Trial Outcomes & Findings for IN.PACT™ AV Access IDE Study (NCT NCT03041467)
NCT ID: NCT03041467
Last Updated: 2024-05-29
Results Overview
Freedom from clinically-driven target lesion revascularization (CD-TLR) or access circuit thrombosis measured through 6 months post-procedure.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
330 participants
Primary outcome timeframe
6 Months Post-Procedure
Results posted on
2024-05-29
Participant Flow
330 subjects from 21 US sites and 8 OUS sites contributed to the global cohort. 204 of subjects came from U.S. sites, 112 of subjects came from Japan sites, and 14 of subjects came from New Zealand sites. There was no minimum enrollment requirement at each site; individual sites were not allowed to enroll more than 20% of the total study subjects.
A total of 488 patients were consented to be reviewed for enrollment. 158 patients were not enrolled in the study. 170 subjects were randomized to IN.PACT AV Drug Coated Balloon treatment and 160 subjects were randomized to the Standard PTA Treatment.
Participant milestones
| Measure |
IN.PACT AV DCB
PTA will be performed using the IN.PACT AV Drug Coated Balloon.
IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon
|
Standard Balloon Angioplasty
PTA will be performed using a commercially available uncoated PTA balloon.
Standard Balloon Angioplasty: Standard PTA Balloon
|
|---|---|---|
|
Overall Study
STARTED
|
170
|
160
|
|
Overall Study
30 Days
|
159
|
154
|
|
Overall Study
3 Months
|
158
|
151
|
|
Overall Study
6 Months
|
145
|
144
|
|
Overall Study
9 Months
|
138
|
138
|
|
Overall Study
12 Months
|
131
|
121
|
|
Overall Study
18 Months
|
123
|
113
|
|
Overall Study
24 Months
|
110
|
101
|
|
Overall Study
36 Months
|
75
|
58
|
|
Overall Study
48 Months
|
54
|
41
|
|
Overall Study
60 Months
|
57
|
41
|
|
Overall Study
COMPLETED
|
57
|
41
|
|
Overall Study
NOT COMPLETED
|
113
|
119
|
Reasons for withdrawal
| Measure |
IN.PACT AV DCB
PTA will be performed using the IN.PACT AV Drug Coated Balloon.
IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon
|
Standard Balloon Angioplasty
PTA will be performed using a commercially available uncoated PTA balloon.
Standard Balloon Angioplasty: Standard PTA Balloon
|
|---|---|---|
|
Overall Study
Death
|
46
|
39
|
|
Overall Study
Withdrawal by Subject
|
36
|
37
|
|
Overall Study
Lost to Follow-up
|
6
|
8
|
|
Overall Study
Declined consent for study extension
|
21
|
33
|
|
Overall Study
Exit reason other than withdrawal, death, or lost to follow up
|
4
|
2
|
Baseline Characteristics
3 subjects in each treatment group did not provide data regarding ethnicity.
Baseline characteristics by cohort
| Measure |
IN.PACT AV DCB
n=170 Participants
PTA will be performed using the IN.PACT AV Drug Coated Balloon.
IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon
|
Standard Balloon Angioplasty
n=160 Participants
PTA will be performed using a commercially available uncoated PTA balloon.
Standard Balloon Angioplasty: Standard PTA Balloon
|
Total
n=330 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.8 years
STANDARD_DEVIATION 13.1 • n=170 Participants
|
65.5 years
STANDARD_DEVIATION 13.4 • n=160 Participants
|
65.6 years
STANDARD_DEVIATION 13.3 • n=330 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=170 Participants
|
59 Participants
n=160 Participants
|
117 Participants
n=330 Participants
|
|
Sex: Female, Male
Male
|
112 Participants
n=170 Participants
|
101 Participants
n=160 Participants
|
213 Participants
n=330 Participants
|
|
Race/Ethnicity, Customized
White
|
42 Participants
n=170 Participants
|
46 Participants
n=160 Participants
|
88 Participants
n=330 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
54 Participants
n=170 Participants
|
48 Participants
n=160 Participants
|
102 Participants
n=330 Participants
|
|
Race/Ethnicity, Customized
Asian
|
63 Participants
n=170 Participants
|
57 Participants
n=160 Participants
|
120 Participants
n=330 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
6 Participants
n=170 Participants
|
4 Participants
n=160 Participants
|
10 Participants
n=330 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=170 Participants
|
0 Participants
n=160 Participants
|
0 Participants
n=330 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 Participants
n=170 Participants
|
5 Participants
n=160 Participants
|
10 Participants
n=330 Participants
|
|
Region of Enrollment
New Zealand
|
8 participants
n=170 Participants
|
6 participants
n=160 Participants
|
14 participants
n=330 Participants
|
|
Region of Enrollment
United States
|
104 participants
n=170 Participants
|
100 participants
n=160 Participants
|
204 participants
n=330 Participants
|
|
Region of Enrollment
Japan
|
58 participants
n=170 Participants
|
54 participants
n=160 Participants
|
112 participants
n=330 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=167 Participants • 3 subjects in each treatment group did not provide data regarding ethnicity.
|
14 Participants
n=157 Participants • 3 subjects in each treatment group did not provide data regarding ethnicity.
|
29 Participants
n=324 Participants • 3 subjects in each treatment group did not provide data regarding ethnicity.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
152 Participants
n=167 Participants • 3 subjects in each treatment group did not provide data regarding ethnicity.
|
143 Participants
n=157 Participants • 3 subjects in each treatment group did not provide data regarding ethnicity.
|
295 Participants
n=324 Participants • 3 subjects in each treatment group did not provide data regarding ethnicity.
|
PRIMARY outcome
Timeframe: 6 Months Post-ProcedurePopulation: Evaluable subjects were all subjects with events or subjects without events but had at least 150 days of clinical follow-up were counted as evaluable subjects. If a subject had no event and abandoned AV Access circuit within 150 days the subject will be considered not evaluable for 6-months effectiveness endpoints.
Freedom from clinically-driven target lesion revascularization (CD-TLR) or access circuit thrombosis measured through 6 months post-procedure.
Outcome measures
| Measure |
IN.PACT AV DCB
n=152 Participants
PTA will be performed using the IN.PACT AV Drug Coated Balloon.
IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon
|
Standard Balloon Angioplasty
n=148 Participants
PTA will be performed using a commercially available uncoated PTA balloon.
Standard Balloon Angioplasty: Standard PTA Balloon
|
|---|---|---|
|
Target Lesion Primary Patency Rate Through 6 Months
|
125 Participants
|
88 Participants
|
PRIMARY outcome
Timeframe: 30 days post procedurePopulation: All subjects with events or subjects without events but had at least 23 days of clinical follow-up were counted as evaluable subjects.
