Trial Outcomes & Findings for Safety and Feasibility of a Novel Endoscopic Intervention for the Treatment of Type II Diabetes (NCT NCT04725890)
NCT ID: NCT04725890
Last Updated: 2026-01-22
Results Overview
Number of participants experiencing one or more device- or procedure-related serious adverse events at 12 weeks post procedure
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
65 participants
Primary outcome timeframe
At 12 weeks post procedure
Results posted on
2026-01-22
Participant Flow
Participants were recruited from 3 medical centers in Australia between January of 2021 and November of 2023. Participants were considered enrolled in the study once they passed endoscopic screening. Screen failures were defined as participants who consented for the study, started the screening process but were not subsequently enrolled. The first participant was enrolled on 20-Apr-2021 and the last on 27-Jul-2023.
A total of 65 participants were enrolled in the study.
Participant milestones
| Measure |
Intervention- Endogenex (PEF) Treatment
Enrolled participants include all eligible participants that met inclusion criteria and did not meet any exclusion criteria and were treated with the Endogenex/DyaMX device. The Endogenex/DyaMX device is designed to induce duodenal mucosal regeneration using pulsed electric field via a non-surgical, endoscopic procedure.
|
|---|---|
|
Overall Study
STARTED
|
65
|
|
Overall Study
COMPLETED
|
59
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Intervention- Endogenex (PEF) Treatment
Enrolled participants include all eligible participants that met inclusion criteria and did not meet any exclusion criteria and were treated with the Endogenex/DyaMX device. The Endogenex/DyaMX device is designed to induce duodenal mucosal regeneration using pulsed electric field via a non-surgical, endoscopic procedure.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
Safety and Feasibility of a Novel Endoscopic Intervention for the Treatment of Type II Diabetes
Baseline characteristics by cohort
| Measure |
Intervention- Non-Insulin Cohort
n=51 Participants
Non-insulin Arm: All participants are on at least one non-insulin, glucose-lowering medications and received the Endogenex treatment
|
Intervention- Insulin Cohort
n=14 Participants
Insulin (IS) Cohort: all participants are on insulin and received the Endogenex treatment.
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.8 years
STANDARD_DEVIATION 8.0 • n=270 Participants
|
58.1 years
STANDARD_DEVIATION 7.0 • n=4 Participants
|
53.9 years
STANDARD_DEVIATION 8.0 • n=9 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=270 Participants
|
8 Participants
n=4 Participants
|
21 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=270 Participants
|
6 Participants
n=4 Participants
|
44 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
49 Participants
n=270 Participants
|
14 Participants
n=4 Participants
|
63 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=270 Participants
|
2 Participants
n=4 Participants
|
13 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=270 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=270 Participants
|
6 Participants
n=4 Participants
|
41 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=270 Participants
|
5 Participants
n=4 Participants
|
9 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=270 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=9 Participants
|
|
Region of Enrollment
Australia
|
51 participants
n=270 Participants
|
14 participants
n=4 Participants
|
65 participants
n=9 Participants
|
|
HbA1c
|
8.8 %
STANDARD_DEVIATION 0.9 • n=270 Participants
|
8.5 %
STANDARD_DEVIATION 0.8 • n=4 Participants
|
8.7 %
STANDARD_DEVIATION 0.9 • n=9 Participants
|
|
Weight
|
93.6 Kg
STANDARD_DEVIATION 15.4 • n=270 Participants
|
80.2 Kg
STANDARD_DEVIATION 11.8 • n=4 Participants
|
90.7 Kg
STANDARD_DEVIATION 15.6 • n=9 Participants
|
|
BMI (kg/m^2)
|
31.5 kg/m^2
STANDARD_DEVIATION 3.5 • n=270 Participants
|
29.5 kg/m^2
STANDARD_DEVIATION 4.2 • n=4 Participants
|
31.1 kg/m^2
STANDARD_DEVIATION 3.7 • n=9 Participants
|
|
Fasting Plasma Glucose (FPG)
|
10.1 mmol/L
STANDARD_DEVIATION 2.7 • n=270 Participants
|
8.6 mmol/L
STANDARD_DEVIATION 1.6 • n=4 Participants
|
9.7 mmol/L
STANDARD_DEVIATION 2.3 • n=9 Participants
|
|
Duration of Diabetes
|
5.5 years
STANDARD_DEVIATION 2.4 • n=270 Participants
|
12.4 years
STANDARD_DEVIATION 5.4 • n=4 Participants
|
7.0 years
STANDARD_DEVIATION 4.3 • n=9 Participants
|
PRIMARY outcome
Timeframe: At 12 weeks post procedureNumber of participants experiencing one or more device- or procedure-related serious adverse events at 12 weeks post procedure
Outcome measures
| Measure |
Intervention- Non-Insulin Cohort
n=51 Participants
Non-insulin Arm: All participants are on at least one non-insulin, glucose-lowering medications and received the Endogenex treatment
|
Intervention- Insulin Cohort
n=14 Participants
Insulin (IS) Cohort: all participants are on insulin and received the Endogenex treatment.
