Trial Outcomes & Findings for VE303 for Treatment of Hepatic Encephalopathy (HE) (NCT NCT04899115)
NCT ID: NCT04899115
Last Updated: 2025-02-07
Results Overview
An adverse event (AE) or suspected adverse reaction is considered "serious" if, in the view of the investigator, it results in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
19 participants
Primary outcome timeframe
Week 6
Results posted on
2025-02-07
Participant Flow
One patient was consented but then failed to meet eligibility criteria soon after enrollment. They did not initiate vancomycin and were not randomized.
Participant milestones
| Measure |
Placebo
Placebo: Starting the last day of oral vancomycin (Day 1), participants randomized to this arm will take 5 capsules of placebo for 14 days taken once daily.
Oral vancomycin: All enrolled participants will receive 5 days of oral vancomycin 125 mg four times a day (q.i.d).
|
VE303
VE303 is a live biotherapeutic product comprising 8 nonpathogenic commensal strains of Clostridia.
VE303: Starting the last day of oral vancomycin (Day 1), participants randomized to this arm will take 5 capsules of VE303 taken daily for 14 days.
The quantity of each strain is proportioned to assure a specific per-strain per-capsule titer. The 8 strains are blended together with a micro-crystalline cellulose flow agent and placed in enteric capsules.
Oral vancomycin: All enrolled subjects will receive 5 days of oral vancomycin 125 mg four times a day (q.i.d).
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
12
|
|
Overall Study
COMPLETED
|
6
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
VE303 for Treatment of Hepatic Encephalopathy (HE)
Baseline characteristics by cohort
| Measure |
Placebo
n=6 Participants
Placebo: Starting the last day of oral vancomycin (Day 1), participants randomized to this arm will take 5 capsules of placebo for 14 days taken once daily.
Oral vancomycin: All enrolled participants will receive 5 days of oral vancomycin 125 mg four times a day (q.i.d).
|
VE303
n=12 Participants
VE303 is a live biotherapeutic product comprising 8 nonpathogenic commensal strains of Clostridia.
VE303: Starting the last day of oral vancomycin (Day 1), participants randomized to this arm will take 5 capsules of VE303 taken daily for 14 days.
The quantity of each strain is proportioned to assure a specific per-strain per-capsule titer. The 8 strains are blended together with a micro-crystalline cellulose flow agent and placed in enteric capsules.
Oral vancomycin: All enrolled participants will receive 5 days of oral vancomycin 125 mg four times a day (q.i.d).
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63 years
STANDARD_DEVIATION 7 • n=99 Participants
|
58 years
STANDARD_DEVIATION 10 • n=107 Participants
|
60 years
STANDARD_DEVIATION 9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
4 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Baseline Psychometric HE Score (PHES)
|
-5.0 units on a scale
STANDARD_DEVIATION 3.7 • n=99 Participants
|
-6.3 units on a scale
STANDARD_DEVIATION 3.4 • n=107 Participants
|
-5.8 units on a scale
STANDARD_DEVIATION 3.5 • n=206 Participants
|
PRIMARY outcome
Timeframe: Week 6An adverse event (AE) or suspected adverse reaction is considered "serious" if, in the view of the investigator, it results in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.
Outcome measures
| Measure |
VE303
n=12 Participants
VE303 is a live biotherapeutic product comprising 8 nonpathogenic commensal strains of Clostridia.
VE303: Starting the last day of oral vancomycin (Day 1), participants randomized to this arm will take 5 capsules of VE303 taken daily for 14 days.
The quantity of each strain is proportioned to assure a specific per-strain per-capsule titer. The 8 strains are blended together with a micro-crystalline cellulose flow agent and placed in enteric capsules.
Oral vancomycin: All enrolled subjects will receive 5 days of oral vancomycin 125 mg four times a day (q.i.d).
|
Placebo
n=6 Participants
Placebo: Starting the last day of oral vancomycin (Day 1), participants randomized to this arm will take 5 capsules of placebo for 14 days taken once daily.