Serious Adverse Event (SAE) rate involving the AV access circuit
Outcome measures
| Measure |
IN.PACT AV DCB
n=166 Participants
PTA will be performed using the IN.PACT AV Drug Coated Balloon.
IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon
|
Standard Balloon Angioplasty
n=158 Participants
PTA will be performed using a commercially available uncoated PTA balloon.
Standard Balloon Angioplasty: Standard PTA Balloon
|
|---|---|---|
|
Primary Safety Endpoint - Serious Adverse Event Rate
|
7 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 3, 6, 9, 12, 18, and 24 MonthsPopulation: There is no planned hypothesis test other than at 6 months time point.
Defined as freedom from re-intervention in the access circuit or access circuit thrombosis through 3 months, 6 months, 9 months,12 months, 18 months, and 24 months post-procedure.
Outcome measures
| Measure |
IN.PACT AV DCB
n=170 Participants
PTA will be performed using the IN.PACT AV Drug Coated Balloon.
IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon
|
Standard Balloon Angioplasty
n=160 Participants
PTA will be performed using a commercially available uncoated PTA balloon.
Standard Balloon Angioplasty: Standard PTA Balloon
|
|---|---|---|
|
Access Circuit Primary Patency
3 Months
|
91.4 Percentage of participants
|
84.6 Percentage of participants
|
|
Access Circuit Primary Patency
6 Months
|
72.5 Percentage of participants
|
48.0 Percentage of participants
|
|
Access Circuit Primary Patency
9 Months
|
66.8 Percentage of participants
|
43.1 Percentage of participants
|
|
Access Circuit Primary Patency
12 Months
|
55.1 Percentage of participants
|
35.0 Percentage of participants
|
|
Access Circuit Primary Patency
18 Months
|
43.6 Percentage of participants
|
28.8 Percentage of participants
|
|
Access Circuit Primary Patency
24 Months
|
39.5 Percentage of participants
|
25.4 Percentage of participants
|
SECONDARY outcome
Timeframe: 3, 9, 12, 18, and 24 MonthsPopulation: There is no planned hypothesis test other than at 6 months time-point.
Percentage of participants with freedom from clinically driven target lesion revascularization or access thrombosis occurring in the target lesion through 3 months, 9 months,12 months, 18 months, and 24 months post-procedure.
Outcome measures
| Measure |
IN.PACT AV DCB
n=170 Participants
PTA will be performed using the IN.PACT AV Drug Coated Balloon.
IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon
|
Standard Balloon Angioplasty
n=160 Participants
PTA will be performed using a commercially available uncoated PTA balloon.
Standard Balloon Angioplasty: Standard PTA Balloon
|
|---|---|---|
|
Target Lesion Primary Patency
3 Months
|
96.9 percentage of participants
|
90.3 percentage of participants
|
|
Target Lesion Primary Patency
9 Months
|
75.6 percentage of participants
|
54.5 percentage of participants
|
|
Target Lesion Primary Patency
12 Months
|
65.3 percentage of participants
|
46.3 percentage of participants
|
|
Target Lesion Primary Patency
18 Months
|
56.4 percentage of participants
|
38.0 percentage of participants
|
|
Target Lesion Primary Patency
24 Months
|
52.2 percentage of participants
|
36.2 percentage of participants
|
SECONDARY outcome
Timeframe: 3, 6, 9,12, 18, and 24 MonthsPopulation: Participants are included in the analyses up to the time consent was withdrawn, or they were exited, whichever is earlier.
The number and percentage of participants with target lesion revascularizations through 3 months, 6 months, 9 months,12 months, 18 months, and 24 months post-procedure.
Outcome measures
| Measure |
IN.PACT AV DCB
n=170 Participants
PTA will be performed using the IN.PACT AV Drug Coated Balloon.
IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon
|
Standard Balloon Angioplasty
n=160 Participants
PTA will be performed using a commercially available uncoated PTA balloon.
Standard Balloon Angioplasty: Standard PTA Balloon
|
|---|---|---|
|
Cumulative Target Lesion Revascularizations
3 Months
|
8 Participants
|
19 Participants
|
|
Cumulative Target Lesion Revascularizations
6 Months
|
25 Participants
|
59 Participants
|
|
Cumulative Target Lesion Revascularizations
9 Months
|
42 Participants
|
78 Participants
|
|
Cumulative Target Lesion Revascularizations
12 Months
|
57 Participants
|
88 Participants
|
|
Cumulative Target Lesion Revascularizations
18 Months
|
70 Participants
|
97 Participants
|
|
Cumulative Target Lesion Revascularizations
24 Months
|
76 Participants
|
101 Participants
|
SECONDARY outcome
Timeframe: 3, 6, 9, 12, 18, and 24 MonthsThe number of target lesion revascularizations per treatment arm through 3 months, 6 months, 9 months, 12 months,18 months, and 24 months post-procedure.
Outcome measures
| Measure |
IN.PACT AV DCB
n=170 Participants
PTA will be performed using the IN.PACT AV Drug Coated Balloon.
IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon
|
Standard Balloon Angioplasty
n=160 Participants
PTA will be performed using a commercially available uncoated PTA balloon.
Standard Balloon Angioplasty: Standard PTA Balloon
|
|---|---|---|
|
Total Number of Interventions Required to Maintain Target Lesion Patency
3 Months
|
10 Total number of interventions
|
19 Total number of interventions
|
|
Total Number of Interventions Required to Maintain Target Lesion Patency
6 Months
|
32 Total number of interventions
|
70 Total number of interventions
|
|
Total Number of Interventions Required to Maintain Target Lesion Patency
9 Months
|
60 Total number of interventions
|
107 Total number of interventions
|
|
Total Number of Interventions Required to Maintain Target Lesion Patency
12 Months
|
93 Total number of interventions
|
144 Total number of interventions
|
|
Total Number of Interventions Required to Maintain Target Lesion Patency
18 Months
|
150 Total number of interventions
|
201 Total number of interventions
|
|
Total Number of Interventions Required to Maintain Target Lesion Patency
24 Months
|
193 Total number of interventions
|
235 Total number of interventions
|
SECONDARY outcome
Timeframe: 3, 6, 9, 12, 18, and 24 MonthsThe number of re-interventions in the target lesion and/or access circuit through 3 months, 6 months, 9 months,12 months, 18 months, and 24 months.
Outcome measures
| Measure |
IN.PACT AV DCB
n=170 Participants
PTA will be performed using the IN.PACT AV Drug Coated Balloon.
IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon
|
Standard Balloon Angioplasty
n=160 Participants
PTA will be performed using a commercially available uncoated PTA balloon.
