Trial Outcomes & Findings for Extension of Phase 3 Gene Therapy for Painful Diabetic Neuropathy (NCT NCT04055090)
NCT ID: NCT04055090
Last Updated: 2025-10-09
Results Overview
Long-term (6 months) safety in terms of the incidence of Treatment-emergent Adverse Events and Treatment-emergent Serious Adverse Events for Subjects who received Engensis or Placebo (in the prior VMDN-003 study)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
101 participants
Primary outcome timeframe
Baseline through Day 365
Results posted on
2025-10-09
Participant Flow
Participant milestones
| Measure |
Subjects Who Received Engensis (VM202)
VM202- Engensis
Long-Term Follow-Up of Patients who Received Engensis (VM202): No study drug is administered in this study.
Patients who received Engensis (VM202) in a previous trial will be evaluated in this trial for long-term safety and efficacy.
|
Subjects Who Received Placebo
Placebo, vehicle
Long-Term Follow-Up of Patients who Received Placebo: No study drug is administered in this study.
Patients who received Placebo in a previous trial will be evaluated in this trial for long-term safety and efficacy.
|
|---|---|---|
|
Overall Study
STARTED
|
65
|
36
|
|
Overall Study
COMPLETED
|
63
|
36
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Subjects Who Received Engensis (VM202)
VM202- Engensis
Long-Term Follow-Up of Patients who Received Engensis (VM202): No study drug is administered in this study.
Patients who received Engensis (VM202) in a previous trial will be evaluated in this trial for long-term safety and efficacy.
|
Subjects Who Received Placebo
Placebo, vehicle
Long-Term Follow-Up of Patients who Received Placebo: No study drug is administered in this study.
Patients who received Placebo in a previous trial will be evaluated in this trial for long-term safety and efficacy.
|
|---|---|---|
|
Overall Study
screen failure
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
The race for one subject who screen failed was missing
Baseline characteristics by cohort
| Measure |
Subjects Who Received Engensis (VM202)
n=65 Participants
VM202- Engensis
Long-Term Follow-Up of Patients who Received Engensis (VM202): No study drug is administered in this study.
Patients who received Engensis (VM202) in a previous trial will be evaluated in this trial for long-term safety and efficacy.
|
Subjects Who Received Placebo
n=36 Participants
Placebo, vehicle
Long-Term Follow-Up of Patients who Received Placebo: No study drug is administered in this study.
Patients who received Placebo in a previous trial will be evaluated in this trial for long-term safety and efficacy.
|
Total
n=101 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
32 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
33 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
49 Participants
n=206 Participants
|
|
Age, Continuous
|
61.6 years
STANDARD_DEVIATION 8.87 • n=99 Participants
|
61.4 years
STANDARD_DEVIATION 8.98 • n=107 Participants
|
61.5 years
STANDARD_DEVIATION 8.86 • n=206 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
68 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Race · American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Race · Asian
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Race · Black or African American
|
9 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Race · White
|
53 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
81 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Race · More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Race · Unknown or Not Reported
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
65 participants
n=99 Participants
|
36 participants
n=107 Participants
|
101 participants
n=206 Participants
|
|
Gabapentin and/or Pregabalin Use
|
31 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
|
Diabetes Type
Type I diabetes
|
2 Participants
n=99 Participants • The race for one subject who screen failed was missing
|
2 Participants
n=107 Participants • The race for one subject who screen failed was missing
|
4 Participants
n=206 Participants • The race for one subject who screen failed was missing
|
|
Diabetes Type
Type II diabetes
|
62 Participants
n=99 Participants • The race for one subject who screen failed was missing
|
34 Participants
n=107 Participants • The race for one subject who screen failed was missing
|
96 Participants
n=206 Participants • The race for one subject who screen failed was missing
|
|
Diabetes Type
Not reported
|
1 Participants
n=99 Participants • The race for one subject who screen failed was missing
|
0 Participants
n=107 Participants • The race for one subject who screen failed was missing
|
1 Participants
n=206 Participants • The race for one subject who screen failed was missing
|
|
Body Mass Index
|
32.7 kg/m^2
STANDARD_DEVIATION 4.79 • n=99 Participants
|
33.2 kg/m^2
STANDARD_DEVIATION 5.45 • n=107 Participants
|
32.9 kg/m^2
STANDARD_DEVIATION 5.01 • n=206 Participants
|
|
HbA1c
|
7.37 percent of glycosylated hemoglobin
STANDARD_DEVIATION 1.19 • n=99 Participants
|
7.22 percent of glycosylated hemoglobin
STANDARD_DEVIATION 0.95 • n=107 Participants
|
7.31 percent of glycosylated hemoglobin
STANDARD_DEVIATION 1.11 • n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline through Day 365Population: Safety population
Long-term (6 months) safety in terms of the incidence of Treatment-emergent Adverse Events and Treatment-emergent Serious Adverse Events for Subjects who received Engensis or Placebo (in the prior VMDN-003 study)
Outcome measures
| Measure |
Subjects Who Received Engensis (VM202)
n=65 Participants
VM202- Engensis
Long-Term Follow-Up of Patients who Received Engensis (VM202): No study drug is administered in this study.
