Trial Outcomes & Findings for A Randomized, Single Centre, Double-blind, Parallel, Sham-controlled Pilot Study Using gammaCore®-G (NCT NCT02388269)
NCT ID: NCT02388269
Last Updated: 2018-03-07
Results Overview
Global Overall Symptom (GOS) scale is self-reported. Patients grade overall severity of dyspepsia symptoms over a retrospective period of time. The scale uses a 7-point Likert scale ranging from minimum 1 = no problem to maximum 7 = very severe problem. Subjects assess how their stomach problems have been over the specific time period, and indicate severity of symptoms for 10 specific upper GI symptoms (epigastric pain, epigastric discomfort, heartburn, acid regurgitation, upper abdominal bloating, excessive belching, nausea, early satiety, postprandial fullness, other epigastric symptoms). Total minimum = 10 and total maximum = 70. The Irritable Bowel Syndrome Score (IBS) measures severity of symptoms by 5 questions: abdominal pain, number days with pain in every 10 days (multiplied by 10), abdominal distension, bowel movement satisfaction, interference with general life. Each question scores from 0 (not severe) to 100 (severe). Total score: Min = 0 healthy; Max = 500 severely sick.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
91 participants
Primary outcome timeframe
Last 2 weeks in the 4 week Randomized period
Results posted on
2018-03-07
Participant Flow
Participant milestones
| Measure |
gammaCore®-G
Active Comparator: Active gammaCore device
gammaCore active stimulation treatment
|
gammaCore®-G Sham
Sham Comparator: sham gammaCore device
gammaCore sham stimulation treatment
|
Not Randomised
Subjects that were not randomised, i.e. screen failures
|
|---|---|---|---|
|
Overall Study
STARTED
|
41
|
40
|
10
|
|
Overall Study
Randomised Period
|
41
|
40
|
0
|
|
Overall Study
Open Label
|
37
|
38
|
0
|
|
Overall Study
COMPLETED
|
32
|
38
|
0
|
|
Overall Study
NOT COMPLETED
|
9
|
2
|
10
|
Reasons for withdrawal
| Measure |
gammaCore®-G
Active Comparator: Active gammaCore device
gammaCore active stimulation treatment
|
gammaCore®-G Sham
Sham Comparator: sham gammaCore device
gammaCore sham stimulation treatment
|
Not Randomised
Subjects that were not randomised, i.e. screen failures
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
0
|
|
Overall Study
less than 50% stimulations
|
1
|
0
|
0
|
|
Overall Study
no diary data
|
3
|
0
|
0
|
|
Overall Study
Protocol Violation
|
2
|
0
|
0
|
|
Overall Study
Screen Failure
|
0
|
0
|
10
|
Baseline Characteristics
A Randomized, Single Centre, Double-blind, Parallel, Sham-controlled Pilot Study Using gammaCore®-G
Baseline characteristics by cohort
| Measure |
gammaCore®-G Functional Dyspepsia
n=20 Participants
Active Comparator: Active gammaCore device
gammaCore active stimulation treatment
|
gammaCore®-G Sham Functional Dyspepsia
n=20 Participants
Sham Comparator: sham gammaCore device
gammaCore sham stimulation treatment
|
gammaCore®-G Irritable Bowel Syndrome
n=21 Participants
Active Comparator: Active gammaCore device
gammaCore active stimulation treatment
|
gammaCore®-G Sham Irritale Bowel Syndrome
n=20 Participants
Sham Comparator: sham gammaCore device
gammaCore sham stimulation treatment
|
Total
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
40.6 years
STANDARD_DEVIATION 14.39 • n=5 Participants
|
33.9 years
STANDARD_DEVIATION 12.01 • n=7 Participants
|
40.1 years
STANDARD_DEVIATION 13.78 • n=5 Participants
|
41.1 years
STANDARD_DEVIATION 16.84 • n=4 Participants
|
38.9 years
STANDARD_DEVIATION 14.4 • n=21 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
56 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
white
|
18 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
70 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
black
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
United Kingdom
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
81 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Last 2 weeks in the 4 week Randomized periodPopulation: Intention To Treat population (ITT)
Global Overall Symptom (GOS) scale is self-reported. Patients grade overall severity of dyspepsia symptoms over a retrospective period of time. The scale uses a 7-point Likert scale ranging from minimum 1 = no problem to maximum 7 = very severe problem. Subjects assess how their stomach problems have been over the specific time period, and indicate severity of symptoms for 10 specific upper GI symptoms (epigastric pain, epigastric discomfort, heartburn, acid regurgitation, upper abdominal bloating, excessive belching, nausea, early satiety, postprandial fullness, other epigastric symptoms). Total minimum = 10 and total maximum = 70. The Irritable Bowel Syndrome Score (IBS) measures severity of symptoms by 5 questions: abdominal pain, number days with pain in every 10 days (multiplied by 10), abdominal distension, bowel movement satisfaction, interference with general life. Each question scores from 0 (not severe) to 100 (severe). Total score: Min = 0 healthy; Max = 500 severely sick.
