Trial Outcomes & Findings for XIENCE V® Everolimus Eluting Coronary Stent System USA Post-Approval Study (XIENCE V® USA-Phase 1) (NCT NCT00676520)
NCT ID: NCT00676520
Last Updated: 2012-11-20
Results Overview
ARC Defines Stent Thrombosis in the following way: Definite Stent Thrombosis: Angiographic or pathologic confirmation of partial or total thrombotic occlusion within the peri-stent region AND at least ONE of the following, additional criteria: Acute ischemic symptoms Ischemic ECG changes Elevated cardiac biomarkers Probable Stent Thrombosis: Any unexplained death within 30 days of stent implantation or any myocardial infarction, which is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause Possible Stent Thrombosis Any unexplained death beyond 30 days For further information on ARC definitions, please refer to the following website: http://circ.ahajournals.org/content/115/17/2344.full#sec-1
Recruitment status
COMPLETED
Target enrollment
8053 participants
Primary outcome timeframe
up to 1 year
Results posted on
2012-11-20
Participant Flow
Subjects are derived from the USA interventional cardiology population.
A sub-set of subjects was randomized to the DAPT portion of this study.
Participant milestones
| Measure |
Subjects Receiving the XIENCE V EECSS
|
|---|---|
|
Overall Study
STARTED
|
8040
|
|
Overall Study
COMPLETED
|
7309
|
|
Overall Study
NOT COMPLETED
|
731
|
Reasons for withdrawal
| Measure |
Subjects Receiving the XIENCE V EECSS
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
163
|
|
Overall Study
Lost to Follow-up
|
162
|
|
Overall Study
Death
|
159
|
|
Overall Study
Physician Decision
|
20
|
|
Overall Study
Ineligible for Randomization to DAPT
|
209
|
|
Overall Study
Other Reason
|
18
|
Baseline Characteristics
XIENCE V® Everolimus Eluting Coronary Stent System USA Post-Approval Study (XIENCE V® USA-Phase 1)
Baseline characteristics by cohort
| Measure |
Subjects Receiving the XIENCE V EECSS
n=8040 Participants
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4121 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
3919 Participants
n=5 Participants
|
|
Age Continuous
|
64.58 years
STANDARD_DEVIATION 10.82 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2441 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5599 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8040 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 1 yearPopulation: Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
ARC Defines Stent Thrombosis in the following way: Definite Stent Thrombosis: Angiographic or pathologic confirmation of partial or total thrombotic occlusion within the peri-stent region AND at least ONE of the following, additional criteria: Acute ischemic symptoms Ischemic ECG changes Elevated cardiac biomarkers Probable Stent Thrombosis: Any unexplained death within 30 days of stent implantation or any myocardial infarction, which is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause Possible Stent Thrombosis Any unexplained death beyond 30 days For further information on ARC definitions, please refer to the following website: http://circ.ahajournals.org/content/115/17/2344.full#sec-1
Outcome measures
| Measure |
Subjects Receiving the XIENCE V EECSS
n=7380 Participants
|
Angina Stability
|
Angina Frequency
|
Treatment Satisfaction
|
Perception of Disease/Quality of Life
|
|---|---|---|---|---|---|
|
Stent Thrombosis (Definite and Probable) Rate as Defined by ARC (Academic Research Constortium).
|
0.81 percentage of participants
Interval 0.62 to 1.05
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
MI= ARC (Academic Research Constortium) defined
Outcome measures
| Measure |
Subjects Receiving the XIENCE V EECSS
n=7522 Participants
|
Angina Stability
|
Angina Frequency
|
Treatment Satisfaction
|
Perception of Disease/Quality of Life
|
|---|---|---|---|---|---|
|
Composite Rate of Cardiac Death and Any Myocardial Infarction (MI)
|
7.2 percentage of participants
Interval 6.67 to 7.85
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: acute: post index procedure until hospital dischargePopulation: Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.
Outcome measures
| Measure |
Subjects Receiving the XIENCE V EECSS
n=11049 Lesions
|
Angina Stability
|
Angina Frequency
|
Treatment Satisfaction
|
Perception of Disease/Quality of Life
|
|---|---|---|---|---|---|
|
Clinical Device Success
|
99.8 percentage of lesions
Interval 99.73 to 99.9
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: acute: post index procedure until hospital dischargePopulation: Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.