Oral vancomycin: All enrolled participants will receive 5 days of oral vancomycin 125 mg four times a day (q.i.d).
|
|---|---|---|
|
Number of Participants Who Experienced Serious Adverse Events up to Week 6
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: baseline (pre-vancomycin), Week 6This score is a battery of 5 paper-pencil tests that evaluate cognitive and psychomotor processing speed and visuomotor coordination. Scores on each subtest are assigned values based on age-related norms (1+ for scores better than 1 standard deviation (SD) above the normal mean to -3 for scores more than 3 SDs below the normal mean). Combined scores vary from +6 to -18, where +6 is the best function and -18 is worst function.
Outcome measures
| Measure |
VE303
n=6 Participants
VE303 is a live biotherapeutic product comprising 8 nonpathogenic commensal strains of Clostridia.
VE303: Starting the last day of oral vancomycin (Day 1), participants randomized to this arm will take 5 capsules of VE303 taken daily for 14 days.
The quantity of each strain is proportioned to assure a specific per-strain per-capsule titer. The 8 strains are blended together with a micro-crystalline cellulose flow agent and placed in enteric capsules.
Oral vancomycin: All enrolled subjects will receive 5 days of oral vancomycin 125 mg four times a day (q.i.d).
|
Placebo
n=12 Participants
Placebo: Starting the last day of oral vancomycin (Day 1), participants randomized to this arm will take 5 capsules of placebo for 14 days taken once daily.
Oral vancomycin: All enrolled participants will receive 5 days of oral vancomycin 125 mg four times a day (q.i.d).
|
|---|---|---|
|
Change in Psychometric Hepatic Encephalopathy Score (PHES) as a Measure of Cognitive Function From Pre-vancomycin to Week 6
|
-1.0 units on a scale
Standard Deviation 3.7
|
1.5 units on a scale
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: 26 weeksShown as a rate (# of episodes/ number of patients) = # per patient.
Outcome measures
| Measure |
VE303
n=6 Participants
VE303 is a live biotherapeutic product comprising 8 nonpathogenic commensal strains of Clostridia.
VE303: Starting the last day of oral vancomycin (Day 1), participants randomized to this arm will take 5 capsules of VE303 taken daily for 14 days.
The quantity of each strain is proportioned to assure a specific per-strain per-capsule titer. The 8 strains are blended together with a micro-crystalline cellulose flow agent and placed in enteric capsules.
Oral vancomycin: All enrolled subjects will receive 5 days of oral vancomycin 125 mg four times a day (q.i.d).
|
Placebo
n=12 Participants
Placebo: Starting the last day of oral vancomycin (Day 1), participants randomized to this arm will take 5 capsules of placebo for 14 days taken once daily.
Oral vancomycin: All enrolled participants will receive 5 days of oral vancomycin 125 mg four times a day (q.i.d).
|
|---|---|---|
|
Number of Hospitalizations for Overt Hepatic Encephalopathy (OHE) up to Week 26
|
.333 episodes/patient
Interval 0.0 to 2.0
|
1.25 episodes/patient
Interval 0.0 to 6.0
|
SECONDARY outcome
Timeframe: up to week 26total number of AEs
Outcome measures
| Measure |
VE303
n=6 Participants
VE303 is a live biotherapeutic product comprising 8 nonpathogenic commensal strains of Clostridia.
VE303: Starting the last day of oral vancomycin (Day 1), participants randomized to this arm will take 5 capsules of VE303 taken daily for 14 days.
The quantity of each strain is proportioned to assure a specific per-strain per-capsule titer. The 8 strains are blended together with a micro-crystalline cellulose flow agent and placed in enteric capsules.
Oral vancomycin: All enrolled subjects will receive 5 days of oral vancomycin 125 mg four times a day (q.i.d).
|
Placebo
n=12 Participants
Placebo: Starting the last day of oral vancomycin (Day 1), participants randomized to this arm will take 5 capsules of placebo for 14 days taken once daily.
Oral vancomycin: All enrolled participants will receive 5 days of oral vancomycin 125 mg four times a day (q.i.d).
|
|---|---|---|
|
Adverse Events up to Week 26
|
38 adverse events
|
135 adverse events
|
SECONDARY outcome
Timeframe: baseline (pre-vancomycin), week 26Population: Data is missing from two VE303 participants because they did not provide it.
The PROMIS v 1.1 is a 10 question scale where participants select answers from (0) up to (10). Higher scores indicate better quality of life. Results are presented as change in scores pertaining to physical and mental health.
