Trial Outcomes & Findings for A Safety, Tolerability, and Efficacy Study of VC-01™ Combination Product in Subjects With Type I Diabetes Mellitus (NCT NCT02239354)
NCT ID: NCT02239354
Last Updated: 2022-03-24
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
19 participants
Primary outcome timeframe
Thru the Month 24 Visit
Results posted on
2022-03-24
Participant Flow
Participant milestones
| Measure |
Cohort 1
Up to 2 VC-01-250™ Combination Product implants
Up to 6 VC-01-20 sentinel units
VC-01™ Combination Product: Biologic and Device
|
Cohort 2
Up to 4 or 6 VC-01™ Combination Product implants
Up to 3 VC-01-20 sentinel units
VC-01™ Combination Product: Biologic and Device
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
0
|
|
Overall Study
COMPLETED
|
9
|
0
|
|
Overall Study
NOT COMPLETED
|
10
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Safety, Tolerability, and Efficacy Study of VC-01™ Combination Product in Subjects With Type I Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Cohort 1
n=19 Participants
Up to 2 VC-01-250™ Combination Product implants
Up to 6 VC-01-20 sentinel units
VC-01™ Combination Product: Biologic and Device
|
Cohort 2
Up to 4 or 6 VC-01™ Combination Product implants
Up to 3 VC-01-20 sentinel units
VC-01™ Combination Product: Biologic and Device
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.0 years
STANDARD_DEVIATION 11.92 • n=5 Participants
|
—
|
29.0 years
STANDARD_DEVIATION 11.92 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
—
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
—
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
—
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
—
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
—
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Thru the Month 24 VisitPopulation: The Safety Analysis Set (SAS) will include all T1DM subjects who were enrolled into the study and in whom an implant surgery was attempted, regardless if any VC-01-250 units or sentinel-sized units were actually implanted. This includes all subjects in both Cohort 1 and Cohort 2.
Outcome measures
| Measure |
Cohort 1
n=19 Participants
Up to 2 VC-01-250™ Combination Product implants
Up to 6 VC-01-20 sentinel units
VC-01™ Combination Product: Biologic and Device
|
|---|---|
|
Number of Adverse Events Reported During the Study.
|
114 events
|
PRIMARY outcome
Timeframe: Baseline to the Month 6 VisitPopulation: No subjects were enrolled in Cohort 2. Therefore, no data was collected for this endpoint.
The Full Analysis Set (FAS) is the intent-to-treat (ITT) set of subjects. This set is defined as all T1DM subjects who were enrolled into the study and received implantation of at least one VC-01-250 or sentinel unit on Study Day 1. The FAS (Cohort 2 T1DM subjects who meet the FAS criteria) will be used to analyze the primary efficacy endpoint.
Outcome measures
Outcome data not reported
Adverse Events
Cohort 1
Serious events: 2 serious events
Other events: 18 other events
Deaths: 0 deaths
Cohort 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1
n=19 participants at risk
Up to 2 VC-01-250™ Combination Product implants
Up to 6 VC-01-20 sentinel units
VC-01™ Combination Product: Biologic and Device
|
Cohort 2
Up to 4 or 6 VC-01™ Combination Product implants
Up to 3 VC-01-20 sentinel units
VC-01™ Combination Product: Biologic and Device
|
|---|---|---|
|
Infections and infestations
Cellulitis
|
5.3%
1/19 • Number of events 1 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
—
0/0 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
|
Infections and infestations
Right middle lobe pneumonia
|
5.3%
1/19 • Number of events 1 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
—
0/0 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
Other adverse events
| Measure |
Cohort 1
n=19 participants at risk
Up to 2 VC-01-250™ Combination Product implants
Up to 6 VC-01-20 sentinel units
VC-01™ Combination Product: Biologic and Device
|
Cohort 2
Up to 4 or 6 VC-01™ Combination Product implants
Up to 3 VC-01-20 sentinel units
VC-01™ Combination Product: Biologic and Device
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
15.8%
3/19 • Number of events 3 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
—
0/0 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
|
Gastrointestinal disorders
Constipation
|
10.5%
2/19 • Number of events 2 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
—
0/0 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
|
Injury, poisoning and procedural complications
Procedural pain
|
73.7%
14/19 • Number of events 30 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
—
0/0 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
|
Injury, poisoning and procedural complications
Contusion
|
10.5%
2/19 • Number of events 2 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
—
0/0 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
|
Injury, poisoning and procedural complications
Incision site haematoma
|
10.5%
2/19 • Number of events 2 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
—
0/0 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
10.5%
2/19 • Number of events 2 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
—
0/0 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
5.3%
1/19 • Number of events 1 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
—
0/0 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
|
Injury, poisoning and procedural complications
Post procedural inflammation
|
5.3%
1/19 • Number of events 1 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
—
0/0 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
|
Injury, poisoning and procedural complications
Post procedural swelling
|
5.3%
1/19 • Number of events 1 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
—
0/0 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
|
Injury, poisoning and procedural complications
Procedural complication
|
5.3%
1/19 • Number of events 1 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
—
0/0 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
5.3%
1/19 • Number of events 1 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
—
0/0 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
|
Injury, poisoning and procedural complications
Venous injury
|
5.3%
1/19 • Number of events 1 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
—
0/0 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
|
Injury, poisoning and procedural complications
Wound
|
5.3%
1/19 • Number of events 1 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
—
0/0 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
5.3%
1/19 • Number of events 1 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
—
0/0 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
|
General disorders
Device dislocation
|
36.8%
7/19 • Number of events 10 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
—
0/0 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
|
General disorders
Device breakage
|
26.3%
5/19 • Number of events 5 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
—
0/0 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
|
General disorders
Implant site extravasation
|
26.3%
5/19 • Number of events 7 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
—
0/0 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
|
General disorders
Implant site haemorrhage
|
10.5%