Standard Balloon Angioplasty: Standard PTA Balloon
|
|---|---|---|
|
Total Number of Interventions Required to Maintain Access Circuit Patency
3 Months
|
16 Total number of interventons
|
23 Total number of interventons
|
|
Total Number of Interventions Required to Maintain Access Circuit Patency
6 Months
|
44 Total number of interventons
|
82 Total number of interventons
|
|
Total Number of Interventions Required to Maintain Access Circuit Patency
9 Months
|
74 Total number of interventons
|
124 Total number of interventons
|
|
Total Number of Interventions Required to Maintain Access Circuit Patency
12 Months
|
110 Total number of interventons
|
168 Total number of interventons
|
|
Total Number of Interventions Required to Maintain Access Circuit Patency
18 Months
|
180 Total number of interventons
|
248 Total number of interventons
|
|
Total Number of Interventions Required to Maintain Access Circuit Patency
24 Months
|
232 Total number of interventons
|
283 Total number of interventons
|
SECONDARY outcome
Timeframe: 3, 6, 9, 12, 18, and 24 MonthsPopulation: Participant withdrawn or lost-to-follow-up are included in the analyses up to the time consent was withdrawn, or they were exited, whichever is earlier.
The number and percentage of participants with access circuit thrombosis through 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months.
Outcome measures
| Measure |
IN.PACT AV DCB
n=170 Participants
PTA will be performed using the IN.PACT AV Drug Coated Balloon.
IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon
|
Standard Balloon Angioplasty
n=160 Participants
PTA will be performed using a commercially available uncoated PTA balloon.
Standard Balloon Angioplasty: Standard PTA Balloon
|
|---|---|---|
|
Cumulative Access Circuit Thromboses
Access Circuit Thromboses Within 3 Months
|
2 Participants
|
1 Participants
|
|
Cumulative Access Circuit Thromboses
Access Circuit Thromboses Within 6 Months
|
3 Participants
|
5 Participants
|
|
Cumulative Access Circuit Thromboses
Access Circuit Thromboses Within 9 Months
|
3 Participants
|
7 Participants
|
|
Cumulative Access Circuit Thromboses
Access Circuit Thromboses Within 12 Months
|
4 Participants
|
8 Participants
|
|
Cumulative Access Circuit Thromboses
Access Circuit Thromboses Within 18 Months
|
7 Participants
|
11 Participants
|
|
Cumulative Access Circuit Thromboses
Access Circuit Thromboses Within 24 Months
|
7 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Time of ProcedureDevice Success is defined as successful delivery, inflation, deflation and retrieval of the intact study balloon device without burst at or below rated burst pressure (RBP) during the index procedure.
Outcome measures
| Measure |
IN.PACT AV DCB
n=212 Devices used
PTA will be performed using the IN.PACT AV Drug Coated Balloon.
IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon
|
Standard Balloon Angioplasty
n=161 Devices used
PTA will be performed using a commercially available uncoated PTA balloon.
Standard Balloon Angioplasty: Standard PTA Balloon
|
|---|---|---|
|
Device Success
|
212 Devices successfully used
|
161 Devices successfully used
|
SECONDARY outcome
Timeframe: Time of ProcedureMaintenance of patency (≤30% residual stenosis) in the absence of peri-procedural serious adverse device effect (SADE).
Outcome measures
| Measure |
IN.PACT AV DCB
n=170 Participants
PTA will be performed using the IN.PACT AV Drug Coated Balloon.
IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon
|
Standard Balloon Angioplasty
n=160 Participants
PTA will be performed using a commercially available uncoated PTA balloon.
Standard Balloon Angioplasty: Standard PTA Balloon
|
|---|---|---|
|
Procedure Success
|
125 Participants
|
122 Participants
|
SECONDARY outcome
Timeframe: From the time of the index procedure to the first successful dialysis session after index procedure. Typically, this is within 1 week of index procedure.Resumption of successful dialysis for at least one session after index procedure.
Outcome measures
| Measure |
IN.PACT AV DCB
n=159 Participants
PTA will be performed using the IN.PACT AV Drug Coated Balloon.
IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon
|
Standard Balloon Angioplasty
n=154 Participants
PTA will be performed using a commercially available uncoated PTA balloon.
Standard Balloon Angioplasty: Standard PTA Balloon
|
|---|---|---|
|
Clinical Success
|
159 Participants
|
154 Participants
|
SECONDARY outcome
Timeframe: 30 days, 3, 6, 9, 12, 18, and 24 Months.Population: Number of Participants with One or More Device-Related Adverse Events
Device Related Adverse Event Rate: defined as the number and percentage of participants with device related Adverse Events through 30 days, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months.
Outcome measures
| Measure |
IN.PACT AV DCB
n=170 Participants
PTA will be performed using the IN.PACT AV Drug Coated Balloon.
IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon
|
Standard Balloon Angioplasty
n=160 Participants
PTA will be performed using a commercially available uncoated PTA balloon.
Standard Balloon Angioplasty: Standard PTA Balloon
|
|---|---|---|
|
Rate of Device Related Adverse Events
Subjects with device related AEs within 30 days
|
2 Participants
|
2 Participants
|
|
Rate of Device Related Adverse Events
Subjects with device related AEs within 3 Months
|
7 Participants
|
5 Participants
|
|
Rate of Device Related Adverse Events
Subjects with device related AEs within 6 Months
|
10 Participants
|
7 Participants
|
|
Rate of Device Related Adverse Events
Subjects with device related AEs within 9 Months
|
12 Participants
|
9 Participants
|
|
Rate of Device Related Adverse Events
Subjects with device related AEs within 12 Months
|
12 Participants
|
9 Participants
|
|
Rate of Device Related Adverse Events
Subjects with device related AEs within 18 Months
|
11 Participants
|
9 Participants
|
|
Rate of Device Related Adverse Events
Subjects with device related AEs within 24 Months
|
11 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 30 Days, 3, 6, 9, 12, 18, and 24 MonthsPopulation: Number of Participants with One or More Procedure-Related Adverse Events
Procedure Related Adverse Event Rate: defined as the number and percentage of participants with procedure related Adverse Events reported post-index procedure until the first successful dialysis session through 30 days, 3 months, 6 months, 9 months, 12 months, 18 months, and 24 months.
Outcome measures
| Measure |
IN.PACT AV DCB
n=170 Participants
PTA will be performed using the IN.PACT AV Drug Coated Balloon.
IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon
|
Standard Balloon Angioplasty
n=160 Participants
PTA will be performed using a commercially available uncoated PTA balloon.