Patients who received Engensis (VM202) in the previous trial (VMDN-003) will remain blinded and were evaluated in this blinded trial for long-term safety and efficacy.
|
Subjects Who Received Placebo
n=36 Participants
Placebo, vehicle
Long-Term Follow-Up of Patients who Received Placebo: No study drug is administered in this study.
Patients who received placebo in the previous trial (VMDN-003) will remain blinded and were evaluated in this blinded trial for long-term safety and efficacy.
|
|---|---|---|
|
Long-term Safety for Engensis Versus Placebo
Subjects with at least one Treatment-emergent Adverse Event (TEAE)
|
10 Participants
|
8 Participants
|
|
Long-term Safety for Engensis Versus Placebo
Subjects with at least one Treatment-emergent Serious Adverse Event (TESAE)
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline to the Day 365Population: ITT population
The Average 24-hour Pain Score was obtained from the Daily Pain and Sleep Interference Diary. The change in the Average 24-hour Pain Score was determined from baseline (Day 0 of Study VMDN-003) to the Day 365 visit. The Average 24-hour Pain Score is an 11-point numerical scale with scores from 0 (No Pain) to 10 (Worst Possible Pain).
Outcome measures
| Measure |
Subjects Who Received Engensis (VM202)
n=65 Participants
VM202- Engensis
Long-Term Follow-Up of Patients who Received Engensis (VM202): No study drug is administered in this study.
Patients who received Engensis (VM202) in the previous trial (VMDN-003) will remain blinded and were evaluated in this blinded trial for long-term safety and efficacy.
|
Subjects Who Received Placebo
n=36 Participants
Placebo, vehicle
Long-Term Follow-Up of Patients who Received Placebo: No study drug is administered in this study.
Patients who received placebo in the previous trial (VMDN-003) will remain blinded and were evaluated in this blinded trial for long-term safety and efficacy.
|
|---|---|---|
|
The Change in the Average 24-hour Pain Score From Baseline (Day 0 of Study VMDN-003) to Day 365 for Engensis Versus Placebo
|
-2.32 score on a scale
Standard Deviation 2.36
|
-1.49 score on a scale
Standard Deviation 1.76
|
SECONDARY outcome
Timeframe: Day 270 to Day 365Population: Intent-to-Treat population
The Average 24-hour Pain Score is from the Daily Pain and Sleep Interference Diary. The change in the Average 24-hour Pain Score was determined for Day 270 to Day 365. The Average 24-hour Pain Score is an 11-point numerical scale with scores from 0 (No Pain) to 10 (Worst Possible Pain).
Outcome measures
| Measure |
Subjects Who Received Engensis (VM202)
n=65 Participants
VM202- Engensis
Long-Term Follow-Up of Patients who Received Engensis (VM202): No study drug is administered in this study.
Patients who received Engensis (VM202) in the previous trial (VMDN-003) will remain blinded and were evaluated in this blinded trial for long-term safety and efficacy.
|
Subjects Who Received Placebo
n=36 Participants
Placebo, vehicle
Long-Term Follow-Up of Patients who Received Placebo: No study drug is administered in this study.