Outcome measures
| Measure |
gammaCore®-G
n=37 Participants
Active Comparator: Active gammaCore device
gammaCore active stimulation treatment
|
gammaCore®-G Sham
n=39 Participants
Sham Comparator: sham gammaCore device
gammaCore sham stimulation treatment
|
gammaCore®-G IBS
Active Comparator: Active gammaCore device
gammaCore active stimulation treatment
|
gammaCore®-G Sham IBS
Sham Comparator: sham gammaCore device
gammaCore sham stimulation treatment
|
Total Active Gammacore
Total Active gammacore - Functional Dyspepsia + Irritable Bowel Syndrome
|
Total Sham Gammacore
Total Sham gammacore - Functional Dyspepsia + Irritable Bowel Syndrome
|
|---|---|---|---|---|---|---|
|
Symptom Changes in Subjects With Functional Gastrointestinal Disorder (Functional Dyspepsia and Irritable Bowel Syndrome)
Functional Dyspepsia
|
-0.6 units on a scale
Standard Deviation 0.62
|
-1.29 units on a scale
Standard Deviation 1.13
|
—
|
—
|
—
|
—
|
|
Symptom Changes in Subjects With Functional Gastrointestinal Disorder (Functional Dyspepsia and Irritable Bowel Syndrome)
Irritable Bowel Syndrome
|
-46.84 units on a scale
Standard Deviation 89.91
|
-40.24 units on a scale
Standard Deviation 78.62
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Run-In (2 weeks), Randomized (4 weeks) and Open Label (4 weeks) periodPopulation: Intention To Treat population (ITT)
Compare Quality of Life in last 2 weeks in the randomized period with the run-in period, and compare of Quality of life in the open label period to randomization period using the Functional Digestive Disorder Quality of Life (FDDQL) questionnaire. The Functional Digestive Disorder Quality of Life (FDDQL) questionnaire is designed to measure Quality of Like (QOL) in patients with Functional Dyspepsia (FD) or Irritable Bowel Syndrome (IBS). The questionnaire is composed of 43 items (questions) investigating 8 dimensions: Daily activities, Anxiety, Diet, Sleep, Discomfort, Health, Coping and Stress. For the 43 items, patients rate the impact of their condition over the 8 dimensions from 1-5, where 1 = Not at all, 2 = A little Bit, 3 = Moderately, 4= Quite a bit, and 5 = Extremely. The mean score of the 8 dimensions is shown in the outcome measure data table.
Outcome measures
| Measure |
gammaCore®-G
n=18 Participants
Active Comparator: Active gammaCore device
gammaCore active stimulation treatment
|
gammaCore®-G Sham
n=20 Participants
Sham Comparator: sham gammaCore device
gammaCore sham stimulation treatment
|
gammaCore®-G IBS
n=19 Participants
Active Comparator: Active gammaCore device
gammaCore active stimulation treatment
|
gammaCore®-G Sham IBS
n=19 Participants
Sham Comparator: sham gammaCore device
gammaCore sham stimulation treatment
|
Total Active Gammacore
Total Active gammacore - Functional Dyspepsia + Irritable Bowel Syndrome
|
Total Sham Gammacore
Total Sham gammacore - Functional Dyspepsia + Irritable Bowel Syndrome
|
|---|---|---|---|---|---|---|
|
Quality of Life (QoL) Using the Functional Digestive Disorder Quality of Life (FDDQL)
Daily Activities Run-in
|
3.1 units on a scale
Standard Deviation 1.03
|
2.9 units on a scale
Standard Deviation 0.83
|
2.9 units on a scale
Standard Deviation 0.80
|
3.2 units on a scale
Standard Deviation 0.90
|
—
|
—
|
|
Quality of Life (QoL) Using the Functional Digestive Disorder Quality of Life (FDDQL)
Daily Activities - Randomized Period
|
2.7 units on a scale
Standard Deviation 1.06
|
2.4 units on a scale
Standard Deviation 0.85
|
2.6 units on a scale
Standard Deviation 0.84
|
2.7 units on a scale
Standard Deviation 0.98
|
—
|
—
|
|
Quality of Life (QoL) Using the Functional Digestive Disorder Quality of Life (FDDQL)
Daily Activities - Open label
|
2.5 units on a scale
Standard Deviation 1.01
|
2.0 units on a scale
Standard Deviation 0.78
|
2.5 units on a scale
Standard Deviation 1.10
|
2.4 units on a scale
Standard Deviation 1.04
|
—
|
—
|
|
Quality of Life (QoL) Using the Functional Digestive Disorder Quality of Life (FDDQL)
Anxiety - Run-in
|
3.3 units on a scale
Standard Deviation 0.92
|
3.3 units on a scale
Standard Deviation 0.83
|
3.4 units on a scale
Standard Deviation 0.94
|
3.2 units on a scale
Standard Deviation 1.03
|
—
|
—
|
|
Quality of Life (QoL) Using the Functional Digestive Disorder Quality of Life (FDDQL)
Anxiety - Randomized
|
2.9 units on a scale
Standard Deviation 0.88
|
2.9 units on a scale
Standard Deviation 0.71
|
3.2 units on a scale
Standard Deviation 1.04
|
3.0 units on a scale
Standard Deviation 0.97
|
—
|
—
|
|
Quality of Life (QoL) Using the Functional Digestive Disorder Quality of Life (FDDQL)
Anxiety - Open-label
|
2.7 units on a scale
Standard Deviation 0.97
|
2.7 units on a scale
Standard Deviation 0.90
|
3.1 units on a scale
Standard Deviation 1.13
|
2.6 units on a scale
Standard Deviation 0.92
|
—
|
—
|
|
Quality of Life (QoL) Using the Functional Digestive Disorder Quality of Life (FDDQL)
Diet - Run-in
|
3.6 units on a scale
Standard Deviation 1.05
|
3.8 units on a scale
Standard Deviation 0.8
|
3.9 units on a scale
Standard Deviation 0.98
|
3.7 units on a scale
Standard Deviation 0.6
|
—
|
—
|
|
Quality of Life (QoL) Using the Functional Digestive Disorder Quality of Life (FDDQL)
Health - Randomized
|
2.9 units on a scale
Standard Deviation 0.91
|
3.1 units on a scale
Standard Deviation 0.76
|
2.7 units on a scale
Standard Deviation 0.71
|
2.8 units on a scale
Standard Deviation 0.79
|
—
|
—
