Trial Outcomes & Findings for Clinical Study of Asahi ViE Dialyzer in Canada (NCT NCT02292212)
NCT ID: NCT02292212
Last Updated: 2019-12-11
Results Overview
In order to calculate removal rate for urea by a dialysis session, blood samples were collected at pre and post dialysis. The removal rate was obtained by calculation using the following equation with Pre-dialysis concentration (Cpre) and Post-dialysis concentration (Cpost) of urea. Removal rate (%) = \[(Cpre - Cpost) / (Cpre)\] \* 100. The removal rates were obtained at one session of the first week with control dialyzer (Pre-ViE phase) and then at each one session of weeks 7 and 13 with ViE-21 (ViE phase), respectively.
COMPLETED
NA
17 participants
Week 1 (Pre-ViE phase), 7, 13 (ViE phase)
2019-12-11
Participant Flow
The patients on hemodialysis at one clinical site in Canada were enrolled to this study. The first patient was enrolled on November 24, 2014 and the last patient on July 13, 2015.
Participant milestones
| Measure |
Single Arm
Total 16 weeks, divided to 3 periods, Pre-ViE phase (2W by control device), ViE phase (12W by target device, ViE-21) and Post-ViE phase (2W by control device).
|
|---|---|
|
Post-ViE Phase
STARTED
|
14
|
|
Post-ViE Phase
COMPLETED
|
14
|
|
Post-ViE Phase
NOT COMPLETED
|
0
|
|
Pre-ViE Phase
STARTED
|
17
|
|
Pre-ViE Phase
COMPLETED
|
17
|
|
Pre-ViE Phase
NOT COMPLETED
|
0
|
|
ViE Phase
STARTED
|
17
|
|
ViE Phase
COMPLETED
|
14
|
|
ViE Phase
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Single Arm
Total 16 weeks, divided to 3 periods, Pre-ViE phase (2W by control device), ViE phase (12W by target device, ViE-21) and Post-ViE phase (2W by control device).
|
|---|---|
|
ViE Phase
Withdrawal by Subject
|
1
|
|
ViE Phase
Protocol Violation
|
2
|
Baseline Characteristics
Clinical Study of Asahi ViE Dialyzer in Canada
Baseline characteristics by cohort
| Measure |
Single Arm
n=17 Participants
Total 16 weeks, divided to 3 phases, Pre-ViE phase (2W by control device), ViE phase (12W by target device, ViE-21) and Post-ViE phase (2W by control device).
|
|---|---|
|
Age, Continuous
|
69.4 years
STANDARD_DEVIATION 10.0 • n=93 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
7 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Asian Filipino
|
4 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Asian Indian
|
2 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Asian Sri Lankan
|
1 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Native Canadian
|
1 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Week 1 (Pre-ViE phase), 7, 13 (ViE phase)Population: The Intent To Treat (ITT) was based on 14 patients that received at least 30 treatments with ViE-21.
In order to calculate removal rate for urea by a dialysis session, blood samples were collected at pre and post dialysis. The removal rate was obtained by calculation using the following equation with Pre-dialysis concentration (Cpre) and Post-dialysis concentration (Cpost) of urea. Removal rate (%) = \[(Cpre - Cpost) / (Cpre)\] \* 100. The removal rates were obtained at one session of the first week with control dialyzer (Pre-ViE phase) and then at each one session of weeks 7 and 13 with ViE-21 (ViE phase), respectively.
Outcome measures
| Measure |
Pre-ViE Phase
n=14 Participants
The first week of dialysis with control dialyzer
|
ViE Phase (1)
n=14 Participants
Seventh week of dialysis with ViE-21
|
ViE Phase (2)
n=14 Participants
13th week of dialysis with ViE-21
|
|---|---|---|---|
|
Removal Rate of Urea
|
76.1 percentage of urea removal
Standard Deviation 5.4
|
74.4 percentage of urea removal
Standard Deviation 8.8
|
73.5 percentage of urea removal
Standard Deviation 4.5
|
PRIMARY outcome
Timeframe: Week 1 (Pre-ViE phase), 7, 13 (ViE phase)Population: The Intent To Treat (ITT) was based on 14 patients that received at least 30 treatments with ViE-21.
In order to calculate removal rate for creatinine by a dialysis session, blood samples were collected at pre and post dialysis. The removal rate was obtained by calculation using the following equation. Removal rate (%) = \[(Cpre - Cpost) / (Cpre)\] \* 100. The removal rates were obtained at one session of the first week with control dialyzer (Pre-ViE phase) and then at each one session of weeks 7 and 13 with ViE-21 (ViE phase), respectively.
