Trial Outcomes & Findings for An Efficacy and Safety Study of SRM003 in the Treatment of Subjects Undergoing Creation of an Arteriovenous Fistula to Facilitate Hemodialysis Access (NCT NCT01806545)
NCT ID: NCT01806545
Last Updated: 2021-06-08
Results Overview
Maturation based on CDUS was assessed in a continuous fashion and was defined by the following criteria: presence of bruit throughout systole and diastole at least 8 centimeters (cm) proximal to the venous anastomosis, blood flow through the outflow vein of at least 500 milliliters (ml) per minute, and a lumen diameter of the outflow vein at least 4 mm. Maturation was determined by CDUS and vascular access examination or by first use of the AVF for hemodialysis based on investigator-reported use. Participants who discontinued prior to the Week 12 visit without assessment of maturity were considered treatment failures.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
64 participants
Primary outcome timeframe
12 weeks after surgery
Results posted on
2021-06-08
Participant Flow
Participant milestones
| Measure |
Participating Site's Standard Practice
Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
|
SRM003
Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
35
|
|
Overall Study
COMPLETED
|
23
|
30
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
Reasons for withdrawal
| Measure |
Participating Site's Standard Practice
Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
|
SRM003
Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
Baseline Characteristics
An Efficacy and Safety Study of SRM003 in the Treatment of Subjects Undergoing Creation of an Arteriovenous Fistula to Facilitate Hemodialysis Access
Baseline characteristics by cohort
| Measure |
Participating Site's Standard Practice
n=29 Participants
Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
|
SRM003
n=35 Participants
Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.2 years
STANDARD_DEVIATION 13.5 • n=99 Participants
|
61.1 years
STANDARD_DEVIATION 10.8 • n=107 Participants
|
63.0 years
STANDARD_DEVIATION 12.2 • n=206 Participants
|
|
Age, Customized
<65 years
|
12 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Age, Customized
≥65 years
|
17 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 12 weeks after surgeryPopulation: The Intent- to-Treat (ITT) population, defined as all randomly assigned participants regardless of receiving treatments or having post-baseline outcome data.
Maturation based on CDUS was assessed in a continuous fashion and was defined by the following criteria: presence of bruit throughout systole and diastole at least 8 centimeters (cm) proximal to the venous anastomosis, blood flow through the outflow vein of at least 500 milliliters (ml) per minute, and a lumen diameter of the outflow vein at least 4 mm. Maturation was determined by CDUS and vascular access examination or by first use of the AVF for hemodialysis based on investigator-reported use. Participants who discontinued prior to the Week 12 visit without assessment of maturity were considered treatment failures.
Outcome measures
| Measure |
Participating Site's Standard Practice
n=29 Participants
Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
|
SRM003
n=35 Participants
Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
|
|---|---|---|
|
Percentage of Participants With Arteriovenous Fistula (AVF) Maturation by Week 12 Visit Based on Hemodialysis or Color-flow Doppler Ultrasound (CDUS) And Vascular Access Examination
|
96.6 percentage of participants
|
85.7 percentage of participants
|
SECONDARY outcome
Timeframe: 26 weeks after surgeryPopulation: The ITT population, defined as all randomly assigned participants regardless of receiving treatments or having post-baseline outcome data.
Maturation based on CDUS was assessed in a continuous fashion and was defined by the following criteria: presence of bruit throughout systole and diastole at least 8 centimeters (cm) proximal to the venous anastomosis, blood flow through the outflow vein of at least 500 milliliters (ml) per minute, and a lumen diameter of the outflow vein at least 4 mm. Maturation was determined by CDUS and vascular access examination or by first use of the AVF for hemodialysis based on investigator-reported use. Participants who discontinued prior to the Week 26 visit without assessment of maturity were considered treatment failures.
Outcome measures
| Measure |
Participating Site's Standard Practice
n=29 Participants
Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
|
SRM003
n=35 Participants
Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
|
|---|---|---|
|
Percentage of Participants With AVF Maturation by Week 26 Visit Based on Hemodialysis or CDUS And Vascular Access Examination
|
96.6 percentage of participants
|
88.6 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 26 weeks after surgeryPopulation: The ITT population, defined as all randomly assigned participants regardless of receiving treatments or having post-baseline outcome data.
Time to AVF maturation was defined as the duration of time (in days) from the date of randomization (AVF creation) to the date of maturation, where the date of maturation corresponds to the earlier of either the date of the first use of the study AVF for hemodialysis as determined by the investigator following discussion with the participant, or the date the AVF meets all of the following 3 criteria as determined through CDUS and vascular access examination: presence of bruit throughout systole and diastole at least 8 centimeters proximal to the venous anastomosis, blood flow through the outflow vein of at least 500 milliliters (ml) per minute, and a lumen diameter of the outflow vein at least 4 mm. Participants who died, underwent a kidney transplant, or were either lost to follow-up or did not mature during the study follow-up were censored at the time of death, time of transplant, or time of last visit, respectively.
