Trial Outcomes & Findings for Effect of Duodenal Mucosal Resurfacing (DMR) Using the Revita System in the Treatment of Type 2 Diabetes (T2D) (NCT NCT02879383)
NCT ID: NCT02879383
Last Updated: 2024-02-14
Results Overview
The primary efficacy endpoint is the change from baseline at 24 weeks in HbA1c, DMR vs Sham
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
109 participants
Primary outcome timeframe
Baseline and 24 Weeks post-procedure
Results posted on
2024-02-14
Participant Flow
All subjects participated in a 4-week oral antidiabetic drug (OAD) run-in period before the index procedure to confirm lack of blood glucose control in conjunction with medication compliance and nutritional counseling. All subjects were managed according to current diabetes standard of care.
Participant milestones
| Measure |
DMR Procedure (Europe)
Subjects randomized to the DMR procedure are unblinded at 24 weeks and followed for an additional 24 weeks.
DMR Procedure: The DMR procedure consists of hydrothermal ablation of the duodenum using the Revita System
|
Sham Procedure (Europe)
Subjects are unblinded at 24 Weeks. Sham subjects given option to cross over to receive DMR treatment at 24 Weeks and followed up for additional 24 weeks. Not all patients crossed over and received DMR treatment at 24 Weeks.
Sham Procedure: The sham procedure consists of placing the Revita Catheter into the stomach for 30 minutes and then removing it from the patient.
|
DMR Procedure (Brazil)
Subjects randomized to the DMR procedure are unblinded at 24 weeks and followed for an additional 24 weeks.
DMR Procedure: The DMR procedure consists of hydrothermal ablation of the duodenum using the Revita System
|
Sham Procedure (Brazil)
Subjects are unblinded at 24 Weeks. Sham subjects given option to cross over to receive DMR treatment at 24 Weeks and followed up for additional 24 weeks. Not all patients crossed over and received DMR treatment at 24 Weeks.
Sham Procedure: The sham procedure consists of placing the Revita Catheter into the stomach for 30 minutes and then removing it from the patient.
|
|---|---|---|---|---|
|
First 24 Weeks
STARTED
|
39
|
37
|
17
|
16
|
|
First 24 Weeks
COMPLETED
|
39
|
36
|
17
|
16
|
|
First 24 Weeks
NOT COMPLETED
|
0
|
1
|
0
|
0
|
|
Second 24 Weeks (Crossover for Sham)
STARTED
|
33
|
0
|
4
|
0
|
|
Second 24 Weeks (Crossover for Sham)
COMPLETED
|
33
|
0
|
4
|
0
|
|
Second 24 Weeks (Crossover for Sham)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
DMR Procedure (Europe)
Subjects randomized to the DMR procedure are unblinded at 24 weeks and followed for an additional 24 weeks.
DMR Procedure: The DMR procedure consists of hydrothermal ablation of the duodenum using the Revita System
|
Sham Procedure (Europe)
Subjects are unblinded at 24 Weeks. Sham subjects given option to cross over to receive DMR treatment at 24 Weeks and followed up for additional 24 weeks. Not all patients crossed over and received DMR treatment at 24 Weeks.
Sham Procedure: The sham procedure consists of placing the Revita Catheter into the stomach for 30 minutes and then removing it from the patient.
|
DMR Procedure (Brazil)
Subjects randomized to the DMR procedure are unblinded at 24 weeks and followed for an additional 24 weeks.
DMR Procedure: The DMR procedure consists of hydrothermal ablation of the duodenum using the Revita System
|
Sham Procedure (Brazil)
Subjects are unblinded at 24 Weeks. Sham subjects given option to cross over to receive DMR treatment at 24 Weeks and followed up for additional 24 weeks. Not all patients crossed over and received DMR treatment at 24 Weeks.
Sham Procedure: The sham procedure consists of placing the Revita Catheter into the stomach for 30 minutes and then removing it from the patient.
|
|---|---|---|---|---|
|
First 24 Weeks
Physician Decision
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Effect of Duodenal Mucosal Resurfacing (DMR) Using the Revita System in the Treatment of Type 2 Diabetes (T2D)
Baseline characteristics by cohort
| Measure |
DMR Procedure (Europe)
n=39 Participants
Subjects randomized to the DMR procedure are unblinded at 24 weeks and followed for an additional 24 weeks.