Outcome measures
| Measure |
Pre-ViE Phase
n=14 Participants
The first week of dialysis with control dialyzer
|
ViE Phase (1)
n=14 Participants
Seventh week of dialysis with ViE-21
|
ViE Phase (2)
n=14 Participants
13th week of dialysis with ViE-21
|
|---|---|---|---|
|
Removal Rate of Creatinine
|
70.7 percentage of creatinine removal
Standard Deviation 4.6
|
70.0 percentage of creatinine removal
Standard Deviation 8.4
|
69.0 percentage of creatinine removal
Standard Deviation 5.4
|
PRIMARY outcome
Timeframe: Week 1 (Pre-ViE phase), 7, 13 (ViE phase)Population: The Intent To Treat (ITT) was based on 14 patients that received at least 30 treatments with ViE-21.
In order to calculate removal rate for albumin by a dialysis session, blood samples were collected at pre and post dialysis. The removal rate was obtained by calculation using the following equation with hematocrit (HCT) at pre (HCTpre) and post (HCTpost). Removal rate (%) = {1-\[HCTpre\*(1-HCTpost/100) \* Cpost\] / \[HCTpost \* (1-HCTpre/100) \* Cpre\]} \* 100. The removal rates were obtained at one session of the first week with control dialyzer (Pre-ViE phase) and then at each one session of weeks 7 and 13 with ViE-21 (ViE phase), respectively. The negative removal rate means the increase of serum concentration of albumin from pre to post dialysis session.
Outcome measures
| Measure |
Pre-ViE Phase
n=14 Participants
The first week of dialysis with control dialyzer
|
ViE Phase (1)
n=14 Participants
Seventh week of dialysis with ViE-21
|
ViE Phase (2)
n=14 Participants
13th week of dialysis with ViE-21
|
|---|---|---|---|
|
Removal Rate of Albumin
|
2.4 percentage of albumin removal
Standard Deviation 6.4
|
-2.4 percentage of albumin removal
Standard Deviation 3.9
|
-1.0 percentage of albumin removal
Standard Deviation 4.4
|
PRIMARY outcome
Timeframe: Week 1 (Pre-ViE phase), 7, 13 (ViE phase)Population: The Intent To Treat (ITT) was based on 14 patients that received at least 30 treatments with ViE-21.
In order to calculate removal rate for B2-MG by a dialysis session, blood samples were collected at pre and post dialysis. The removal rate was obtained by calculation using the following equation. Removal rate (%) = {1-\[HCTpre\*(1-HCTpost/100) \* Cpost\] / \[HCTpost \* (1-HCTpre/100) \* Cpre\]} \* 100. The removal rates were obtained at one session of the first week with control dialyzer (Pre-ViE phase) and then at each one session of weeks 7 and 13 with ViE-21 (ViE phase), respectively.
Outcome measures
| Measure |
Pre-ViE Phase
n=14 Participants
The first week of dialysis with control dialyzer
|
ViE Phase (1)
n=14 Participants
Seventh week of dialysis with ViE-21
|
ViE Phase (2)
n=14 Participants
13th week of dialysis with ViE-21
|
|---|---|---|---|
|
Removal Rate of Beta-2-microglobulin (B2-MG)
|
65.5 percentage of B2MG removal
Standard Deviation 6.6
|
65.8 percentage of B2MG removal
Standard Deviation 8.8
|
65.9 percentage of B2MG removal
Standard Deviation 6.5
|
PRIMARY outcome
Timeframe: Week 1 or 2 (Pre-ViE phase), 3-8 and 9-14 (ViE phase)Population: The Intent To Treat (ITT) was based on 14 patients that received at least 30 treatments with ViE-21.
The KUF is important for regulating the rate and amount of fluid flow across the dialyzer membrane. It is calculated by dividing ultrafiltration rate with the transmembrane pressure (TMP). More specifically, transmembrane pressures were recorded at 10, 20, 30, 40 and 50 minutes after the initiation of the dialysis session with adjustment of the ultrafiltration rate at 0, 600, 1000, 1400 and 1800 mL/hr respectively. These determinations were made during the 2nd or 3rd treatment session during the 1st or 2nd week for control dialyzer (Pre-ViE phase), and for ViE-21 during week 3-8 and week 9-14 (ViE phase).
Outcome measures
| Measure |
Pre-ViE Phase
n=14 Participants
The first week of dialysis with control dialyzer
|
ViE Phase (1)
n=14 Participants
Seventh week of dialysis with ViE-21
|
ViE Phase (2)
n=14 Participants
13th week of dialysis with ViE-21
|
|---|---|---|---|
|
Ultrafiltration Coefficient (KUF)
|
61.2 mL/(hr*mmHg)
Standard Deviation 13.6
|
67.8 mL/(hr*mmHg)
Standard Deviation 8.6
|
68.6 mL/(hr*mmHg)
Standard Deviation 9.3
|
PRIMARY outcome
Timeframe: Week 1 (Pre-ViE phase), 7, 13 (ViE phase)Population: The Intent To Treat (ITT) was based on 14 patients that received at least 30 treatments with ViE-21.
