Trial Outcomes & Findings for Safety Study of Gene Therapy for Ischemic Heart Disease in Korea (NCT NCT01422772)
NCT ID: NCT01422772
Last Updated: 2025-10-03
Results Overview
Subjects who have been administered the investigational drug will be included, regardless of protocol violations or adherence to visit schedules. This clinical trial is designed to evaluate safety over a 6-month period. Assessments Include: Adverse reactions, vital signs, physical exam, laboratory test results
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
9 participants
Primary outcome timeframe
24 weeks
Results posted on
2025-10-03
Participant Flow
16 participants were screened. 9 participants were randomized/enrolled, with 7 screen failures.
Participant milestones
| Measure |
Group 1 - 0.5 mg/1 mL
VM202 (Engensis) 0.5 mg/1 mL was intramyocardially injected into 4 sites 0.125 mg/0.25 mL/injection point) of the incompletely revascularized area after Coronary Artery Bypass Graft.
|
Group 2 - 1.0 mg/2 mL
VM202 (Engensis) 1 mg/2 mL was intramyocardially injected into 8 sites (0.125 mg/0.25 mL/injection point) of the incompletely revascularized area after Coronary Artery Bypass Graft.
|
Group 3 - 2 mg/4 mL
VM202 (Engensis) 2 mg/4 mL was intramyocardially injected into 8 sites (0.25 mg/0.5 mL/injection point) of the incompletely revascularized area after Coronary Artery Bypass Graft.
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety Study of Gene Therapy for Ischemic Heart Disease in Korea
Baseline characteristics by cohort
| Measure |
Group 1 - VM202 - 0.5 mg/ 1mL
n=3 Participants
VM202RY 0.5 mg/ 1 mL was intramyocardially injected into 4 sites (0.125 mg/0.25 mL/injection point) of the incompletely revascularized area after Coronary Artery Bypass Graft.
|
Group 2 - VM202 - 1.0 mg/2 mL
n=3 Participants
VM202RY 1 mg/2 mL was intramyocardially injected into 8 sites (0.125 mg/0.25 mL/injection point) of the incompletely revascularized area after Coronary Artery Bypass Graft.
|
Group 3 - VM202 - 2 mg/4 mL
n=3 Participants
VM202RY 2 mg/4 mL was intramyocardially injected into 8 sites (0.25 mg/0.5 mL/injection point) of the incompletely revascularized area after Coronary Artery Bypass Graft.
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
61.00 years
STANDARD_DEVIATION 12.77 • n=99 Participants
|
59.00 years
STANDARD_DEVIATION 6.93 • n=107 Participants
|
67.67 years
STANDARD_DEVIATION 6.11 • n=206 Participants
|
62.56 years
STANDARD_DEVIATION 8.60 • n=7 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Region of Enrollment
South Korea
|
3 participants
n=99 Participants
|
3 participants
n=107 Participants
|
3 participants
n=206 Participants
|
9 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Total Number of Adverse Events (ITT Safety)
Subjects who have been administered the investigational drug will be included, regardless of protocol violations or adherence to visit schedules. This clinical trial is designed to evaluate safety over a 6-month period. Assessments Include: Adverse reactions, vital signs, physical exam, laboratory test results
Outcome measures
| Measure |
Group 1 - 0.5 mg/1 mL
n=60 Total AEs
VM202 (Engensis) 0.5 mg/1 mL was intramyocardially injected into 4 sites 0.125 mg/0.25 mL/injection point) of the incompletely revascularized area after Coronary Artery Bypass Graft.
|
Group 2 - 1.0 mg/2 mL
n=18 Total AEs
VM202 (Engensis) 1 mg/2 mL was intramyocardially injected into 8 sites (0.125 mg/0.25 mL/injection point) of the incompletely revascularized area after Coronary Artery Bypass Graft.
|
Group 3 - 2 mg/4 mL
n=36 Total AEs
VM202 (Engensis) 2 mg/4 mL was intramyocardially injected into 8 sites (0.25 mg/0.5 mL/injection point) of the incompletely revascularized area after Coronary Artery Bypass Graft.