2/19 • Number of events 3 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
—
0/0 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
|
General disorders
Implant site hypoaesthesia
|
10.5%
2/19 • Number of events 2 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
—
0/0 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
|
General disorders
Implant site swelling
|
10.5%
2/19 • Number of events 2 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
—
0/0 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
|
General disorders
Calcinosis
|
5.3%
1/19 • Number of events 1 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
—
0/0 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
|
General disorders
Complication of device removal
|
5.3%
1/19 • Number of events 1 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
—
0/0 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
|
General disorders
Device difficult to use
|
5.3%
1/19 • Number of events 1 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
—
0/0 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
|
General disorders
Device extrusion
|
5.3%
1/19 • Number of events 1 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
—
0/0 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
|
General disorders
Implant site oedema
|
5.3%
1/19 • Number of events 1 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
—
0/0 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
|
General disorders
Implant site pain
|
5.3%
1/19 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
—
0/0 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
|
General disorders
Implant site rash
|
5.3%
1/19 • Number of events 1 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
—
0/0 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
|
General disorders
Localised oedema
|
5.3%
1/19 • Number of events 1 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
—
0/0 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
|
General disorders
Oedema peripheral
|
5.3%
1/19 • Number of events 1 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
—
0/0 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
10.5%
2/19 • Number of events 2 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
—
0/0 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
|
Skin and subcutaneous tissue disorders
Erythema
|
10.5%
2/19 • Number of events 2 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
—
0/0 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
|
Skin and subcutaneous tissue disorders
Acne
|
5.3%
1/19 • Number of events 1 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
—
0/0 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
5.3%
1/19 • Number of events 1 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
—
0/0 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
|
Skin and subcutaneous tissue disorders
Eczema
|
5.3%
1/19 • Number of events 1 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
—
0/0 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
5.3%
1/19 • Number of events 1 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
—
0/0 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
5.3%
1/19 • Number of events 1 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
—
0/0 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
|
Blood and lymphatic system disorders
Anaemia
|
5.3%
1/19 • Number of events 1 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
—
0/0 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
5.3%
1/19 • Number of events 1 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
—
0/0 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.3%
1/19 • Number of events 1 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
—
0/0 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
|
Blood and lymphatic system disorders
White blood cell disorder
|
5.3%
1/19 • Number of events 1 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
—
0/0 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
|
Gastrointestinal disorders
Vomiting
|
10.5%
2/19 • Number of events 2 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
—
0/0 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
|
Gastrointestinal disorders
Colitis ulcerative
|
5.3%
1/19 • Number of events 1 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
—
0/0 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
|
Gastrointestinal disorders
Diarrhoea
|
5.3%
1/19 • Number of events 1 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
—
0/0 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
|
Infections and infestations
Cellulitis
|
10.5%
2/19 • Number of events 2 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
—
0/0 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
|
Infections and infestations
Pneumonia
|
5.3%
1/19 • Number of events 1 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
—
0/0 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
|
Infections and infestations
Wound infection
|
5.3%
1/19 • Number of events 1 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
—
0/0 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
|
Nervous system disorders
Hypoaesthesia
|
5.3%
1/19 • Number of events 1 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
—
0/0 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
|
Nervous system disorders
Paraesthesia
|
5.3%
1/19 • Number of events 1 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
—
0/0 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
5.3%
1/19 • Number of events 1 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
—
0/0 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.3%
1/19 • Number of events 1 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
—
0/0 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
|
Immune system disorders
Sensitisation
|
5.3%
1/19 • Number of events 1 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
—
0/0 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.3%
1/19 • Number of events 1 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
—
0/0 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
|
Vascular disorders
Thrombophlebitis superficial
|
5.3%
1/19 • Number of events 1 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
—
0/0 • AEs are recorded on the CRF from Visit 2 (Week-3) through the last subject visit (out to two years). At the conclusion of the trial, any ongoing AEs were followed up for 28 days after the explantation procedure.
All observed or volunteered AEs regardless of suspected causal relationship to the investigational product were reported. For all AEs, the Investigator obtained information adequate to determine the outcome of the AE, whether it meets the criteria for classification as a serious adverse event(SAE), the causality, and the severity,
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If a multi-center publication is not published within 14 to 18 months (depends on the individual PI's contract) after completion of the study, the PI will have the right to publish and present results. The PI will submit any proposed publication or presentation to the Sponsor for review at least 30 to 60 days (depending on the individual PI's contract) prior to submitting any such proposed publication to a publisher, proceeding with such proposed presentation or making any other disclosure.
- Publication restrictions are in place
Restriction type: OTHER