Trial Outcomes & Findings for Improve Sudden Cardiac Arrest Study (NCT NCT02099721)
NCT ID: NCT02099721
Last Updated: 2020-10-28
Results Overview
Time to the first occurrence of an episode of true ventricular tachycardia or fibrillation 24 Month rates will be provided for the two groups used in the primary endpoint definition. However, the primary endpoint of hazard ratio is presented in Statistical Analysis 1 as a ratio between Groups A and C.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
4222 participants
Primary outcome timeframe
Hazard ratio from study enrollment to approximately 4 years post-implant/enrollment (as reported in Statistical Analysis 1), and estimated 24 month VT-VF rate (as compared in the Outcome Measure table between Groups A and C).
Results posted on
2020-10-28
Participant Flow
Participant milestones
| Measure |
Group A: Secondary Prevention Patients- Device Implant
Patients who are guideline indicated for an ICD/CRT-D for secondary prevention of sudden cardiac arrest.
These subjects receive an ICD/CRT-D implant.
ICD or CRT-D Device: Subjects who receive an ICD/CRT-D device implant will be implanted and follow protocol-specified programming. The programming is not investigational. Consistent programming is desirable in order to compare groups during statistical analysis.
|
Group B: Secondary Prevention Patients - no Device Implant
Patients who are guideline indicated for an ICD/CRT-D for secondary prevention of sudden cardiac arrest.
These subjects chose not to receive an ICD/CRT-D implant.
|
Group C: 1.5 Prevention Patients - Device Implant
Patients who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they have one of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF).
These subjects receive an ICD/CRT-D implant.
ICD or CRT-D Device: Subjects who receive an ICD/CRT-D device implant will be implanted and follow protocol-specified programming. The programming is not investigational. Consistent programming is desirable in order to compare groups during statistical analysis.
|
Group D: 1.5 Prevention Patients - no Device Implant
Patients who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they have one of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF).
These subjects chose not to receive an ICD/CRT-D implant.
|
Group E: Primary, Non-1.5 Patients - Device Implant
Patients who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they do NOT fall into the 1.5 prevention group. These patients do not have one of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF) which would put them into the 1.5 prevention group.
These subjects receive an ICD/CRT-D implant.
ICD or CRT-D Device: Subjects who receive an ICD/CRT-D device implant will be implanted and follow protocol-specified programming. The programming is not investigational. Consistent programming is desirable in order to compare groups during statistical analysis.
|
Group F: Primary, Non-1.5 Patients - no Device
Patients who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they do NOT fall into the 1.5 prevention group. These patients do not have one of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF) which would put them into the 1.5 prevention group.
These subjects chose not to receive an ICD/CRT-D implant.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1066
|
127
|
1068
|
845
|
331
|
452
|
|
Overall Study
COMPLETED
|
990
|
0
|
983
|
774
|
304
|
432
|
|
Overall Study
NOT COMPLETED
|
76
|
127
|
85
|
71
|
27
|
20
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
One patient in Group F did not specify any of the above categories.
Baseline characteristics by cohort
| Measure |
Group A: Secondary Prevention Patients- Device Implant
n=1066 Participants
Patients who are guideline indicated for an ICD/CRT-D for secondary prevention of sudden cardiac arrest.
These subjects receive an ICD/CRT-D implant.
ICD or CRT-D Device: Subjects who receive an ICD/CRT-D device implant will be implanted and follow protocol-specified programming. The programming is not investigational. Consistent programming is desirable in order to compare groups during statistical analysis.
|
Group B: Secondary Prevention Patients - no Device Implant
n=127 Participants
Patients who are guideline indicated for an ICD/CRT-D for secondary prevention of sudden cardiac arrest.
These subjects choose not to receive an ICD/CRT-D implant.
|
Group C: 1.5 Prevention Patients - Device Implant
n=1068 Participants
Patients who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they have one of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF).
These subjects receive an ICD/CRT-D implant.
ICD or CRT-D Device: Subjects who receive an ICD/CRT-D device implant will be implanted and follow protocol-specified programming. The programming is not investigational. Consistent programming is desirable in order to compare groups during statistical analysis.
|
Group D: 1.5 Prevention Patients - no Device Implant
n=845 Participants
Patients who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they have one of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF).
These subjects choose not to receive an ICD/CRT-D implant.
|
Group E: Primary, Non-1.5 Patients - Device Implant
n=331 Participants
Patients who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they do NOT fall into the 1.5 prevention group. These patients do not have one of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF) which would put them into the 1.5 prevention group.