DMR Procedure: The DMR procedure consists of hydrothermal ablation of the duodenum using the Revita System
|
Sham Procedure (Europe)
n=36 Participants
Subjects are unblinded at 24 Weeks. Sham subjects to cross over to receive DMR treatment at 24 Weeks and followed up for additional 24 weeks.
Sham Procedure: The sham procedure consists of placing the Revita Catheter into the stomach for 30 minutes and then removing it from the patient.
|
DMR Procedure (Brazil)
n=17 Participants
Subjects randomized to the DMR procedure are unblinded at 24 weeks and followed for an additional 24 weeks.
DMR Procedure: The DMR procedure consists of hydrothermal ablation of the duodenum using the Revita System
|
Sham Procedure (Brazil)
n=16 Participants
Subjects are unblinded at 24 Weeks. Sham subjects to cross over to receive DMR treatment at 24 Weeks and followed up for additional 24 weeks.
Sham Procedure: The sham procedure consists of placing the Revita Catheter into the stomach for 30 minutes and then removing it from the patient.
|
Total
n=108 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
86 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
22 Participants
n=31 Participants
|
|
Age, Continuous
|
59 years
n=99 Participants
|
56.5 years
n=107 Participants
|
56 years
n=206 Participants
|
57.6 years
n=7 Participants
|
58 years
n=31 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
33 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
75 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
25 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
71 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Race · undisclosed
|
13 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
25 Participants
n=31 Participants
|
|
Region of Enrollment
Netherlands
|
8 participants
n=99 Participants
|
9 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
17 participants
n=31 Participants
|
|
Region of Enrollment
Belgium
|
9 participants
n=99 Participants
|
7 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
16 participants
n=31 Participants
|
|
Region of Enrollment
Brazil
|
0 participants
n=99 Participants
|
0 participants
n=107 Participants
|
17 participants
n=206 Participants
|
16 participants
n=7 Participants
|
33 participants
n=31 Participants
|
|
Region of Enrollment
United Kingdom
|
11 participants
n=99 Participants
|
12 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
23 participants
n=31 Participants
|
|
Region of Enrollment
Italy
|
11 participants
n=99 Participants
|
8 participants
n=107 Participants
|
0 participants
n=206 Participants
|
0 participants
n=7 Participants
|
19 participants
n=31 Participants
|
|
BMI (kg/m2)
|
31.4 kg/m2
n=99 Participants
|
30.4 kg/m2
n=107 Participants
|
32.3 kg/m2
n=206 Participants
|
31.6 kg/m2
n=7 Participants
|
31.4 kg/m2
n=31 Participants
|
|
Fasting Glucose
|
191 mg/dL
n=99 Participants
|
185 mg/dL
n=107 Participants
|
190 mg/dL
n=206 Participants
|
182 mg/dL
n=7 Participants
|
187 mg/dL
n=31 Participants
|
|
HbA1c (%)
|
8.1 % of glycosylated hemoglobin
n=99 Participants
|
8.2 % of glycosylated hemoglobin
n=107 Participants
|
8.6 % of glycosylated hemoglobin
n=206 Participants
|
8.15 % of glycosylated hemoglobin
n=7 Participants
|
8.26 % of glycosylated hemoglobin
n=31 Participants
|
|
MRI-PDFF (%) among subjects with baseline MRI-PDFF >5%
|
16.46 % of liver fat
n=99 Participants
|
16.11 % of liver fat
n=107 Participants
|
16.45 % of liver fat
n=206 Participants
|
16.98 % of liver fat
n=7 Participants
|
16.5 % of liver fat
n=31 Participants
|
PRIMARY outcome
Timeframe: Baseline and 24 Weeks post-procedurePopulation: mITT population
The primary efficacy endpoint is the change from baseline at 24 weeks in HbA1c, DMR vs Sham
Outcome measures
| Measure |
DMR Procedure (Europe)
n=39 Participants
Subjects randomized to the DMR procedure are unblinded at 24 weeks and followed for an additional 24 weeks.