|
|---|---|---|---|
|
The Incidence of Adverse Events - Total Adverse Events (AE)
Treatment Emergent AEs
|
58 Total AEs
|
18 Total AEs
|
36 Total AEs
|
|
The Incidence of Adverse Events - Total Adverse Events (AE)
AEs related to Investigational Product
|
0 Total AEs
|
0 Total AEs
|
0 Total AEs
|
|
The Incidence of Adverse Events - Total Adverse Events (AE)
Serious Adverse Events
|
2 Total AEs
|
0 Total AEs
|
0 Total AEs
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Total Adverse Events by Severity (ITT Safety)
Subjects who have been administered the investigational drug will be included, regardless of protocol violations or adherence to visit schedules. This clinical trial is designed to evaluate safety over a 6-month period. Assessments Include: Adverse reactions, vital signs, physical exam, laboratory test results
Outcome measures
| Measure |
Group 1 - 0.5 mg/1 mL
n=3 Participants
VM202 (Engensis) 0.5 mg/1 mL was intramyocardially injected into 4 sites 0.125 mg/0.25 mL/injection point) of the incompletely revascularized area after Coronary Artery Bypass Graft.
|
Group 2 - 1.0 mg/2 mL
n=3 Participants
VM202 (Engensis) 1 mg/2 mL was intramyocardially injected into 8 sites (0.125 mg/0.25 mL/injection point) of the incompletely revascularized area after Coronary Artery Bypass Graft.
|
Group 3 - 2 mg/4 mL
n=3 Participants
VM202 (Engensis) 2 mg/4 mL was intramyocardially injected into 8 sites (0.25 mg/0.5 mL/injection point) of the incompletely revascularized area after Coronary Artery Bypass Graft.
|
|---|---|---|---|
|
The Severity of Adverse Events - Total Adverse Events by Severity
Grade 1/Mild-Severity of AEs
|
31 Total AEs
|
6 Total AEs
|
12 Total AEs
|
|
The Severity of Adverse Events - Total Adverse Events by Severity
Grade 2/Moderate-Severity of AEs
|
27 Total AEs
|
12 Total AEs
|
24 Total AEs
|
|
The Severity of Adverse Events - Total Adverse Events by Severity
Grade 3/Severe-Severity of AEs
|
0 Total AEs
|
0 Total AEs
|
0 Total AEs
|
|
The Severity of Adverse Events - Total Adverse Events by Severity
Grade 4/Severe-Severity of AEs
|
0 Total AEs
|
0 Total AEs
|
0 Total AEs
|
SECONDARY outcome
Timeframe: Day 0, 12 weeks, 24 weeksPopulation: Intent to Treat - Left Ventricular Ejection Percentage Fraction - Measured by Magnetic Resonance Imaging (MRI)
Changes in Percentage of Left Ventricular Ejection Fraction by Cardiac Magnetic Resonance Imaging (MRI). Cardiac MRI will be used to monitor for the development of intramyocardial hemangiomas. Analysis will follow the standard cardiac MRI protocols of the Department of Radiology at Seoul National University Hospital, using an appropriate segment model based on the patient's heart size. Parameters evaluated will include left ventricular volume (mL), wall motion index, myocardial thickness (mm), and LVEF (%). Comparisons will be made between baseline/screening and follow-up measurements for each patient, as well as between treatment groups.
Outcome measures
| Measure |
Group 1 - 0.5 mg/1 mL
n=3 Participants
VM202 (Engensis) 0.5 mg/1 mL was intramyocardially injected into 4 sites 0.125 mg/0.25 mL/injection point) of the incompletely revascularized area after Coronary Artery Bypass Graft.
|
Group 2 - 1.0 mg/2 mL
n=3 Participants
VM202 (Engensis) 1 mg/2 mL was intramyocardially injected into 8 sites (0.125 mg/0.25 mL/injection point) of the incompletely revascularized area after Coronary Artery Bypass Graft.
|
Group 3 - 2 mg/4 mL
n=3 Participants
VM202 (Engensis) 2 mg/4 mL was intramyocardially injected into 8 sites (0.25 mg/0.5 mL/injection point) of the incompletely revascularized area after Coronary Artery Bypass Graft.