Patients who received placebo in the previous trial (VMDN-003) will remain blinded and were evaluated in this blinded trial for long-term safety and efficacy.
|
|---|---|---|
|
Change in the Average 24-hour Pain Score From Day 270 to Day 365 for Engensis Versus Placebo
|
0.26 score on a scale
Standard Deviation 1.525
|
0.29 score on a scale
Standard Deviation 1.430
|
SECONDARY outcome
Timeframe: At the Day 365 visitPopulation: Intent-to-Treat population
The Patient's Global Impression of Change was completed by subjects (self-administered) at the Day 365 visit. The subject evaluated how his/her overall status had changed since the start of the study using a 7-point Patient's Global Impression of Change questionnaire scale, where 1 = Very Much Improved, 2 = Much Improved, 3 = Minimally Improved, 4 = No Change, 5 = Minimally Worse, 6 = Much Worse, and 7 = Very Much Worse. The Outcome Measure was the Patient's Global Impression of Change Categories of Scores as follows: 1 = Very Much Improved or Much Improved, 0 = Minimally Improved/Worsened or No Change, and -1 = Much Worse or Very Much Worse.
Outcome measures
| Measure |
Subjects Who Received Engensis (VM202)
n=65 Participants
VM202- Engensis
Long-Term Follow-Up of Patients who Received Engensis (VM202): No study drug is administered in this study.
Patients who received Engensis (VM202) in the previous trial (VMDN-003) will remain blinded and were evaluated in this blinded trial for long-term safety and efficacy.
|
Subjects Who Received Placebo
n=36 Participants
Placebo, vehicle
Long-Term Follow-Up of Patients who Received Placebo: No study drug is administered in this study.
Patients who received placebo in the previous trial (VMDN-003) will remain blinded and were evaluated in this blinded trial for long-term safety and efficacy.
|
|---|---|---|
|
Patient's Global Impression of Change at the Day 365 Visit for Engensis Versus Placebo
1: Very much improved or much improved
|
31 Participants
|
14 Participants
|
|
Patient's Global Impression of Change at the Day 365 Visit for Engensis Versus Placebo
0: Minimally improved/worsened or no change
|
31 Participants
|
20 Participants
|
|
Patient's Global Impression of Change at the Day 365 Visit for Engensis Versus Placebo
-1: Much worse or very much worse
|
1 Participants
|
2 Participants
|
|
Patient's Global Impression of Change at the Day 365 Visit for Engensis Versus Placebo
Not Reported
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to Day 365Population: Intent-to-Treat population subgroup analysis of Subjects without gabapentin and/or pregabalin use
The Average 24-hour Pain Score was obtained from the Daily Pain and Sleep Interference Diary and the change in the Average 24-hour Pain Score from baseline (Day 0 of Study VMDN-003) to the Day 365 follow-up was determined. The Average 24-hour Pain Score is an 11-point numerical scale with scores from 0 (No Pain) to 10 (Worst Possible Pain).
Outcome measures
| Measure |
Subjects Who Received Engensis (VM202)
n=34 Participants
VM202- Engensis
Long-Term Follow-Up of Patients who Received Engensis (VM202): No study drug is administered in this study.
Patients who received Engensis (VM202) in the previous trial (VMDN-003) will remain blinded and were evaluated in this blinded trial for long-term safety and efficacy.
|
Subjects Who Received Placebo
n=19 Participants
Placebo, vehicle
Long-Term Follow-Up of Patients who Received Placebo: No study drug is administered in this study.
Patients who received placebo in the previous trial (VMDN-003) will remain blinded and were evaluated in this blinded trial for long-term safety and efficacy.
|
|---|---|---|
|
Subgroup Analysis of the Change in the Average 24-hour Pain Score From Baseline (Day 0 of Study VMDN-003) to Day 365 for Engensis Versus Placebo for Subjects Without Gabapentin and/or Pregabalin Use at Baseline
|
-2.30 score on a scale
Standard Error 0.352
|
-0.82 score on a scale
Standard Error 0.470
|
Adverse Events
Subjects Who Received Engensis (VM202)
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Subjects Who Received Placebo
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Subjects Who Received Engensis (VM202)
n=65 participants at risk
VM202- Engensis
Long-Term Follow-Up of Patients who Received Engensis (VM202): No study drug is administered in this study.