DMR Procedure: The DMR procedure consists of hydrothermal ablation of the duodenum using the Revita System
|
Sham Procedure (Europe)
n=36 Participants
Subjects are unblinded at 24 Weeks. Sham subjects to cross over to receive DMR treatment at 24 Weeks and followed up for additional 24 weeks.
Sham Procedure: The sham procedure consists of placing the Revita Catheter into the stomach for 30 minutes and then removing it from the patient.
|
DMR Procedure (Brazil)
n=17 Participants
Subjects randomized to the DMR procedure are unblinded at 24 weeks and followed for an additional 24 weeks.
DMR Procedure: The DMR procedure consists of hydrothermal ablation of the duodenum using the Revita System
|
Sham Procedure (Brazil)
n=16 Participants
Subjects are unblinded at 24 Weeks. Sham subjects to cross over to receive DMR treatment at 24 Weeks and followed up for additional 24 weeks.
Sham Procedure: The sham procedure consists of placing the Revita Catheter into the stomach for 30 minutes and then removing it from the patient.
|
|---|---|---|---|---|
|
Change From Baseline at 24 Weeks in Hemoglobin A1c (HbA1c), DMR vs Sham.
|
-0.60 percentage change from baseline
Interval -1.4 to 0.2
|
-0.30 percentage change from baseline
Interval -0.8 to 0.2
|
-1.85 percentage change from baseline
Interval -2.4 to -1.1
|
-1.60 percentage change from baseline
Interval -2.0 to -1.1
|
PRIMARY outcome
Timeframe: Baseline and 12 Weeks post-procedurePopulation: mITT population; not all patients from participant flow were able to undergo a MRI-PDFF. All patients who had a MRI-PDFF performed are analyzed and represented below.
The absolute change from baseline at 12 weeks in MR-PDFF in patients with baseline MR-PDFF \> 5% , DMR vs Sham
Outcome measures
| Measure |
DMR Procedure (Europe)
n=33 Participants
Subjects randomized to the DMR procedure are unblinded at 24 weeks and followed for an additional 24 weeks.
DMR Procedure: The DMR procedure consists of hydrothermal ablation of the duodenum using the Revita System
|
Sham Procedure (Europe)
n=28 Participants
Subjects are unblinded at 24 Weeks. Sham subjects to cross over to receive DMR treatment at 24 Weeks and followed up for additional 24 weeks.
Sham Procedure: The sham procedure consists of placing the Revita Catheter into the stomach for 30 minutes and then removing it from the patient.
|
DMR Procedure (Brazil)
n=15 Participants
Subjects randomized to the DMR procedure are unblinded at 24 weeks and followed for an additional 24 weeks.
DMR Procedure: The DMR procedure consists of hydrothermal ablation of the duodenum using the Revita System
|
Sham Procedure (Brazil)
n=15 Participants
Subjects are unblinded at 24 Weeks. Sham subjects to cross over to receive DMR treatment at 24 Weeks and followed up for additional 24 weeks.
Sham Procedure: The sham procedure consists of placing the Revita Catheter into the stomach for 30 minutes and then removing it from the patient.
|
|---|---|---|---|---|
|
Change From Baseline at 12 Weeks in MR-PDFF, DMR vs Sham
|
-5.4 percentage change from baseline
Interval -8.35 to -2.25
|
-2.24 percentage change from baseline
Interval -4.61 to -0.32
|
-5.4 percentage change from baseline
Interval -12.0 to -2.84
|
-6.07 percentage change from baseline
Interval -10.95 to -3.12
|
Adverse Events
DMR Procedure (Europe)
Serious events: 5 serious events
Other events: 31 other events
Deaths: 0 deaths
Sham Procedure (Europe)
Serious events: 1 serious events
Other events: 26 other events
Deaths: 0 deaths
DMR Procedure (Brazil)
Serious events: 3 serious events
Other events: 16 other events
Deaths: 0 deaths
Sham Procedure (Brazil)
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Sham Crossover (Europe)
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Sham Crossover (Brazil)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DMR Procedure (Europe)
n=39 participants at risk
Subjects randomized to the DMR procedure are unblinded at 24 weeks and followed for an additional 24 weeks.