|
|
Quality of Life (QoL) Using the Functional Digestive Disorder Quality of Life (FDDQL)
Diet - Randomized
|
3.6 units on a scale
Standard Deviation 0.99
|
3.3 units on a scale
Standard Deviation 0.95
|
3.6 units on a scale
Standard Deviation 1.02
|
3.6 units on a scale
Standard Deviation 0.70
|
—
|
—
|
|
Quality of Life (QoL) Using the Functional Digestive Disorder Quality of Life (FDDQL)
Diet - Open-label
|
3.4 units on a scale
Standard Deviation 1.05
|
3.4 units on a scale
Standard Deviation 1.07
|
3.3 units on a scale
Standard Deviation 1.12
|
3.2 units on a scale
Standard Deviation 0.82
|
—
|
—
|
|
Quality of Life (QoL) Using the Functional Digestive Disorder Quality of Life (FDDQL)
Sleep - Run-in
|
2.6 units on a scale
Standard Deviation 0.96
|
2.7 units on a scale
Standard Deviation 0.67
|
2.6 units on a scale
Standard Deviation 0.88
|
2.8 units on a scale
Standard Deviation 0.84
|
—
|
—
|
|
Quality of Life (QoL) Using the Functional Digestive Disorder Quality of Life (FDDQL)
Sleep - Randomized
|
2.5 units on a scale
Standard Deviation 0.82
|
2.3 units on a scale
Standard Deviation 1.05
|
2.4 units on a scale
Standard Deviation 0.76
|
2.5 units on a scale
Standard Deviation 0.76
|
—
|
—
|
|
Quality of Life (QoL) Using the Functional Digestive Disorder Quality of Life (FDDQL)
Sleep - Open label
|
2.3 units on a scale
Standard Deviation 0.90
|
2.4 units on a scale
Standard Deviation 1.02
|
2.4 units on a scale
Standard Deviation 0.89
|
2.3 units on a scale
Standard Deviation 0.95
|
—
|
—
|
|
Quality of Life (QoL) Using the Functional Digestive Disorder Quality of Life (FDDQL)
Discomfort - Run-in
|
3.5 units on a scale
Standard Deviation 0.82
|
3.4 units on a scale
Standard Deviation 0.72
|
3.7 units on a scale
Standard Deviation 0.61
|
3.5 units on a scale
Standard Deviation 0.74
|
—
|
—
|
|
Quality of Life (QoL) Using the Functional Digestive Disorder Quality of Life (FDDQL)
Discomfort - Randomized
|
3.4 units on a scale
Standard Deviation 0.85
|
3.0 units on a scale
Standard Deviation 0.59
|
3.2 units on a scale
Standard Deviation 0.96
|
3.4 units on a scale
Standard Deviation 0.69
|
—
|
—
|
|
Quality of Life (QoL) Using the Functional Digestive Disorder Quality of Life (FDDQL)
Discomfort - Open label
|
3.0 units on a scale
Standard Deviation 0.83
|
2.9 units on a scale
Standard Deviation 0.62
|
3.1 units on a scale
Standard Deviation 1.09
|
2.8 units on a scale
Standard Deviation 0.86
|
—
|
—
|
|
Quality of Life (QoL) Using the Functional Digestive Disorder Quality of Life (FDDQL)
Health - Run-in
|
2.8 units on a scale
Standard Deviation 0.71
|
2.9 units on a scale
Standard Deviation 0.63
|
2.6 units on a scale
Standard Deviation 0.54
|
2.7 units on a scale
Standard Deviation 0.72
|
—
|
—
|
|
Quality of Life (QoL) Using the Functional Digestive Disorder Quality of Life (FDDQL)
Health - Open label
|
2.9 units on a scale
Standard Deviation 0.87
|
3.0 units on a scale
Standard Deviation 0.81
|
2.9 units on a scale
Standard Deviation 0.82
|
2.9 units on a scale
Standard Deviation 0.86
|
—
|
—
|
|
Quality of Life (QoL) Using the Functional Digestive Disorder Quality of Life (FDDQL)
Coping - Run-in
|
3.2 units on a scale
Standard Deviation 0.85
|
3.5 units on a scale
Standard Deviation 0.75
|
3.5 units on a scale
Standard Deviation 0.91
|
3.5 units on a scale
Standard Deviation 0.92
|
—
|
—
|
|
Quality of Life (QoL) Using the Functional Digestive Disorder Quality of Life (FDDQL)
Coping - Randomized
|
3.4 units on a scale
Standard Deviation 0.91
|
3.1 units on a scale
Standard Deviation 0.77
|
3.2 units on a scale
Standard Deviation 1.04
|
3.4 units on a scale
Standard Deviation 0.82
|
—
|
—
|
|
Quality of Life (QoL) Using the Functional Digestive Disorder Quality of Life (FDDQL)
Coping - Open label
|
3.0 units on a scale
Standard Deviation 0.89
|
3.0 units on a scale
Standard Deviation 0.81
|
3.3 units on a scale
Standard Deviation 1.20
|
3.1 units on a scale
Standard Deviation 0.97
|
—
|
—
|
|
Quality of Life (QoL) Using the Functional Digestive Disorder Quality of Life (FDDQL)
Stress - Run-in
|
3.5 units on a scale
Standard Deviation 0.83
|
3.5 units on a scale
Standard Deviation 1.05
|
3.3 units on a scale
Standard Deviation 1.16
|
3.1 units on a scale
Standard Deviation 1.03
|
—
|
—
|
|
Quality of Life (QoL) Using the Functional Digestive Disorder Quality of Life (FDDQL)
Stress - Randomized
|
3.5 units on a scale
Standard Deviation 0.72
|
3.6 units on a scale
Standard Deviation 1.07
|
3.2 units on a scale
Standard Deviation 1.05
|
3.2 units on a scale
Standard Deviation 1.05
|
—
|
—
|
|
Quality of Life (QoL) Using the Functional Digestive Disorder Quality of Life (FDDQL)
Stress - Open label
|
3.6 units on a scale
Standard Deviation 0.90
|
3.4 units on a scale
Standard Deviation 0.99
|
3.2 units on a scale
Standard Deviation 1.15
|
3.1 units on a scale
Standard Deviation 1.01
|
—
|
—
|
SECONDARY outcome
Timeframe: Run-In (2 weeks), Randomized (4 weeks) and Open Label (4 weeks) periodPopulation: Intention to Treat