These subjects receive an ICD/CRT-D implant.
ICD or CRT-D Device: Subjects who receive an ICD/CRT-D device implant will be implanted and follow protocol-specified programming. The programming is not investigational. Consistent programming is desirable in order to compare groups during statistical analysis.
|
Group F: Primary, Non-1.5 Patients - no Device
n=452 Participants
Patients who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they do NOT fall into the 1.5 prevention group. These patients do not have one of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF) which would put them into the 1.5 prevention group.
These subjects choose not to receive an ICD/CRT-D implant.
|
Total
n=3889 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
57.1 years
STANDARD_DEVIATION 14.3 • n=1066 Participants
|
55.7 years
STANDARD_DEVIATION 15.5 • n=127 Participants
|
61.1 years
STANDARD_DEVIATION 11.7 • n=1068 Participants
|
59.1 years
STANDARD_DEVIATION 13.3 • n=845 Participants
|
61.3 years
STANDARD_DEVIATION 11.3 • n=331 Participants
|
57.8 years
STANDARD_DEVIATION 13.7 • n=452 Participants
|
59.0 years
STANDARD_DEVIATION 13.3 • n=3889 Participants
|
|
Sex: Female, Male
Female
|
254 Participants
n=1066 Participants
|
27 Participants
n=127 Participants
|
253 Participants
n=1068 Participants
|
176 Participants
n=845 Participants
|
95 Participants
n=331 Participants
|
103 Participants
n=452 Participants
|
908 Participants
n=3889 Participants
|
|
Sex: Female, Male
Male
|
812 Participants
n=1066 Participants
|
100 Participants
n=127 Participants
|
815 Participants
n=1068 Participants
|
669 Participants
n=845 Participants
|
236 Participants
n=331 Participants
|
349 Participants
n=452 Participants
|
2981 Participants
n=3889 Participants
|
|
Race/Ethnicity, Customized
Race / Ethnic Origin · Asian Indian
|
159 Participants
n=1066 Participants • One patient in Group F did not specify any of the above categories.
|
23 Participants
n=127 Participants • One patient in Group F did not specify any of the above categories.
|
115 Participants
n=1068 Participants • One patient in Group F did not specify any of the above categories.
|
273 Participants
n=845 Participants • One patient in Group F did not specify any of the above categories.
|
44 Participants
n=331 Participants • One patient in Group F did not specify any of the above categories.
|
239 Participants
n=451 Participants • One patient in Group F did not specify any of the above categories.
|
853 Participants
n=3888 Participants • One patient in Group F did not specify any of the above categories.
|
|
Race/Ethnicity, Customized
Race / Ethnic Origin · Black or African
|
7 Participants
n=1066 Participants • One patient in Group F did not specify any of the above categories.
|
0 Participants
n=127 Participants • One patient in Group F did not specify any of the above categories.
|
8 Participants
n=1068 Participants • One patient in Group F did not specify any of the above categories.
|
2 Participants
n=845 Participants • One patient in Group F did not specify any of the above categories.
|
3 Participants
n=331 Participants • One patient in Group F did not specify any of the above categories.
|
1 Participants
n=451 Participants • One patient in Group F did not specify any of the above categories.
|
21 Participants
n=3888 Participants • One patient in Group F did not specify any of the above categories.
|
|
Race/Ethnicity, Customized
Race / Ethnic Origin · Chinese
|
529 Participants
n=1066 Participants • One patient in Group F did not specify any of the above categories.
|
97 Participants
n=127 Participants • One patient in Group F did not specify any of the above categories.
|
595 Participants
n=1068 Participants • One patient in Group F did not specify any of the above categories.
|
475 Participants
n=845 Participants • One patient in Group F did not specify any of the above categories.
|
158 Participants
n=331 Participants • One patient in Group F did not specify any of the above categories.
|
182 Participants
n=451 Participants • One patient in Group F did not specify any of the above categories.
|
2036 Participants
n=3888 Participants • One patient in Group F did not specify any of the above categories.
|
|
Race/Ethnicity, Customized
Race / Ethnic Origin · Korean
|
229 Participants
n=1066 Participants • One patient in Group F did not specify any of the above categories.
|
4 Participants
n=127 Participants • One patient in Group F did not specify any of the above categories.
|
158 Participants
n=1068 Participants • One patient in Group F did not specify any of the above categories.
|
25 Participants
n=845 Participants • One patient in Group F did not specify any of the above categories.
