
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Investigations
Glycosylated haemoglobin increased
|
3.8%
8/212 • Number of events 10 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
7.4%
8/108 • Number of events 9 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Investigations
Haematocrit decreased
|
1.4%
3/212 • Number of events 4 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
2.8%
3/108 • Number of events 3 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Investigations
Haematocrit increased
|
0.00%
0/212 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Investigations
Haemoglobin decreased
|
2.8%
6/212 • Number of events 7 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Investigations
Haemoglobin increased
|
0.94%
2/212 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Investigations
Hepatic enzyme increased
|
0.47%
1/212 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Investigations
High density lipoprotein decreased
|
0.94%
2/212 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Investigations
Insulin C-peptide increased
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Investigations
Iron binding capacity total increased
|
1.9%
4/212 • Number of events 4 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
1.9%
2/108 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Investigations
Laboratory test abnormal
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Investigations
Lipase decreased
|
2.4%
5/212 • Number of events 5 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Investigations
Lipase increased
|
0.00%
0/212 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Investigations
Lipids increased
|
0.00%
0/212 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Investigations
Liver function test abnormal
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Investigations
Low density lipoprotein decreased
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Investigations
Low density lipoprotein increased
|
1.9%
4/212 • Number of events 4 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Investigations
Oxygen saturation decreased
|
0.94%
2/212 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Investigations
QRS axis abnormal
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Investigations
Serum ferritin decreased
|
1.4%
3/212 • Number of events 5 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Investigations
Serum ferritin increased
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Investigations
Transaminases increased
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Investigations
Transferrin saturation decreased
|
9.9%
21/212 • Number of events 28 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
12.0%
13/108 • Number of events 16 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Investigations
Transferrin saturation increased
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Investigations
Vitamin B12 decreased
|
5.2%
11/212 • Number of events 13 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Investigations
Vitamin B12 increased
|
0.94%
2/212 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Investigations
Vitamin D decreased
|
6.6%
14/212 • Number of events 15 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
5.6%
6/108 • Number of events 6 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.4%
3/212 • Number of events 3 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.94%
2/212 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/212 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Metabolism and nutrition disorders
Gout
|
1.4%
3/212 • Number of events 8 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
17.0%
36/212 • Number of events 72 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
11.1%
12/108 • Number of events 33 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Investigations
Hyperuricaemia
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.94%
2/212 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Metabolism and nutrition disorders
Iron deficiency
|
19.8%
42/212 • Number of events 45 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
13.0%
14/108 • Number of events 14 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
1.9%
4/212 • Number of events 4 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
6.6%
14/212 • Number of events 14 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
11.1%
12/108 • Number of events 13 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.7%
10/212 • Number of events 10 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
3.7%
4/108 • Number of events 5 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
21.2%
45/212 • Number of events 56 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
8.3%
9/108 • Number of events 9 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Musculoskeletal and connective tissue disorders
Bone loss
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Musculoskeletal and connective tissue disorders
Fasciitis
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.94%
2/212 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/212 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.94%
2/212 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Musculoskeletal and connective tissue disorders
Monarthritis
|
0.00%
0/212 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
4.2%
9/212 • Number of events 9 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
3.7%
4/108 • Number of events 4 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/212 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.94%
2/212 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
5.6%
6/108 • Number of events 6 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.94%
2/212 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
5.6%
6/108 • Number of events 6 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.2%
9/212 • Number of events 10 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
4.6%
5/108 • Number of events 5 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.9%
4/212 • Number of events 4 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.2%
9/212 • Number of events 11 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
3.7%
4/108 • Number of events 4 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
1.4%
3/212 • Number of events 3 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/212 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of thyroid gland
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Nervous system disorders
Diabetic neuropathy
|
0.94%
2/212 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Nervous system disorders
Disturbance in attention
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Nervous system disorders
Dizziness
|
5.2%
11/212 • Number of events 12 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
2.8%
3/108 • Number of events 4 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/212 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Nervous system disorders
Dysgeusia
|
0.94%
2/212 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Nervous system disorders
Headache
|
11.3%
24/212 • Number of events 25 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
16.7%