Compare last 2 weeks in randomized period with the run-in period; \& compare open label period to randomization period using Short-Form Dyspepsia Questionnaire (SFLDQ).The SFLDQ is a validated, self-completed questionnaire that measures frequency and severity of dyspepsia. The questionnaire comprises of 5 questions, questions 1 to 4 are about the patients dyspeptic symptoms and question 5 is about the most troublesome symptom for the patient. Questions 1 to 4 comprise of two stems concerning 'frequency' (how often the subject has the symptom over the last 2 months) and 'severity' (how often has this symptom interfered with normal activities over the last 2 months). Subjects choose from: Not at all, less than monthly, between monthly \& weekly, between weekly \& daily, more than daily or no response. In question 5 the subject reports which symptoms has been most troublesome for each of the study periods. Results for Question 5 of the SFLDQ are reported separately in outcome measure 7.
Outcome measures
| Measure |
gammaCore®-G
n=18 Participants
Active Comparator: Active gammaCore device
gammaCore active stimulation treatment
|
gammaCore®-G Sham
n=20 Participants
Sham Comparator: sham gammaCore device
gammaCore sham stimulation treatment
|
gammaCore®-G IBS
n=18 Participants
Active Comparator: Active gammaCore device
gammaCore active stimulation treatment
|
gammaCore®-G Sham IBS
n=20 Participants
Sham Comparator: sham gammaCore device
gammaCore sham stimulation treatment
|
Total Active Gammacore
Total Active gammacore - Functional Dyspepsia + Irritable Bowel Syndrome
|
Total Sham Gammacore
Total Sham gammacore - Functional Dyspepsia + Irritable Bowel Syndrome
|
|---|---|---|---|---|---|---|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
INDIGESTION:Open-label- Between weekly an daily
|
5 Participants
|
8 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
NAUSEA:Run-in- Bewteen weekly & daily
|
5 Participants
|
7 Participants
|
3 Participants
|
8 Participants
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
NAUSEA:Randomized- etween monthly & weekly
|
3 Participants
|
5 Participants
|
2 Participants
|
3 Participants
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
NAUSEA:Run-in- Less than monthly
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
NAUSEA:Run-in- Between monthly & weekly
|
2 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
NAUSEA:Run-in- More than daily
|
7 Participants
|
7 Participants
|
5 Participants
|
4 Participants
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
NAUSEA:Run-in- No response
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
NAUSEA:Randomized- Not at all
|
0 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
NAUSEA:Randomized- Less than monthly
|
3 Participants
|
3 Participants
|
4 Participants
|
5 Participants
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
NAUSEA:Randomized- Between weekly & daily
|
2 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
NAUSEA:Randomized- More than daily
|
8 Participants
|
5 Participants
|
4 Participants
|
4 Participants
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
NAUSEA:Randomized- No response
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
Nausea: Open-label- Not at all
|
0 Participants
|
1 Participants
|
5 Participants
|
4 Participants
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
Nausea: Open-label- Less than monthly
|
4 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
Nausea: Open-label- Between monthly & weekly
|
2 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
Nausea: Open-label- Between weekly & daily
|
7 Participants
|
6 Participants
|
2 Participants
|
5 Participants
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
Nausea: Open-label- More than daily
|
3 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
Nausea: Open-label- No response
|
2 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
INDIGESTION:Run-in - Not at all
|
1 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
INDIGESTION:Run-in - Less than monthly
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
INDIGESTION:Run-in - Between weekly & monthly
|
2 Participants
|
4 Participants
|
4 Participants
|
6 Participants
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
INDIGESTION:Run-in -Between weekly & daily
|
5 Participants
|
8 Participants
|
2 Participants
|
5 Participants
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
INDIGESTION:Run-in - More than daily
|
10 Participants
|
7 Participants
|
8 Participants
|
5 Participants
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
INDIGESTION:Run-in - No response
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
INDIGESTION:Randomized- Not at all
|
1 Participants
|
3 Participants
|
5 Participants
|
3 Participants
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
INDIGESTION:Randomized- Less than monthly
|
0 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
INDIGESTION:Randomized- Between weekly & monthly
|
1 Participants
|
1 Participants
|
0 Participants
|
5 Participants
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
INDIGESTION:Randomized- Between weekly & daily
|
11 Participants
|
8 Participants
|
5 Participants
|
3 Participants
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
INDIGESTION:Randomized- More than daily
|
3 Participants
|
6 Participants
|
3 Participants
|
4 Participants
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
INDIGESTION:Randomized- No response
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
INDIGESTION:Open-label- Not at all
|
1 Participants
|
3 Participants
|
5 Participants
|
5 Participants
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
INDIGESTION:Open-label- Less than monthly
|
2 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
INDIGESTION:Open-label- Between monthly & weekly