|
50 Participants
n=331 Participants • One patient in Group F did not specify any of the above categories.
|
15 Participants
n=451 Participants • One patient in Group F did not specify any of the above categories.
|
481 Participants
n=3888 Participants • One patient in Group F did not specify any of the above categories.
|
|
Race/Ethnicity, Customized
Race / Ethnic Origin · Other Asian
|
35 Participants
n=1066 Participants • One patient in Group F did not specify any of the above categories.
|
1 Participants
n=127 Participants • One patient in Group F did not specify any of the above categories.
|
28 Participants
n=1068 Participants • One patient in Group F did not specify any of the above categories.
|
50 Participants
n=845 Participants • One patient in Group F did not specify any of the above categories.
|
9 Participants
n=331 Participants • One patient in Group F did not specify any of the above categories.
|
5 Participants
n=451 Participants • One patient in Group F did not specify any of the above categories.
|
128 Participants
n=3888 Participants • One patient in Group F did not specify any of the above categories.
|
|
Race/Ethnicity, Customized
Race / Ethnic Origin · White or Caucasian
|
85 Participants
n=1066 Participants • One patient in Group F did not specify any of the above categories.
|
2 Participants
n=127 Participants • One patient in Group F did not specify any of the above categories.
|
119 Participants
n=1068 Participants • One patient in Group F did not specify any of the above categories.
|
10 Participants
n=845 Participants • One patient in Group F did not specify any of the above categories.
|
52 Participants
n=331 Participants • One patient in Group F did not specify any of the above categories.
|
4 Participants
n=451 Participants • One patient in Group F did not specify any of the above categories.
|
272 Participants
n=3888 Participants • One patient in Group F did not specify any of the above categories.
|
|
Race/Ethnicity, Customized
Race / Ethnic Origin · Other Race
|
17 Participants
n=1066 Participants • One patient in Group F did not specify any of the above categories.
|
0 Participants
n=127 Participants • One patient in Group F did not specify any of the above categories.
|
42 Participants
n=1068 Participants • One patient in Group F did not specify any of the above categories.
|
10 Participants
n=845 Participants • One patient in Group F did not specify any of the above categories.
|
14 Participants
n=331 Participants • One patient in Group F did not specify any of the above categories.
|
5 Participants
n=451 Participants • One patient in Group F did not specify any of the above categories.
|
88 Participants
n=3888 Participants • One patient in Group F did not specify any of the above categories.
|
|
Race/Ethnicity, Customized
Race / Ethnic Origin · Not reportable per local laws or regulations
|
1 Participants
n=1066 Participants • One patient in Group F did not specify any of the above categories.
|
0 Participants
n=127 Participants • One patient in Group F did not specify any of the above categories.
|
1 Participants
n=1068 Participants • One patient in Group F did not specify any of the above categories.
|
0 Participants
n=845 Participants • One patient in Group F did not specify any of the above categories.
|
1 Participants
n=331 Participants • One patient in Group F did not specify any of the above categories.
|
0 Participants
n=451 Participants • One patient in Group F did not specify any of the above categories.
|
3 Participants
n=3888 Participants • One patient in Group F did not specify any of the above categories.
|
|
Race/Ethnicity, Customized
Race / Ethnic Origin · Subject/physician chose not to provide information
|
4 Participants
n=1066 Participants • One patient in Group F did not specify any of the above categories.
|
0 Participants
n=127 Participants • One patient in Group F did not specify any of the above categories.
|
2 Participants
n=1068 Participants • One patient in Group F did not specify any of the above categories.
|
0 Participants
n=845 Participants • One patient in Group F did not specify any of the above categories.
|
0 Participants
n=331 Participants • One patient in Group F did not specify any of the above categories.
|
0 Participants
n=451 Participants • One patient in Group F did not specify any of the above categories.
|
6 Participants
n=3888 Participants • One patient in Group F did not specify any of the above categories.