Outcome measures
| Measure |
Subjects Receiving the XIENCE V EECSS
n=8002 Participants
|
Angina Stability
|
Angina Frequency
|
Treatment Satisfaction
|
Perception of Disease/Quality of Life
|
|---|---|---|---|---|---|
|
Procedural Success
|
97.3 percentage of participants
Interval 96.87 to 97.6
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at 30 daysPopulation: Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
MI= Academic Research Consortium (ARC) defined
Outcome measures
| Measure |
Subjects Receiving the XIENCE V EECSS
n=7963 Participants
|
Angina Stability
|
Angina Frequency
|
Treatment Satisfaction
|
Perception of Disease/Quality of Life
|
|---|---|---|---|---|---|
|
Composite Rate of Cardiac Death and Any MI (Q-wave and Non Q-wave)
|
3.6 percentage of participants
Interval 3.19 to 4.02
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at 180 daysPopulation: Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
MI= Academic Research Consortium (ARC) defined
Outcome measures
| Measure |
Subjects Receiving the XIENCE V EECSS
n=7854 Participants
|
Angina Stability
|
Angina Frequency
|
Treatment Satisfaction
|
Perception of Disease/Quality of Life
|
|---|---|---|---|---|---|
|
Composite Rate of Cardiac Death and Any MI (Q-wave and Non Q-wave)
|
5.4 percentage of participants
Interval 4.88 to 5.89
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at 30 daysPopulation: Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
MI= Academic Research Consortium (ARC) defined
Outcome measures
| Measure |
Subjects Receiving the XIENCE V EECSS
n=7963 Participants
|
Angina Stability
|
Angina Frequency
|
Treatment Satisfaction
|
Perception of Disease/Quality of Life
|
|---|---|---|---|---|---|
|
Composite Rate of All Death and Any MI (Q-wave and Non Q-wave)
|
3.6 percentage of participants
Interval 3.23 to 4.06
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at 180 daysPopulation: Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
MI= Academic Research Consortium (ARC) defined
Outcome measures
| Measure |
Subjects Receiving the XIENCE V EECSS
n=7854 Participants
|
Angina Stability
|
Angina Frequency
|
Treatment Satisfaction
|
Perception of Disease/Quality of Life
|
|---|---|---|---|---|---|
|
Composite Rate of All Death and Any MI (Q-wave and Non Q-wave)
|
5.8 percentage of participants
Interval 5.34 to 6.39
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at 1 yearPopulation: Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
MI= Academic Research Consortium (ARC) defined
Outcome measures
| Measure |
Subjects Receiving the XIENCE V EECSS
n=7522 Participants
|
Angina Stability
|
Angina Frequency
|
Treatment Satisfaction
|
Perception of Disease/Quality of Life
|
|---|---|---|---|---|---|
|
Composite Rate of All Death and Any MI (Q-wave and Non Q-wave)
|
8.3 percentage of participants
Interval 7.67 to 8.93
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at 30 daysPopulation: Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
MI= Academic Research Consortium (ARC) defined
Outcome measures
| Measure |
Subjects Receiving the XIENCE V EECSS
n=7963 Participants
|
Angina Stability
|
Angina Frequency
|
Treatment Satisfaction
|
Perception of Disease/Quality of Life
|
|---|---|---|---|---|---|
|
Composite Rate of All Death, Any MI (Q-wave and Non Q-wave) and Any Repeat Revascularization (Percutaneous Coronary Intervention [PCI] and Coronary Artery Bypass Graft [CABG])
|
4.3 percentage of participants
Interval 3.82 to 4.72
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at 180 daysPopulation: Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
MI= Academic Research Consortium (ARC) defined
Outcome measures
| Measure |
Subjects Receiving the XIENCE V EECSS
n=7854 Participants
|
Angina Stability
|
Angina Frequency
|
Treatment Satisfaction
|
Perception of Disease/Quality of Life
|
|---|---|---|---|---|---|
|
Composite Rate of All Death, Any MI (Q-wave and Non Q-wave) and Any Repeat Revascularization (Percutaneous Coronary Intervention [PCI] and Coronary Artery Bypass Graft [CABG])
|
9.4 percentage of participants
Interval 8.77 to 10.08
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at 1 yearPopulation: Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
MI= Academic Research Consortium (ARC) defined
Outcome measures
| Measure |
Subjects Receiving the XIENCE V EECSS
n=7522 Participants
|
Angina Stability
|
Angina Frequency
|
Treatment Satisfaction
|
Perception of Disease/Quality of Life
|
|---|---|---|---|---|---|
|
Composite Rate of All Death, Any MI (Q-wave and Non Q-wave) and Any Repeat Revascularization (Percutaneous Coronary Intervention [PCI] and Coronary Artery Bypass Graft [CABG])
|
14.9 percentage of participants
Interval 14.11 to 15.73