Outcome measures
| Measure |
Participating Site's Standard Practice
n=29 Participants
Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
|
SRM003
n=35 Participants
Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
|
|---|---|---|
|
Time to AVF Maturation Based on Hemodialysis or CDUS and Vascular Access Examination
|
9 days
Interval 8.0 to 28.0
|
10 days
Interval 8.0 to 59.0
|
SECONDARY outcome
Timeframe: Up to 26 weeks after surgeryPopulation: The ITT population, defined as all randomly assigned participants regardless of receiving treatments or having post-baseline outcome data.
The time to loss of unassisted primary patency (intervention--free access survival) was defined as the duration of time in days from the date of randomization (AVF creation) until the first date of (a) any intervention designed to establish, maintain, or restore patency; (b) occlusion (commonly due to thrombosis); or (c) access abandonment.
Outcome measures
| Measure |
Participating Site's Standard Practice
n=29 Participants
Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
|
SRM003
n=35 Participants
Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
|
|---|---|---|
|
Percentage of Participants With Loss of Unassisted Primary Patency
|
20.7 percentage of participants
|
37.1 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 26 weeks after surgeryPopulation: The ITT population, defined as all randomly assigned participants regardless of receiving treatments or having post-baseline outcome data.
The time to loss of assisted primary patency (thrombosis--free access survival) was defined as the duration of time in days from the date of randomization (AVF creation) until the first date of (a) occlusion (commonly due to thrombosis) or (b) access abandonment.
Outcome measures
| Measure |
Participating Site's Standard Practice
n=29 Participants
Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
|
SRM003
n=35 Participants
Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
|
|---|---|---|
|
Percentage of Participants With Loss of Assisted Primary Patency
|
6.9 percentage of participants
|
17.1 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 26 weeks after surgeryPopulation: The ITT population, defined as all randomly assigned participants regardless of receiving treatments or having post-baseline outcome data.
The time to loss of secondary patency (access survival until abandonment) was defined as the duration of time in days from the date of randomization (AVF creation) until the date of access abandonment.
Outcome measures
| Measure |
Participating Site's Standard Practice
n=29 Participants
Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
|
SRM003
n=35 Participants
Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
|
|---|---|---|
|
Percentage of Participants With Loss of Secondary Patency
|
3.4 percentage of participants
|
14.3 percentage of participants
|
SECONDARY outcome
Timeframe: 1, 12, and 26 weeks after surgeryPopulation: The ITT population, defined as all randomly assigned participants regardless of receiving treatments or having post-baseline outcome data.
B-mode lumen diameter measurements were obtained in the outflow vein as 3 separate images for each location: at 1, 3, and 5 centimeter into the vein and from the toe of the venous anastomosis. The average of lumen diameter measurements obtained at 1, 3, and 5 cm from the anastomosis was used for this endpoint.
Outcome measures
| Measure |
Participating Site's Standard Practice
n=29 Participants
Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
|
SRM003
n=35 Participants
Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
|
|---|---|---|
|
Change From Week 1 in Average Vascular Access Lumen Diameter Using CDUS
Week 12, n=21, 28
|
1.897 millimeters
Standard Deviation 1.2587
|
1.253 millimeters
Standard Deviation 1.9908
|
|
Change From Week 1 in Average Vascular Access Lumen Diameter Using CDUS
Week 26, n=20, 25
|
2.489 millimeters
Standard Deviation 1.4525
|
2.416 millimeters
Standard Deviation 2.3941
|
SECONDARY outcome
Timeframe: 12 and 26 weeks after surgeryPopulation: The ITT population, defined as all randomly assigned participants regardless of receiving treatments or having post-baseline outcome data.
Clinical success was defined as the ability to undergo hemodialysis using the AVF. The date of clinical success corresponded to the date of the first use of the study AVF for hemodialysis as determined by the investigator, following discussion with the subject. Clinical success was assessed in a continuous fashion and, once achieved, the AVF was considered a clinical success at that and all subsequent time points. The date of clinical success based on the first use of the AVF for hemodialysis was compared with the dates of each study visit (Week 12 and Week 26); for study visits occurring prior to the date of clinical success based on the first use of the AVF for hemodialysis, the subject was counted as a nonsuccess and for study visits occurring on or after the date of maturation based on the first use of the AVF for hemodialysis, the subject was counted as a success.
