Trial Outcomes & Findings for Safety and Efficacy Study Using Gene Therapy for Critical Limb Ischemia (NCT NCT01064440)
NCT ID: NCT01064440
Last Updated: 2025-10-06
Results Overview
The number of participants with treatment-emergent adverse events (TEAEs), defined as adverse events occurring after the first injection of Engensis (VM202), was assessed in moderate or high-risk Critical Limb Ischemia subjects.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
52 participants
Primary outcome timeframe
Baseline - Days 0, 14, 28, 42, 49, 90, 180, 270 and 365
Results posted on
2025-10-06
Participant Flow
Participant milestones
| Measure |
Low Dose Engensis (8 mg)
Subjects in this group received 8 mg total of Engensis (VM202) Day 0: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day14: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day 28: 16 injections of 0.5 mL of normal saline Day 42: 16 injections of 0.5 mL of normal saline
Low Dose VM202: Day 0: 4mg of VM202 (16 injections of 0.5ml of VM202) Day14: 4mg of VM202 (16 injections of 0.5ml of VM202)
Placebo: Day 0: 16 injections of 0.5ml of normal saline Day 14: 16 injections of 0.5ml of normal saline Day 28: 16 injections of 0.5ml of normal saline Day 42: 16 injections of 0.5ml of normal saline
|
High Dose Engensis (16 mg)
Subjects in this treatment group received a total of 16 mg Engensis (VM202) Day 0: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day14: 4 mg of Engensis (16 injections of 0.5 mL Engensis) Day 28: 4 mg of Engensis (16 injections of 0.5 mL Engensis) Day42: 4 mg of Engensis (16 injections of 0.5 mL Engensis)
High Dose Engensis: Day 0: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day 14: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day 28: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day 42: 4 mg Engensis (16 injections of 0.5 mL Engensis)
|
Placebo
Subjects in this group will receive a total of 8ml normal saline. Day 0: 16 injections of 0.5 mL of normal saline Day 14: 16 injections of 0.5 mL of normal saline Day 28: 16 injections of 0.5 mL of normal saline Day 42: 16 injections of 0.5 mL of normal saline
Placebo: Day 0: 16 injections of 0.5 mL of normal saline Day 14: 16 injections of 0.5 mL of normal saline Day 28: 16 injections of 0.5 mL of normal saline Day 42: 16 injections of 0.5 mL of normal saline
|
|---|---|---|---|
|
Overall Study
STARTED
|
21
|
20
|
11
|
|
Overall Study
COMPLETED
|
18
|
17
|
8
|
|
Overall Study
NOT COMPLETED
|
3
|
3
|
3
|
Reasons for withdrawal
| Measure |
Low Dose Engensis (8 mg)
Subjects in this group received 8 mg total of Engensis (VM202) Day 0: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day14: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day 28: 16 injections of 0.5 mL of normal saline Day 42: 16 injections of 0.5 mL of normal saline
Low Dose VM202: Day 0: 4mg of VM202 (16 injections of 0.5ml of VM202) Day14: 4mg of VM202 (16 injections of 0.5ml of VM202)
Placebo: Day 0: 16 injections of 0.5ml of normal saline Day 14: 16 injections of 0.5ml of normal saline Day 28: 16 injections of 0.5ml of normal saline Day 42: 16 injections of 0.5ml of normal saline
|
High Dose Engensis (16 mg)
Subjects in this treatment group received a total of 16 mg Engensis (VM202) Day 0: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day14: 4 mg of Engensis (16 injections of 0.5 mL Engensis) Day 28: 4 mg of Engensis (16 injections of 0.5 mL Engensis) Day42: 4 mg of Engensis (16 injections of 0.5 mL Engensis)
High Dose Engensis: Day 0: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day 14: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day 28: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day 42: 4 mg Engensis (16 injections of 0.5 mL Engensis)
|
Placebo
Subjects in this group will receive a total of 8ml normal saline. Day 0: 16 injections of 0.5 mL of normal saline Day 14: 16 injections of 0.5 mL of normal saline Day 28: 16 injections of 0.5 mL of normal saline Day 42: 16 injections of 0.5 mL of normal saline
Placebo: Day 0: 16 injections of 0.5 mL of normal saline Day 14: 16 injections of 0.5 mL of normal saline Day 28: 16 injections of 0.5 mL of normal saline Day 42: 16 injections of 0.5 mL of normal saline
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
1
|
|
Overall Study
Non-compliance
|
0
|
1
|
0
|
|
Overall Study
Death
|
1
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
|
Overall Study
Other: amputation
|
1
|
0
|
0
|
Baseline Characteristics
Safety and Efficacy Study Using Gene Therapy for Critical Limb Ischemia
Baseline characteristics by cohort
| Measure |
Engensis 8 mg
n=21 Participants
Subjects in this group received 8 mg total of Engensis (VM202) Day 0: 4 mg Engensis (16 injections of 0.5 mL, 0.25 mg Engensis) Day14: 4 mg Engensis (16 injections of 0.5 mL. 0.25 mg Engensis) Day 28: 16 injections of 0.5 mL of normal saline Day 42: 16 injections of 0.5 mL of normal saline
|
Engensis 16 mg
n=20 Participants
Subjects in this group received a total of 16 mg Engensis (VM202) Day 0: 4 mg Engensis (16 injections of 0.5 mL, 0.25 mg Engensis) Day14: 4 mg of Engensis (16 injections of 0.5 mL, 0.25 mg Engensis) Day 28: 4 mg of Engensis (16 injections of 0.5 mL, 0.25 mg Engensis) Day42: 4 mg of Engensis (16 injections of 0.5 mL, 0.25 mg Engensis)
|
Placebo
n=11 Participants
Subjects in this group received a total of 8 mL normal saline. Day 0: 16 injections of 0.5 mL of normal saline Day 14: 16 injections of 0.5 mL of normal saline Day 28: 16 injections of 0.5 mL of normal saline Day 42: 16 injections of 0.5 mL of normal saline
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
65.9 years
STANDARD_DEVIATION 10.7 • n=99 Participants
|
67.2 years
STANDARD_DEVIATION 10.9 • n=107 Participants
|
64.3 years
STANDARD_DEVIATION 14.5 • n=206 Participants
|
NA years
STANDARD_DEVIATION NA • n=7 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
19 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
33 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
30 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Region of Enrollment
South Korea
|
2 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
1 participants
n=7 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=99 Participants
|
19 participants
n=107 Participants
|
9 participants
n=206 Participants
|
51 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline - Days 0, 14, 28, 42, 49, 90, 180, 270 and 365Population: The Safety Population included all subjects who received at least 1 study drug injection of Engensis or Placebo
The number of participants with treatment-emergent adverse events (TEAEs), defined as adverse events occurring after the first injection of Engensis (VM202), was assessed in moderate or high-risk Critical Limb Ischemia subjects.