Outcome measures
| Measure |
VE303
n=6 Participants
VE303 is a live biotherapeutic product comprising 8 nonpathogenic commensal strains of Clostridia.
VE303: Starting the last day of oral vancomycin (Day 1), participants randomized to this arm will take 5 capsules of VE303 taken daily for 14 days.
The quantity of each strain is proportioned to assure a specific per-strain per-capsule titer. The 8 strains are blended together with a micro-crystalline cellulose flow agent and placed in enteric capsules.
Oral vancomycin: All enrolled subjects will receive 5 days of oral vancomycin 125 mg four times a day (q.i.d).
|
Placebo
n=10 Participants
Placebo: Starting the last day of oral vancomycin (Day 1), participants randomized to this arm will take 5 capsules of placebo for 14 days taken once daily.
Oral vancomycin: All enrolled participants will receive 5 days of oral vancomycin 125 mg four times a day (q.i.d).
|
|---|---|---|
|
Change in Patient Reported Outcome Measurement Information System (PROMIS) Global Health Reported From Pre-vancomycin to Week 26
Change in PROMIS Physical Health Scores
|
1.8 score on a scale
Standard Deviation 1.8
|
0.4 score on a scale
Standard Deviation 1.9
|
|
Change in Patient Reported Outcome Measurement Information System (PROMIS) Global Health Reported From Pre-vancomycin to Week 26
Change in PROMIS Mental Health Scores
|
1.2 score on a scale
Standard Deviation 2.1
|
0 score on a scale
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: up to 26 weeksThis is the number of days from Day 1 of Vancomycin to the first OHE event or to the end of study, whichever came first.
Outcome measures
| Measure |
VE303
n=6 Participants
VE303 is a live biotherapeutic product comprising 8 nonpathogenic commensal strains of Clostridia.
VE303: Starting the last day of oral vancomycin (Day 1), participants randomized to this arm will take 5 capsules of VE303 taken daily for 14 days.
The quantity of each strain is proportioned to assure a specific per-strain per-capsule titer. The 8 strains are blended together with a micro-crystalline cellulose flow agent and placed in enteric capsules.
Oral vancomycin: All enrolled subjects will receive 5 days of oral vancomycin 125 mg four times a day (q.i.d).
|
Placebo
n=12 Participants
Placebo: Starting the last day of oral vancomycin (Day 1), participants randomized to this arm will take 5 capsules of placebo for 14 days taken once daily.
Oral vancomycin: All enrolled participants will receive 5 days of oral vancomycin 125 mg four times a day (q.i.d).
|
|---|---|---|
|
Time to Overt HE
|
180 days
Interval 170.0 to 182.0
|
147 days
Interval 16.0 to 182.0
|
SECONDARY outcome
Timeframe: baseline (pre-vancomycin), week 26Population: Participants analyzed reflect participants from whom week 26 stool samples could be obtained. Not every participant was able to provide a stool sample at week 26, and therefore this outcome was missing for those patients.
This will be calculated by alpha diversity between stool collection timepoints and will have metagenomic sequencing on stool to assess this. The Shannon index is a calculation used to measure the diversity of microbial species within a sample, taking into account both the number of different species present (richness) and how evenly distributed their abundances are (evenness). A higher Shannon index indicates a more diverse microbial community, meaning a wider variety of microbes present in roughly equal proportions. The Shannon index was calculated for each sample as part of metagenomic sequencing analysis performed with the tool MetaPhlAn (version 3.0). The minimum Shannon index value is 0 and it could theoretically go to infinity; however, typical values range more in the 1-4 range. Now, this outcome is measuring the CHANGE in Shannon index, therefore negative values are possible, if the diversity of specimens dropped from the pre-vancomycin to the week 26 samples.
Outcome measures
| Measure |
VE303
n=6 Participants
VE303 is a live biotherapeutic product comprising 8 nonpathogenic commensal strains of Clostridia.
VE303: Starting the last day of oral vancomycin (Day 1), participants randomized to this arm will take 5 capsules of VE303 taken daily for 14 days.
The quantity of each strain is proportioned to assure a specific per-strain per-capsule titer. The 8 strains are blended together with a micro-crystalline cellulose flow agent and placed in enteric capsules.