|
3 Participants
|
2 Participants
|
1 Participants
|
6 Participants
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
INDIGESTION:Open-label- More than daily
|
5 Participants
|
2 Participants
|
5 Participants
|
2 Participants
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
INDIGESTION:Open-label- No response
|
2 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
HEARTBURN:Run-in- Not at all
|
2 Participants
|
5 Participants
|
7 Participants
|
8 Participants
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
HEARTBURN:Run-in- Less than monthly
|
4 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
HEARTBURN:Run-in- Between monthly & weekly
|
6 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
HEARTBURN:Run-in- Between weekly & daily
|
5 Participants
|
6 Participants
|
4 Participants
|
5 Participants
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
HEARTBURN:Run-in- More than daily
|
1 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
HEARTBURN:Run-in- No response
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
HEARTBURN:Randomised- Not at all
|
6 Participants
|
5 Participants
|
11 Participants
|
10 Participants
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
HEARTBURN:Randomised- Less than monthly
|
6 Participants
|
5 Participants
|
4 Participants
|
1 Participants
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
HEARTBURN:Randomised- Between monthly and weekly
|
2 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
HEARTBURN:Randomised- Between weekly and daily
|
1 Participants
|
6 Participants
|
0 Participants
|
4 Participants
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
HEARTBURN:Randomised- More than daily
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
HEARTBURN:Randomised- No response
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
HEARTBURN:Open-label- Not at all
|
3 Participants
|
6 Participants
|
8 Participants
|
9 Participants
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
HEARTBURN:Open-label- Less than monthly
|
6 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
HEARTBURN:Open-label- Between monthly & weekly
|
2 Participants
|
4 Participants
|
0 Participants
|
4 Participants
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
HEARTBURN:Open-label- Between weekly and daily
|
4 Participants
|
5 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
HEARTBURN:Open-label- More than daily
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
HEARTBURN:Open-label- No reposnse
|
2 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
REGURGITATION:Run-in- Not at all
|
1 Participants
|
5 Participants
|
5 Participants
|
9 Participants
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
REGURGITATION:Run-in- Less than monthly
|
3 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
REGURGITATION:Run-in- Between monthly and weekly
|
7 Participants
|
4 Participants
|
5 Participants
|
2 Participants
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
REGURGITATION:Run-in- Between weekly & daily
|
5 Participants
|
3 Participants
|
3 Participants
|
6 Participants
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
REGURGITATION:Run-in- More than daily
|
2 Participants
|
6 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
REGURGITATION:Run-in- No response
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
REGURGITATION:Randomized- Not at all
|
3 Participants
|
5 Participants
|
7 Participants
|
7 Participants
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
REGURGITATION:Randomized- Less than monthly
|
4 Participants
|
4 Participants
|
3 Participants
|
5 Participants
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
REGURGITATION:Randomized- Between monthly & weekly
|
2 Participants
|
7 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
REGURGITATION:Randomized- Between weekly & daily
|
2 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
REGURGITATION:Randomized- More than daily
|
5 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
REGURGITATION:Randomized- No response
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
REGURGITATION:Open-label- Not at all
|
2 Participants
|
3 Participants
|
5 Participants
|
7 Participants
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
REGURGITATION:Open-label- Less than monthly
|
4 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
REGURGITATION:Open-label- Between monthly & weekly
|
2 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
REGURGITATION:Open-label- Between weekly & daily
|
4 Participants
|
6 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
REGURGITATION:Open-label- More than daily
|
4 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
REGURGITATION:Open-label- No response
|
2 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
NAUSEA:Run-in- Not at all
|
3 Participants
|
3 Participants
|
6 Participants
|
3 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Run-In (2 weeks) and Randomized (4 weeks)Population: Intent-to-Treat
Compare last 2 weeks in randomised period with the run-in period, comparison open label period to randomization period. Concomitant medications were recorded and the number of subjects taking one or more concomitant medications is compared in the active and shams groups for both Functional Dyspepsia and Irritable Bowel Syndrome cohorts during the run-in, randomized and open label periods.