Outcome measures
| Measure |
Low Dose Engensis (8 mg)
n=21 Participants
Subjects in this group received 8 mg total of Engensis (VM202) Day 0: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day14: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day 28: 16 injections of 0.5 mL of normal saline Day 42: 16 injections of 0.5 mL of normal saline
Low Dose VM202: Day 0: 4mg of VM202 (16 injections of 0.5ml of VM202) Day14: 4mg of VM202 (16 injections of 0.5ml of VM202)
Placebo: Day 0: 16 injections of 0.5ml of normal saline Day 14: 16 injections of 0.5ml of normal saline Day 28: 16 injections of 0.5ml of normal saline Day 42: 16 injections of 0.5ml of normal saline
|
High Dose Engensis (16 mg)
n=20 Participants
Subjects in this treatment group received a total of 16 mg Engensis (VM202) Day 0: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day14: 4 mg of Engensis (16 injections of 0.5 mL Engensis) Day 28: 4 mg of Engensis (16 injections of 0.5 mL Engensis) Day42: 4 mg of Engensis (16 injections of 0.5 mL Engensis)
High Dose Engensis: Day 0: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day 14: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day 28: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day 42: 4 mg Engensis (16 injections of 0.5 mL Engensis)
|
Placebo
n=11 Participants
Subjects in this group will receive a total of 8ml normal saline. Day 0: 16 injections of 0.5 mL of normal saline Day 14: 16 injections of 0.5 mL of normal saline Day 28: 16 injections of 0.5 mL of normal saline Day 42: 16 injections of 0.5 mL of normal saline
Placebo: Day 0: 16 injections of 0.5 mL of normal saline Day 14: 16 injections of 0.5 mL of normal saline Day 28: 16 injections of 0.5 mL of normal saline Day 42: 16 injections of 0.5 mL of normal saline
|
|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events Following Intramuscular Administration of 8 and 16 mg Engensis (VM202) or Placebo in Subjects With Critical Limb Ischemia.
Cellulitis
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Following Intramuscular Administration of 8 and 16 mg Engensis (VM202) or Placebo in Subjects With Critical Limb Ischemia.
Gangrene
|
0 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Following Intramuscular Administration of 8 and 16 mg Engensis (VM202) or Placebo in Subjects With Critical Limb Ischemia.
Urinary tract infection
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Following Intramuscular Administration of 8 and 16 mg Engensis (VM202) or Placebo in Subjects With Critical Limb Ischemia.
Wound infection
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Following Intramuscular Administration of 8 and 16 mg Engensis (VM202) or Placebo in Subjects With Critical Limb Ischemia.
Cystitis
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Following Intramuscular Administration of 8 and 16 mg Engensis (VM202) or Placebo in Subjects With Critical Limb Ischemia.
Gastrointestinal disorders
|
9 Participants
|
7 Participants
|
7 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Following Intramuscular Administration of 8 and 16 mg Engensis (VM202) or Placebo in Subjects With Critical Limb Ischemia.
Diarrhoea
|
3 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Following Intramuscular Administration of 8 and 16 mg Engensis (VM202) or Placebo in Subjects With Critical Limb Ischemia.
Vomiting
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Following Intramuscular Administration of 8 and 16 mg Engensis (VM202) or Placebo in Subjects With Critical Limb Ischemia.
Hiatus hernia
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Following Intramuscular Administration of 8 and 16 mg Engensis (VM202) or Placebo in Subjects With Critical Limb Ischemia.
General disorders and administration site conditions
|
12 Participants
|
6 Participants
|
5 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Following Intramuscular Administration of 8 and 16 mg Engensis (VM202) or Placebo in Subjects With Critical Limb Ischemia.
Infections and infestations
|
8 Participants
|
10 Participants
|
6 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Following Intramuscular Administration of 8 and 16 mg Engensis (VM202) or Placebo in Subjects With Critical Limb Ischemia.
Sinusitis
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Following Intramuscular Administration of 8 and 16 mg Engensis (VM202) or Placebo in Subjects With Critical Limb Ischemia.
Tooth Abscess
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Following Intramuscular Administration of 8 and 16 mg Engensis (VM202) or Placebo in Subjects With Critical Limb Ischemia.
Constipation
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Following Intramuscular Administration of 8 and 16 mg Engensis (VM202) or Placebo in Subjects With Critical Limb Ischemia.
Nausea
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Following Intramuscular Administration of 8 and 16 mg Engensis (VM202) or Placebo in Subjects With Critical Limb Ischemia.
Gastritis
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Following Intramuscular Administration of 8 and 16 mg Engensis (VM202) or Placebo in Subjects With Critical Limb Ischemia.
skin ulcer
|
4 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Following Intramuscular Administration of 8 and 16 mg Engensis (VM202) or Placebo in Subjects With Critical Limb Ischemia.
blister
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Following Intramuscular Administration of 8 and 16 mg Engensis (VM202) or Placebo in Subjects With Critical Limb Ischemia.
Oedema peripheral
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Following Intramuscular Administration of 8 and 16 mg Engensis (VM202) or Placebo in Subjects With Critical Limb Ischemia.
Injection site haematoma
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Following Intramuscular Administration of 8 and 16 mg Engensis (VM202) or Placebo in Subjects With Critical Limb Ischemia.
Pyrexia
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Following Intramuscular Administration of 8 and 16 mg Engensis (VM202) or Placebo in Subjects With Critical Limb Ischemia.
Musculoskeletal and connective tissue disorders
|
9 Participants
|
8 Participants
|
4 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Following Intramuscular Administration of 8 and 16 mg Engensis (VM202) or Placebo in Subjects With Critical Limb Ischemia.
Pain in extremity
|
4 Participants
|
6 Participants
|
2 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Following Intramuscular Administration of 8 and 16 mg Engensis (VM202) or Placebo in Subjects With Critical Limb Ischemia.
Muscle spasms
|
4 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Following Intramuscular Administration of 8 and 16 mg Engensis (VM202) or Placebo in Subjects With Critical Limb Ischemia.
Arthralgia
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Following Intramuscular Administration of 8 and 16 mg Engensis (VM202) or Placebo in Subjects With Critical Limb Ischemia.
Vascular disorders
|
9 Participants
|
7 Participants
|
4 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Following Intramuscular Administration of 8 and 16 mg Engensis (VM202) or Placebo in Subjects With Critical Limb Ischemia.
Peripheral arterial occlusive disease
|
2 Participants
|
4 Participants
|
1 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Following Intramuscular Administration of 8 and 16 mg Engensis (VM202) or Placebo in Subjects With Critical Limb Ischemia.
Arterial thrombosis limb
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Following Intramuscular Administration of 8 and 16 mg Engensis (VM202) or Placebo in Subjects With Critical Limb Ischemia.
Metabolism and nutrition disorders
|
5 Participants
|
6 Participants
|
5 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Following Intramuscular Administration of 8 and 16 mg Engensis (VM202) or Placebo in Subjects With Critical Limb Ischemia.
Hypoglycaemia
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Following Intramuscular Administration of 8 and 16 mg Engensis (VM202) or Placebo in Subjects With Critical Limb Ischemia.
Decreased appetite
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Following Intramuscular Administration of 8 and 16 mg Engensis (VM202) or Placebo in Subjects With Critical Limb Ischemia.
Hyperglycaemia
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Following Intramuscular Administration of 8 and 16 mg Engensis (VM202) or Placebo in Subjects With Critical Limb Ischemia.
Skin and subcutaneous tissue disorders
|
8 Participants
|
3 Participants
|
5 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Following Intramuscular Administration of 8 and 16 mg Engensis (VM202) or Placebo in Subjects With Critical Limb Ischemia.
Injury, poisoning and procedureal complications
|
8 Participants
|
3 Participants
|
4 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Following Intramuscular Administration of 8 and 16 mg Engensis (VM202) or Placebo in Subjects With Critical Limb Ischemia.
Contusion
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Following Intramuscular Administration of 8 and 16 mg Engensis (VM202) or Placebo in Subjects With Critical Limb Ischemia.
Procedural pain
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Following Intramuscular Administration of 8 and 16 mg Engensis (VM202) or Placebo in Subjects With Critical Limb Ischemia.
Limb injury
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Following Intramuscular Administration of 8 and 16 mg Engensis (VM202) or Placebo in Subjects With Critical Limb Ischemia.
Nervous system disorders
|
1 Participants
|
7 Participants
|
3 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Following Intramuscular Administration of 8 and 16 mg Engensis (VM202) or Placebo in Subjects With Critical Limb Ischemia.
Headache
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Following Intramuscular Administration of 8 and 16 mg Engensis (VM202) or Placebo in Subjects With Critical Limb Ischemia.