Oral vancomycin: All enrolled subjects will receive 5 days of oral vancomycin 125 mg four times a day (q.i.d).
|
Placebo
n=2 Participants
Placebo: Starting the last day of oral vancomycin (Day 1), participants randomized to this arm will take 5 capsules of placebo for 14 days taken once daily.
Oral vancomycin: All enrolled participants will receive 5 days of oral vancomycin 125 mg four times a day (q.i.d).
|
|---|---|---|
|
Change in Microbiome Composition From Pre-vancomycin to Week 26
|
0.37 Shannon index
Standard Deviation 0.72
|
-0.15 Shannon index
Standard Deviation 0.06
|
SECONDARY outcome
Timeframe: pre-vancomycin up to week 26Population: Note: Significant data loss due to some participants not participating in this test at 26 weeks
This score is a battery of 5 paper-pencil tests that evaluate cognitive and psychomotor processing speed and visuomotor coordination. Scores on each subtest are assigned values based on age-related norms (+1 for scores better than 1 standard deviation (SD) above the normal mean to -3 for scores more than 3 SDs below the normal mean). Combined scores vary from +6 to -18.
Outcome measures
| Measure |
VE303
n=4 Participants
VE303 is a live biotherapeutic product comprising 8 nonpathogenic commensal strains of Clostridia.
VE303: Starting the last day of oral vancomycin (Day 1), participants randomized to this arm will take 5 capsules of VE303 taken daily for 14 days.
The quantity of each strain is proportioned to assure a specific per-strain per-capsule titer. The 8 strains are blended together with a micro-crystalline cellulose flow agent and placed in enteric capsules.
Oral vancomycin: All enrolled subjects will receive 5 days of oral vancomycin 125 mg four times a day (q.i.d).
|
Placebo
n=9 Participants
Placebo: Starting the last day of oral vancomycin (Day 1), participants randomized to this arm will take 5 capsules of placebo for 14 days taken once daily.
Oral vancomycin: All enrolled participants will receive 5 days of oral vancomycin 125 mg four times a day (q.i.d).
|
|---|---|---|
|
PHES From Pre-vancomycin to Week 26
|
-1 score on a scale
Interval -3.0 to 1.0
|
1 score on a scale
Interval -6.0 to 10.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline (pre-vancomycin), week 26Outcome measures
Outcome data not reported
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
VE303
Serious events: 5 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=6 participants at risk
Placebo: Starting the last day of oral vancomycin (Day 1), participants randomized to this arm will take 5 capsules of placebo for 14 days taken once daily.
Oral vancomycin: All enrolled participants will receive 5 days of oral vancomycin 125 mg four times a day (q.i.d).
|
VE303
n=12 participants at risk
VE303 is a live biotherapeutic product comprising 8 nonpathogenic commensal strains of Clostridia.
VE303: Starting the last day of oral vancomycin (Day 1), participants randomized to this arm will take 5 capsules of VE303 taken daily for 14 days.
The quantity of each strain is proportioned to assure a specific per-strain per-capsule titer. The 8 strains are blended together with a micro-crystalline cellulose flow agent and placed in enteric capsules.
Oral vancomycin: All enrolled subjects will receive 5 days of oral vancomycin 125 mg four times a day (q.i.d).
|
|---|---|---|
|
Metabolism and nutrition disorders
Hospitalization for Diabetic Ketoacidosis
|
0.00%
0/6 • 6 months
|
8.3%
1/12 • 6 months
|
|
Injury, poisoning and procedural complications
Pain and Bleeding from Surgical Site
|
16.7%
1/6 • 6 months
|
0.00%
0/12 • 6 months
|
|
Injury, poisoning and procedural complications
Wound Dehiscence
|
16.7%
1/6 • 6 months
|
0.00%
0/12 • 6 months
|
|
Gastrointestinal disorders
Hospitalization due to Esophageal Bleed
|
16.7%
1/6 • 6 months
|
0.00%
0/12 • 6 months
|
|
Surgical and medical procedures
Elective Total Hip Replacement
|
0.00%
0/6 • 6 months
|
8.3%
1/12 • 6 months
|
|
Injury, poisoning and procedural complications
Hospitalization due to Post-Surgical Complications
|
0.00%
0/6 • 6 months
|
8.3%
1/12 • 6 months
|
|
Hepatobiliary disorders
Hospitalized for Hepatic Encephalopathy
|
16.7%
1/6 • 6 months
|
33.3%
4/12 • 6 months
|
|
Surgical and medical procedures
Inpatient Catheter Service
|
0.00%
0/6 • 6 months
|
8.3%
1/12 • 6 months
|
|
Metabolism and nutrition disorders
Hyperglycemic Hyperosmolar Syndrome
|
0.00%
0/6 • 6 months
|
8.3%
1/12 • 6 months
|
|
Hepatobiliary disorders
Hospitalization due to Ascites Accumulation
|
0.00%
0/6 • 6 months
|
8.3%
1/12 • 6 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/6 • 6 months
|
8.3%
1/12 • 6 months
|
Other adverse events
| Measure |
Placebo
n=6 participants at risk
Placebo: Starting the last day of oral vancomycin (Day 1), participants randomized to this arm will take 5 capsules of placebo for 14 days taken once daily.