DMR Procedure: The DMR procedure consists of hydrothermal ablation of the duodenum using the Revita System
|
Sham Procedure (Europe)
n=37 participants at risk
Subjects are unblinded at 24 Weeks. Sham subjects to cross over to receive DMR treatment at 24 Weeks and followed up for additional 24 weeks.
Sham Procedure: The sham procedure consists of placing the Revita Catheter into the stomach for 30 minutes and then removing it from the patient.
|
DMR Procedure (Brazil)
n=17 participants at risk
Subjects randomized to the DMR procedure are unblinded at 24 weeks and followed for an additional 24 weeks.
DMR Procedure: The DMR procedure consists of hydrothermal ablation of the duodenum using the Revita System
|
Sham Procedure (Brazil)
n=16 participants at risk
Subjects are unblinded at 24 Weeks. Sham subjects to cross over to receive DMR treatment at 24 Weeks and followed up for additional 24 weeks.
Sham Procedure: The sham procedure consists of placing the Revita Catheter into the stomach for 30 minutes and then removing it from the patient.
|
Sham Crossover (Europe)
n=33 participants at risk
Subjects that were in sham arm (Europe) until 24 weeks and then crossover to receive DMR treatment at 24 weeks and followed up for additional 24 weeks. AEs captured from time of DMR procedure through follow up to end of study.
|
Sham Crossover (Brazil)
n=4 participants at risk
Subjects that were in sham arm (Brazil) until 24 weeks and then crossover to receive DMR treatment at 24 weeks and followed up for additional 24 weeks. AEs captured from time of DMR procedure through follow up to end of study.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Jejunal perforation
|
0.00%
0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
5.9%
1/17 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
|
Cardiac disorders
Acute myocardial infarction
|
2.6%
1/39 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/17 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
|
Musculoskeletal and connective tissue disorders
back pain
|
2.6%
1/39 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/17 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
|
Ear and labyrinth disorders
Ear Disorder
|
0.00%
0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
2.7%
1/37 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/17 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
2.6%
1/39 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/17 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
|
Injury, poisoning and procedural complications
Arterial injury
|
2.6%
1/39 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/17 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.6%
1/39 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/17 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
5.9%
1/17 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
5.9%
1/17 • Number of events 2 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
Other adverse events
| Measure |
DMR Procedure (Europe)
n=39 participants at risk
Subjects randomized to the DMR procedure are unblinded at 24 weeks and followed for an additional 24 weeks.
DMR Procedure: The DMR procedure consists of hydrothermal ablation of the duodenum using the Revita System
|
Sham Procedure (Europe)
n=37 participants at risk
Subjects are unblinded at 24 Weeks. Sham subjects to cross over to receive DMR treatment at 24 Weeks and followed up for additional 24 weeks.
Sham Procedure: The sham procedure consists of placing the Revita Catheter into the stomach for 30 minutes and then removing it from the patient.
|
DMR Procedure (Brazil)
n=17 participants at risk
Subjects randomized to the DMR procedure are unblinded at 24 weeks and followed for an additional 24 weeks.
DMR Procedure: The DMR procedure consists of hydrothermal ablation of the duodenum using the Revita System
|
Sham Procedure (Brazil)
n=16 participants at risk
Subjects are unblinded at 24 Weeks. Sham subjects to cross over to receive DMR treatment at 24 Weeks and followed up for additional 24 weeks.
Sham Procedure: The sham procedure consists of placing the Revita Catheter into the stomach for 30 minutes and then removing it from the patient.
|
Sham Crossover (Europe)
n=33 participants at risk
Subjects that were in sham arm (Europe) until 24 weeks and then crossover to receive DMR treatment at 24 weeks and followed up for additional 24 weeks. AEs captured from time of DMR procedure through follow up to end of study.