|
|---|---|---|---|
|
Percentage of Change From Baseline/Screening in Left Ventricular Ejection Fraction Evaluated by Magnetic Resonance Imaging
Week 12
|
1.77 percentage of change from screening
Standard Deviation 6.54
|
1.63 percentage of change from screening
Standard Deviation 6.96
|
2.67 percentage of change from screening
Standard Deviation 5.12
|
|
Percentage of Change From Baseline/Screening in Left Ventricular Ejection Fraction Evaluated by Magnetic Resonance Imaging
Week 24
|
0.45 percentage of change from screening
Standard Deviation 3.89
|
6.80 percentage of change from screening
Standard Deviation 6.93
|
0.13 percentage of change from screening
Standard Deviation 11.19
|
SECONDARY outcome
Timeframe: Day 0, Day 7, 12 weeks, 24 weeksPopulation: Intent to Treat - Left Ventricular Ejection Percentage Fraction - Measured by Trans Thoracic Echocardiography
Changes from screening in cardiac function evaluated based on Percentage of Left Ventricular Ejection Fraction by cardiac Trans-thoracic Echocardiography (TTE). From transthoracic echocardiography, left ventricular diameter (mm), ejection fraction (%), and wall thickness (mL) will be measured and compared from Screening/Baseline to follow-up results after surgery. The Wall Motion Score Index will be calculated by dividing the myocardium into 16 segments and assigning a score to each area based on motion: \[1 = normal, 2 = hypokinetic, 3 = akinetic, 4 = dyskinetic\]. The total score for the entire myocardium and the right coronary artery region will be averaged by the number of segments.
Outcome measures
| Measure |
Group 1 - 0.5 mg/1 mL
n=3 Participants
VM202 (Engensis) 0.5 mg/1 mL was intramyocardially injected into 4 sites 0.125 mg/0.25 mL/injection point) of the incompletely revascularized area after Coronary Artery Bypass Graft.
|
Group 2 - 1.0 mg/2 mL
n=3 Participants
VM202 (Engensis) 1 mg/2 mL was intramyocardially injected into 8 sites (0.125 mg/0.25 mL/injection point) of the incompletely revascularized area after Coronary Artery Bypass Graft.
|
Group 3 - 2 mg/4 mL
n=3 Participants
VM202 (Engensis) 2 mg/4 mL was intramyocardially injected into 8 sites (0.25 mg/0.5 mL/injection point) of the incompletely revascularized area after Coronary Artery Bypass Graft.
|
|---|---|---|---|
|
Percentage of Change From Baseline/Screening in Cardiac Function Evaluated by Echocardiography
Day 7
|
-1.00 percentage of change from screening
Standard Deviation 2.65
|
0.0 percentage of change from screening
Standard Deviation 2.0
|
-1.0 percentage of change from screening
Standard Deviation 3.0
|
|
Percentage of Change From Baseline/Screening in Cardiac Function Evaluated by Echocardiography
Week 12
|
3.0 percentage of change from screening
Standard Deviation 6.08
|
-2.0 percentage of change from screening
Standard Deviation 4.58
|
-1.33 percentage of change from screening
Standard Deviation 3.79
|
|
Percentage of Change From Baseline/Screening in Cardiac Function Evaluated by Echocardiography
Week 24
|
8.0 percentage of change from screening
Standard Deviation 4.24
|
3.0 percentage of change from screening
Standard Deviation 12.12
|
3.33 percentage of change from screening
Standard Deviation 11.93
|
SECONDARY outcome
Timeframe: Day 0, 12 weeks, 24 weeksPopulation: Intent to Treat - myocardium thickness by Magnetic Resonance Imaging - End-Systolic Thickness
The size of the viable myocardium was evaluated based on the myocardium thickness at the site of intramyocardial gene injection by Magnetic Resonance Imaging - End-Systolic Thickness. Using cardiac MRI, the myocardial thickness at the gene injection site, the extent of late gadolinium enhancement, and local wall motion strength will be evaluated. Differences between groups before and after VM202RY administration will be tested using the Kruskal-Wallis test.