|
|---|---|---|
|
Number of Participants With Device- or Procedure-related Serious Adverse Events (SAE)
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Follow up at 12, 24, and 48 weeks post procedurePopulation: The unit of measure for HbA1c is %. Six participants were exited from the study. For the IS Cohort, one of the 6 was exited prior to 12 weeks and one participant missed the 24 week visit. In the NIS Cohort, two were exited prior to the 24 week visit and three after the 24 week visit/prior to the 48 week visit. Two additional NIS participants missed their 24 week visit.
Mean HbA1c (%) by Post Procedure Follow-up Visit. The unit of measure for HbA1c is %.
Outcome measures
| Measure |
Intervention- Non-Insulin Cohort
n=51 Participants
Non-insulin Arm: All participants are on at least one non-insulin, glucose-lowering medications and received the Endogenex treatment
|
Intervention- Insulin Cohort
n=14 Participants
Insulin (IS) Cohort: all participants are on insulin and received the Endogenex treatment.
|
|---|---|---|
|
HbA1c by Post Procedure Follow-up Visit
Mean HbA1c at Baseline
|
8.8 HbA1c %
Standard Deviation 0.9
|
8.5 HbA1c %
Standard Deviation 0.8
|
|
HbA1c by Post Procedure Follow-up Visit
Mean HbA1c at 12 Weeks
|
7.7 HbA1c %
Standard Deviation 1.2
|
7.9 HbA1c %
Standard Deviation 0.99
|
|
HbA1c by Post Procedure Follow-up Visit
Mean HbA1c at 24 Weeks
|
7.8 HbA1c %
Standard Deviation 2.4
|
8.1 HbA1c %
Standard Deviation 1.0
|
|
HbA1c by Post Procedure Follow-up Visit
Mean HbA1c at 48 Weeks
|
7.7 HbA1c %
Standard Deviation 2.4
|
7.6 HbA1c %
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Baseline, 12, 24, and 48 weeksPopulation: Six participants were exited from the study. For the IS Cohort, one of the 6 was exited prior to 12 weeks and one participant missed the 24 week visit. In the NIS Cohort, two were exited prior to the 24 week visit and three after the 24 week visit/prior to the 48 week visit. Two additional participants missed their 24 week visit.
Mean Fasting Plasma Glucose by Visit
Outcome measures
| Measure |
Intervention- Non-Insulin Cohort
n=51 Participants
Non-insulin Arm: All participants are on at least one non-insulin, glucose-lowering medications and received the Endogenex treatment
|
Intervention- Insulin Cohort
n=14 Participants
Insulin (IS) Cohort: all participants are on insulin and received the Endogenex treatment.