Standard Balloon Angioplasty: Standard PTA Balloon
|
|---|---|---|
|
Procedure Related Adverse Event Rate
Subjects with Procedure-Related AEs within 30 Days
|
7 Participants
|
7 Participants
|
|
Procedure Related Adverse Event Rate
Subjects with Procedure-Related AEs within 3 Months
|
7 Participants
|
7 Participants
|
|
Procedure Related Adverse Event Rate
Subjects with Procedure-Related AEs within 6 Months
|
7 Participants
|
7 Participants
|
|
Procedure Related Adverse Event Rate
Subjects with Procedure-Related AEs within 9 Months
|
8 Participants
|
8 Participants
|
|
Procedure Related Adverse Event Rate
Subjects with Procedure-Related AEs within 12 Months
|
8 Participants
|
8 Participants
|
|
Procedure Related Adverse Event Rate
Subjects with Procedure-Related AEs within 18 Months
|
8 Participants
|
8 Participants
|
|
Procedure Related Adverse Event Rate
Subjects with Procedure-Related AEs within 24 Months
|
8 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 6, 9, 12, 18, 24, and 36 MonthsPopulation: There is no planned hypothesis test.
Defined as the percentage of participants who had an event, the Kaplan-Meier method was used to estimate Cumulative Incidence up to 36 months post-index procedure.
Outcome measures
| Measure |
IN.PACT AV DCB
n=170 Participants
PTA will be performed using the IN.PACT AV Drug Coated Balloon.
IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon
|
Standard Balloon Angioplasty
n=160 Participants
PTA will be performed using a commercially available uncoated PTA balloon.
Standard Balloon Angioplasty: Standard PTA Balloon
|
|---|---|---|
|
Target Lesion Revascularizations (TLR)
6 Months
|
16.0 % of Cumulative Incidence Rate
|
39.6 % of Cumulative Incidence Rate
|
|
Target Lesion Revascularizations (TLR)
9 Months
|
27.8 % of Cumulative Incidence Rate
|
53.1 % of Cumulative Incidence Rate
|
|
Target Lesion Revascularizations (TLR)
12 Months
|
38.7 % of Cumulative Incidence Rate
|
59.9 % of Cumulative Incidence Rate
|
|
Target Lesion Revascularizations (TLR)
18 Months
|
48.4 % of Cumulative Incidence Rate
|
66.3 % of Cumulative Incidence Rate
|
|
Target Lesion Revascularizations (TLR)
24 Months
|
53.6 % of Cumulative Incidence Rate
|
69.9 % of Cumulative Incidence Rate
|
|
Target Lesion Revascularizations (TLR)
36 Months
|
62.5 % of Cumulative Incidence Rate
|
79.3 % of Cumulative Incidence Rate
|
SECONDARY outcome
Timeframe: 6, 9, 12, 18, 24, and 36 MonthsPopulation: There is no planned hypothesis test for this endpoint.
Defined as the percentage of participants who had an event, the Kaplan-Meier method was used to estimate Cumulative Incidence with CD-TLR up to 36 months post index procedure
Outcome measures
| Measure |
IN.PACT AV DCB
n=170 Participants
PTA will be performed using the IN.PACT AV Drug Coated Balloon.
IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon
|
Standard Balloon Angioplasty
n=160 Participants
PTA will be performed using a commercially available uncoated PTA balloon.
Standard Balloon Angioplasty: Standard PTA Balloon
|
|---|---|---|
|
Clinically-Driven Target Lesion Revascularizations (CD-TLR)
6 Months
|
12.3 Percentage of participants
|
30.4 Percentage of participants
|
|
Clinically-Driven Target Lesion Revascularizations (CD-TLR)
9 Months
|
23.4 Percentage of participants
|
44.8 Percentage of participants
|
|
Clinically-Driven Target Lesion Revascularizations (CD-TLR)
12 Months
|
33.7 Percentage of participants
|
51.8 Percentage of participants
|
|
Clinically-Driven Target Lesion Revascularizations (CD-TLR)
18 Months
|
42.7 Percentage of participants
|
60.1 Percentage of participants
|
|
Clinically-Driven Target Lesion Revascularizations (CD-TLR)
24 Months
|
47.0 Percentage of participants
|
62.0 Percentage of participants
|
|
Clinically-Driven Target Lesion Revascularizations (CD-TLR)
36 Months
|
54.9 Percentage of participants
|
69.1 Percentage of participants
|
SECONDARY outcome
Timeframe: 6, 9, 12, 18, 24, and 36 MonthsPopulation: There is no planned hypothesis test for this endpoint.
Defined as the percentage of participants who had a reinterventions occurring within the access circuit. The Kaplan-Meier method was used to estimate Cumulative Incidence up to 36 months post-index procedure.
Outcome measures
| Measure |
IN.PACT AV DCB
n=170 Participants
PTA will be performed using the IN.PACT AV Drug Coated Balloon.
IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon
|
Standard Balloon Angioplasty
n=160 Participants
PTA will be performed using a commercially available uncoated PTA balloon.
Standard Balloon Angioplasty: Standard PTA Balloon
|
|---|---|---|
|
Re-interventions in the Access Circuit
6 Months
|
20.4 Percentage of participants
|
44.0 Percentage of participants
|
|
Re-interventions in the Access Circuit
9 Months
|
32.2 Percentage of participants
|
56.8 Percentage of participants
|
|
Re-interventions in the Access Circuit
12 Months
|
43.7 Percentage of participants
|
65.1 Percentage of participants
|
|
Re-interventions in the Access Circuit
18 Months
|
55.6 Percentage of participants
|
70.8 Percentage of participants
|
|
Re-interventions in the Access Circuit
24 Months
|
59.8 Percentage of participants
|
74.2 Percentage of participants
|
|
Re-interventions in the Access Circuit
36 Months
|
71.9 Percentage of participants
|
83.1 Percentage of participants
|
SECONDARY outcome
Timeframe: 6, 9, 12, 18, 24, and 36 MonthsDefined as number of participants with abandonment of the target AV up to 36 months post-index procedure.
Outcome measures
| Measure |
IN.PACT AV DCB
n=170 Participants
PTA will be performed using the IN.PACT AV Drug Coated Balloon.
IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon
|
Standard Balloon Angioplasty
n=160 Participants
PTA will be performed using a commercially available uncoated PTA balloon.
Standard Balloon Angioplasty: Standard PTA Balloon
|
|---|---|---|
|
Abandonment of Target AVF
6 Months
|
2 Participants
|
9 Participants
|
|
Abandonment of Target AVF
9 Months
|
3 Participants
|
10 Participants
|
|
Abandonment of Target AVF
12 Months
|
5 Participants
|
14 Participants
|
|
Abandonment of Target AVF
18 Months
|
13 Participants
|
18 Participants
|
|
Abandonment of Target AVF
24 Months
|
18 Participants
|
22 Participants
|
|
Abandonment of Target AVF
36 Months
|
23 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: 6, 12, 24, and 36 MonthsSerious Adverse Event Rate: defined as the number and percentage of participants with one or more Serious Adverse Events reported post-index procedure through 6 months, 12 months, 24 months, and 36 months.
Outcome measures
| Measure |
IN.PACT AV DCB
n=170 Participants
PTA will be performed using the IN.PACT AV Drug Coated Balloon.
IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon
|
Standard Balloon Angioplasty
n=160 Participants
PTA will be performed using a commercially available uncoated PTA balloon.
Standard Balloon Angioplasty: Standard PTA Balloon
|
|---|---|---|
|
Serious Adverse Event Rate
Subjects with SAEs within 1080 Days
|
146 Participants
|
137 Participants
|
|
Serious Adverse Event Rate
Subjects with SAEs within 180 Days
|
71 Participants
|
85 Participants
|
|
Serious Adverse Event Rate
Subjects with SAEs within 360 Days
|
105 Participants
|
115 Participants
|
|
Serious Adverse Event Rate
Subjects with SAEs within 720 Days
|
131 Participants
|
128 Participants
|
SECONDARY outcome
Timeframe: 6, 12, 24, 36, 48, and 60 MonthsPercentage of participants who had all-cause death post vital status update. The Kaplan-Meier method was used to estimate survival probability up to 60 months post-index procedure through 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months.
Outcome measures
| Measure |
IN.PACT AV DCB
n=170 Participants
PTA will be performed using the IN.PACT AV Drug Coated Balloon.
IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon
|
Standard Balloon Angioplasty
n=160 Participants
PTA will be performed using a commercially available uncoated PTA balloon.
Standard Balloon Angioplasty: Standard PTA Balloon
|
|---|---|---|
|
Rate of Freedom From All-Cause Mortality Post Vital Status Update
Within 180 Days
|
93.4 % of Survival
|
98.1 % of Survival
|
|
Rate of Freedom From All-Cause Mortality Post Vital Status Update
Within 360 Days
|
89.1 % of Survival
|
89.6 % of Survival
|
|
Rate of Freedom From All-Cause Mortality Post Vital Status Update
Within 720 Days
|
80.2 % of Survival
|
81.8 % of Survival
|
|
Rate of Freedom From All-Cause Mortality Post Vital Status Update
Within 1080 Days
|
73.4 % of Survival
|
68.8 % of Survival
|
|
Rate of Freedom From All-Cause Mortality Post Vital Status Update
Within 1440 Days
|
65.4 % of Survival
|
58.2 % of Survival
|
|
Rate of Freedom From All-Cause Mortality Post Vital Status Update
Within 1800Days
|
59.0 % of Survival
|
53.5 % of Survival
|
Adverse Events
IN.PACT AV DCB
Serious events: 148 serious events
Other events: 31 other events
Deaths: 59 deaths
Standard Balloon Angioplasty
Serious events: 143 serious events
Other events: 32 other events
Deaths: 60 deaths
Serious adverse events
| Measure |
IN.PACT AV DCB
n=170 participants at risk
PTA will be performed using the IN.PACT AV Drug Coated Balloon.
IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon
|
Standard Balloon Angioplasty
n=160 participants at risk
PTA will be performed using a commercially available uncoated PTA balloon.
Standard Balloon Angioplasty: Standard PTA Balloon
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.4%
4/170 • Number of events 5 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
1.9%
3/160 • Number of events 5 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Blood and lymphatic system disorders
Anaemia Of Chronic Disease
|
0.59%
1/170 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Blood and lymphatic system disorders
Blood Loss Anaemia
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
1.2%
2/170 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Blood and lymphatic system disorders
Nephrogenic Anaemia
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Cardiac disorders
Acute Coronary Syndrome
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Cardiac disorders
Acute Left Ventricular Failure
|
1.8%
3/170 • Number of events 5 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Cardiac disorders
Acute Myocardial Infarction
|
1.8%
3/170 • Number of events 3 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
3.8%
6/160 • Number of events 6 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Cardiac disorders
Angina Pectoris
|
3.5%
6/170 • Number of events 9 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
3.8%
6/160 • Number of events 6 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Cardiac disorders
Angina Unstable
|
1.2%
2/170 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Cardiac disorders
Aortic Valve Incompetence
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Cardiac disorders
Aortic Valve Stenosis
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
1.2%
2/160 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Cardiac disorders
Arteriosclerosis Coronary Artery
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Cardiac disorders
Atrial Fibrillation
|
4.7%
8/170 • Number of events 8 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
3.1%
5/160 • Number of events 6 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Cardiac disorders
Atrial Flutter
|
2.4%
4/170 • Number of events 4 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Cardiac disorders
Atrioventricular Block
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Cardiac disorders
Bradycardia
|
1.2%
2/170 • Number of events 3 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Cardiac disorders
Cardiac Arrest
|
4.7%
8/170 • Number of events 8 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
3.8%
6/160 • Number of events 7 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Cardiac disorders
Cardiac Failure
|
2.4%
4/170 • Number of events 4 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Cardiac disorders
Cardiac Failure Acute
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Cardiac disorders
Cardiac Failure Chronic
|
0.59%
1/170 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
1.2%
2/160 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
4.7%
8/170 • Number of events 9 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
7.5%
12/160 • Number of events 14 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Cardiac disorders
Cardiogenic Shock
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Cardiac disorders
Cardiomyopathy
|
1.2%
2/170 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Cardiac disorders
Chronic Left Ventricular Failure
|
1.2%
2/170 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Cardiac disorders
Coronary Artery Disease
|
3.5%
6/170 • Number of events 6 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
1.2%
2/160 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Cardiac disorders
Coronary Artery Occlusion
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Cardiac disorders
Coronary Artery Stenosis
|
2.4%
4/170 • Number of events 5 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
1.9%
3/160 • Number of events 3 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Cardiac disorders
Diastolic Dysfunction
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Cardiac disorders
Ischaemic Cardiomyopathy
|
1.2%
2/170 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Cardiac disorders
Mitral Valve Incompetence
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
1.2%
2/160 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Cardiac disorders
Myocardial Ischaemia
|
1.2%
2/170 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
1.9%
3/160 • Number of events 3 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Cardiac disorders
Pericardial Effusion
|
1.8%
3/170 • Number of events 3 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Cardiac disorders
Pulseless Electrical Activity
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Cardiac disorders
Tachycardia
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Congenital, familial and genetic disorders
Acetylcholinesterase Deficiency
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Ear and labyrinth disorders
Deafness Neurosensory
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Ear and labyrinth disorders
Vertigo
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Endocrine disorders
Hyperparathyroidism Secondary
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Eye disorders
Cataract
|
2.4%
4/170 • Number of events 6 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
2.5%
4/160 • Number of events 4 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Eye disorders
Glaucoma
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Eye disorders
Vitreous Haemorrhage
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Gastrointestinal disorders
Ascites
|
1.2%
2/170 • Number of events 3 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Gastrointestinal disorders
Colitis Ischaemic
|
0.59%
1/170 • Number of events 3 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Gastrointestinal disorders
Constipation
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Gastrointestinal disorders
Diabetic Gastroparesis
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.2%
2/170 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Gastrointestinal disorders
Diverticulum
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Gastrointestinal disorders
Diverticulum Intestinal Haemorrhagic
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
1.2%
2/160 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Gastrointestinal disorders
Faeces Discoloured
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Gastrointestinal disorders
Gastric Polyps
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Gastrointestinal disorders
Gastric Ulcer
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Gastrointestinal disorders
Gastritis
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
1.8%
3/170 • Number of events 5 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
1.9%
3/160 • Number of events 5 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Gastrointestinal disorders
Gastrointestinal Necrosis
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Gastrointestinal disorders
Ileus
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Gastrointestinal disorders
Intestinal Ischaemia
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Gastrointestinal disorders
Intra-Abdominal Haematoma
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Gastrointestinal disorders
Ischaemic Enteritis
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Gastrointestinal disorders
Large Intestinal Stenosis
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Gastrointestinal disorders
Large Intestine Polyp
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Gastrointestinal disorders
Lower Gastrointestinal Haemorrhage
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Gastrointestinal disorders
Mesenteric Arterial Occlusion
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Gastrointestinal disorders
Mesenteric Haematoma
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Gastrointestinal disorders
Nausea
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Gastrointestinal disorders
Oesophageal Perforation
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Gastrointestinal disorders