18/108 • Number of events 23 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Nervous system disorders
Hypoaesthesia
|
0.94%
2/212 • Number of events 3 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Nervous system disorders
Migraine with aura
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Nervous system disorders
Neuropathy peripheral
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Nervous system disorders
Paraesthesia
|
0.47%
1/212 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Nervous system disorders
Poor quality sleep
|
0.94%
2/212 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Nervous system disorders
Sciatic nerve neuropathy
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Nervous system disorders
Sinus headache
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Nervous system disorders
Syncope
|
1.4%
3/212 • Number of events 3 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.00%
0/212 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Psychiatric disorders
Depression
|
2.8%
6/212 • Number of events 6 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Psychiatric disorders
Insomnia
|
0.94%
2/212 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Renal and urinary disorders
Chromaturia
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Renal and urinary disorders
Dysuria
|
0.94%
2/212 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/212 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Renal and urinary disorders
Pollakiuria
|
0.94%
2/212 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/212 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Renal and urinary disorders
Renal cyst
|
0.94%
2/212 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Renal and urinary disorders
Renal mass
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Renal and urinary disorders
Urinary retention
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Reproductive system and breast disorders
Amenorrhoea
|
0.00%
0/212 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/212 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Reproductive system and breast disorders
Breast cyst
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Reproductive system and breast disorders
Breast mass
|
0.94%
2/212 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Reproductive system and breast disorders
Fallopian tube disorder
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Reproductive system and breast disorders
Menopausal symptoms
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/212 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Reproductive system and breast disorders
Scrotal mass
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.00%
0/212 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Reproductive system and breast disorders
Vulvovaginal pain
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.94%
2/212 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.9%
4/212 • Number of events 4 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
3.7%
4/108 • Number of events 4 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.94%
2/212 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
1.9%
2/108 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Respiratory, thoracic and mediastinal disorders
Increased upper airway secretion
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.47%
1/212 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
18.9%
40/212 • Number of events 54 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
20.4%
22/108 • Number of events 25 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.94%
2/212 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/212 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/212 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
1.9%
2/108 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.94%
2/212 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar inflammation
|
0.00%
0/212 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.2%
11/212 • Number of events 11 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/212 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
2.8%
3/108 • Number of events 3 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Skin and subcutaneous tissue disorders
Diabetic ulcer
|
0.00%
0/212 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Skin and subcutaneous tissue disorders
Excessive granulation tissue
|
1.9%
4/212 • Number of events 4 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.4%
3/212 • Number of events 4 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
1.9%
2/108 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.94%
2/212 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.9%
4/212 • Number of events 4 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.9%
4/212 • Number of events 5 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
1.9%
2/108 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/212 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/212 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Surgical and medical procedures
Artificial crown procedure
|
0.00%
0/212 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Surgical and medical procedures
Knee operation
|
0.00%
0/212 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Surgical and medical procedures
Nephrectomy
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Surgical and medical procedures
Rhinoplasty
|
0.00%
0/212 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Surgical and medical procedures
Skin lesion excision
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Surgical and medical procedures
Wisdom teeth removal
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Vascular disorders
Aortic disorder
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Vascular disorders
Hot flush
|
0.00%
0/212 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.93%
1/108 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Vascular disorders
Hypertension
|
0.00%
0/212 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
1.9%
2/108 • Number of events 2 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Vascular disorders
Hypotension
|
1.4%
3/212 • Number of events 4 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Vascular disorders
Peripheral coldness
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Vascular disorders
Shock
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
|
Vascular disorders
Varicose vein
|
0.47%
1/212 • Number of events 1 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
0.00%
0/108 • 18 months for device subjects, 12 months for sham subjects
The calculation of SAE rates uses the denominator of 212 for the EndoBarrier group; this is the number of subjects who had a device implant attempted (i.e., passed through the mouth of the subject regardless of a successful implant or not).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI to provide to Sponsor for review at least sixty (60) days in advance of submission for publication. Sponsor reserves the right to delete any Confidential Information or other proprietary information of Sponsor (including trade secrets but not including Results) from the proposed publication or presentation.
- Publication restrictions are in place
Restriction type: OTHER