Outcome measures
| Measure |
Participating Site's Standard Practice
n=29 Participants
Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
|
SRM003
n=35 Participants
Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
|
|---|---|---|
|
Percentage of Participants With Clinical Success Based on First Use of The Study AVF For Hemodialysis
Week 12
|
37.9 percentage of participants
|
34.3 percentage of participants
|
|
Percentage of Participants With Clinical Success Based on First Use of The Study AVF For Hemodialysis
Week 26
|
55.2 percentage of participants
|
62.9 percentage of participants
|
SECONDARY outcome
Timeframe: 12 and 26 weeks after surgeryPopulation: The ITT population, defined as all randomly assigned participants regardless of receiving treatments or having post-baseline outcome data.
The total number of interventions to establish, maintain, or restore patency was recorded for each participant.
Outcome measures
| Measure |
Participating Site's Standard Practice
n=29 Participants
Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
|
SRM003
n=35 Participants
Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
|
|---|---|---|
|
Number of Interventions to Establish, Maintain, or Restore Patency
Week 12
|
0.1 interventions
Standard Deviation 0.31
|
0.3 interventions
Standard Deviation 0.61
|
|
Number of Interventions to Establish, Maintain, or Restore Patency
Week 26
|
0.2 interventions
Standard Deviation 0.49
|
0.8 interventions
Standard Deviation 1.52
|
Adverse Events
Participating Site's Standard Practice
Serious events: 16 serious events
Other events: 17 other events
Deaths: 0 deaths
SRM003
Serious events: 13 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Participating Site's Standard Practice
n=29 participants at risk
Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
|
SRM003
n=35 participants at risk
Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
6.9%
2/29 • Number of events 3
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
5.7%
2/35 • Number of events 2
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
Cardiac disorders
Cardiac failure congestive
|
6.9%
2/29 • Number of events 2
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
2.9%
1/35 • Number of events 1
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/29
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
5.7%
2/35 • Number of events 2
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
General disorders
Non cardiac chest pain
|
6.9%
2/29 • Number of events 2
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
0.00%
0/35
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
Infections and infestations
Pneumonia
|
6.9%
2/29 • Number of events 2
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
0.00%
0/35
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
3.4%
1/29 • Number of events 1
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
5.7%
2/35 • Number of events 2
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
Metabolism and nutrition disorders
Fluid overload
|
6.9%
2/29 • Number of events 2
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
2.9%
1/35 • Number of events 3
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
Renal and urinary disorders
Renal failure chronic
|
3.4%
1/29 • Number of events 1
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
8.6%
3/35 • Number of events 3
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
Vascular disorders
Steal syndrome
|
6.9%
2/29 • Number of events 2
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
0.00%
0/35
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/29
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
2.9%
1/35 • Number of events 1
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/29
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
2.9%
1/35 • Number of events 1
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/29
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
2.9%
1/35 • Number of events 1
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
Cardiac disorders
Cardiac failure chronic
|
0.00%
0/29
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
2.9%
1/35 • Number of events 1
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
Cardiac disorders
Coronary artery disease
|
3.4%
1/29 • Number of events 1
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
0.00%
0/35
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/29
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
2.9%
1/35 • Number of events 1
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/29
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
2.9%
1/35 • Number of events 1
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/29
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
2.9%
1/35 • Number of events 1
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
3.4%
1/29 • Number of events 1
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
0.00%
0/35
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/29
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
2.9%
1/35 • Number of events 1
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/29
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
2.9%
1/35 • Number of events 1
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/29
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
2.9%
1/35 • Number of events 1
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
General disorders
Chest pain
|
3.4%
1/29 • Number of events 1
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
2.9%
1/35 • Number of events 1
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
General disorders
Influenza like illness
|
3.4%
1/29 • Number of events 1
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
0.00%
0/35
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
General disorders
Pyrexia
|
3.4%
1/29 • Number of events 1
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
0.00%
0/35
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/29
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
2.9%
1/35 • Number of events 1
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
Infections and infestations
Lower respiratory tract infection
|
3.4%
1/29 • Number of events 1
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
0.00%
0/35
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
Infections and infestations
Sepsis
|
0.00%
0/29
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
2.9%
1/35 • Number of events 1
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
0.00%
0/29
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
2.9%
1/35 • Number of events 2
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/29
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
2.9%
1/35 • Number of events 1
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
3.4%
1/29 • Number of events 1
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
0.00%
0/35
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
3.4%
1/29 • Number of events 1
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
0.00%
0/35
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/29
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
2.9%
1/35 • Number of events 1
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/29
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
2.9%
1/35 • Number of events 1
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
Nervous system disorders
Cerebrovascular accident
|
3.4%
1/29 • Number of events 1
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
0.00%
0/35
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/29
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
2.9%
1/35 • Number of events 1
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/29
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
2.9%
1/35 • Number of events 1
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/29
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
2.9%
1/35 • Number of events 1
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
Nervous system disorders
Syncope
|
3.4%
1/29 • Number of events 1
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
0.00%
0/35
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
Psychiatric disorders
Mental status changes
|
3.4%
1/29 • Number of events 1
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