Pancreatitis Acute
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Gastrointestinal disorders
Portal Hypertensive Gastropathy
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Gastrointestinal disorders
Upper Gastrointestinal Haemorrhage
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
1.2%
2/160 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Gastrointestinal disorders
Vomiting
|
1.2%
2/170 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
2.5%
4/160 • Number of events 4 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
General disorders
Asthenia
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
General disorders
Chest Pain
|
1.8%
3/170 • Number of events 3 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
3.1%
5/160 • Number of events 5 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
General disorders
Complication Associated With Device
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
General disorders
Death
|
10.6%
18/170 • Number of events 18 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
15.0%
24/160 • Number of events 24 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
General disorders
General Physical Health Deterioration
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
General disorders
Multiple Organ Dysfunction Syndrome
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
General disorders
Non-Cardiac Chest Pain
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
General disorders
Peripheral Swelling
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
1.2%
2/160 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
General disorders
Physical Deconditioning
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
General disorders
Pyrexia
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
General disorders
Stent-Graft Endoleak
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
General disorders
Strangulated Hernia
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
General disorders
Vascular Stent Occlusion
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
General disorders
Vascular Stent Stenosis
|
0.59%
1/170 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
1.2%
2/160 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Hepatobiliary disorders
Bile Duct Stone
|
0.59%
1/170 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Hepatobiliary disorders
Cholangitis
|
1.2%
2/170 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Hepatobiliary disorders
Hepatic Cirrhosis
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Hepatobiliary disorders
Hepatic Failure
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Immune system disorders
Kidney Transplant Rejection
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Infections and infestations
Abdominal Abscess
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Infections and infestations
Abscess Limb
|
1.2%
2/170 • Number of events 3 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Infections and infestations
Acinetobacter Bacteraemia
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Infections and infestations
Anal Abscess
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Infections and infestations
Appendicitis
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Infections and infestations
Arteriovenous Fistula Site Infection
|
0.59%
1/170 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Infections and infestations
Arteriovenous Graft Site Infection
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Infections and infestations
Arthritis Bacterial
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Infections and infestations
Bacteraemia
|
1.2%
2/170 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Infections and infestations
Bacterial Infection
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Infections and infestations
Bronchitis
|
1.8%
3/170 • Number of events 3 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
3.1%
5/160 • Number of events 5 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Infections and infestations
Cellulitis
|
4.1%
7/170 • Number of events 8 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
2.5%
4/160 • Number of events 4 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Infections and infestations
Clostridium Difficile Colitis
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Infections and infestations
Clostridium Difficile Infection
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Infections and infestations
Coronavirus Infection
|
1.2%
2/170 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Infections and infestations
Covid-19
|
2.4%
4/170 • Number of events 4 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Infections and infestations
Covid-19 Pneumonia
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Infections and infestations
Cytomegalovirus Enteritis
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Infections and infestations
Device Related Infection
|
1.2%
2/170 • Number of events 4 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Infections and infestations
Endocarditis
|
1.2%
2/170 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Infections and infestations
Enterococcal Infection
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Infections and infestations
Escherichia Bacteraemia
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Infections and infestations
Escherichia Urinary Tract Infection
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Infections and infestations
Gangrene
|
2.9%
5/170 • Number of events 6 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Infections and infestations
Gastroenteritis
|
2.4%
4/170 • Number of events 4 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Infections and infestations
Gastrointestinal Infection
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Infections and infestations
Groin Infection
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Infections and infestations
Hordeolum
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Infections and infestations
Infected Dermal Cyst
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Infections and infestations
Infected Skin Ulcer
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Infections and infestations
Infection
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
1.2%
2/160 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Infections and infestations
Influenza
|
3.5%
6/170 • Number of events 6 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
2.5%
4/160 • Number of events 5 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Infections and infestations
Intervertebral Discitis
|
0.59%
1/170 • Number of events 3 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Infections and infestations
Klebsiella Bacteraemia
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Infections and infestations
Localised Infection
|
1.2%
2/170 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Infections and infestations
Necrotising Fasciitis
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Infections and infestations
Osteomyelitis
|
3.5%
6/170 • Number of events 11 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
1.2%
2/160 • Number of events 4 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Infections and infestations
Pneumonia
|
11.2%
19/170 • Number of events 23 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
8.1%
13/160 • Number of events 15 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Infections and infestations
Pneumonia Aspiration
|
1.2%
2/170 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
1.2%
2/160 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Infections and infestations
Pneumonia Bacterial
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Infections and infestations
Pneumonia Staphylococcal
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Infections and infestations
Portal Pyaemia
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Infections and infestations
Postoperative Wound Infection
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Infections and infestations
Pulmonary Sepsis
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Infections and infestations
Pustule
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Infections and infestations
Pyelonephritis
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Infections and infestations
Respiratory Syncytial Virus Infection
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Infections and infestations
Sepsis
|
4.7%
8/170 • Number of events 8 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
3.8%
6/160 • Number of events 6 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Infections and infestations
Septic Shock
|
2.9%
5/170 • Number of events 5 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Infections and infestations
Staphylococcal Bacteraemia
|
1.2%
2/170 • Number of events 3 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
1.2%
2/160 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Infections and infestations
Staphylococcal Infection
|
1.2%
2/170 • Number of events 4 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Infections and infestations
Staphylococcal Osteomyelitis
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Infections and infestations
Staphylococcal Sepsis
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Infections and infestations
Urinary Tract Infection
|
1.8%
3/170 • Number of events 3 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
3.1%
5/160 • Number of events 6 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Infections and infestations
Urinary Tract Infection Bacterial
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Infections and infestations
Viral Infection
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
1.2%
2/160 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Infections and infestations
Wound Infection Staphylococcal
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Infections and infestations
Wound Sepsis
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Injury, poisoning and procedural complications
Acetabulum Fracture
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Injury, poisoning and procedural complications
Anastomotic Stenosis
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Injury, poisoning and procedural complications
Arteriovenous Fistula Aneurysm
|
5.3%
9/170 • Number of events 10 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
6.2%
10/160 • Number of events 11 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Injury, poisoning and procedural complications
Arteriovenous Fistula Occlusion
|
5.3%
9/170 • Number of events 19 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
12.5%