Outcome measures
| Measure |
Group 1 - 0.5 mg/1 mL
n=3 Participants
VM202 (Engensis) 0.5 mg/1 mL was intramyocardially injected into 4 sites 0.125 mg/0.25 mL/injection point) of the incompletely revascularized area after Coronary Artery Bypass Graft.
|
Group 2 - 1.0 mg/2 mL
n=3 Participants
VM202 (Engensis) 1 mg/2 mL was intramyocardially injected into 8 sites (0.125 mg/0.25 mL/injection point) of the incompletely revascularized area after Coronary Artery Bypass Graft.
|
Group 3 - 2 mg/4 mL
n=3 Participants
VM202 (Engensis) 2 mg/4 mL was intramyocardially injected into 8 sites (0.25 mg/0.5 mL/injection point) of the incompletely revascularized area after Coronary Artery Bypass Graft.
|
|---|---|---|---|
|
Changes in Size of Viable Myocardium - End-Systolic Thickness
Week 12
|
0.58 mm
Standard Deviation 1.40
|
0.08 mm
Standard Deviation 1.67
|
0.93 mm
Standard Deviation 1.37
|
|
Changes in Size of Viable Myocardium - End-Systolic Thickness
Week 24
|
0.99 mm
Standard Deviation 2.59
|
0.36 mm
Standard Deviation 1.63
|
1.15 mm
Standard Deviation 1.38
|
SECONDARY outcome
Timeframe: Day 0, 12 weeks, 24 weeksPopulation: Intent to Treat - myocardium thickness by Magnetic Resonance Imaging - End-Diastolic Thickness
The size of the viable myocardium was evaluated based on the myocardium thickness at the site of intramyocardial gene injection by Magnetic Resonance Imaging - End-Diastolic Thickness. Using cardiac MRI, the myocardial thickness at the gene injection site, the extent of late gadolinium enhancement, and local wall motion strength will be evaluated. Differences between groups before and after VM202RY administration will be tested using the Kruskal-Wallis test.
Outcome measures
| Measure |
Group 1 - 0.5 mg/1 mL
n=3 Participants
VM202 (Engensis) 0.5 mg/1 mL was intramyocardially injected into 4 sites 0.125 mg/0.25 mL/injection point) of the incompletely revascularized area after Coronary Artery Bypass Graft.
|
Group 2 - 1.0 mg/2 mL
n=3 Participants
VM202 (Engensis) 1 mg/2 mL was intramyocardially injected into 8 sites (0.125 mg/0.25 mL/injection point) of the incompletely revascularized area after Coronary Artery Bypass Graft.
|
Group 3 - 2 mg/4 mL
n=3 Participants
VM202 (Engensis) 2 mg/4 mL was intramyocardially injected into 8 sites (0.25 mg/0.5 mL/injection point) of the incompletely revascularized area after Coronary Artery Bypass Graft.
|
|---|---|---|---|
|
Changes in Size of Viable Myocardium - End-Diastolic Thickness
Week 12
|
0.47 mm
Standard Deviation 1.13
|
0.71 mm
Standard Deviation 0.23
|
0.44 mm
Standard Deviation 0.46
|
|
Changes in Size of Viable Myocardium - End-Diastolic Thickness
Week 24
|
1.85 mm
Standard Deviation 0.10
|
0.43 mm
Standard Deviation 1.53
|
0.17 mm
Standard Deviation 0.81
|
SECONDARY outcome
Timeframe: Day 0, 12 weeks, 24 weeksPopulation: Intent to Treat - Changes in Myocardial Ischemic Area evaluated by SPECT based on Percentage of perfusion volume - Stress Condition
Changes in Myocardial Ischemic Area evaluated by 99mTc Sestamibi Methoxyl Isobutyl Isonitrile Single Photon Emission Computed Tomography (SPECT) based on Percentage of perfusion volume - Stress Condition
Outcome measures
| Measure |
Group 1 - 0.5 mg/1 mL
n=3 Participants
VM202 (Engensis) 0.5 mg/1 mL was intramyocardially injected into 4 sites 0.125 mg/0.25 mL/injection point) of the incompletely revascularized area after Coronary Artery Bypass Graft.
|
Group 2 - 1.0 mg/2 mL
n=3 Participants
VM202 (Engensis) 1 mg/2 mL was intramyocardially injected into 8 sites (0.125 mg/0.25 mL/injection point) of the incompletely revascularized area after Coronary Artery Bypass Graft.
|
Group 3 - 2 mg/4 mL
n=3 Participants
VM202 (Engensis) 2 mg/4 mL was intramyocardially injected into 8 sites (0.25 mg/0.5 mL/injection point) of the incompletely revascularized area after Coronary Artery Bypass Graft.