Phantom pain
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Following Intramuscular Administration of 8 and 16 mg Engensis (VM202) or Placebo in Subjects With Critical Limb Ischemia.
Dizziness
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Following Intramuscular Administration of 8 and 16 mg Engensis (VM202) or Placebo in Subjects With Critical Limb Ischemia.
Renal and urinary disorders
|
7 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Following Intramuscular Administration of 8 and 16 mg Engensis (VM202) or Placebo in Subjects With Critical Limb Ischemia.
Renal failure acute
|
5 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Following Intramuscular Administration of 8 and 16 mg Engensis (VM202) or Placebo in Subjects With Critical Limb Ischemia.
Respiratory, thoracic and mediastinal disorders
|
6 Participants
|
5 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Following Intramuscular Administration of 8 and 16 mg Engensis (VM202) or Placebo in Subjects With Critical Limb Ischemia.
Chronic obstructive pulmonary disease
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Following Intramuscular Administration of 8 and 16 mg Engensis (VM202) or Placebo in Subjects With Critical Limb Ischemia.
Dyspnoea
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Following Intramuscular Administration of 8 and 16 mg Engensis (VM202) or Placebo in Subjects With Critical Limb Ischemia.
Psychiatric disorders
|
4 Participants
|
5 Participants
|
1 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Following Intramuscular Administration of 8 and 16 mg Engensis (VM202) or Placebo in Subjects With Critical Limb Ischemia.
Anxiety
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Following Intramuscular Administration of 8 and 16 mg Engensis (VM202) or Placebo in Subjects With Critical Limb Ischemia.
Mental status changes
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Following Intramuscular Administration of 8 and 16 mg Engensis (VM202) or Placebo in Subjects With Critical Limb Ischemia.
Depression
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Following Intramuscular Administration of 8 and 16 mg Engensis (VM202) or Placebo in Subjects With Critical Limb Ischemia.
Blood and lymphatic system disorders
|
5 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Following Intramuscular Administration of 8 and 16 mg Engensis (VM202) or Placebo in Subjects With Critical Limb Ischemia.
Anaemia
|
4 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Following Intramuscular Administration of 8 and 16 mg Engensis (VM202) or Placebo in Subjects With Critical Limb Ischemia.
Cardiac disorders
|
3 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants With Treatment-emergent Adverse Events Following Intramuscular Administration of 8 and 16 mg Engensis (VM202) or Placebo in Subjects With Critical Limb Ischemia.
Acute myocardial infarction
|
0 Participants
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Days 0, 90, 180, 270, and 365Population: The Per-Protocol (PP) Population included all subjects who received the correct dose of study drug, had the 9-month (Day 270) VAS assessment, and did not have any protocol violations or major deviations. The PP Population was determined in a blinded review before database lock. Subjects were analyzed according to the treatment to which they were randomized. Primary efficacy analyses were performed on the PP population.
The Visual Analog Scale (VAS) for Pain scoring instrument is a 10 cm line, oriented horizontally, with the left end score of "0" indicating "no pain", and the right end score of "10" representing "pain as bad as it can be"
Outcome measures
| Measure |
Low Dose Engensis (8 mg)
n=15 Participants
Subjects in this group received 8 mg total of Engensis (VM202) Day 0: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day14: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day 28: 16 injections of 0.5 mL of normal saline Day 42: 16 injections of 0.5 mL of normal saline
Low Dose VM202: Day 0: 4mg of VM202 (16 injections of 0.5ml of VM202) Day14: 4mg of VM202 (16 injections of 0.5ml of VM202)
Placebo: Day 0: 16 injections of 0.5ml of normal saline Day 14: 16 injections of 0.5ml of normal saline Day 28: 16 injections of 0.5ml of normal saline Day 42: 16 injections of 0.5ml of normal saline
|
High Dose Engensis (16 mg)
n=12 Participants
Subjects in this treatment group received a total of 16 mg Engensis (VM202) Day 0: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day14: 4 mg of Engensis (16 injections of 0.5 mL Engensis) Day 28: 4 mg of Engensis (16 injections of 0.5 mL Engensis) Day42: 4 mg of Engensis (16 injections of 0.5 mL Engensis)
High Dose Engensis: Day 0: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day 14: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day 28: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day 42: 4 mg Engensis (16 injections of 0.5 mL Engensis)
|
Placebo
n=5 Participants
Subjects in this group will receive a total of 8ml normal saline. Day 0: 16 injections of 0.5 mL of normal saline Day 14: 16 injections of 0.5 mL of normal saline Day 28: 16 injections of 0.5 mL of normal saline Day 42: 16 injections of 0.5 mL of normal saline
Placebo: Day 0: 16 injections of 0.5 mL of normal saline Day 14: 16 injections of 0.5 mL of normal saline Day 28: 16 injections of 0.5 mL of normal saline Day 42: 16 injections of 0.5 mL of normal saline
|
|---|---|---|---|
|
Change From Baseline in Visual Analog Scale (VAS) for Pain
Day 270
|
-8.2 units on a scale
Standard Deviation 22.3
|
-34.5 units on a scale
Standard Deviation 39.6
|
-38.6 units on a scale
Standard Deviation 41.1
|
|
Change From Baseline in Visual Analog Scale (VAS) for Pain
Baseline (Day 0) - Actual values only
|
40.5 units on a scale
Standard Deviation 31.3
|
62.3 units on a scale
Standard Deviation 22.5
|
60.6 units on a scale
Standard Deviation 30.1
|
|
Change From Baseline in Visual Analog Scale (VAS) for Pain
Day 90
|
-13.0 units on a scale
Standard Deviation 15.1
|
-32.7 units on a scale
Standard Deviation 19.8
|
-29.0 units on a scale
Standard Deviation 19.9
|
|
Change From Baseline in Visual Analog Scale (VAS) for Pain
Day 180
|
-17.2 units on a scale
Standard Deviation 25.6
|
-28.9 units on a scale
Standard Deviation 31.1
|
-29.0 units on a scale
Standard Deviation 28.5
|
|
Change From Baseline in Visual Analog Scale (VAS) for Pain
Day 365
|
-17.6 units on a scale
Standard Deviation 30.3
|
-29.1 units on a scale
Standard Deviation 21.7
|
-45.8 units on a scale
Standard Deviation 30.8
|
SECONDARY outcome
Timeframe: Day 0 to Days 180, 270, and 365Population: The Intent-to-Treat population included all subjects who were randomized regardless of whether treatment was received
Tissue Oxygenation (TcPO2) measurement is reported for the dorsum of the foot. The change in baseline for the TcPO2 measured in the dorsal surface of the foot results are reported for each of the 3 study groups: 8 mg, or 16 mg for the Engensis (VM202) group, or the Placebo group. Because of the indication being peripheral vascular disease, the dorsal surface of the foot was decided by the sponsor to be a good representative of the lower extremity for any of the other measured sites.