|
|---|---|---|
|
Fasting Plasma Glucose by Visit
Mean FPG at Baseline
|
10.1 mmol/L
Standard Deviation 2.7
|
8.6 mmol/L
Standard Deviation 1.6
|
|
Fasting Plasma Glucose by Visit
Mean FPG at 12 Weeks
|
8.4 mmol/L
Standard Deviation 2.3
|
8.3 mmol/L
Standard Deviation 2.3
|
|
Fasting Plasma Glucose by Visit
Mean FPG at 24 Weeks
|
7.6 mmol/L
Standard Deviation 2.6
|
8.8 mmol/L
Standard Deviation 2.9
|
|
Fasting Plasma Glucose by Visit
Mean FPG at 48 Weeks
|
7.9 mmol/L
Standard Deviation 3.1
|
7.5 mmol/L
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: Baseline, 12, 24, and 48 weeksPopulation: Six participants were exited from the study. For the IS Cohort, one of the 6 was exited prior to 12 weeks and one participant missed the 24 week visit. In the NIS Cohort, two were exited prior to the 24 week visit and three after the 24 week visit/prior to the 48 week visit. Two additional participants missed their 24 week visit.
Mean Weight by Visit
Outcome measures
| Measure |
Intervention- Non-Insulin Cohort
n=51 Participants
Non-insulin Arm: All participants are on at least one non-insulin, glucose-lowering medications and received the Endogenex treatment
|
Intervention- Insulin Cohort
n=14 Participants
Insulin (IS) Cohort: all participants are on insulin and received the Endogenex treatment.
|
|---|---|---|
|
Weight by Visit
Mean Weight at 12 Weeks
|
90 kg
Standard Deviation 14
|
79 kg
Standard Deviation 11
|
|
Weight by Visit
Mean Weight at 24 Weeks
|
86 kg
Standard Deviation 32
|
77 kg
Standard Deviation 12
|
|
Weight by Visit
Mean Weight at 48 Weeks
|
89 kg
Standard Deviation 30
|
73 kg
Standard Deviation 12
|
|
Weight by Visit
Mean Weight at Baseline
|
94 kg
Standard Deviation 15
|
80 kg
Standard Deviation 12
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At the time of the Index ProcedurePercentage of participants with successful DMR procedure
Outcome measures
| Measure |
Intervention- Non-Insulin Cohort
n=51 Participants
Non-insulin Arm: All participants are on at least one non-insulin, glucose-lowering medications and received the Endogenex treatment
|
Intervention- Insulin Cohort
n=14 Participants
Insulin (IS) Cohort: all participants are on insulin and received the Endogenex treatment.
|
|---|---|---|
|
Procedural Success
|
51 Participants
|
14 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Time of ProcedureTime between catheter insertion to catheter removal
Outcome measures
| Measure |
Intervention- Non-Insulin Cohort
n=51 Participants
Non-insulin Arm: All participants are on at least one non-insulin, glucose-lowering medications and received the Endogenex treatment
|
Intervention- Insulin Cohort
n=14 Participants
Insulin (IS) Cohort: all participants are on insulin and received the Endogenex treatment.
|
|---|---|---|
|
Procedural Time
|
74.3 Minutes
Standard Deviation 31.7
|
102.5 Minutes
Standard Deviation 36.5
|
Adverse Events
Intervention- Endogenex (PEF) Treatment
Serious events: 5 serious events
Other events: 58 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intervention- Endogenex (PEF) Treatment
n=65 participants at risk
Enrolled participants include all eligible participants that met inclusion criteria and did not meet any exclusion criteria and were treated with the Endogenex/DyaMX device. The Endogenex/DyaMX device is designed to induce duodenal mucosal regeneration using pulsed electric field via a non-surgical, endoscopic procedure.