Outcome measures
| Measure |
gammaCore®-G
n=20 Participants
Active Comparator: Active gammaCore device
gammaCore active stimulation treatment
|
gammaCore®-G Sham
n=20 Participants
Sham Comparator: sham gammaCore device
gammaCore sham stimulation treatment
|
gammaCore®-G IBS
n=21 Participants
Active Comparator: Active gammaCore device
gammaCore active stimulation treatment
|
gammaCore®-G Sham IBS
n=20 Participants
Sham Comparator: sham gammaCore device
gammaCore sham stimulation treatment
|
Total Active Gammacore
Total Active gammacore - Functional Dyspepsia + Irritable Bowel Syndrome
|
Total Sham Gammacore
Total Sham gammacore - Functional Dyspepsia + Irritable Bowel Syndrome
|
|---|---|---|---|---|---|---|
|
Use of Concomitant Medication (Intake and Dose) During the Course of the Study
Subjects taking multiple medications in run-in
|
15 Participants
|
18 Participants
|
18 Participants
|
18 Participants
|
—
|
—
|
|
Use of Concomitant Medication (Intake and Dose) During the Course of the Study
Subjects taking multiple medications in randomised
|
17 Participants
|
17 Participants
|
19 Participants
|
17 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Run-In (2 weeks), Randomized (4 weeks) and Open Label (4 weeks) periodPopulation: Intention To Treat (ITT)
Global Overall Symptom (GOS) scale is self-reported. Patients grade overall severity of dyspepsia symptoms over a retrospective period of time. The scale uses a 7-point Likert scale ranging from minimum 1 = no problem to maximum 7 = very severe problem. Subjects assess how their stomach problems have been over the specific time period, and indicate severity of symptoms for 10 specific upper GI symptoms (epigastric pain, epigastric discomfort, heartburn, acid regurgitation, upper abdominal bloating, excessive belching, nausea, early satiety, postprandial fullness, other epigastric symptoms). Total minimum = 10 and total maximum = 70. The Irritable Bowel Syndrome Score (IBS) measures severity of symptoms by 5 questions: abdominal pain, number days with pain in every 10 days (multiplied by 10), abdominal distension, bowel movement satisfaction, interference with general life. Each question scores from 0 (not severe) to 100 (severe). Total score: Min = 0 healthy; Max = 500 severely sick.
Outcome measures
| Measure |
gammaCore®-G
n=37 Participants
Active Comparator: Active gammaCore device
gammaCore active stimulation treatment
|
gammaCore®-G Sham
n=39 Participants
Sham Comparator: sham gammaCore device
gammaCore sham stimulation treatment
|
gammaCore®-G IBS
Active Comparator: Active gammaCore device
gammaCore active stimulation treatment
|
gammaCore®-G Sham IBS
Sham Comparator: sham gammaCore device
gammaCore sham stimulation treatment
|
Total Active Gammacore
Total Active gammacore - Functional Dyspepsia + Irritable Bowel Syndrome
|
Total Sham Gammacore
Total Sham gammacore - Functional Dyspepsia + Irritable Bowel Syndrome
|
|---|---|---|---|---|---|---|
|
Symptom Change at 8 Weeks Compared to 4 Weeks (GOS Dyspepsia or IBS Severity Scoring System)
Functional Dyspepsia
|
-0.03 units on a scale
Standard Deviation 0.99
|
-0.13 units on a scale
Standard Deviation 0.66
|
—
|
—
|
—
|
—
|
|
Symptom Change at 8 Weeks Compared to 4 Weeks (GOS Dyspepsia or IBS Severity Scoring System)
Irritable Bowel Syndrome
|
0.27 units on a scale
Standard Deviation 91.16
|
-34.90 units on a scale
Standard Deviation 65.84
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Run-In (2 weeks), Randomized (4 weeks) and Open Label (4 weeks) periodPopulation: Safety Population
Summary of Treatment Emergent Adverse Events. Subjects were monitored for occurrence of adverse events from the start of the run-in period to the end of the open label period..