|
Sham Crossover (Brazil)
n=4 participants at risk
Subjects that were in sham arm (Brazil) until 24 weeks and then crossover to receive DMR treatment at 24 weeks and followed up for additional 24 weeks. AEs captured from time of DMR procedure through follow up to end of study.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Oesophagitis
|
7.7%
3/39 • Number of events 3 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
5.4%
2/37 • Number of events 2 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
11.8%
2/17 • Number of events 2 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
|
Gastrointestinal disorders
vomiting
|
5.1%
2/39 • Number of events 2 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
5.9%
1/17 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
6.1%
2/33 • Number of events 2 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
|
Gastrointestinal disorders
Abdominal pain
|
17.9%
7/39 • Number of events 7 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
10.8%
4/37 • Number of events 4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
29.4%
5/17 • Number of events 5 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
9.1%
3/33 • Number of events 5 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
|
Blood and lymphatic system disorders
Iron Deficiency anaemia
|
0.00%
0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
5.9%
1/17 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.7%
3/39 • Number of events 4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
5.4%
2/37 • Number of events 2 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
17.6%
3/17 • Number of events 4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
12.5%
2/16 • Number of events 2 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
24.2%
8/33 • Number of events 9 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
|
Gastrointestinal disorders
constipation
|
2.6%
1/39 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
2.7%
1/37 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
5.9%
1/17 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
12.5%
2/16 • Number of events 2 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
3.0%
1/33 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.6%
1/39 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
16.2%
6/37 • Number of events 8 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
11.8%
2/17 • Number of events 2 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
6.2%
1/16 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
15.2%
5/33 • Number of events 7 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
25.0%
1/4 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
5.9%
1/17 • Number of events 2 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
6.2%
1/16 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
3.0%
1/33 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
|
Gastrointestinal disorders
duodenitis
|
10.3%
4/39 • Number of events 4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
10.8%
4/37 • Number of events 4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/17 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
3.0%
1/33 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
|
Gastrointestinal disorders
Gastritis Erosive
|
0.00%
0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
5.9%
1/17 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
|
Gastrointestinal disorders
Hematochezia
|
0.00%
0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
5.9%
1/17 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
|
Gastrointestinal disorders
haemorrhoids
|
0.00%
0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
5.9%
1/17 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
|
Gastrointestinal disorders
Nausea
|
2.6%
1/39 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
2.7%
1/37 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
17.6%
3/17 • Number of events 3 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
9.1%
3/33 • Number of events 3 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
5.9%
1/17 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
|
General disorders
asthenia
|
0.00%
0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
11.8%
2/17 • Number of events 2 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
6.1%
2/33 • Number of events 2 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
|
General disorders
polyp
|
0.00%
0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
5.9%
1/17 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
|
General disorders
fatigue
|
5.1%
2/39 • Number of events 2 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/17 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
3.0%
1/33 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
|
General disorders
Oedema peripheral
|
5.1%
2/39 • Number of events 2 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/17 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
|
Immune system disorders
food allergy
|
0.00%
0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
5.9%
1/17 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
|
Infections and infestations
Cystitis
|
7.7%
3/39 • Number of events 3 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/17 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
|
Infections and infestations
Ear infection
|
5.1%
2/39 • Number of events 2 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/17 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
|
Infections and infestations
Influenza
|
5.1%
2/39 • Number of events 2 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
5.4%
2/37 • Number of events 2 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
5.9%
1/17 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
6.2%
1/16 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
2.7%
1/37 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
5.9%
1/17 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
3.0%
1/33 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
|
Infections and infestations
Infection
|
0.00%
0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
5.9%
1/17 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
|
Infections and infestations
Nasopharyngitis
|
12.8%
5/39 • Number of events 6 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
13.5%
5/37 • Number of events 6 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/17 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
15.2%
5/33 • Number of events 5 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
|
Infections and infestations
Pharyngitis
|
2.6%
1/39 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
5.9%
1/17 • Number of events 2 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
3.0%
1/33 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
|
Infections and infestations
pneumonia
|
0.00%
0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
5.9%
1/17 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
5.9%
1/17 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
5.9%
1/17 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
5.9%
1/17 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
12.5%
2/16 • Number of events 2 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
25.0%
1/4 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
|
Infections and infestations
Urinary tract infection
|
10.3%
4/39 • Number of events 4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
2.7%
1/37 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
5.9%
1/17 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
6.2%
1/16 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
5.9%
1/17 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
17.9%
7/39 • Number of events 16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