|
|
Region of Enrollment
Colombia
|
11 participants
n=1066 Participants
|
0 participants
n=127 Participants
|
25 participants
n=1068 Participants
|
0 participants
n=845 Participants
|
6 participants
n=331 Participants
|
0 participants
n=452 Participants
|
42 participants
n=3889 Participants
|
|
Region of Enrollment
Argentina
|
27 participants
n=1066 Participants
|
0 participants
n=127 Participants
|
33 participants
n=1068 Participants
|
1 participants
n=845 Participants
|
21 participants
n=331 Participants
|
0 participants
n=452 Participants
|
82 participants
n=3889 Participants
|
|
Region of Enrollment
Singapore
|
14 participants
n=1066 Participants
|
5 participants
n=127 Participants
|
42 participants
n=1068 Participants
|
76 participants
n=845 Participants
|
23 participants
n=331 Participants
|
27 participants
n=452 Participants
|
187 participants
n=3889 Participants
|
|
Region of Enrollment
Egypt
|
6 participants
n=1066 Participants
|
2 participants
n=127 Participants
|
1 participants
n=1068 Participants
|
1 participants
n=845 Participants
|
1 participants
n=331 Participants
|
1 participants
n=452 Participants
|
12 participants
n=3889 Participants
|
|
Region of Enrollment
Malaysia
|
45 participants
n=1066 Participants
|
0 participants
n=127 Participants
|
23 participants
n=1068 Participants
|
30 participants
n=845 Participants
|
0 participants
n=331 Participants
|
0 participants
n=452 Participants
|
98 participants
n=3889 Participants
|
|
Region of Enrollment
United Arab Emirates
|
3 participants
n=1066 Participants
|
0 participants
n=127 Participants
|
3 participants
n=1068 Participants
|
1 participants
n=845 Participants
|
5 participants
n=331 Participants
|
0 participants
n=452 Participants
|
12 participants
n=3889 Participants
|
|
Region of Enrollment
Belarus
|
8 participants
n=1066 Participants
|
0 participants
n=127 Participants
|
7 participants
n=1068 Participants
|
1 participants
n=845 Participants
|
1 participants
n=331 Participants
|
0 participants
n=452 Participants
|
17 participants
n=3889 Participants
|
|
Region of Enrollment
India
|
149 participants
n=1066 Participants
|
22 participants
n=127 Participants
|
104 participants
n=1068 Participants
|
263 participants
n=845 Participants
|
39 participants
n=331 Participants
|
236 participants
n=452 Participants
|
813 participants
n=3889 Participants
|
|
Region of Enrollment
Russia
|
21 participants
n=1066 Participants
|
0 participants
n=127 Participants
|
46 participants
n=1068 Participants
|
0 participants
n=845 Participants
|
24 participants
n=331 Participants
|
0 participants
n=452 Participants
|
91 participants
n=3889 Participants
|
|
Region of Enrollment
South Korea
|
232 participants
n=1066 Participants
|
4 participants
n=127 Participants
|
160 participants
n=1068 Participants
|
25 participants
n=845 Participants
|
52 participants
n=331 Participants
|
15 participants
n=452 Participants
|
488 participants
n=3889 Participants
|
|
Region of Enrollment
China
|
385 participants
n=1066 Participants
|
85 participants
n=127 Participants
|
545 participants
n=1068 Participants
|
359 participants
n=845 Participants
|
144 participants
n=331 Participants
|
136 participants
n=452 Participants
|
1654 participants
n=3889 Participants
|
|
Region of Enrollment
Taiwan
|
125 participants
n=1066 Participants
|
9 participants
n=127 Participants
|
18 participants
n=1068 Participants
|
72 participants
n=845 Participants
|
1 participants
n=331 Participants
|
29 participants
n=452 Participants
|
254 participants
n=3889 Participants
|
|
Region of Enrollment
Brazil
|
9 participants
n=1066 Participants
|
0 participants
n=127 Participants
|
6 participants
n=1068 Participants
|
0 participants
n=845 Participants
|
0 participants
n=331 Participants
|
0 participants
n=452 Participants
|
15 participants
n=3889 Participants
|
|
Region of Enrollment
Mexico
|
3 participants
n=1066 Participants
|
0 participants
n=127 Participants
|
17 participants
n=1068 Participants
|
9 participants
n=845 Participants
|
5 participants
n=331 Participants
|
4 participants
n=452 Participants
|
38 participants
n=3889 Participants
|
|
Region of Enrollment
South Africa
|
5 participants
n=1066 Participants
|
0 participants
n=127 Participants
|
9 participants
n=1068 Participants
|
2 participants
n=845 Participants
|
3 participants
n=331 Participants
|
1 participants
n=452 Participants
|
20 participants
n=3889 Participants
|
|
Region of Enrollment
Tunisia
|
22 participants
n=1066 Participants
|
0 participants
n=127 Participants
|
28 participants
n=1068 Participants
|
5 participants
n=845 Participants
|
6 participants
n=331 Participants
|
3 participants
n=452 Participants
|
64 participants
n=3889 Participants
|
|
Region of Enrollment
Malta
|
1 participants
n=1066 Participants
|
0 participants
n=127 Participants
|
1 participants
n=1068 Participants
|
0 participants
n=845 Participants
|
0 participants
n=331 Participants
|
0 participants
n=452 Participants
|
2 participants
n=3889 Participants
|
PRIMARY outcome
Timeframe: Hazard ratio from study enrollment to approximately 4 years post-implant/enrollment (as reported in Statistical Analysis 1), and estimated 24 month VT-VF rate (as compared in the Outcome Measure table between Groups A and C).Population: Implanted 1.5 primary prevention and implanted secondary prevention patients. Since the primary objective is the hazard ratio of implanted 1.5 patients to implanted secondary patients, Groups B, D, E and F are not compared for this outcome. While not the primary endpoint, 24-month rates are provided to illustrate the underlying data.