Blood samples were obtained during the first week of dialysis with control dialyzer and then during weeks 7 and 13 with ViE-21. WBC count was measured pre dialysis, at 15 minutes and post dialysis. The values were corrected with HCT and then leveled by defining the pre-dialysis value as 100%.
Outcome measures
| Measure |
Pre-ViE Phase
n=14 Participants
The first week of dialysis with control dialyzer
|
ViE Phase (1)
n=14 Participants
Seventh week of dialysis with ViE-21
|
ViE Phase (2)
n=14 Participants
13th week of dialysis with ViE-21
|
|---|---|---|---|
|
White Blood Cell (WBC)
15 min
|
82.3 percentage of WBC level
Standard Deviation 13.1
|
86.5 percentage of WBC level
Standard Deviation 9.8
|
92.7 percentage of WBC level
Standard Deviation 8.0
|
|
White Blood Cell (WBC)
Post dialysis
|
95.1 percentage of WBC level
Standard Deviation 12.1
|
94.1 percentage of WBC level
Standard Deviation 12.4
|
97.1 percentage of WBC level
Standard Deviation 12.3
|
PRIMARY outcome
Timeframe: Week 1 (Pre-ViE phase), 7, 13 (ViE phase)Population: The Intent To Treat (ITT) was based on 14 patients that received at least 30 treatments with ViE-21.
Blood samples were obtained during the first week of dialysis with control dialyzer and then during weeks 7 and 13 with ViE-21. Platelet count was measured pre dialysis, at 15 minutes and post dialysis. The values were corrected with HCT and then leveled by defining the pre-dialysis value as 100%.
Outcome measures
| Measure |
Pre-ViE Phase
n=14 Participants
The first week of dialysis with control dialyzer
|
ViE Phase (1)
n=14 Participants
Seventh week of dialysis with ViE-21
|
ViE Phase (2)
n=14 Participants
13th week of dialysis with ViE-21
|
|---|---|---|---|
|
Platelet
15 min
|
94.6 percentage of platelet level
Standard Deviation 8.5
|
98.4 percentage of platelet level
Standard Deviation 4.6
|
98.2 percentage of platelet level
Standard Deviation 3.7
|
|
Platelet
Post dialysis
|
93.9 percentage of platelet level
Standard Deviation 8.4
|
99.0 percentage of platelet level
Standard Deviation 7.4
|
99.8 percentage of platelet level
Standard Deviation 7.5
|
PRIMARY outcome
Timeframe: Week 1 (Pre-ViE phase), 7, 13 (ViE phase)Population: The Intent To Treat (ITT) was based on 14 patients that received at least 30 treatments with ViE-21.
Blood samples were obtained during the first week of dialysis with control dialyzer and then during weeks 7 and 13 with ViE-21. C3a was measured pre dialysis, at 15 minutes and post dialysis. The values were corrected with HCT and then leveled by defining the pre-dialysis value as 100%.
Outcome measures
| Measure |
Pre-ViE Phase
n=14 Participants
The first week of dialysis with control dialyzer
|
ViE Phase (1)
n=14 Participants
Seventh week of dialysis with ViE-21
|
ViE Phase (2)
n=14 Participants
13th week of dialysis with ViE-21
|
|---|---|---|---|
|
Activated Complement Factor III (C3a )
15 min
|
224.1 percentage of C3a level
Standard Deviation 112.2
|
236.2 percentage of C3a level
Standard Deviation 115.2
|
198.1 percentage of C3a level
Standard Deviation 99.2
|
|
Activated Complement Factor III (C3a )
Post dialysis
|
97.3 percentage of C3a level
Standard Deviation 29.5
|
103.1 percentage of C3a level
Standard Deviation 29.2
|
90.2 percentage of C3a level
Standard Deviation 33.7
|
SECONDARY outcome
Timeframe: Week 1 to 2 (Pre-ViE phase), 3 to 14 (ViE phase), and 15 to 16 (Post-ViE phase)Population: The safety analysis population (SAA) that is comprised of all patients that received at least one session with the ViE-21
Outcome measures
| Measure |
Pre-ViE Phase
n=17 Participants
The first week of dialysis with control dialyzer
|
ViE Phase (1)
n=17 Participants
Seventh week of dialysis with ViE-21
|
ViE Phase (2)
n=14 Participants
13th week of dialysis with ViE-21
|
|---|---|---|---|
|
Device Malfunctions
|
0 malfunctions
|
3 malfunctions
|
0 malfunctions
|
Adverse Events
Pre-ViE Phase
ViE Phase
Post-ViE Phase
Serious adverse events
| Measure |
Pre-ViE Phase
n=17 participants at risk
Two weeks (six sessions) on control dialyzer
|
ViE Phase
n=17 participants at risk
12 weeks (36 sessions) on ViE-21
|
Post-ViE Phase
n=14 participants at risk
Two weeks (six sessions) on the same model control dialyzer used during the pre-ViE phase
|
|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/17 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
0.00%
0/17 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
7.1%
1/14 • Number of events 1 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
Other adverse events
| Measure |
Pre-ViE Phase
n=17 participants at risk
Two weeks (six sessions) on control dialyzer
|
ViE Phase
n=17 participants at risk
12 weeks (36 sessions) on ViE-21
|
Post-ViE Phase
n=14 participants at risk
Two weeks (six sessions) on the same model control dialyzer used during the pre-ViE phase
|
|---|---|---|---|
|
Vascular disorders
Hypotension
|
64.7%
11/17 • Number of events 27 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
70.6%
12/17 • Number of events 110 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
64.3%
9/14 • Number of events 28 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
29.4%
5/17 • Number of events 11 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
64.7%
11/17 • Number of events 26 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
14.3%
2/14 • Number of events 3 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
|
Metabolism and nutrition disorders
Fluid Overload
|
23.5%
4/17 • Number of events 5 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
64.7%
11/17 • Number of events 28 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
21.4%
3/14 • Number of events 4 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
|
Nervous system disorders
Dizziness
|
29.4%
5/17 • Number of events 6 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
41.2%
7/17 • Number of events 13 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
14.3%
2/14 • Number of events 2 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/17 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