Outcome measures
| Measure |
Low Dose Engensis (8 mg)
n=21 Participants
Subjects in this group received 8 mg total of Engensis (VM202) Day 0: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day14: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day 28: 16 injections of 0.5 mL of normal saline Day 42: 16 injections of 0.5 mL of normal saline
Low Dose VM202: Day 0: 4mg of VM202 (16 injections of 0.5ml of VM202) Day14: 4mg of VM202 (16 injections of 0.5ml of VM202)
Placebo: Day 0: 16 injections of 0.5ml of normal saline Day 14: 16 injections of 0.5ml of normal saline Day 28: 16 injections of 0.5ml of normal saline Day 42: 16 injections of 0.5ml of normal saline
|
High Dose Engensis (16 mg)
n=20 Participants
Subjects in this treatment group received a total of 16 mg Engensis (VM202) Day 0: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day14: 4 mg of Engensis (16 injections of 0.5 mL Engensis) Day 28: 4 mg of Engensis (16 injections of 0.5 mL Engensis) Day42: 4 mg of Engensis (16 injections of 0.5 mL Engensis)
High Dose Engensis: Day 0: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day 14: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day 28: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day 42: 4 mg Engensis (16 injections of 0.5 mL Engensis)
|
Placebo
n=11 Participants
Subjects in this group will receive a total of 8ml normal saline. Day 0: 16 injections of 0.5 mL of normal saline Day 14: 16 injections of 0.5 mL of normal saline Day 28: 16 injections of 0.5 mL of normal saline Day 42: 16 injections of 0.5 mL of normal saline
Placebo: Day 0: 16 injections of 0.5 mL of normal saline Day 14: 16 injections of 0.5 mL of normal saline Day 28: 16 injections of 0.5 mL of normal saline Day 42: 16 injections of 0.5 mL of normal saline
|
|---|---|---|---|
|
Change From Baseline in Tissue Oxygenation (TcPO2) for the Dorsal Surface of the Foot Following Engensis (VM202) or Placebo
Baseline (Day 0) Actual values only
|
33.4 mmHg
Standard Deviation 19.4
|
35.0 mmHg
Standard Deviation 18.4
|
40.3 mmHg
Standard Deviation 21.5
|
|
Change From Baseline in Tissue Oxygenation (TcPO2) for the Dorsal Surface of the Foot Following Engensis (VM202) or Placebo
Day 180
|
5.9 mmHg
Standard Deviation 19.7
|
7.1 mmHg
Standard Deviation 16.6
|
-9.6 mmHg
Standard Deviation 13.5
|
|
Change From Baseline in Tissue Oxygenation (TcPO2) for the Dorsal Surface of the Foot Following Engensis (VM202) or Placebo
Day 270
|
3.6 mmHg
Standard Deviation 19.0
|
1.7 mmHg
Standard Deviation 17.8
|
-7.1 mmHg
Standard Deviation 14.4
|
|
Change From Baseline in Tissue Oxygenation (TcPO2) for the Dorsal Surface of the Foot Following Engensis (VM202) or Placebo
Day 365
|
4.1 mmHg
Standard Deviation 20.5
|
13.4 mmHg
Standard Deviation 15.6
|
-9.1 mmHg
Standard Deviation 15.3
|
SECONDARY outcome
Timeframe: Days 0, 28, 90, 180, 270, and 365Population: Intent-to-treat population: includes all subjects who were randomized regardless of whether treatment was received
Change in the Resting Ankle-Brachial Index (ABI) from Baseline (Day 0) for the Index Leg to Days 180, 270, and 365. Note that by default, Day 0 has no change from baseline. Days 28 and 90 time point data was not included,as they were not relevant to assess efficacy, because of the delayed effect of Engensis, the investigational product.
Outcome measures
| Measure |
Low Dose Engensis (8 mg)
n=21 Participants
Subjects in this group received 8 mg total of Engensis (VM202) Day 0: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day14: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day 28: 16 injections of 0.5 mL of normal saline Day 42: 16 injections of 0.5 mL of normal saline
Low Dose VM202: Day 0: 4mg of VM202 (16 injections of 0.5ml of VM202) Day14: 4mg of VM202 (16 injections of 0.5ml of VM202)
Placebo: Day 0: 16 injections of 0.5ml of normal saline Day 14: 16 injections of 0.5ml of normal saline Day 28: 16 injections of 0.5ml of normal saline Day 42: 16 injections of 0.5ml of normal saline
|
High Dose Engensis (16 mg)
n=20 Participants
Subjects in this treatment group received a total of 16 mg Engensis (VM202) Day 0: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day14: 4 mg of Engensis (16 injections of 0.5 mL Engensis) Day 28: 4 mg of Engensis (16 injections of 0.5 mL Engensis) Day42: 4 mg of Engensis (16 injections of 0.5 mL Engensis)
High Dose Engensis: Day 0: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day 14: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day 28: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day 42: 4 mg Engensis (16 injections of 0.5 mL Engensis)
|
Placebo
n=11 Participants
Subjects in this group will receive a total of 8ml normal saline. Day 0: 16 injections of 0.5 mL of normal saline Day 14: 16 injections of 0.5 mL of normal saline Day 28: 16 injections of 0.5 mL of normal saline Day 42: 16 injections of 0.5 mL of normal saline
Placebo: Day 0: 16 injections of 0.5 mL of normal saline Day 14: 16 injections of 0.5 mL of normal saline Day 28: 16 injections of 0.5 mL of normal saline Day 42: 16 injections of 0.5 mL of normal saline
|
|---|---|---|---|
|
Change From Baseline in Hemodynamic Assessment for Ankle Brachial-Index (mmHg) for the Index Leg
Day 180
|
0.009 mm Hg
Standard Deviation 0.130
|
-0.004 mm Hg
Standard Deviation 0.239
|
0.112 mm Hg
Standard Deviation 0.267
|
|
Change From Baseline in Hemodynamic Assessment for Ankle Brachial-Index (mmHg) for the Index Leg
Day 270
|
0.006 mm Hg
Standard Deviation 0.181
|
0.010 mm Hg
Standard Deviation 0.276
|
0.042 mm Hg
Standard Deviation 0.216
|
|
Change From Baseline in Hemodynamic Assessment for Ankle Brachial-Index (mmHg) for the Index Leg
Day 365
|
-0.012 mm Hg
Standard Deviation 0.123
|
-0.011 mm Hg
Standard Deviation 0.277
|
-0.010 mm Hg
Standard Deviation 0.142
|
SECONDARY outcome
Timeframe: Day 0 to Days 180 and 270Population: ITT population or Per protocol population - Note: Only 1 subject had both a baseline and post-treatment MRA performed. Unfortunately, no quantitative perfusion data were collected.
The quantitative blood flow of the occluded target artery and the volumetric analysis of the newly developed artery by Magnetic Resonance Angiogram (MRA) were recorded. Note that "no change from baseline table of data" is not presented because there was only one subject with both a Baseline and Post Treatment value for Magnetic Resonance Angiogram (MRA) measurement.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 0, 14, 28, 42, 49, 90, 180, 270, and 365Population: Intent-to-Treat population
The length and width (in cm) was based on photographs and measurements of ulcers. If a ulcer was determined to be 100% healed, the area of the ulcer was set to 0
Outcome measures
| Measure |
Low Dose Engensis (8 mg)
n=13 Participants
Subjects in this group received 8 mg total of Engensis (VM202) Day 0: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day14: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day 28: 16 injections of 0.5 mL of normal saline Day 42: 16 injections of 0.5 mL of normal saline
Low Dose VM202: Day 0: 4mg of VM202 (16 injections of 0.5ml of VM202) Day14: 4mg of VM202 (16 injections of 0.5ml of VM202)
Placebo: Day 0: 16 injections of 0.5ml of normal saline Day 14: 16 injections of 0.5ml of normal saline Day 28: 16 injections of 0.5ml of normal saline Day 42: 16 injections of 0.5ml of normal saline
|
High Dose Engensis (16 mg)
n=8 Participants
Subjects in this treatment group received a total of 16 mg Engensis (VM202) Day 0: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day14: 4 mg of Engensis (16 injections of 0.5 mL Engensis) Day 28: 4 mg of Engensis (16 injections of 0.5 mL Engensis) Day42: 4 mg of Engensis (16 injections of 0.5 mL Engensis)
High Dose Engensis: Day 0: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day 14: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day 28: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day 42: 4 mg Engensis (16 injections of 0.5 mL Engensis)
|
Placebo
n=4 Participants
Subjects in this group will receive a total of 8ml normal saline. Day 0: 16 injections of 0.5 mL of normal saline Day 14: 16 injections of 0.5 mL of normal saline Day 28: 16 injections of 0.5 mL of normal saline Day 42: 16 injections of 0.5 mL of normal saline
Placebo: Day 0: 16 injections of 0.5 mL of normal saline Day 14: 16 injections of 0.5 mL of normal saline Day 28: 16 injections of 0.5 mL of normal saline Day 42: 16 injections of 0.5 mL of normal saline
|
|---|---|---|---|
|
Subjects With 100% Wound Healing
Day 270
|
7 Participants
|
3 Participants
|
0 Participants
|
|
Subjects With 100% Wound Healing
Day 14
|
1 Participants
|
3 Participants
|
0 Participants
|
|
Subjects With 100% Wound Healing
Day 28
|
1 Participants
|
4 Participants
|
0 Participants
|
|
Subjects With 100% Wound Healing
Day 42
|
2 Participants
|
4 Participants
|
0 Participants
|
|
Subjects With 100% Wound Healing
Day 49
|
2 Participants
|
4 Participants
|
0 Participants
|
|
Subjects With 100% Wound Healing
Day 90
|
4 Participants
|
4 Participants
|
0 Participants
|
|
Subjects With 100% Wound Healing
Day 180
|
8 Participants
|
4 Participants
|
0 Participants
|
|
Subjects With 100% Wound Healing
Day 365
|
5 Participants
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Days 0, 90, 270, and 365Population: Per-protocol population
The Vascular Quality of Life Total Score (VascuQol) questionnaire has 25 questions that reviewed five domains: activity level (8 items), symptoms (4 items), pain (4 items), emotional (7 items), and social (2 items). The total score is the total of the non-missing scored divided by the number of responded questions. The Vascular Quality of Life Total Score (VascuQol) scale is a 7-point scale with "1" as the worst change from baseline score, and "7" is the least change from baseline score.