Time to the first occurrence of an episode of true ventricular tachycardia or fibrillation 24 Month rates will be provided for the two groups used in the primary endpoint definition. However, the primary endpoint of hazard ratio is presented in Statistical Analysis 1 as a ratio between Groups A and C.
Outcome measures
| Measure |
Group A: Secondary Prevention Patients - Device Implant
n=1053 Participants
Patients who are guideline indicated for an ICD/CRT-D for secondary prevention of sudden cardiac arrest.
These subjects receive an ICD/CRT-D implant.
ICD or CRT-D Device: Subjects who receive an ICD/CRT-D device implant will be implanted and follow protocol-specified programming. The programming is not investigational. Consistent programming is desirable in order to compare groups during statistical analysis.
|
Group C: 1.5 Prevention Patients - Device Implant
n=1068 Participants
Patients who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they have any one of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF).
These subjects receive an ICD/CRT-D implant.
ICD or CRT-D Device: Subjects who receive an ICD/CRT-D device implant will be implanted and follow protocol-specified programming. The programming is not investigational. Consistent programming is desirable in order to compare groups during statistical analysis.
|
|---|---|---|
|
Time to the First Occurrence of a Ventricular Arrhythmia
|
32.5 Estimated 24-Month VT-VF Pct of Patients
Interval 29.3 to 36.0
|
18.3 Estimated 24-Month VT-VF Pct of Patients
Interval 15.6 to 21.5
|
SECONDARY outcome
Timeframe: Hazard ratio from study enrollment to approximately 4 years post-implant/enrollment (as reported in Statistical Analysis 1), and estimated 24 month mortality rate (as compared in the Outcome Measure table between Groups C and D).Population: Implanted and not-implanted 1.5 primary prevention patients. Since the secondary objective is the hazard ratio of implanted 1.5 patients to not-implanted 1.5 patients, Groups A, B, E and F are not compared for this outcome. While not the secondary endpoint, 24-month rates are provided to illustrate the underlying data.
Time to all-cause mortality
Outcome measures
| Measure |
Group A: Secondary Prevention Patients - Device Implant
n=1068 Participants
Patients who are guideline indicated for an ICD/CRT-D for secondary prevention of sudden cardiac arrest.
These subjects receive an ICD/CRT-D implant.
ICD or CRT-D Device: Subjects who receive an ICD/CRT-D device implant will be implanted and follow protocol-specified programming. The programming is not investigational. Consistent programming is desirable in order to compare groups during statistical analysis.
|
Group C: 1.5 Prevention Patients - Device Implant
n=845 Participants
Patients who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they have any one of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF).
These subjects receive an ICD/CRT-D implant.
ICD or CRT-D Device: Subjects who receive an ICD/CRT-D device implant will be implanted and follow protocol-specified programming. The programming is not investigational. Consistent programming is desirable in order to compare groups during statistical analysis.
|
|---|---|---|
|
Mortality
|
12.1 24 Mo. Mortality Rate (Pct. of Patients)
Interval 10.0 to 14.5
|
18.3 24 Mo. Mortality Rate (Pct. of Patients)
Interval 15.6 to 21.5
|
Adverse Events
Group A: Secondary Prevention Patients - Device Implanted
Serious events: 88 serious events
Other events: 0 other events
Deaths: 33 deaths
Group B: Secondary Prevention Patients - No Device Implanted
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group C: 1.5 Prevention Patients - Device Implant
Serious events: 72 serious events
Other events: 0 other events
Deaths: 24 deaths
Group D: 1.5 Prevention Patients - No Device Implant
Serious events: 37 serious events
Other events: 0 other events
Deaths: 24 deaths
Group E: 1.0 Prevention Patients - Device Implant
Serious events: 20 serious events
Other events: 0 other events
Deaths: 3 deaths
Group F: 1.0 Prevention Patients - No Device Implant
Serious events: 10 serious events
Other events: 0 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Group A: Secondary Prevention Patients - Device Implanted
n=371 participants at risk
Patients in South Korea, Singapore and Taiwan who are guideline indicated for an ICD/CRT-D for secondary prevention of sudden cardiac arrest.