Outcome measures
| Measure |
gammaCore®-G
n=20 Participants
Active Comparator: Active gammaCore device
gammaCore active stimulation treatment
|
gammaCore®-G Sham
n=20 Participants
Sham Comparator: sham gammaCore device
gammaCore sham stimulation treatment
|
gammaCore®-G IBS
n=21 Participants
Active Comparator: Active gammaCore device
gammaCore active stimulation treatment
|
gammaCore®-G Sham IBS
n=20 Participants
Sham Comparator: sham gammaCore device
gammaCore sham stimulation treatment
|
Total Active Gammacore
n=41 Participants
Total Active gammacore - Functional Dyspepsia + Irritable Bowel Syndrome
|
Total Sham Gammacore
n=40 Participants
Total Sham gammacore - Functional Dyspepsia + Irritable Bowel Syndrome
|
|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events
At least one event
|
15 Participants
|
13 Participants
|
16 Participants
|
16 Participants
|
31 Participants
|
29 Participants
|
|
Number of Participants With Adverse Events
At least one related event
|
10 Participants
|
10 Participants
|
14 Participants
|
10 Participants
|
24 Participants
|
20 Participants
|
|
Number of Participants With Adverse Events
At least one adverse device effect
|
10 Participants
|
10 Participants
|
14 Participants
|
10 Participants
|
24 Participants
|
20 Participants
|
|
Number of Participants With Adverse Events
At least one severe event
|
4 Participants
|
2 Participants
|
7 Participants
|
2 Participants
|
11 Participants
|
4 Participants
|
|
Number of Participants With Adverse Events
At least one serious event
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events
At least one event leading to discontinuation
|
3 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
6 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Run-In (2 weeks), Randomized (4 weeks) and Open Label (4 weeks) periodShort-Form Leeds Dyspepsia Questionnaire (SFLDQ): Question 5: Most Troublesome Symptom. In question five of the SFLDQ the subject reports which of the symptoms has been most troublesome to them, this is also reported for each of the study periods. (Note: results of questions 1-4 of the SFLDQ are reported separately in outcome measure 3.)
Outcome measures
| Measure |
gammaCore®-G
n=18 Participants
Active Comparator: Active gammaCore device
gammaCore active stimulation treatment
|
gammaCore®-G Sham
n=20 Participants
Sham Comparator: sham gammaCore device
gammaCore sham stimulation treatment
|
gammaCore®-G IBS
Active Comparator: Active gammaCore device
gammaCore active stimulation treatment
|
gammaCore®-G Sham IBS
Sham Comparator: sham gammaCore device
gammaCore sham stimulation treatment
|
Total Active Gammacore
Total Active gammacore - Functional Dyspepsia + Irritable Bowel Syndrome
|
Total Sham Gammacore
Total Sham gammacore - Functional Dyspepsia + Irritable Bowel Syndrome
|
|---|---|---|---|---|---|---|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
Open-Label - Regurgitation
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
Run-in - Indigestion
|
8 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
Run-in - Heartburn
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
Run-in - Regurgitation
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
Run-in - Nausea
|
8 Participants
|
9 Participants
|
—
|
—
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
Run-in - None of these have troubled me
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
Run-in Missing
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
Randomized - Indigestion
|
4 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
Randomized - Heartburn
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
Randomized - Regurgitation
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
Randomized - Nausea
|
9 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
Randomized - None of these have troubled me
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
Randomized - Missing
|
2 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
Open-Label - Indigestion
|
7 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
Open-Label - Heartburn
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
Open-Label - Nausea
|
6 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
Open-Label - None of these have troubled me
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Change in Frequency of Symptoms Using the Short-Form Leeds Dyspepsia Questionnaire (SFLDQ)
Open-Label - Missing
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
Adverse Events
gammaCore®-G FD
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
gammaCore®-G Sham FD
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
gammaCore®-G IBS
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
gammaCore®-G Sham IBS
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
gammaCore®-G FD
n=20 participants at risk
Active Comparator: Active gammaCore device
gammaCore active stimulation treatment
|
gammaCore®-G Sham FD
n=20 participants at risk
Sham Comparator: sham gammaCore device
gammaCore sham stimulation treatment
|
gammaCore®-G IBS
n=21 participants at risk
Active Comparator: Active gammaCore device
gammaCore active stimulation treatment
|
gammaCore®-G Sham IBS
n=20 participants at risk
Sham Comparator: sham gammaCore device
gammaCore sham stimulation treatment
|
|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
5.0%
1/20 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
5.0%
1/20 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
4.8%
1/21 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
|
Ear and labyrinth disorders
Ear Pain
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
9.5%
2/21 • Number of events 2 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
9.5%
2/21 • Number of events 2 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
|
Eye disorders
Blepharospasm
|
5.0%
1/20 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/21 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
|
Eye disorders
Conjunctivitis Allergic
|
5.0%
1/20 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
4.8%
1/21 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
|
Eye disorders
Mydriasis
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
5.0%
1/20 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/21 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/21 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
5.0%
1/20 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
1/20 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/21 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.0%
1/20 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
5.0%
1/20 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/21 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
|
Gastrointestinal disorders
Food Poisoning
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/21 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
5.0%
1/20 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
|
Gastrointestinal disorders
Hypoaesthesia
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/21 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
5.0%
1/20 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
9.5%
2/21 • Number of events 2 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
9.5%
2/21 • Number of events 2 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
5.0%
1/20 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
|
General disorders
Odynophagia
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
4.8%
1/21 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
|
Gastrointestinal disorders
Paraethesia Oral
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/21 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
5.0%
1/20 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
|
Gastrointestinal disorders
Toothache
|
5.0%
1/20 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
9.5%
2/21 • Number of events 2 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
5.0%
1/20 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
9.5%
2/21 • Number of events 2 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
5.0%
1/20 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
|
General disorders
Chest Discomfort
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
5.0%
1/20 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/21 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
|
General disorders
Chest Pain
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
5.0%
1/20 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/21 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
5.0%
1/20 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
|
General disorders
Fatigue
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
5.0%
1/20 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/21 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
10.0%
2/20 • Number of events 2 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
|
General disorders
Influenza like illness
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/21 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
5.0%
1/20 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
|
General disorders
Oedema
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/21 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
5.0%
1/20 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
|
General disorders
Pain
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
10.0%
2/20 • Number of events 2 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/21 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