Outcome measures
| Measure |
Low Dose Engensis (8 mg)
n=15 Participants
Subjects in this group received 8 mg total of Engensis (VM202) Day 0: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day14: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day 28: 16 injections of 0.5 mL of normal saline Day 42: 16 injections of 0.5 mL of normal saline
Low Dose VM202: Day 0: 4mg of VM202 (16 injections of 0.5ml of VM202) Day14: 4mg of VM202 (16 injections of 0.5ml of VM202)
Placebo: Day 0: 16 injections of 0.5ml of normal saline Day 14: 16 injections of 0.5ml of normal saline Day 28: 16 injections of 0.5ml of normal saline Day 42: 16 injections of 0.5ml of normal saline
|
High Dose Engensis (16 mg)
n=12 Participants
Subjects in this treatment group received a total of 16 mg Engensis (VM202) Day 0: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day14: 4 mg of Engensis (16 injections of 0.5 mL Engensis) Day 28: 4 mg of Engensis (16 injections of 0.5 mL Engensis) Day42: 4 mg of Engensis (16 injections of 0.5 mL Engensis)
High Dose Engensis: Day 0: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day 14: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day 28: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day 42: 4 mg Engensis (16 injections of 0.5 mL Engensis)
|
Placebo
n=5 Participants
Subjects in this group will receive a total of 8ml normal saline. Day 0: 16 injections of 0.5 mL of normal saline Day 14: 16 injections of 0.5 mL of normal saline Day 28: 16 injections of 0.5 mL of normal saline Day 42: 16 injections of 0.5 mL of normal saline
Placebo: Day 0: 16 injections of 0.5 mL of normal saline Day 14: 16 injections of 0.5 mL of normal saline Day 28: 16 injections of 0.5 mL of normal saline Day 42: 16 injections of 0.5 mL of normal saline
|
|---|---|---|---|
|
Change From Baseline in the Vascular Quality of Life Total Score
Baseline (Day 0) - Actual values only
|
3.57 score on a scale
Standard Deviation 1.13
|
3.20 score on a scale
Standard Deviation 1.15
|
3.50 score on a scale
Standard Deviation 1.60
|
|
Change From Baseline in the Vascular Quality of Life Total Score
Day 90
|
0.53 score on a scale
Standard Deviation 1.25
|
1.40 score on a scale
Standard Deviation 1.06
|
2.27 score on a scale
Standard Deviation 1.39
|
|
Change From Baseline in the Vascular Quality of Life Total Score
Day 270
|
0.55 score on a scale
Standard Deviation 1.16
|
1.26 score on a scale
Standard Deviation 1.53
|
2.30 score on a scale
Standard Deviation 1.34
|
|
Change From Baseline in the Vascular Quality of Life Total Score
Day 365
|
0.88 score on a scale
Standard Deviation 1.36
|
0.89 score on a scale
Standard Deviation 1.16
|
2.07 score on a scale
Standard Deviation 1.23
|
SECONDARY outcome
Timeframe: Day 0 through Day 365Population: Intent-to-treat population
The number and percentage of subjects with major amputations during the trial
Outcome measures
| Measure |
Low Dose Engensis (8 mg)
n=21 Participants
Subjects in this group received 8 mg total of Engensis (VM202) Day 0: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day14: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day 28: 16 injections of 0.5 mL of normal saline Day 42: 16 injections of 0.5 mL of normal saline
Low Dose VM202: Day 0: 4mg of VM202 (16 injections of 0.5ml of VM202) Day14: 4mg of VM202 (16 injections of 0.5ml of VM202)
Placebo: Day 0: 16 injections of 0.5ml of normal saline Day 14: 16 injections of 0.5ml of normal saline Day 28: 16 injections of 0.5ml of normal saline Day 42: 16 injections of 0.5ml of normal saline
|
High Dose Engensis (16 mg)
n=20 Participants
Subjects in this treatment group received a total of 16 mg Engensis (VM202) Day 0: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day14: 4 mg of Engensis (16 injections of 0.5 mL Engensis) Day 28: 4 mg of Engensis (16 injections of 0.5 mL Engensis) Day42: 4 mg of Engensis (16 injections of 0.5 mL Engensis)
High Dose Engensis: Day 0: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day 14: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day 28: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day 42: 4 mg Engensis (16 injections of 0.5 mL Engensis)
|
Placebo
n=11 Participants
Subjects in this group will receive a total of 8ml normal saline. Day 0: 16 injections of 0.5 mL of normal saline Day 14: 16 injections of 0.5 mL of normal saline Day 28: 16 injections of 0.5 mL of normal saline Day 42: 16 injections of 0.5 mL of normal saline
Placebo: Day 0: 16 injections of 0.5 mL of normal saline Day 14: 16 injections of 0.5 mL of normal saline Day 28: 16 injections of 0.5 mL of normal saline Day 42: 16 injections of 0.5 mL of normal saline
|
|---|---|---|---|
|
Number of Subjects With Major, Lower Leg, Amputations During the Trial
|
3 Participants
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 0 to Day 365Population: Intent-to-treat population
The number and percentage of subjects who died during the trial
Outcome measures
| Measure |
Low Dose Engensis (8 mg)
n=21 Participants
Subjects in this group received 8 mg total of Engensis (VM202) Day 0: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day14: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day 28: 16 injections of 0.5 mL of normal saline Day 42: 16 injections of 0.5 mL of normal saline
Low Dose VM202: Day 0: 4mg of VM202 (16 injections of 0.5ml of VM202) Day14: 4mg of VM202 (16 injections of 0.5ml of VM202)
Placebo: Day 0: 16 injections of 0.5ml of normal saline Day 14: 16 injections of 0.5ml of normal saline Day 28: 16 injections of 0.5ml of normal saline Day 42: 16 injections of 0.5ml of normal saline
|
High Dose Engensis (16 mg)
n=20 Participants
Subjects in this treatment group received a total of 16 mg Engensis (VM202) Day 0: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day14: 4 mg of Engensis (16 injections of 0.5 mL Engensis) Day 28: 4 mg of Engensis (16 injections of 0.5 mL Engensis) Day42: 4 mg of Engensis (16 injections of 0.5 mL Engensis)
High Dose Engensis: Day 0: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day 14: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day 28: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day 42: 4 mg Engensis (16 injections of 0.5 mL Engensis)
|
Placebo
n=11 Participants
Subjects in this group will receive a total of 8ml normal saline. Day 0: 16 injections of 0.5 mL of normal saline Day 14: 16 injections of 0.5 mL of normal saline Day 28: 16 injections of 0.5 mL of normal saline Day 42: 16 injections of 0.5 mL of normal saline
Placebo: Day 0: 16 injections of 0.5 mL of normal saline Day 14: 16 injections of 0.5 mL of normal saline Day 28: 16 injections of 0.5 mL of normal saline Day 42: 16 injections of 0.5 mL of normal saline
|
|---|---|---|---|
|
The Number of Deaths During the Trial
|
1 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Days 0 (baseline), 9 months (Day 270)Population: The Per-Protocol (PP) Population included all subjects who received the correct dose of study drug, had the 9-month (Day 270) VAS assessment, and did not have any protocol violations or major deviations. The PP Population was determined in a blinded review before database lock. Subjects were analyzed according to the treatment to which they were randomized. Primary efficacy analyses were performed on the PP population.