0.00%
0/35
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
Renal and urinary disorders
Renal failure acute
|
3.4%
1/29 • Number of events 1
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
0.00%
0/35
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/29
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
2.9%
1/35 • Number of events 1
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
3.4%
1/29 • Number of events 1
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
0.00%
0/35
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.4%
1/29 • Number of events 1
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
2.9%
1/35 • Number of events 1
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/29
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
2.9%
1/35 • Number of events 1
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
3.4%
1/29 • Number of events 1
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
0.00%
0/35
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
Vascular disorders
Hypertension
|
3.4%
1/29 • Number of events 2
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
0.00%
0/35
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
Vascular disorders
Hypertensive emergency
|
0.00%
0/29
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
2.9%
1/35 • Number of events 1
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/29
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
2.9%
1/35 • Number of events 1
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
Other adverse events
| Measure |
Participating Site's Standard Practice
n=29 participants at risk
Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
|
SRM003
n=35 participants at risk
Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.9%
2/29 • Number of events 2
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
2.9%
1/35 • Number of events 1
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
Cardiac disorders
Atrial fibrillation
|
6.9%
2/29 • Number of events 2
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
0.00%
0/35
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
Cardiac disorders
Cardiac failure congestive
|
6.9%
2/29 • Number of events 2
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
0.00%
0/35
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/29
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
8.6%
3/35 • Number of events 3
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
Gastrointestinal disorders
Nausea
|
10.3%
3/29 • Number of events 3
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
11.4%
4/35 • Number of events 4
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
Gastrointestinal disorders
Vomiting
|
3.4%
1/29 • Number of events 1
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
8.6%
3/35 • Number of events 3
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
General disorders
Fatigue
|
0.00%
0/29
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
8.6%
3/35 • Number of events 3
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
General disorders
Local swelling
|
6.9%
2/29 • Number of events 2
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
8.6%
3/35 • Number of events 3
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
General disorders
Medical device complication
|
0.00%
0/29
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
8.6%
3/35 • Number of events 5
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
General disorders
Non-cardiac chest pain
|
6.9%
2/29 • Number of events 2
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
0.00%
0/35
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
General disorders
Oedema peripheral
|
0.00%
0/29
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
5.7%
2/35 • Number of events 2
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
General disorders
Pain
|
0.00%
0/29
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
5.7%
2/35 • Number of events 2
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.9%
2/29 • Number of events 2
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
2.9%
1/35 • Number of events 1
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
Infections and infestations
Urinary tract infection
|
3.4%
1/29 • Number of events 1
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
5.7%
2/35 • Number of events 2
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula occlusion
|
3.4%
1/29 • Number of events 1
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
5.7%
2/35 • Number of events 2
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
17.2%
5/29 • Number of events 8
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
20.0%
7/35 • Number of events 12
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
0.00%
0/29
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
8.6%
3/35 • Number of events 3
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
Injury, poisoning and procedural complications
Laceration
|
6.9%
2/29 • Number of events 2
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
2.9%
1/35 • Number of events 1
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
6.9%
2/29 • Number of events 2
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
5.7%
2/35 • Number of events 2
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/29
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
5.7%
2/35 • Number of events 2
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/29
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
5.7%
2/35 • Number of events 2
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.4%
1/29 • Number of events 1
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
5.7%
2/35 • Number of events 2
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
3.4%
1/29 • Number of events 1
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
8.6%
3/35 • Number of events 3
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.9%
2/29 • Number of events 2
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
8.6%
3/35 • Number of events 3
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/29
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
8.6%
3/35 • Number of events 3
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
Nervous system disorders
Hypoaesthesia
|
13.8%
4/29 • Number of events 5
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
5.7%
2/35 • Number of events 3
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
Nervous system disorders
Paraesthesia
|
3.4%
1/29 • Number of events 1
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
8.6%
3/35 • Number of events 3
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/29
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
8.6%
3/35 • Number of events 3
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
Renal and urinary disorders
Renal failure chronic
|
6.9%
2/29 • Number of events 4
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
2.9%
1/35 • Number of events 1
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.3%
3/29 • Number of events 3
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
2.9%
1/35 • Number of events 1
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.9%
2/29 • Number of events 2
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
5.7%
2/35 • Number of events 2
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
6.9%
2/29 • Number of events 2
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
0.00%
0/35
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/29
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
5.7%
2/35 • Number of events 2
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
Vascular disorders
Haematoma
|
6.9%
2/29 • Number of events 2
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
0.00%
0/35
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
|
Vascular disorders
Hypotension
|
10.3%
3/29 • Number of events 3
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
8.6%
3/35 • Number of events 3
Treatment emergent adverse events are presented for the safety population, defined as all randomly assigned participants who received either SRM003 treatment or participating sites' standard practice treatments.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually
- Publication restrictions are in place
Restriction type: OTHER