Oral vancomycin: All enrolled participants will receive 5 days of oral vancomycin 125 mg four times a day (q.i.d).
|
VE303
n=12 participants at risk
VE303 is a live biotherapeutic product comprising 8 nonpathogenic commensal strains of Clostridia.
VE303: Starting the last day of oral vancomycin (Day 1), participants randomized to this arm will take 5 capsules of VE303 taken daily for 14 days.
The quantity of each strain is proportioned to assure a specific per-strain per-capsule titer. The 8 strains are blended together with a micro-crystalline cellulose flow agent and placed in enteric capsules.
Oral vancomycin: All enrolled subjects will receive 5 days of oral vancomycin 125 mg four times a day (q.i.d).
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Distension
|
0.00%
0/6 • 6 months
|
58.3%
7/12 • 6 months
|
|
Gastrointestinal disorders
Increased Bowel Movements
|
16.7%
1/6 • 6 months
|
41.7%
5/12 • 6 months
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/6 • 6 months
|
8.3%
1/12 • 6 months
|
|
Skin and subcutaneous tissue disorders
Bruising
|
0.00%
0/6 • 6 months
|
25.0%
3/12 • 6 months
|
|
General disorders
Fatigue
|
16.7%
1/6 • 6 months
|
25.0%
3/12 • 6 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
16.7%
1/6 • 6 months
|
58.3%
7/12 • 6 months
|
|
Blood and lymphatic system disorders
Decreased Lymphocyte Count
|
16.7%
1/6 • 6 months
|
58.3%
7/12 • 6 months
|
|
Blood and lymphatic system disorders
Decreased Platelet Count
|
50.0%
3/6 • 6 months
|
25.0%
3/12 • 6 months
|
|
Hepatobiliary disorders
Alkaline Phosphatase Increase
|
33.3%
2/6 • 6 months
|
25.0%
3/12 • 6 months
|
|
Musculoskeletal and connective tissue disorders
Worsening Gout Symptoms
|
16.7%
1/6 • 6 months
|
0.00%
0/12 • 6 months
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
2/6 • 6 months
|
66.7%
8/12 • 6 months
|
|
Hepatobiliary disorders
Alanine Transaminase Increase
|
33.3%
2/6 • 6 months
|
0.00%
0/12 • 6 months
|
|
Hepatobiliary disorders
Increased Blood Bilirubin
|
16.7%
1/6 • 6 months
|
25.0%
3/12 • 6 months
|
|
Gastrointestinal disorders
Increased Lipase
|
33.3%
2/6 • 6 months
|
33.3%
4/12 • 6 months
|
|
Blood and lymphatic system disorders
Leukopenia/Decreased White Blood Cell Count
|
16.7%
1/6 • 6 months
|
25.0%
3/12 • 6 months
|
|
General disorders
Chills
|
0.00%
0/6 • 6 months
|
25.0%
3/12 • 6 months
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • 6 months
|
58.3%
7/12 • 6 months
|
|
Gastrointestinal disorders
Increased Amylase Levels
|
16.7%
1/6 • 6 months
|
16.7%
2/12 • 6 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/6 • 6 months
|
8.3%
1/12 • 6 months
|
|
Skin and subcutaneous tissue disorders
Skin Numbness
|
0.00%
0/6 • 6 months
|
8.3%
1/12 • 6 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/6 • 6 months
|
25.0%
3/12 • 6 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/6 • 6 months
|
33.3%
4/12 • 6 months
|
|
General disorders
Leg Pain and Swelling
|
16.7%
1/6 • 6 months
|
8.3%
1/12 • 6 months