The VAS scoring instrument is a 10 cm line, oriented horizontally, with the left end indicating "no pain" (score = 0 mm, better outcome) and the right end representing "pain as bad as it can be (score = 100 mm, worse outcome).
Outcome measures
| Measure |
Low Dose Engensis (8 mg)
n=15 Participants
Subjects in this group received 8 mg total of Engensis (VM202) Day 0: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day14: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day 28: 16 injections of 0.5 mL of normal saline Day 42: 16 injections of 0.5 mL of normal saline
Low Dose VM202: Day 0: 4mg of VM202 (16 injections of 0.5ml of VM202) Day14: 4mg of VM202 (16 injections of 0.5ml of VM202)
Placebo: Day 0: 16 injections of 0.5ml of normal saline Day 14: 16 injections of 0.5ml of normal saline Day 28: 16 injections of 0.5ml of normal saline Day 42: 16 injections of 0.5ml of normal saline
|
High Dose Engensis (16 mg)
n=12 Participants
Subjects in this treatment group received a total of 16 mg Engensis (VM202) Day 0: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day14: 4 mg of Engensis (16 injections of 0.5 mL Engensis) Day 28: 4 mg of Engensis (16 injections of 0.5 mL Engensis) Day42: 4 mg of Engensis (16 injections of 0.5 mL Engensis)
High Dose Engensis: Day 0: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day 14: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day 28: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day 42: 4 mg Engensis (16 injections of 0.5 mL Engensis)
|
Placebo
n=5 Participants
Subjects in this group will receive a total of 8ml normal saline. Day 0: 16 injections of 0.5 mL of normal saline Day 14: 16 injections of 0.5 mL of normal saline Day 28: 16 injections of 0.5 mL of normal saline Day 42: 16 injections of 0.5 mL of normal saline
Placebo: Day 0: 16 injections of 0.5 mL of normal saline Day 14: 16 injections of 0.5 mL of normal saline Day 28: 16 injections of 0.5 mL of normal saline Day 42: 16 injections of 0.5 mL of normal saline
|
|---|---|---|---|
|
Change From Baseline in Visual Analog Scale (VAS) for Pain at 9 Months- by Sex
Males - Baseline (Day 0) - Actual values only
|
39.1 units on a scale
Standard Deviation 31.2
|
70.9 units on a scale
Standard Deviation 14.4
|
60.6 units on a scale
Standard Deviation 30.1
|
|
Change From Baseline in Visual Analog Scale (VAS) for Pain at 9 Months- by Sex
Males - Day 270
|
-6.0 units on a scale
Standard Deviation 22.2
|
-43.8 units on a scale
Standard Deviation 36.2
|
-38.6 units on a scale
Standard Deviation 41.1
|
|
Change From Baseline in Visual Analog Scale (VAS) for Pain at 9 Months- by Sex
Females - Baseline (Day 0) - Actual values only
|
44.3 units on a scale
Standard Deviation 36.2
|
53.7 units on a scale
Standard Deviation 27.0
|
—
|
|
Change From Baseline in Visual Analog Scale (VAS) for Pain at 9 Months- by Sex
Females Day 270
|
-14.4 units on a scale
Standard Deviation 24.7
|
-25.3 units on a scale
Standard Deviation 43.9
|
—
|
SECONDARY outcome
Timeframe: Days 0 (baseline), 9 months (Day 270)Population: The Per-Protocol (PP) Population included all subjects who received the correct dose of study drug, had the 9-month (Day 270) VAS assessment, and did not have any protocol violations or major deviations. The PP Population was determined in a blinded review before database lock. Subjects were analyzed according to the treatment to which they were randomized. Primary efficacy analyses were performed on the PP population.
The VAS scoring instrument is a 10 cm line, oriented horizontally, with the left end indicating "no pain" (score = 0 mm, better outcome) and the right end representing "pain as bad as it can be (score = 100 mm, worse outcome).
Outcome measures
| Measure |
Low Dose Engensis (8 mg)
n=15 Participants
Subjects in this group received 8 mg total of Engensis (VM202) Day 0: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day14: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day 28: 16 injections of 0.5 mL of normal saline Day 42: 16 injections of 0.5 mL of normal saline
Low Dose VM202: Day 0: 4mg of VM202 (16 injections of 0.5ml of VM202) Day14: 4mg of VM202 (16 injections of 0.5ml of VM202)
Placebo: Day 0: 16 injections of 0.5ml of normal saline Day 14: 16 injections of 0.5ml of normal saline Day 28: 16 injections of 0.5ml of normal saline Day 42: 16 injections of 0.5ml of normal saline
|
High Dose Engensis (16 mg)
n=12 Participants
Subjects in this treatment group received a total of 16 mg Engensis (VM202) Day 0: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day14: 4 mg of Engensis (16 injections of 0.5 mL Engensis) Day 28: 4 mg of Engensis (16 injections of 0.5 mL Engensis) Day42: 4 mg of Engensis (16 injections of 0.5 mL Engensis)
High Dose Engensis: Day 0: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day 14: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day 28: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day 42: 4 mg Engensis (16 injections of 0.5 mL Engensis)
|
Placebo
n=5 Participants
Subjects in this group will receive a total of 8ml normal saline. Day 0: 16 injections of 0.5 mL of normal saline Day 14: 16 injections of 0.5 mL of normal saline Day 28: 16 injections of 0.5 mL of normal saline Day 42: 16 injections of 0.5 mL of normal saline
Placebo: Day 0: 16 injections of 0.5 mL of normal saline Day 14: 16 injections of 0.5 mL of normal saline Day 28: 16 injections of 0.5 mL of normal saline Day 42: 16 injections of 0.5 mL of normal saline
|
|---|---|---|---|
|
Change From Baseline in Visual Analog Scale (VAS) for Pain at 9 Months- by Renal Dysfunction Status
Has Renal Dysfunction - Baseline (Day 0) - Actual values only
|
13.5 units on a scale
Standard Deviation 9.0
|
59.0 units on a scale
Standard Deviation 26.8
|
52.0 units on a scale
Standard Deviation 38.2
|
|
Change From Baseline in Visual Analog Scale (VAS) for Pain at 9 Months- by Renal Dysfunction Status
Has Renal Dysfunction - Day 270
|
-4.0 units on a scale
Standard Deviation 11.1
|
-37.1 units on a scale
Standard Deviation 45.2
|
-27.5 units on a scale
Standard Deviation 61.5
|
|
Change From Baseline in Visual Analog Scale (VAS) for Pain at 9 Months- by Renal Dysfunction Status
No Renal Dysfunction - Baseline (Day 0) - Actual values only
|
47.2 units on a scale
Standard Deviation 31.4
|
64.6 units on a scale
Standard Deviation 20.8
|
66.3 units on a scale
Standard Deviation 30.9
|
|
Change From Baseline in Visual Analog Scale (VAS) for Pain at 9 Months- by Renal Dysfunction Status
No Renal Dysfunction - Day 270
|
-9.3 units on a scale
Standard Deviation 24.6
|
-32.6 units on a scale
Standard Deviation 38.7
|
-46.0 units on a scale
Standard Deviation 35.7
|
SECONDARY outcome
Timeframe: Days 0 (baseline), 9 months (Day 270)Population: The Per-Protocol (PP) Population included all subjects who received the correct dose of study drug, had the 9-month (Day 270) VAS assessment, and did not have any protocol violations or major deviations. The PP Population was determined in a blinded review before database lock. Subjects were analyzed according to the treatment to which they were randomized. Primary efficacy analyses were performed on the PP population.