These subjects receive an ICD/CRT-D implant. ICD or CRT-D Device: Subjects who receive an ICD/CRT-D device implant will be implanted and follow protocol-specified programming.
The programming is not investigational.
Consistent programming is desirable in order to compare groups during statistical analysis.
|
Group B: Secondary Prevention Patients - No Device Implanted
n=18 participants at risk
Patients in South Korea, Singapore and Taiwan who are guideline indicated for an ICD/CRT-D for secondary prevention of sudden cardiac arrest.
These subjects did not receive an ICD/CRT-D implant.
|
Group C: 1.5 Prevention Patients - Device Implant
n=220 participants at risk
Patients in South Korea, Singapore and Taiwan who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they have any one of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF).
These subjects receive an ICD/CRT-D implant. ICD or CRT-D Device: Subjects who receive an ICD/CRT-D device implant will be implanted and follow protocol-specified programming.
The programming is not investigational.
Consistent programming is desirable in order to compare groups during statistical analysis.
|
Group D: 1.5 Prevention Patients - No Device Implant
n=173 participants at risk
Patients in South Korea, Singapore and Taiwan who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they have any one of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF).
These subjects did not receive an ICD/CRT-D implant.
|
Group E: 1.0 Prevention Patients - Device Implant
n=76 participants at risk
Patients in South Korea, Singapore and Taiwan who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they have none of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF).
These subjects receive an ICD/CRT-D implant. ICD or CRT-D Device: Subjects who receive an ICD/CRT-D device implant will be implanted and follow protocol-specified programming.
The programming is not investigational.
Consistent programming is desirable in order to compare groups during statistical analysis.
|
Group F: 1.0 Prevention Patients - No Device Implant
n=71 participants at risk
Patients in South Korea, Singapore and Taiwan who are guideline indicated for an ICD/CRT-D for primary prevention of sudden cardiac arrest fall into this group if they have none of the 4 additional risk factors (syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent preventricular contractions (PVCs), or low left ventricular ejection fraction (low LVEF).
These subjects did not receive an ICD/CRT-D implant.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Cardiac Failure
|
2.2%
8/371 • Number of events 8 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
9.5%
21/220 • Number of events 30 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
1.2%
2/173 • Number of events 3 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
6.6%
5/76 • Number of events 5 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.81%
3/371 • Number of events 3 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
7.7%
17/220 • Number of events 20 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.58%
1/173 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
5.3%
4/76 • Number of events 5 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
1.4%
1/71 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Cardiac disorders
Ventricular tachycardia
|
4.6%
17/371 • Number of events 21 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.91%
2/220 • Number of events 2 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
1.7%
3/173 • Number of events 4 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Cardiac disorders
Cardiac failure congestive
|
1.6%
6/371 • Number of events 7 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
2.3%
5/220 • Number of events 7 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
1.7%
3/173 • Number of events 8 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
3.9%
3/76 • Number of events 4 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
2.8%
2/71 • Number of events 2 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Infections and infestations
Pneumonia
|
1.3%
5/371 • Number of events 8 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
1.8%
4/220 • Number of events 4 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
2.9%
5/173 • Number of events 5 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
2.8%
2/71 • Number of events 2 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Cardiac disorders
Atrial Fibrillation
|
0.54%
2/371 • Number of events 2 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
2.3%
5/220 • Number of events 5 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.58%
1/173 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
General disorders
Death
|
1.3%
5/371 • Number of events 5 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.91%
2/220 • Number of events 2 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.58%
1/173 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.54%
2/371 • Number of events 3 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.45%
1/220 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.58%
1/173 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
1.3%
1/76 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Nervous system disorders
Syncope
|
0.27%
1/371 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
1.8%
4/220 • Number of events 4 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
1.4%
3/220 • Number of events 3 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.58%
1/173 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
1.3%
1/76 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
1.4%
1/71 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Cardiac disorders
Arrhythmia
|
0.81%
3/371 • Number of events 4 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Cardiac disorders
Atrial flutter
|
0.81%
3/371 • Number of events 3 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.45%
1/220 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Cardiac disorders
Cardiac arrest
|
0.54%
2/371 • Number of events 2 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.91%
2/220 • Number of events 2 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Nervous system disorders
Cerebral infarction
|
0.81%
3/371 • Number of events 3 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
1.3%
1/76 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Infections and infestations
Septic shock
|
0.81%
3/371 • Number of events 3 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.45%
1/220 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.54%
2/371 • Number of events 3 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.45%
1/220 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Cardiac disorders
Acute myocardial infarction
|
0.54%
2/371 • Number of events 2 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.45%
1/220 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
1.2%
2/173 • Number of events 2 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.45%
1/220 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.58%
1/173 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
2.6%
2/76 • Number of events 2 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Cardiac disorders
Cardiac failure acute
|
0.54%
2/371 • Number of events 2 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.45%
1/220 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
1.2%
2/173 • Number of events 2 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
1.4%
1/71 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Cardiac disorders
Coronary artery disease
|
0.54%
2/371 • Number of events 3 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.45%
1/220 • Number of events 3 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Infections and infestations
Liver abscess