18.9%
7/37 • Number of events 13 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
64.7%
11/17 • Number of events 106 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
75.0%
12/16 • Number of events 107 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
12.1%
4/33 • Number of events 10 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
50.0%
2/4 • Number of events 16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
12.8%
5/39 • Number of events 36 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
10.8%
4/37 • Number of events 11 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/17 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
18.2%
6/33 • Number of events 11 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
5.9%
1/17 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.1%
2/39 • Number of events 3 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
5.9%
1/17 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
6.2%
1/16 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
|
Musculoskeletal and connective tissue disorders
back pain
|
12.8%
5/39 • Number of events 5 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
8.1%
3/37 • Number of events 3 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/17 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
6.1%
2/33 • Number of events 2 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
5.9%
1/17 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
6.2%
1/16 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
|
Nervous system disorders
Diabetic neuropathy
|
0.00%
0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
5.9%
1/17 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
6.2%
1/16 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
|
Nervous system disorders
Headache
|
7.7%
3/39 • Number of events 4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
2.7%
1/37 • Number of events 2 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
17.6%
3/17 • Number of events 3 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
12.5%
2/16 • Number of events 2 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
|
Psychiatric disorders
Generalised anxiety disorder
|
0.00%
0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
5.9%
1/17 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
5.9%
1/17 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
|
Surgical and medical procedures
Hydrocele operation
|
0.00%
0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
5.9%
1/17 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
|
Surgical and medical procedures
Inguinal hernia repair
|
0.00%
0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
5.9%
1/17 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.1%
2/39 • Number of events 2 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
5.4%
2/37 • Number of events 2 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/17 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
6.2%
1/16 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
3.0%
1/33 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
5.9%
1/17 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
3.0%
1/33 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.1%
2/39 • Number of events 2 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
2.7%
1/37 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/17 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
asthma
|
0.00%
0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
5.4%
2/37 • Number of events 2 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/17 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
|
Blood and lymphatic system disorders
anaemia
|
0.00%
0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/17 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
6.2%
1/16 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
|
Nervous system disorders
Dizziness
|
2.6%
1/39 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
2.7%
1/37 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/17 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
6.2%
1/16 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/17 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
6.2%
1/16 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
|
Renal and urinary disorders
Renal Cyst
|
0.00%
0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/17 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
6.2%
1/16 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
|
Renal and urinary disorders
Urinary Incontinence
|
0.00%
0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/17 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
6.2%
1/16 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
|
Gastrointestinal disorders
abdominal Discomfort
|
0.00%
0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/17 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
6.1%
2/33 • Number of events 2 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
|
Infections and infestations
conjunctivitis
|
2.6%
1/39 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
2.7%
1/37 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/17 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
6.2%
1/16 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
|
Metabolism and nutrition disorders
vitamin D deficiency
|
0.00%
0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/17 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
18.8%
3/16 • Number of events 3 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/17 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
6.2%
1/16 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
|
Infections and infestations
Oral Herpes
|
0.00%
0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/17 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
25.0%
1/4 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
|
Injury, poisoning and procedural complications
fall
|
0.00%
0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/17 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
25.0%
1/4 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
|
Injury, poisoning and procedural complications
limb injury
|
0.00%
0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
2.7%
1/37 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/17 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
25.0%
1/4 • Number of events 1 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
|
Nervous system disorders
facial paralysis
|
0.00%
0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/17 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/33 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
25.0%
1/4 • Number of events 2 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
0.00%
0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/17 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
12.1%
4/33 • Number of events 4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
|
Injury, poisoning and procedural complications
ligament sprain
|
0.00%
0/39 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/37 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/17 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/16 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
6.1%
2/33 • Number of events 2 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
0.00%
0/4 • Adverse events for subjects randomized to DMR (and all training cases) were followed for up to a maximum of 56 weeks. Adverse events for subjects randomized to sham who crossed-over to DMR at 24 weeks were followed for up to a maximum of 56 weeks.
|
Additional Information
Sarah Hackett, Director of Clinical Operations
Fractyl Laboratories, Inc.
Phone: (781) 902-8840
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60