The VAS scoring instrument is a 10 cm line, oriented horizontally, with the left end indicating "no pain" (score = 0 mm, better outcome) and the right end representing "pain as bad as it can be (score = 100 mm, worse outcome).
Outcome measures
| Measure |
Low Dose Engensis (8 mg)
n=15 Participants
Subjects in this group received 8 mg total of Engensis (VM202) Day 0: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day14: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day 28: 16 injections of 0.5 mL of normal saline Day 42: 16 injections of 0.5 mL of normal saline
Low Dose VM202: Day 0: 4mg of VM202 (16 injections of 0.5ml of VM202) Day14: 4mg of VM202 (16 injections of 0.5ml of VM202)
Placebo: Day 0: 16 injections of 0.5ml of normal saline Day 14: 16 injections of 0.5ml of normal saline Day 28: 16 injections of 0.5ml of normal saline Day 42: 16 injections of 0.5ml of normal saline
|
High Dose Engensis (16 mg)
n=12 Participants
Subjects in this treatment group received a total of 16 mg Engensis (VM202) Day 0: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day14: 4 mg of Engensis (16 injections of 0.5 mL Engensis) Day 28: 4 mg of Engensis (16 injections of 0.5 mL Engensis) Day42: 4 mg of Engensis (16 injections of 0.5 mL Engensis)
High Dose Engensis: Day 0: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day 14: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day 28: 4 mg Engensis (16 injections of 0.5 mL Engensis) Day 42: 4 mg Engensis (16 injections of 0.5 mL Engensis)
|
Placebo
n=5 Participants
Subjects in this group will receive a total of 8ml normal saline. Day 0: 16 injections of 0.5 mL of normal saline Day 14: 16 injections of 0.5 mL of normal saline Day 28: 16 injections of 0.5 mL of normal saline Day 42: 16 injections of 0.5 mL of normal saline
Placebo: Day 0: 16 injections of 0.5 mL of normal saline Day 14: 16 injections of 0.5 mL of normal saline Day 28: 16 injections of 0.5 mL of normal saline Day 42: 16 injections of 0.5 mL of normal saline
|
|---|---|---|---|
|
Change From Baseline in Visual Analog Scale (VAS) for Pain at 9 Months- by Diabetes Status
Has Diabetes - Baseline (Day 0) - Actual values only
|
32.6 units on a scale
Standard Deviation 28.0
|
63.8 units on a scale
Standard Deviation 21.8
|
77.0 units on a scale
Standard Deviation 2.8
|
|
Change From Baseline in Visual Analog Scale (VAS) for Pain at 9 Months- by Diabetes Status
Has Diabetes - Day 270
|
-4.2 units on a scale
Standard Deviation 21.3
|
-48.2 units on a scale
Standard Deviation 29.3
|
-46.5 units on a scale
Standard Deviation 34.6
|
|
Change From Baseline in Visual Analog Scale (VAS) for Pain at 9 Months- by Diabetes Status
No Diabetes - Baseline (Day 0) - Actual values only
|
56.3 units on a scale
Standard Deviation 34.8
|
60.8 units on a scale
Standard Deviation 25.2
|
49.7 units on a scale
Standard Deviation 36.8
|
|
Change From Baseline in Visual Analog Scale (VAS) for Pain at 9 Months- by Diabetes Status
No Diabetes - Day 270
|
-16.3 units on a scale
Standard Deviation 24.4
|
-20.8 units on a scale
Standard Deviation 46.3
|
-33.3 units on a scale
Standard Deviation 51.6
|
Adverse Events
Engensis 8 mg
Serious events: 9 serious events
Other events: 18 other events
Deaths: 1 deaths
Engensis 16 mg
Serious events: 11 serious events
Other events: 18 other events
Deaths: 0 deaths
Placebo
Serious events: 6 serious events
Other events: 10 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Engensis 8 mg
n=21 participants at risk
Subjects in this group received 8 mg total of Engensis (VM202) Day 0: 4 mg Engensis (16 injections of 0.5 mL, 0.25 mg Engensis) Day14: 4 mg Engensis (16 injections of 0.5 mL. 0.25 mg Engensis) Day 28: 16 injections of 0.5 mL of normal saline Day 42: 16 injections of 0.5 mL of normal saline
|
Engensis 16 mg
n=20 participants at risk
Subjects in this group received a total of 16 mg Engensis (VM202) Day 0: 4 mg Engensis (16 injections of 0.5 mL, 0.25 mg Engensis) Day14: 4 mg of Engensis (16 injections of 0.5 mL, 0.25 mg Engensis) Day 28: 4 mg of Engensis (16 injections of 0.5 mL, 0.25 mg Engensis) Day42: 4 mg of Engensis (16 injections of 0.5 mL, 0.25 mg Engensis)
|
Placebo
n=11 participants at risk
Subjects in this group received a total of 8 mL normal saline. Day 0: 16 injections of 0.5 mL of normal saline Day 14: 16 injections of 0.5 mL of normal saline Day 28: 16 injections of 0.5 mL of normal saline Day 42: 16 injections of 0.5 mL of normal saline
|
|---|---|---|---|
|
Vascular disorders
Peripheral arterial occlusive disease
|
4.8%
1/21 • Number of events 2
|
20.0%
4/20 • Number of events 5
|
9.1%
1/11 • Number of events 2
|
|
Vascular disorders
Peripheral ischaemia
|
9.5%
2/21 • Number of events 2
|
5.0%
1/20 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
|
Vascular disorders
Arterial thrombosis limb
|
0.00%
0/21
|
10.0%
2/20 • Number of events 3
|
0.00%
0/11
|
|
Infections and infestations
Gangrene
|
0.00%
0/21
|
15.0%
3/20 • Number of events 3
|
18.2%
2/11 • Number of events 2
|
|
Infections and infestations
Osteomyelitis
|
9.5%
2/21 • Number of events 3
|
0.00%
0/20
|
0.00%
0/11
|
|
Renal and urinary disorders
Renal failure acute
|
14.3%
3/21 • Number of events 6
|
5.0%
1/20 • Number of events 2
|
0.00%
0/11
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/21
|
10.0%
2/20 • Number of events 2
|
0.00%
0/11
|
|
Vascular disorders
Arterial stenosis limb
|
0.00%
0/21
|
0.00%
0/20
|
9.1%
1/11 • Number of events 1
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/21
|
5.0%
1/20 • Number of events 1
|
0.00%
0/11
|
|
Vascular disorders
Femoral artery occlusion
|
4.8%
1/21 • Number of events 2
|
0.00%
0/20
|
0.00%
0/11
|
|
Vascular disorders
Hypertension
|
4.8%
1/21 • Number of events 1
|
0.00%
0/20
|
0.00%
0/11
|
|
Vascular disorders
Hypotension
|
0.00%
0/21
|
5.0%
1/20 • Number of events 1
|
0.00%
0/11
|
|
Vascular disorders
Ischaemic limb pain
|
4.8%
1/21 • Number of events 1
|
0.00%
0/20
|
0.00%
0/11
|
|
Infections and infestations
Celulitis
|
0.00%
0/21
|
0.00%
0/20
|
9.1%
1/11 • Number of events 1
|
|
Infections and infestations
Cystitis
|
0.00%
0/21
|
5.0%
1/20 • Number of events 1
|
0.00%
0/11
|
|
Infections and infestations
Infection
|
4.8%
1/21 • Number of events 1
|
0.00%
0/20
|
0.00%
0/11
|
|
Infections and infestations
Localised infection