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.91%
2/220 • Number of events 3 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.27%
1/371 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.91%
2/220 • Number of events 2 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.45%
1/220 • Number of events 2 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
1.3%
1/76 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Cardiac disorders
Ventricular fibrillation
|
0.54%
2/371 • Number of events 2 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.45%
1/220 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
General disorders
Asthenia
|
0.27%
1/371 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
1.3%
1/76 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.45%
1/220 • Number of events 2 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.27%
1/371 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.45%
1/220 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.91%
2/220 • Number of events 2 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.54%
2/371 • Number of events 2 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Congenital, familial and genetic disorders
Hypertrophic cardiomyopathy
|
0.54%
2/371 • Number of events 2 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.27%
1/371 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.45%
1/220 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Infections and infestations
Influenza
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.91%
2/220 • Number of events 2 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Nervous system disorders
Ischaemic stroke
|
0.27%
1/371 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.45%
1/220 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Product Issues
Lead dislodgment
|
0.27%
1/371 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.45%
1/220 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Infections and infestations
Medical device site abscess
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.45%
1/220 • Number of events 2 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Infections and infestations
Medical device site infection
|
0.27%
1/371 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.45%
1/220 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.45%
1/220 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
1.2%
2/173 • Number of events 2 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
1.4%
1/71 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Infections and infestations
Sepsis
|
0.27%
1/371 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.45%
1/220 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
1.3%
1/76 • Number of events 2 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
1.3%
1/76 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Vascular disorders
Aortic dissection
|
0.27%
1/371 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.45%
1/220 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.45%
1/220 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
1.3%
1/76 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign salivary gland neoplasm
|
0.27%
1/371 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.45%
1/220 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Investigations
Blood glucose increased
|
0.27%
1/371 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Vascular disorders
Brachiocephalic vein stenosis
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.45%
1/220 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.27%
1/371 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.58%
1/173 • Number of events 2 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Infections and infestations
Bronchiolitis
|
0.27%
1/371 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Cardiac disorders
Brugada syndrome
|
0.27%
1/371 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Cardiac disorders
Cardiac amyloidosis
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.45%
1/220 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Cardiac disorders
Cardiac tamponade
|
0.27%
1/371 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Eye disorders
Cataract
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
1.3%
1/76 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.45%
1/220 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
General disorders
Chest pain
|
0.27%
1/371 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.45%
1/220 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.27%
1/371 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.45%
1/220 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
1.3%
1/76 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Psychiatric disorders
Delirium
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
1.3%
1/76 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Product Issues
Device lead issue
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.45%
1/220 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Product Issues
Device pacing issue
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.45%
1/220 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Infections and infestations
Device related infection
|
0.27%
1/371 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.45%
1/220 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
1.3%
1/76 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Gastrointestinal disorders
Dieulafoy's vascular malformation
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.45%
1/220 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Infections and infestations
Diverticulitis
|
0.27%
1/371 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Nervous system disorders
Dizziness
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.45%
1/220 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.45%
1/220 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.58%
1/173 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
General disorders
Dystrophic calcification
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.45%
1/220 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Nervous system disorders
Embolic stroke
|
0.27%
1/371 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Renal and urinary disorders
End stage renal disease
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.45%
1/220 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.58%
1/173 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Infections and infestations
Endocarditis
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.45%
1/220 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.45%
1/220 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.27%
1/371 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.45%
1/220 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.45%
1/220 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Vascular disorders
Haematoma
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.45%
1/220 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Renal and urinary disorders
Haematuria
|
0.27%
1/371 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.45%
1/220 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Surgical and medical procedures
Heart transplant
|
0.27%
1/371 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Nervous system disorders
Hemiplegia
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.45%
1/220 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Hepatobiliary disorders
Hepatic failure
|
0.27%
1/371 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.27%
1/371 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Blood and lymphatic system disorders
Hypereosinophilic syndrome
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.45%
1/220 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.45%