Patients who received Engensis (VM202) in a previous trial will be evaluated in this trial for long-term safety and efficacy.
|
Subjects Who Received Placebo
n=36 participants at risk
Placebo, vehicle
Long-Term Follow-Up of Patients who Received Placebo: No study drug is administered in this study.
Patients who received Placebo in a previous trial will be evaluated in this trial for long-term safety and efficacy.
|
|---|---|---|
|
Cardiac disorders
acute left ventricular failure
|
0.00%
0/65 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
2.8%
1/36 • Number of events 1 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
|
Cardiac disorders
Palpitations
|
1.5%
1/65 • Number of events 1 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
0.00%
0/36 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
|
General disorders
Chest pain
|
1.5%
1/65 • Number of events 1 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
0.00%
0/36 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/65 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
2.8%
1/36 • Number of events 1 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
Other adverse events
| Measure |
Subjects Who Received Engensis (VM202)
n=65 participants at risk
VM202- Engensis
Long-Term Follow-Up of Patients who Received Engensis (VM202): No study drug is administered in this study.
Patients who received Engensis (VM202) in a previous trial will be evaluated in this trial for long-term safety and efficacy.
|
Subjects Who Received Placebo
n=36 participants at risk
Placebo, vehicle
Long-Term Follow-Up of Patients who Received Placebo: No study drug is administered in this study.
Patients who received Placebo in a previous trial will be evaluated in this trial for long-term safety and efficacy.
|
|---|---|---|
|
Infections and infestations
Acute sinusitis
|
1.5%
1/65 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
0.00%
0/36 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
|
Infections and infestations
Bronchitis
|
1.5%
1/65 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
0.00%
0/36 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
|
Infections and infestations
Diverticulitis
|
1.5%
1/65 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
0.00%
0/36 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/65 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
2.8%
1/36 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
|
Infections and infestations
Nasopharyngitis
|
1.5%
1/65 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
0.00%
0/36 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
|
Infections and infestations
Viral infection
|
0.00%
0/65 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
2.8%
1/36 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.5%
1/65 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
2.8%
1/36 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/65 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
2.8%
1/36 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/65 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
2.8%
1/36 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/65 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
2.8%
1/36 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/65 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
2.8%
1/36 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/65 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
2.8%
1/36 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/65 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
2.8%
1/36 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/65 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
2.8%
1/36 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
|
Metabolism and nutrition disorders
Dehydration
|
1.5%
1/65 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
0.00%
0/36 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.5%
1/65 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
0.00%
0/36 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/65 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
2.8%
1/36 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/65 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
2.8%
1/36 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
|
Nervous system disorders
Amnesia
|
0.00%
0/65 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
2.8%
1/36 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
|
Nervous system disorders
Headache
|
0.00%
0/65 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
2.8%
1/36 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
|
Nervous system disorders
Nerve compression
|
1.5%
1/65 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
0.00%
0/36 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.5%
1/65 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
0.00%
0/36 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/65 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
2.8%
1/36 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/65 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
2.8%
1/36 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
|
Gastrointestinal disorders
Anal skin tags
|
0.00%
0/65 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
2.8%
1/36 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/65 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
2.8%
1/36 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/65 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
2.8%
1/36 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
|
General disorders
Oedema peripheral
|
1.5%
1/65 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
0.00%
0/36 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
1.5%
1/65 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
0.00%
0/36 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
|
Injury, poisoning and procedural complications
Contusion
|
1.5%
1/65 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
0.00%
0/36 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
|
Injury, poisoning and procedural complications
Fall
|
1.5%
1/65 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
0.00%
0/36 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
|
Vascular disorders
Hypertension
|
0.00%
0/65 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
2.8%
1/36 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
|
Vascular disorders
Hypotension
|
1.5%
1/65 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
0.00%
0/36 • Adverse event data were collected from Day 270 (start of VMDN-003b study) to Day 365
Treatment-emergent adverse events
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Investigator Agreement
- Publication restrictions are in place
Restriction type: OTHER