|
0.00%
0/21
|
5.0%
1/20 • Number of events 1
|
0.00%
0/11
|
|
Infections and infestations
Sepsis
|
0.00%
0/21
|
5.0%
1/20 • Number of events 1
|
0.00%
0/11
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/21
|
0.00%
0/20
|
9.1%
1/11 • Number of events 1
|
|
Infections and infestations
Wound infection
|
0.00%
0/21
|
5.0%
1/20 • Number of events 1
|
0.00%
0/11
|
|
Renal and urinary disorders
Renal failure chronic
|
4.8%
1/21 • Number of events 1
|
0.00%
0/20
|
9.1%
1/11 • Number of events 1
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/21
|
0.00%
0/20
|
9.1%
1/11 • Number of events 1
|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/21
|
5.0%
1/20 • Number of events 1
|
0.00%
0/11
|
|
General disorders
Chest pain
|
4.8%
1/21 • Number of events 1
|
0.00%
0/20
|
9.1%
1/11 • Number of events 1
|
|
General disorders
Asthenia
|
4.8%
1/21 • Number of events 1
|
0.00%
0/20
|
0.00%
0/11
|
|
General disorders
Device occlusion
|
4.8%
1/21 • Number of events 1
|
0.00%
0/20
|
0.00%
0/11
|
|
Blood and lymphatic system disorders
Anaemia
|
4.8%
1/21 • Number of events 1
|
0.00%
0/20
|
0.00%
0/11
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
4.8%
1/21 • Number of events 1
|
0.00%
0/20
|
0.00%
0/11
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/21
|
5.0%
1/20 • Number of events 1
|
0.00%
0/11
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
4.8%
1/21 • Number of events 1
|
0.00%
0/20
|
0.00%
0/11
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/21
|
5.0%
1/20 • Number of events 1
|
0.00%
0/11
|
|
Injury, poisoning and procedural complications
Graft complication
|
4.8%
1/21 • Number of events 1
|
0.00%
0/20
|
0.00%
0/11
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
4.8%
1/21 • Number of events 1
|
0.00%
0/20
|
0.00%
0/11
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/21
|
5.0%
1/20 • Number of events 1
|
0.00%
0/11
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
4.8%
1/21 • Number of events 1
|
0.00%
0/20
|
0.00%
0/11
|
Other adverse events
| Measure |
Engensis 8 mg
n=21 participants at risk
Subjects in this group received 8 mg total of Engensis (VM202) Day 0: 4 mg Engensis (16 injections of 0.5 mL, 0.25 mg Engensis) Day14: 4 mg Engensis (16 injections of 0.5 mL. 0.25 mg Engensis) Day 28: 16 injections of 0.5 mL of normal saline Day 42: 16 injections of 0.5 mL of normal saline
|
Engensis 16 mg
n=20 participants at risk
Subjects in this group received a total of 16 mg Engensis (VM202) Day 0: 4 mg Engensis (16 injections of 0.5 mL, 0.25 mg Engensis) Day14: 4 mg of Engensis (16 injections of 0.5 mL, 0.25 mg Engensis) Day 28: 4 mg of Engensis (16 injections of 0.5 mL, 0.25 mg Engensis) Day42: 4 mg of Engensis (16 injections of 0.5 mL, 0.25 mg Engensis)
|
Placebo
n=11 participants at risk
Subjects in this group received a total of 8 mL normal saline. Day 0: 16 injections of 0.5 mL of normal saline Day 14: 16 injections of 0.5 mL of normal saline Day 28: 16 injections of 0.5 mL of normal saline Day 42: 16 injections of 0.5 mL of normal saline
|
|---|---|---|---|
|
Infections and infestations
Cellulitis
|
14.3%
3/21 • Number of events 3
|
5.0%
1/20 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
|
Infections and infestations
Urinary tract infection
|
9.5%
2/21 • Number of events 2
|
5.0%
1/20 • Number of events 2
|
18.2%
2/11 • Number of events 3
|
|
Infections and infestations
Wound infection
|
4.8%
1/21 • Number of events 1
|
10.0%
2/20 • Number of events 3
|
0.00%
0/11
|
|
Infections and infestations
Cystitis
|
0.00%
0/21
|
10.0%
2/20 • Number of events 10
|
0.00%
0/11
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/21
|
5.0%
1/20 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
9.5%
2/21 • Number of events 2
|
0.00%
0/20
|
0.00%
0/11
|
|
Infections and infestations
Sinusitis
|
0.00%
0/21
|
10.0%
2/20 • Number of events 4
|
0.00%
0/11
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/21
|
0.00%
0/20
|
18.2%
2/11 • Number of events 2
|
|
Infections and infestations
Upper respiratory infection
|
4.8%
1/21 • Number of events 1
|
5.0%
1/20 • Number of events 1
|
0.00%
0/11
|
|
Infections and infestations
Bronchitis
|
0.00%
0/21
|
5.0%
1/20 • Number of events 1
|
0.00%
0/11
|
|
Infections and infestations
Candidiasis
|
0.00%
0/21
|
0.00%
0/20
|
9.1%
1/11 • Number of events 1
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/21
|
5.0%
1/20 • Number of events 1
|
0.00%
0/11
|
|
Infections and infestations
Labyrinithitis
|
0.00%
0/21
|
5.0%
1/20 • Number of events 1
|
0.00%
0/11
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/21
|
5.0%
1/20 • Number of events 1
|
0.00%
0/11
|
|
Infections and infestations
Otitis media
|
0.00%
0/21
|
0.00%
0/20
|
9.1%
1/11 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhoea
|
14.3%
3/21 • Number of events 3
|
10.0%
2/20 • Number of events 2
|
18.2%
2/11 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
9.5%
2/21 • Number of events 3
|
5.0%
1/20 • Number of events 1
|
27.3%
3/11 • Number of events 3
|
|
Gastrointestinal disorders
Nausea
|
9.5%
2/21 • Number of events 4
|
10.0%
2/20 • Number of events 4
|
18.2%
2/11 • Number of events 2
|
|
Gastrointestinal disorders
Gastritis
|
4.8%
1/21 • Number of events 1
|
10.0%
2/20 • Number of events 2
|
9.1%
1/11 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
4.8%
1/21 • Number of events 1
|
5.0%
1/20 • Number of events 1
|
18.2%
2/11 • Number of events 2
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/21
|
10.0%
2/20 • Number of events 2
|
0.00%
0/11
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/21
|
0.00%
0/20
|
9.1%
1/11 • Number of events 1
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/21
|
5.0%
1/20 • Number of events 1
|
0.00%
0/11
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/21
|
5.0%
1/20 • Number of events 1
|
0.00%
0/11
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/21
|
5.0%
1/20 • Number of events 1
|
0.00%
0/11
|
|
Gastrointestinal disorders
Inflammatory bowel disease
|
0.00%
0/21
|
5.0%
1/20 • Number of events 1
|
0.00%
0/11
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/21
|
5.0%
1/20 • Number of events 1
|
0.00%
0/11
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/21
|
5.0%
1/20 • Number of events 1
|
0.00%
0/11
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place