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • 6 months
|
16.7%
2/12 • 6 months
|
|
Skin and subcutaneous tissue disorders
Skin Discoloration (foot)
|
0.00%
0/6 • 6 months
|
8.3%
1/12 • 6 months
|
|
Blood and lymphatic system disorders
Easy Bleeding
|
0.00%
0/6 • 6 months
|
8.3%
1/12 • 6 months
|
|
General disorders
Long Sleeping Duration
|
16.7%
1/6 • 6 months
|
0.00%
0/12 • 6 months
|
|
Nervous system disorders
Limb Weakness/Numbness
|
16.7%
1/6 • 6 months
|
0.00%
0/12 • 6 months
|
|
Blood and lymphatic system disorders
Anemia
|
16.7%
1/6 • 6 months
|
25.0%
3/12 • 6 months
|
|
Blood and lymphatic system disorders
Decreased Neutrophil Count
|
16.7%
1/6 • 6 months
|
8.3%
1/12 • 6 months
|
|
Blood and lymphatic system disorders
Hypoalbuminemia
|
16.7%
1/6 • 6 months
|
8.3%
1/12 • 6 months
|
|
Nervous system disorders
Bilateral Hand Tremors
|
0.00%
0/6 • 6 months
|
8.3%
1/12 • 6 months
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/6 • 6 months
|
25.0%
3/12 • 6 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • 6 months
|
16.7%
2/12 • 6 months
|
|
General disorders
Lightheadedness
|
0.00%
0/6 • 6 months
|
8.3%
1/12 • 6 months
|
|
General disorders
Weight Gain
|
0.00%
0/6 • 6 months
|
8.3%
1/12 • 6 months
|
|
Infections and infestations
Flu Symptoms
|
0.00%
0/6 • 6 months
|
8.3%
1/12 • 6 months
|
|
General disorders
Mild Edema
|
0.00%
0/6 • 6 months
|
8.3%
1/12 • 6 months
|
|
Infections and infestations
COVID
|
0.00%
0/6 • 6 months
|
8.3%
1/12 • 6 months
|
|
Ear and labyrinth disorders
Bleeding from preexisting ear condition
|
16.7%
1/6 • 6 months
|
0.00%
0/12 • 6 months
|
|
Immune system disorders
Eosinophilia
|
16.7%
1/6 • 6 months
|
8.3%
1/12 • 6 months
|
|
Ear and labyrinth disorders
Ear Ache post Ear AVM ablation
|
16.7%
1/6 • 6 months
|
0.00%
0/12 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
1/6 • 6 months
|
8.3%
1/12 • 6 months
|
|
General disorders
Hot Flashes/Night Sweats
|
0.00%
0/6 • 6 months
|
16.7%
2/12 • 6 months
|
|
Blood and lymphatic system disorders
Increased INR
|
0.00%
0/6 • 6 months
|
16.7%
2/12 • 6 months
|
|
General disorders
Weight Loss
|
0.00%
0/6 • 6 months
|
8.3%
1/12 • 6 months
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • 6 months
|
25.0%
3/12 • 6 months
|
|
General disorders
Difficulty Falling Asleep
|
0.00%
0/6 • 6 months
|
8.3%
1/12 • 6 months
|
|
Renal and urinary disorders
Increased Creatinine
|
0.00%
0/6 • 6 months
|
8.3%
1/12 • 6 months
|
|
Nervous system disorders
Disorientation
|
0.00%
0/6 • 6 months
|
8.3%
1/12 • 6 months
|
|
Nervous system disorders
Slow Speech
|
0.00%
0/6 • 6 months
|
8.3%
1/12 • 6 months
|
|
Nervous system disorders
Asterixis
|
0.00%
0/6 • 6 months
|
8.3%
1/12 • 6 months
|
|
General disorders
Headache
|
16.7%
1/6 • 6 months
|
33.3%
4/12 • 6 months
|
|
General disorders
Loss of Appetite
|
16.7%
1/6 • 6 months
|
0.00%
0/12 • 6 months
|
|
Hepatobiliary disorders
Increase in Aspartate Aminotransferase
|
0.00%
0/6 • 6 months
|
8.3%
1/12 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place