|
|---|---|
|
Gastrointestinal disorders
Colon Cancer
|
1.5%
1/65 • Number of events 1 • Baseline through 48 Weeks (duration of the study)
|
|
Nervous system disorders
Cerebrovascular Accident
|
1.5%
1/65 • Number of events 1 • Baseline through 48 Weeks (duration of the study)
|
|
Cardiac disorders
Myocardial ischemia
|
1.5%
1/65 • Number of events 1 • Baseline through 48 Weeks (duration of the study)
|
|
General disorders
Pyrexia
|
1.5%
1/65 • Number of events 1 • Baseline through 48 Weeks (duration of the study)
|
|
Infections and infestations
Tonsillitis
|
1.5%
1/65 • Number of events 1 • Baseline through 48 Weeks (duration of the study)
|
|
Gastrointestinal disorders
Celiac Artery stenosis
|
1.5%
1/65 • Number of events 1 • Baseline through 48 Weeks (duration of the study)
|
|
Gastrointestinal disorders
Pancreatitis
|
1.5%
1/65 • Number of events 1 • Baseline through 48 Weeks (duration of the study)
|
Other adverse events
| Measure |
Intervention- Endogenex (PEF) Treatment
n=65 participants at risk
Enrolled participants include all eligible participants that met inclusion criteria and did not meet any exclusion criteria and were treated with the Endogenex/DyaMX device. The Endogenex/DyaMX device is designed to induce duodenal mucosal regeneration using pulsed electric field via a non-surgical, endoscopic procedure.
|
|---|---|
|
Hepatobiliary disorders
Hepatic enzyme increased
|
1.5%
1/65 • Number of events 1 • Baseline through 48 Weeks (duration of the study)
|
|
Infections and infestations
Herpes zoster
|
1.5%
1/65 • Number of events 1 • Baseline through 48 Weeks (duration of the study)
|
|
Metabolism and nutrition disorders
Iron deficiency
|
1.5%
1/65 • Number of events 1 • Baseline through 48 Weeks (duration of the study)
|
|
Metabolism and nutrition disorders
Ketosis
|
1.5%
1/65 • Number of events 1 • Baseline through 48 Weeks (duration of the study)
|
|
Metabolism and nutrition disorders
Lactose intolerance
|
1.5%
1/65 • Number of events 1 • Baseline through 48 Weeks (duration of the study)
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
1.5%
1/65 • Number of events 1 • Baseline through 48 Weeks (duration of the study)
|
|
Injury, poisoning and procedural complications
Limb injury
|
1.5%
1/65 • Number of events 1 • Baseline through 48 Weeks (duration of the study)
|
|
Infections and infestations
Lower respiratory tract infection
|
1.5%
1/65 • Number of events 1 • Baseline through 48 Weeks (duration of the study)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.5%
1/65 • Number of events 1 • Baseline through 48 Weeks (duration of the study)
|
|
Infections and infestations
Nasopharyngitis
|
1.5%
1/65 • Number of events 1 • Baseline through 48 Weeks (duration of the study)
|
|
Gastrointestinal disorders
Esophagitis
|
1.5%
1/65 • Number of events 1 • Baseline through 48 Weeks (duration of the study)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.5%
1/65 • Number of events 1 • Baseline through 48 Weeks (duration of the study)
|
|
Infections and infestations
Parainfluenza virus infection
|
1.5%
1/65 • Number of events 1 • Baseline through 48 Weeks (duration of the study)
|
|
Cardiac disorders
Presyncope
|
1.5%
1/65 • Number of events 1 • Baseline through 48 Weeks (duration of the study)
|
|
Renal and urinary disorders
Pyelonephritis
|
1.5%
1/65 • Number of events 1 • Baseline through 48 Weeks (duration of the study)
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.5%
1/65 • Number of events 1 • Baseline through 48 Weeks (duration of the study)
|
|
Skin and subcutaneous tissue disorders
Skin Infection
|
1.5%
1/65 • Number of events 1 • Baseline through 48 Weeks (duration of the study)
|
|
Infections and infestations
Tooth abscess
|
1.5%
1/65 • Number of events 1 • Baseline through 48 Weeks (duration of the study)