1/220 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Vascular disorders
Hypertension
|
0.27%
1/371 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
1.3%
1/76 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.45%
1/220 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.45%
1/220 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
General disorders
Impaired hearing
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.45%
1/220 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Infections and infestations
Implant site infection
|
0.27%
1/371 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.27%
1/371 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Investigations
Investigation
|
0.27%
1/371 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Investigations
Liver function test abnormal
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.45%
1/220 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Nervous system disorders
Loss of consciousness
|
0.27%
1/371 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.45%
1/220 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Eye disorders
Macular cyst
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.45%
1/220 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of unknown primary site
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.45%
1/220 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Surgical and medical procedures
Medical device change
|
0.27%
1/371 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Infections and infestations
Medical device site cellulitis
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.45%
1/220 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
General disorders
Medical device site swelling
|
0.27%
1/371 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.27%
1/371 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.58%
1/173 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neurogenic tumour
|
0.27%
1/371 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.27%
1/371 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Vascular disorders
Orthostatic hypotension
|
0.27%
1/371 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Nervous system disorders
Paraesthesia
|
0.27%
1/371 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.45%
1/220 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.58%
1/173 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
General disorders
Peripheral swelling
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.45%
1/220 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Infections and infestations
Pharyngitis
|
0.27%
1/371 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.27%
1/371 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.45%
1/220 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
1.3%
1/76 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Infections and infestations
Pseudomembranous colitis
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.45%
1/220 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.45%
1/220 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.27%
1/371 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.45%
1/220 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Injury, poisoning and procedural complications
Scapula fracture
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.45%
1/220 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Cardiac disorders
Sinus tachycardia
|
0.27%
1/371 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.27%
1/371 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
1.3%
1/76 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.27%
1/371 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
General disorders
Sudden cardiac death
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
1.3%
1/76 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Psychiatric disorders
Suicide attempt
|
0.27%
1/371 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.45%
1/220 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.27%
1/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Infections and infestations
Tinea faciei
|
0.27%
1/371 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
1.3%
1/76 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.45%
1/220 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.45%
1/220 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Infections and infestations
Wound infection staphylococcal
|
0.27%
1/371 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.45%
1/220 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.58%
1/173 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign gastric neoplasm
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.58%
1/173 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer recurrent
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.58%
1/173 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.58%
1/173 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.58%
1/173 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
1.4%
1/71 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
General disorders
Chest discomfort
|
0.27%
1/371 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.58%
1/173 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
1.4%
1/71 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Cardiac disorders
Extrasystoles
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.58%
1/173 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Infections and infestations
Gangrene
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.58%
1/173 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
1.2%
2/173 • Number of events 2 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.58%
1/173 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.58%
1/173 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Surgical and medical procedures
Mitral valve replacement
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
1.4%
1/71 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
2.9%
5/173 • Number of events 5 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
1.4%
1/71 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Infections and infestations
Skin infection
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/173 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
1.4%
1/71 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Vascular disorders
Steal syndrome
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.58%
1/173 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.58%
1/173 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Infections and infestations
Urosepsis
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.58%
1/173 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.58%
1/173 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
|
Cardiac disorders
Ventricular flutter
|
0.00%
0/371 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/18 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/220 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.58%
1/173 • Number of events 1 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/76 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
0.00%
0/71 • Baseline through approximately 42 months of follow-up
As the devices in the trial are market approved, adverse event collection was not required to meet study objectives. However, collection of SAEs, serious adverse device events (SADEs) and unanticipated serious adverse device events (USADEs) were mandated in South Korea, Singapore and Taiwan. Since only SAEs, SADEs and USADEs in these three countries were collected, Other (Not Including Serious) Adverse Events were not monitored or assessed
|
Other adverse events
Adverse event data not reported
Additional Information
Katy Muckala, Sr. Clinical Research Specialist
Medtronic CRHF
Phone: (763) 526-1767
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place