|
|---|---|---|---|
|
Changes in Myocardial Ischemic Area - Stress Condition
Week 12
|
7.83 percentage of Perfusion Volume
Standard Deviation 7.91
|
8.33 percentage of Perfusion Volume
Standard Deviation 1.53
|
1.67 percentage of Perfusion Volume
Standard Deviation 7.75
|
|
Changes in Myocardial Ischemic Area - Stress Condition
Week 24
|
7.50 percentage of Perfusion Volume
Standard Deviation 7.07
|
5.00 percentage of Perfusion Volume
Standard Deviation 1.50
|
5.33 percentage of Perfusion Volume
Standard Deviation 8.13
|
SECONDARY outcome
Timeframe: Day 0, 12 weeks, 24 weeksPopulation: Intent to Treat - Changes in Myocardial Ischemic Area evaluated by SPECT based on Percentage of perfusion volume - Resting Condition
Changes in Myocardial Ischemic Area evaluated by 99mTc Sestamibi Methoxyl Isobutyl Isonitrile Single Photon Emission Computed Tomography (SPECT) based on Percentage of perfusion volume - Resting Condition
Outcome measures
| Measure |
Group 1 - 0.5 mg/1 mL
n=3 Participants
VM202 (Engensis) 0.5 mg/1 mL was intramyocardially injected into 4 sites 0.125 mg/0.25 mL/injection point) of the incompletely revascularized area after Coronary Artery Bypass Graft.
|
Group 2 - 1.0 mg/2 mL
n=3 Participants
VM202 (Engensis) 1 mg/2 mL was intramyocardially injected into 8 sites (0.125 mg/0.25 mL/injection point) of the incompletely revascularized area after Coronary Artery Bypass Graft.
|
Group 3 - 2 mg/4 mL
n=3 Participants
VM202 (Engensis) 2 mg/4 mL was intramyocardially injected into 8 sites (0.25 mg/0.5 mL/injection point) of the incompletely revascularized area after Coronary Artery Bypass Graft.
|
|---|---|---|---|
|
Changes in Myocardial Ischemic Area - Resting Condition
Week 12
|
7.33 percentage of Perfusion Volume
Standard Deviation 8.50
|
0.83 percentage of Perfusion Volume
Standard Deviation 1.53
|
4.67 percentage of Perfusion Volume
Standard Deviation 4.86
|
|
Changes in Myocardial Ischemic Area - Resting Condition
Week 24
|
-3.50 percentage of Perfusion Volume
Standard Deviation 0.71
|
1.33 percentage of Perfusion Volume
Standard Deviation 2.75
|
5.17 percentage of Perfusion Volume
Standard Deviation 10.41
|
Adverse Events
Group 1 - VM202 - 0.5 mg/ 1mL
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Group 2 - VM202 - 1.0 mg/2 mL
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Group 3 - VM202 - 2 mg/4 mL
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1 - VM202 - 0.5 mg/ 1mL
n=3 participants at risk
VM202RY 0.5mg/1mL was intramyocardially injected into 4 sites
|
Group 2 - VM202 - 1.0 mg/2 mL
n=3 participants at risk
VM202RY 1mg/2mL was intramyocardially injected into 8 sites
|
Group 3 - VM202 - 2 mg/4 mL
n=3 participants at risk
VM202RY 2mg/4mL was intramyocardially injected into 8 sites
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Worsening Spinal Stenosis
|
33.3%
1/3 • Number of events 1 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
|
Infections and infestations
Infectious Spondylitis
|
33.3%
1/3 • Number of events 1 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
Other adverse events
| Measure |
Group 1 - VM202 - 0.5 mg/ 1mL
n=3 participants at risk
VM202RY 0.5mg/1mL was intramyocardially injected into 4 sites
|
Group 2 - VM202 - 1.0 mg/2 mL
n=3 participants at risk
VM202RY 1mg/2mL was intramyocardially injected into 8 sites
|
Group 3 - VM202 - 2 mg/4 mL
n=3 participants at risk
VM202RY 2mg/4mL was intramyocardially injected into 8 sites
|
|---|---|---|---|
|
Cardiac disorders
Supraventricular extrasystoles
|
100.0%
3/3 • Number of events 4 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
33.3%
1/3 • Number of events 1 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
66.7%
2/3 • Number of events 5 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
100.0%
3/3 • Number of events 5 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
|
Cardiac disorders
Sinus tachycardia
|
33.3%
1/3 • Number of events 1 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
33.3%
1/3 • Number of events 2 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
33.3%
1/3 • Number of events 1 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
|
Cardiac disorders
Supraventricular tachycardia
|
33.3%
1/3 • Number of events 1 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
33.3%
1/3 • Number of events 1 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
|
Cardiac disorders
Extrasystoles
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
33.3%
1/3 • Number of events 1 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
33.3%
1/3 • Number of events 1 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
33.3%
1/3 • Number of events 1 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
33.3%
1/3 • Number of events 1 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
33.3%
1/3 • Number of events 1 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
1/3 • Number of events 3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
|
Gastrointestinal disorders
Dyspepsia
|
33.3%
1/3 • Number of events 2 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
33.3%
1/3 • Number of events 1 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Number of events 1 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
33.3%
1/3 • Number of events 1 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
|
Gastrointestinal disorders
Abdominal discomfort
|
33.3%
1/3 • Number of events 2 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