20/160 • Number of events 39 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Injury, poisoning and procedural complications
Arteriovenous Fistula Site Complication
|
50.6%
86/170 • Number of events 375 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
60.0%
96/160 • Number of events 427 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Injury, poisoning and procedural complications
Arteriovenous Fistula Site Haematoma
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Injury, poisoning and procedural complications
Arteriovenous Fistula Site Haemorrhage
|
1.2%
2/170 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
1.9%
3/160 • Number of events 3 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Injury, poisoning and procedural complications
Arteriovenous Fistula Site Pseudoaneurysm
|
1.8%
3/170 • Number of events 3 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Injury, poisoning and procedural complications
Arteriovenous Fistula Thrombosis
|
3.5%
6/170 • Number of events 7 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
6.2%
10/160 • Number of events 12 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Injury, poisoning and procedural complications
Arteriovenous Graft Site Pseudoaneurysm
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Injury, poisoning and procedural complications
Arteriovenous Graft Site Stenosis
|
0.59%
1/170 • Number of events 4 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
1.2%
2/160 • Number of events 6 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Injury, poisoning and procedural complications
Burns Second Degree
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Injury, poisoning and procedural complications
Complications Of Transplanted Kidney
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Injury, poisoning and procedural complications
Coronary Artery Restenosis
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Injury, poisoning and procedural complications
Femoral Neck Fracture
|
1.2%
2/170 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
1.8%
3/170 • Number of events 3 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Injury, poisoning and procedural complications
Foot Fracture
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Injury, poisoning and procedural complications
Haemodialysis Complication
|
1.8%
3/170 • Number of events 3 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
1.2%
2/160 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Injury, poisoning and procedural complications
Humerus Fracture
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Injury, poisoning and procedural complications
Inadequate Haemodialysis
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Injury, poisoning and procedural complications
Incarcerated Incisional Hernia
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Injury, poisoning and procedural complications
Joint Injury
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Injury, poisoning and procedural complications
Limb Injury
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Injury, poisoning and procedural complications
Multiple Fractures
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
1.2%
2/160 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Injury, poisoning and procedural complications
Pelvic Fracture
|
0.59%
1/170 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Injury, poisoning and procedural complications
Radius Fracture
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Injury, poisoning and procedural complications
Rectal Injury
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Injury, poisoning and procedural complications
Shunt Malfunction
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Injury, poisoning and procedural complications
Skull Fracture
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
1.2%
2/160 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Injury, poisoning and procedural complications
Subdural Haematoma
|
1.2%
2/170 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Injury, poisoning and procedural complications
Tibia Fracture
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Injury, poisoning and procedural complications
Toxicity To Various Agents
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
1.2%
2/160 • Number of events 4 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Injury, poisoning and procedural complications
Ulna Fracture
|
1.2%
2/170 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Injury, poisoning and procedural complications
Upper Limb Fracture
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Injury, poisoning and procedural complications
Vascular Access Malfunction
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Injury, poisoning and procedural complications
Vascular Access Site Pain
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Injury, poisoning and procedural complications
Vascular Graft Complication
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Injury, poisoning and procedural complications
Vascular Graft Occlusion
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Injury, poisoning and procedural complications
Wound Dehiscence
|
1.2%
2/170 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Investigations
Anticoagulation Drug Level Below Therapeutic
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Investigations
Blood Pressure Decreased
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Investigations
Brain Natriuretic Peptide Increased
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Investigations
Occult Blood
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Investigations
Troponin Increased
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Metabolism and nutrition disorders
Failure To Thrive
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.59%
1/170 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
4.1%
7/170 • Number of events 8 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
5.6%
9/160 • Number of events 11 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
3.5%
6/170 • Number of events 7 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
4.4%
7/160 • Number of events 8 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.2%
2/170 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
1.2%
2/160 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Metabolism and nutrition disorders
Lactic Acidosis
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Metabolism and nutrition disorders
Type 2 Diabetes Mellitus
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.8%
3/170 • Number of events 3 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Musculoskeletal and connective tissue disorders
Arthritis Reactive
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis Pyrophosphate
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
1.2%
2/170 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Musculoskeletal and connective tissue disorders
Foot Deformity
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Musculoskeletal and connective tissue disorders
Lumbar Spinal Stenosis
|
1.2%
2/170 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Musculoskeletal and connective tissue disorders
Osteolysis
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid Arthritis
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Musculoskeletal and connective tissue disorders
Spinal Osteoarthritis
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Musculoskeletal and connective tissue disorders
Spinal Stenosis
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Angiosarcoma
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Cancer
|
1.2%
2/170 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Angiosarcoma
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholesteatoma
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic Cancer
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Adenocarcinoma
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases To Peritoneum
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic Syndrome
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid Tumour Benign
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pituitary Tumour Benign
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer Metastatic
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Cancer
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional Cell Carcinoma
|
0.59%
1/170 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Nervous system disorders
Brain Stem Stroke
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Nervous system disorders
Carotid Artery Stenosis
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Nervous system disorders
Carpal Tunnel Syndrome
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Nervous system disorders
Cerebral Haemorrhage
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Nervous system disorders
Cerebral Infarction
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
3.1%
5/160 • Number of events 5 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Nervous system disorders
Cerebrovascular Accident
|
2.4%
4/170 • Number of events 8 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
1.2%
2/160 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Nervous system disorders
Cervical Radiculopathy
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Nervous system disorders
Cognitive Disorder
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Nervous system disorders
Cubital Tunnel Syndrome
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Nervous system disorders
Dementia
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Nervous system disorders
Dementia Alzheimer's Type
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Nervous system disorders
Encephalopathy
|
1.2%
2/170 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
1.9%
3/160 • Number of events 3 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Nervous system disorders
Haemorrhagic Cerebral Infarction
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Nervous system disorders
Haemorrhagic Stroke
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Nervous system disorders
Headache
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Nervous system disorders
Hepatic Encephalopathy
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Nervous system disorders
Hypertensive Encephalopathy
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Nervous system disorders
Ischaemic Stroke
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Nervous system disorders
Lacunar Infarction
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Nervous system disorders
Metabolic Encephalopathy
|
1.2%
2/170 • Number of events 3 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
1.2%