|
General disorders
Pyrexia
|
5.0%
1/20 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/21 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
|
General disorders
Tenderness
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
4.8%
1/21 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
|
Infections and infestations
Influenza
|
5.0%
1/20 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
10.0%
2/20 • Number of events 2 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
14.3%
3/21 • Number of events 3 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
15.0%
3/20 • Number of events 3 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
|
Infections and infestations
Lower respiratory tract infection
|
5.0%
1/20 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/21 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
5.0%
1/20 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
4.8%
1/21 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
4.8%
1/21 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/21 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
5.0%
1/20 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
4.8%
1/21 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/21 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
5.0%
1/20 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
|
Injury, poisoning and procedural complications
Ligament Injury
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
5.0%
1/20 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/21 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
4.8%
1/21 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
|
Injury, poisoning and procedural complications
Stress Fracture
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/21 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
5.0%
1/20 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
4.8%
1/21 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
4.8%
1/21 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
10.0%
2/20 • Number of events 2 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
10.0%
2/20 • Number of events 2 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
9.5%
2/21 • Number of events 2 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
5.0%
1/20 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
4.8%
1/21 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
4.8%
1/21 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
|
Musculoskeletal and connective tissue disorders
MuscleTwitching
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
10.0%
2/20 • Number of events 2 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
4.8%
1/21 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
10.0%
2/20 • Number of events 2 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/21 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
5.0%
1/20 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.0%
1/20 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
10.0%
2/20 • Number of events 2 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/21 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
5.0%
1/20 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.0%
1/20 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
5.0%
1/20 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
9.5%
2/21 • Number of events 2 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
5.0%
1/20 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
4.8%
1/21 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
9.5%
2/21 • Number of events 2 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
5.0%
1/20 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
|
Musculoskeletal and connective tissue disorders
Pain in Jaw
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
4.8%
1/21 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
10.0%
2/20 • Number of events 2 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
5.0%
1/20 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/21 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
|
Nervous system disorders
Dizziness
|
5.0%
1/20 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
25.0%
5/20 • Number of events 5 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
9.5%
2/21 • Number of events 2 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
10.0%
2/20 • Number of events 2 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
|
Nervous system disorders
Headache
|
25.0%
5/20 • Number of events 5 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
20.0%
4/20 • Number of events 4 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
23.8%
5/21 • Number of events 5 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
25.0%
5/20 • Number of events 5 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
5.0%
1/20 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/21 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
10.0%
2/20 • Number of events 2 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
|
Nervous system disorders
Hypokinesia
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
5.0%
1/20 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/21 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
|
Nervous system disorders
Migraine
|
10.0%
2/20 • Number of events 2 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/21 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/21 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
5.0%
1/20 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
|
Nervous system disorders
Tremor
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
5.0%
1/20 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/21 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
|
Psychiatric disorders
Anxiety
|
5.0%
1/20 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/21 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
5.0%
1/20 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
5.0%
1/20 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
4.8%
1/21 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
5.0%
1/20 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
|
Product Issues
Panic Attack
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/21 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
5.0%
1/20 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
|
Renal and urinary disorders
Renal Colic
|
5.0%
1/20 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/21 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/21 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
10.0%
2/20 • Number of events 2 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
5.0%
1/20 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
9.5%
2/21 • Number of events 2 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/21 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
5.0%
1/20 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
15.0%
3/20 • Number of events 3 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/21 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
5.0%
1/20 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Tract Ulceration
|
5.0%
1/20 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/21 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/21 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
5.0%
1/20 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Allergic
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
4.8%
1/21 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
4.8%
1/21 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
5.0%
1/20 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/21 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.0%
1/20 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
10.0%
2/20 • Number of events 2 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
4.8%
1/21 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
5.0%
1/20 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
|
Skin and subcutaneous tissue disorders
Skin Irritation
|
5.0%
1/20 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
15.0%
3/20 • Number of events 3 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
14.3%
3/21 • Number of events 3 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
20.0%
4/20 • Number of events 4 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
|
Skin and subcutaneous tissue disorders
Skin Lesion
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/21 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
5.0%
1/20 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/21 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
5.0%
1/20 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
|
Vascular disorders
Hypotension
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
5.0%
1/20 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
4.8%
1/21 • Number of events 1 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
0.00%
0/20 • Adverse Event data was captured from the data of signature of informed consent (day -14) until final study visit (day 56), a total of 10 weeks. Any AE that was when the subject completed the study or was withdrawn from the study was followed-up until the AE was resolved or the clinical investigator decided that the AE was stable and needed no further follow up.
|
Additional Information
Clinical Affairs Department electroCore LLC
electroCore LLC
Phone: +1 973 355 6683
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60