|
Gastrointestinal disorders
Colitis
|
33.3%
1/3 • Number of events 2 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • Number of events 1 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
33.3%
1/3 • Number of events 1 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
|
Gastrointestinal disorders
Faecal incontinence
|
33.3%
1/3 • Number of events 1 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
|
Gastrointestinal disorders
Abdominal pain upper
|
33.3%
1/3 • Number of events 1 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
|
Gastrointestinal disorders
Faecaloma
|
33.3%
1/3 • Number of events 1 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
|
Gastrointestinal disorders
Mouth ulceration
|
33.3%
1/3 • Number of events 1 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
33.3%
1/3 • Number of events 1 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
|
Injury, poisoning and procedural complications
Wound Complication
|
33.3%
1/3 • Number of events 3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
100.0%
3/3 • Number of events 3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
100.0%
3/3 • Number of events 3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
66.7%
2/3 • Number of events 2 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
33.3%
1/3 • Number of events 1 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
1/3 • Number of events 3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
33.3%
1/3 • Number of events 1 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3 • Number of events 1 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • Number of events 1 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
33.3%
1/3 • Number of events 1 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
33.3%
1/3 • Number of events 1 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
33.3%
1/3 • Number of events 1 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
|
General disorders
Chills
|
66.7%
2/3 • Number of events 2 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
|
General disorders
Chest pain
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
33.3%
1/3 • Number of events 2 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
|
General disorders
Pyrexia
|
33.3%
1/3 • Number of events 1 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
|
General disorders
Irritability
|
33.3%
1/3 • Number of events 1 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
33.3%
1/3 • Number of events 1 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
33.3%
1/3 • Number of events 4 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
33.3%
1/3 • Number of events 2 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
33.3%
1/3 • Number of events 1 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
33.3%
1/3 • Number of events 1 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
|
Eye disorders
Asthenopia
|
33.3%
1/3 • Number of events 1 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
|
Eye disorders
Retinopathy hypertensive
|
33.3%
1/3 • Number of events 1 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
|
Eye disorders
Cataract
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
33.3%
1/3 • Number of events 1 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
|
Eye disorders
Dry eye
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
33.3%
1/3 • Number of events 1 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
|
Eye disorders
Foreign body sensation in eyes
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
33.3%
1/3 • Number of events 1 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
33.3%
1/3 • Number of events 3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
1/3 • Number of events 1 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
33.3%
1/3 • Number of events 1 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
|
Renal and urinary disorders
Urinary retention
|
33.3%
1/3 • Number of events 4 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
33.3%
1/3 • Number of events 1 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
|
Nervous system disorders
Headache
|
66.7%
2/3 • Number of events 2 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
|
Nervous system disorders
Dizziness
|
33.3%
1/3 • Number of events 1 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
|
Nervous system disorders
Periphery motor neuropathy
|
33.3%
1/3 • Number of events 1 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
33.3%
1/3 • Number of events 3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
|
Infections and infestations
Herpes zoster
|
33.3%
1/3 • Number of events 1 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
|
Infections and infestations
Infective spondylitis
|
33.3%
1/3 • Number of events 1 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
|
Vascular disorders
Phlebitis
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
33.3%
1/3 • Number of events 1 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
33.3%
1/3 • Number of events 1 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
|
Psychiatric disorders
Insomnia
|
33.3%
1/3 • Number of events 1 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
0.00%
0/3 • 6 months
The incidence and the number of cases for all the treatment-emergent AEs and the investigational product-related ADRs
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place