|
|
Infections and infestations
Upper respiratory tract infection bacterial
|
1.5%
1/65 • Number of events 1 • Baseline through 48 Weeks (duration of the study)
|
|
Renal and urinary disorders
Urinary tract infection viral
|
1.5%
1/65 • Number of events 1 • Baseline through 48 Weeks (duration of the study)
|
|
Infections and infestations
Viral Infection
|
1.5%
1/65 • Number of events 1 • Baseline through 48 Weeks (duration of the study)
|
|
Infections and infestations
Viral upper respiratory tract infection
|
1.5%
1/65 • Number of events 1 • Baseline through 48 Weeks (duration of the study)
|
|
Gastrointestinal disorders
Vomiting
|
1.5%
1/65 • Number of events 1 • Baseline through 48 Weeks (duration of the study)
|
|
Infections and infestations
Candida infection
|
3.1%
2/65 • Number of events 2 • Baseline through 48 Weeks (duration of the study)
|
|
Infections and infestations
Cellulitis
|
3.1%
2/65 • Number of events 2 • Baseline through 48 Weeks (duration of the study)
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
3.1%
2/65 • Number of events 2 • Baseline through 48 Weeks (duration of the study)
|
|
Injury, poisoning and procedural complications
Gastrointestinal procedural complication
|
3.1%
2/65 • Number of events 2 • Baseline through 48 Weeks (duration of the study)
|
|
Endocrine disorders
Hyperglycemia
|
3.1%
2/65 • Number of events 2 • Baseline through 48 Weeks (duration of the study)
|
|
Infections and infestations
Influenza
|
3.1%
2/65 • Number of events 2 • Baseline through 48 Weeks (duration of the study)
|
|
General disorders
Injection site pain
|
3.1%
2/65 • Number of events 2 • Baseline through 48 Weeks (duration of the study)
|
|
Gastrointestinal disorders
Lethargy
|
3.1%
2/65 • Number of events 2 • Baseline through 48 Weeks (duration of the study)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.1%
2/65 • Number of events 2 • Baseline through 48 Weeks (duration of the study)
|
|
General disorders
Pyrexia
|
1.5%
1/65 • Number of events 1 • Baseline through 48 Weeks (duration of the study)
|
|
Infections and infestations
Tonsillitis
|
1.5%
1/65 • Number of events 1 • Baseline through 48 Weeks (duration of the study)
|
|
Immune system disorders
Vaccination complication
|
3.1%
2/65 • Number of events 2 • Baseline through 48 Weeks (duration of the study)
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.5%
1/65 • Number of events 1 • Baseline through 48 Weeks (duration of the study)
|
|
Eye disorders
Anesthesia eye
|
1.5%
1/65 • Number of events 1 • Baseline through 48 Weeks (duration of the study)
|
|
Musculoskeletal and connective tissue disorders
Back injury
|
1.5%
1/65 • Number of events 1 • Baseline through 48 Weeks (duration of the study)
|
|
Reproductive system and breast disorders
Balanoposthitis
|
1.5%
1/65 • Number of events 1 • Baseline through 48 Weeks (duration of the study)
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
1.5%
1/65 • Number of events 1 • Baseline through 48 Weeks (duration of the study)
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
1.5%
1/65 • Number of events 1 • Baseline through 48 Weeks (duration of the study)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.5%
1/65 • Number of events 1 • Baseline through 48 Weeks (duration of the study)
|
|
General disorders
Dental caries
|
1.5%
1/65 • Number of events 1 • Baseline through 48 Weeks (duration of the study)
|
|
Psychiatric disorders
Depression
|
1.5%
1/65 • Number of events 1 • Baseline through 48 Weeks (duration of the study)
|
|
Gastrointestinal disorders
Diverticulitis
|
1.5%
1/65 • Number of events 1 • Baseline through 48 Weeks (duration of the study)
|
|
Cardiac disorders
Dizziness postural
|
1.5%
1/65 • Number of events 1 • Baseline through 48 Weeks (duration of the study)
|
|