23.5%
4/17 • Number of events 4 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
0.00%
0/14 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/17 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
17.6%
3/17 • Number of events 3 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
0.00%
0/14 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.9%
1/17 • Number of events 3 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
11.8%
2/17 • Number of events 3 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
0.00%
0/14 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
|
Vascular disorders
Hypertension
|
5.9%
1/17 • Number of events 2 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
11.8%
2/17 • Number of events 3 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
7.1%
1/14 • Number of events 1 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/17 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
11.8%
2/17 • Number of events 2 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
0.00%
0/14 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
|
General disorders
Pain
|
0.00%
0/17 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
11.8%
2/17 • Number of events 2 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
0.00%
0/14 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/17 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
5.9%
1/17 • Number of events 3 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
7.1%
1/14 • Number of events 1 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/17 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
5.9%
1/17 • Number of events 2 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
0.00%
0/14 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/17 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
5.9%
1/17 • Number of events 2 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
0.00%
0/14 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
|
Gastrointestinal disorders
Constipation
|
5.9%
1/17 • Number of events 1 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
5.9%
1/17 • Number of events 1 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
0.00%
0/14 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/17 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
5.9%
1/17 • Number of events 1 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
0.00%
0/14 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
|
Infections and infestations
Pneumonia
|
0.00%
0/17 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
5.9%
1/17 • Number of events 1 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
0.00%
0/14 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/17 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
5.9%
1/17 • Number of events 1 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
0.00%
0/14 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Stiffness
|
0.00%
0/17 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
5.9%
1/17 • Number of events 1 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
0.00%
0/14 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/17 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
5.9%
1/17 • Number of events 1 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
0.00%
0/14 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
|
Nervous system disorders
Headache
|
0.00%
0/17 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
5.9%
1/17 • Number of events 1 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
0.00%
0/14 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
|
Nervous system disorders
Lethargy
|
0.00%
0/17 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
5.9%
1/17 • Number of events 1 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
0.00%
0/14 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
|
Nervous system disorders
Somnolence
|
0.00%
0/17 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
5.9%
1/17 • Number of events 1 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
0.00%
0/14 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
|
Nervous system disorders
Tremor
|
0.00%
0/17 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
5.9%
1/17 • Number of events 1 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
0.00%
0/14 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/17 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
5.9%
1/17 • Number of events 1 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
0.00%
0/14 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/17 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
5.9%
1/17 • Number of events 1 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
0.00%
0/14 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/17 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
5.9%
1/17 • Number of events 1 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
0.00%
0/14 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
|
Surgical and medical procedures
Angioplasty
|
0.00%
0/17 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
5.9%
1/17 • Number of events 1 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
0.00%
0/14 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
|
Vascular disorders
Haematoma
|
0.00%
0/17 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
5.9%
1/17 • Number of events 1 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
0.00%
0/14 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/17 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
0.00%
0/17 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
7.1%
1/14 • Number of events 1 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/17 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
0.00%
0/17 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
7.1%
1/14 • Number of events 1 • Two weeks for Pre-ViE phase, 12 weeks for ViE phase and 2 weeks for Post-ViE phase
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60