2/160 • Number of events 3 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Nervous system disorders
Myelopathy
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Nervous system disorders
Narcolepsy
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Nervous system disorders
Neuropathy Peripheral
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Nervous system disorders
Seizure
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
1.2%
2/160 • Number of events 3 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Nervous system disorders
Spondylitic Myelopathy
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Nervous system disorders
Syncope
|
1.2%
2/170 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
1.2%
2/160 • Number of events 4 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Nervous system disorders
Thrombotic Cerebral Infarction
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Nervous system disorders
Toxic Encephalopathy
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Nervous system disorders
Transient Ischaemic Attack
|
1.2%
2/170 • Number of events 5 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Product Issues
Device Malfunction
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Psychiatric disorders
Confusional State
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Psychiatric disorders
Delirium Tremens
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Psychiatric disorders
Mental Status Changes
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
3.8%
6/160 • Number of events 6 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Renal and urinary disorders
Chronic Kidney Disease
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Renal and urinary disorders
End Stage Renal Disease
|
1.2%
2/170 • Number of events 3 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
5.0%
8/160 • Number of events 8 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Renal and urinary disorders
Haematuria
|
0.59%
1/170 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Renal and urinary disorders
Renal Cyst
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Renal and urinary disorders
Renal Failure
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Renal and urinary disorders
Renal Mass
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Reproductive system and breast disorders
Benign Prostatic Hyperplasia
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Pulmonary Oedema
|
1.2%
2/170 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
5.3%
9/170 • Number of events 15 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
3.8%
6/160 • Number of events 8 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
2.9%
5/170 • Number of events 8 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.8%
3/170 • Number of events 3 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.8%
3/170 • Number of events 5 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.2%
2/170 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
3.5%
6/170 • Number of events 7 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Hypertension
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
1.9%
3/160 • Number of events 4 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
1.2%
2/170 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
1.2%
2/160 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Arrest
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
1.2%
2/170 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
5.0%
8/160 • Number of events 10 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Skin and subcutaneous tissue disorders
Acute Generalised Exanthematous Pustulosis
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Skin and subcutaneous tissue disorders
Decubitus Ulcer
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Skin and subcutaneous tissue disorders
Dermal Cyst
|
0.59%
1/170 • Number of events 3 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Exfoliative Generalised
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Skin and subcutaneous tissue disorders
Diabetic Foot
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Skin and subcutaneous tissue disorders
Erythema Multiforme
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Skin and subcutaneous tissue disorders
Ischaemic Skin Ulcer
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Skin and subcutaneous tissue disorders
Skin Mass
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
1.2%
2/170 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Social circumstances
Loss Of Personal Independence In Daily Activities
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Social circumstances
Refusal Of Treatment By Patient
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Surgical and medical procedures
Arteriovenous Fistula Operation
|
1.2%
2/170 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
1.2%
2/160 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Surgical and medical procedures
Cardiac Pacemaker Replacement
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Surgical and medical procedures
Dialysis Device Insertion
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Surgical and medical procedures
Intervertebral Disc Operation
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Surgical and medical procedures
Leg Amputation
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Surgical and medical procedures
Peripheral Revascularisation
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Surgical and medical procedures
Renal Transplant
|
1.2%
2/170 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Vascular disorders
Aneurysm
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Vascular disorders
Aortic Aneurysm
|
1.2%
2/170 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Vascular disorders
Aortic Stenosis
|
1.2%
2/170 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Vascular disorders
Arteriovenous Fistula
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Vascular disorders
Brachiocephalic Vein Stenosis
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Vascular disorders
Dry Gangrene
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Vascular disorders
Extremity Necrosis
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Vascular disorders
Haematoma
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
1.2%
2/160 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Vascular disorders
Hypertension
|
1.2%
2/170 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Vascular disorders
Hypertensive Crisis
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Vascular disorders
Hypertensive Emergency
|
1.2%
2/170 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Vascular disorders
Hypertensive Urgency
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Vascular disorders
Hypotension
|
2.4%
4/170 • Number of events 4 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
3.8%
6/160 • Number of events 8 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Vascular disorders
Intermittent Claudication
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Vascular disorders
Peripheral Arterial Occlusive Disease
|
5.9%
10/170 • Number of events 15 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
5.0%
8/160 • Number of events 13 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Vascular disorders
Peripheral Artery Occlusion
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Vascular disorders
Peripheral Artery Stenosis
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
1.2%
2/160 • Number of events 5 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Vascular disorders
Peripheral Ischaemia
|
1.2%
2/170 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Vascular disorders
Peripheral Vascular Disorder
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Vascular disorders
Peripheral Vein Stenosis
|
1.2%
2/170 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Vascular disorders
Secondary Hypertension
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Vascular disorders
Shock Haemorrhagic
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Vascular disorders
Steal Syndrome
|
2.4%
4/170 • Number of events 5 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
2.5%
4/160 • Number of events 4 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Vascular disorders
Subclavian Artery Stenosis
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Vascular disorders
Subclavian Vein Occlusion
|
0.59%
1/170 • Number of events 3 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Vascular disorders
Subclavian Vein Stenosis
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Vascular disorders
Subclavian Vein Thrombosis
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.62%
1/160 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Vascular disorders
Superior Vena Cava Stenosis
|
1.2%
2/170 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Vascular disorders
Venous Stenosis
|
0.00%
0/170 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
1.2%
2/160 • Number of events 2 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
|
Vascular disorders
Venous Thrombosis Limb
|
0.59%
1/170 • Number of events 1 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
0.00%
0/160 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
Other adverse events
| Measure |
IN.PACT AV DCB
n=170 participants at risk
PTA will be performed using the IN.PACT AV Drug Coated Balloon.
IN.PACT AV DCB: IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon
|
Standard Balloon Angioplasty
n=160 participants at risk
PTA will be performed using a commercially available uncoated PTA balloon.
Standard Balloon Angioplasty: Standard PTA Balloon
|
|---|---|---|
|
Injury, poisoning and procedural complications
Arteriovenous Fistula Site Complication
|
18.2%
31/170 • Number of events 80 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
20.0%
32/160 • Number of events 128 • All Adverse Events were collected from the time of consent through 6 Months post procedure. After 6 months, only SAEs, ADEs, SADEs, and UADEs were collected through 36 months. After 36 month, only vital status and SAEs related to death were collected and reported up to 60 months. Deaths in US participants who were alive at the time of discontinuing the study were collected and reported up to 60 months.
All participant death within the database snapshot were included. Participants in the United States who were alive at the time of discontinuing the study continued to be monitored for death for up to 60 months. Any deaths that were observed in this population during this time period are included in the All-Cause Mortality data table. Events collected post vital update were included.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place