Gastrointestinal disorders
Dyspepsia
|
1.5%
1/65 • Number of events 1 • Baseline through 48 Weeks (duration of the study)
|
|
Gastrointestinal disorders
Epigastric discomfort
|
1.5%
1/65 • Number of events 1 • Baseline through 48 Weeks (duration of the study)
|
|
General disorders
Fatigue
|
1.5%
1/65 • Number of events 1 • Baseline through 48 Weeks (duration of the study)
|
|
Gastrointestinal disorders
Gastric Ulcer
|
1.5%
1/65 • Number of events 1 • Baseline through 48 Weeks (duration of the study)
|
|
Gastrointestinal disorders
Gastritis
|
1.5%
1/65 • Number of events 1 • Baseline through 48 Weeks (duration of the study)
|
|
Gastrointestinal disorders
Gastroenteritis
|
1.5%
1/65 • Number of events 1 • Baseline through 48 Weeks (duration of the study)
|
|
Infections and infestations
Gastroenteritis viral
|
1.5%
1/65 • Number of events 1 • Baseline through 48 Weeks (duration of the study)
|
|
Vascular disorders
Hemorrhoidal hemorrhage
|
1.5%
1/65 • Number of events 1 • Baseline through 48 Weeks (duration of the study)
|
|
Gastrointestinal disorders
Helicobacter gastritis
|
1.5%
1/65 • Number of events 1 • Baseline through 48 Weeks (duration of the study)
|
|
Infections and infestations
COVID-19
|
40.0%
26/65 • Number of events 26 • Baseline through 48 Weeks (duration of the study)
|
|
Gastrointestinal disorders
Oropharyngeal pain
|
40.0%
26/65 • Number of events 26 • Baseline through 48 Weeks (duration of the study)
|
|
Gastrointestinal disorders
Diarrhea
|
23.1%
15/65 • Number of events 16 • Baseline through 48 Weeks (duration of the study)
|
|
Gastrointestinal disorders
Nausea
|
10.8%
7/65 • Number of events 7 • Baseline through 48 Weeks (duration of the study)
|
|
Gastrointestinal disorders
Constipation
|
9.2%
6/65 • Number of events 6 • Baseline through 48 Weeks (duration of the study)
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
7.7%
5/65 • Number of events 5 • Baseline through 48 Weeks (duration of the study)
|
|
General disorders
Adverse Drug Reaction
|
6.2%
4/65 • Number of events 4 • Baseline through 48 Weeks (duration of the study)
|
|
Gastrointestinal disorders
Abdominal pain
|
4.6%
3/65 • Number of events 3 • Baseline through 48 Weeks (duration of the study)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.6%
3/65 • Number of events 3 • Baseline through 48 Weeks (duration of the study)
|
|
Gastrointestinal disorders
Flatulence
|
4.6%
3/65 • Number of events 3 • Baseline through 48 Weeks (duration of the study)
|
|
Nervous system disorders
Headache
|
4.6%
3/65 • Number of events 3 • Baseline through 48 Weeks (duration of the study)
|
|
Musculoskeletal and connective tissue disorders
Joint injury
|
4.6%
3/65 • Number of events 3 • Baseline through 48 Weeks (duration of the study)
|
|
Injury, poisoning and procedural complications
Lip Injury
|
4.6%
3/65 • Number of events 3 • Baseline through 48 Weeks (duration of the study)
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
4.6%
3/65 • Number of events 3 • Baseline through 48 Weeks (duration of the study)
|
|
Infections and infestations
Respiratory tract infection
|
4.6%
3/65 • Number of events 3 • Baseline through 48 Weeks (duration of the study)
|
|
Infections and infestations
Upper respiratory tract infectio
|
4.6%
3/65 • Number of events 3 • Baseline through 48 Weeks (duration of the study)
|
|
Infections and infestations
Urinary tract infection
|
4.6%
3/65 • Number of events 3 • Baseline through 48 Weeks (duration of the study)
|
|
Gastrointestinal disorders
Abdominal distension
|
3.1%
2/65 • Number of events 2 • Baseline through 48 Weeks (duration of the study)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.1%
2/65 • Number of events 2 • Baseline through 48 Weeks (duration of the study)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60