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at 30 daysPopulation: Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
MI= Academic Research Consortium (ARC) defined
Outcome measures
| Measure |
Subjects Receiving the XIENCE V EECSS
n=7963 Participants
|
Angina Stability
|
Angina Frequency
|
Treatment Satisfaction
|
Perception of Disease/Quality of Life
|
|---|---|---|---|---|---|
|
Composite Rate of Cardiac Death, Any MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Target Lesion Revascularization (TLR) (PCI and CABG)
|
3.5 percentage of participants
Interval 3.1 to 3.92
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at 180 daysPopulation: Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
MI= Academic Research Consortium (ARC) defined
Outcome measures
| Measure |
Subjects Receiving the XIENCE V EECSS
n=7854 Participants
|
Angina Stability
|
Angina Frequency
|
Treatment Satisfaction
|
Perception of Disease/Quality of Life
|
|---|---|---|---|---|---|
|
Composite Rate of Cardiac Death, Any MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Target Lesion Revascularization (TLR) (PCI and CABG)
|
6.3 percentage of participants
Interval 5.81 to 6.9
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at 1 yearPopulation: Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
MI= Academic Research Consortium (ARC) defined
Outcome measures
| Measure |
Subjects Receiving the XIENCE V EECSS
n=7522 Participants
|
Angina Stability
|
Angina Frequency
|
Treatment Satisfaction
|
Perception of Disease/Quality of Life
|
|---|---|---|---|---|---|
|
Composite Rate of Cardiac Death, Any MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Target Lesion Revascularization (TLR) (PCI and CABG)
|
9.6 percentage of participants
Interval 8.97 to 10.31
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at 30 daysPopulation: Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
Outcome measures
| Measure |
Subjects Receiving the XIENCE V EECSS
n=7963 Participants
|
Angina Stability
|
Angina Frequency
|
Treatment Satisfaction
|
Perception of Disease/Quality of Life
|
|---|---|---|---|---|---|
|
Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death)
|
0.4 percentage of participants
Interval 0.23 to 0.51
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at 180 daysPopulation: Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
Outcome measures
| Measure |
Subjects Receiving the XIENCE V EECSS
n=7854 Participants
|
Angina Stability
|
Angina Frequency
|
Treatment Satisfaction
|
Perception of Disease/Quality of Life
|
|---|---|---|---|---|---|
|
Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death)
|
1.4 percentage of participants
Interval 1.13 to 1.66
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at 1 yearPopulation: Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
Outcome measures
| Measure |
Subjects Receiving the XIENCE V EECSS
n=7522 Participants
|
Angina Stability
|
Angina Frequency
|
Treatment Satisfaction
|
Perception of Disease/Quality of Life
|
|---|---|---|---|---|---|
|
Death (Cardiac Death, Vascular Death, and Non-cardiovascular Death)
|
2.6 percentage of participants
Interval 2.23 to 2.96
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at 30 daysPopulation: Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
MI= Academic Research Consortium (ARC) defined
Outcome measures
| Measure |
Subjects Receiving the XIENCE V EECSS
n=7963 Participants
|
Angina Stability
|
Angina Frequency
|
Treatment Satisfaction
|
Perception of Disease/Quality of Life
|
|---|---|---|---|---|---|
|
Any MI (Q-wave and Non Q-wave)
|
3.3 percentage of participants
Interval 2.96 to 3.76
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at 180 daysPopulation: Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
MI= Academic Research Consortium (ARC) defined
Outcome measures
| Measure |
Subjects Receiving the XIENCE V EECSS
n=7854 Participants
|
Angina Stability
|
Angina Frequency
|
Treatment Satisfaction
|
Perception of Disease/Quality of Life
|
|---|---|---|---|---|---|
|
Any MI (Q-wave and Non Q-wave)
|
4.7 percentage of participants
Interval 4.28 to 5.23
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at 1 yearPopulation: Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
MI= Academic Research Consortium (ARC) defined
Outcome measures
| Measure |
Subjects Receiving the XIENCE V EECSS
n=7522 Participants
|
Angina Stability
|
Angina Frequency
|
Treatment Satisfaction
|
Perception of Disease/Quality of Life
|
|---|---|---|---|---|---|
|
Any MI (Q-wave and Non Q-wave)
|
6.3 percentage of participants
Interval 5.78 to 6.89
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at 30 daysPopulation: Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
Outcome measures
| Measure |
Subjects Receiving the XIENCE V EECSS
n=7963 Participants
|
Angina Stability
|
Angina Frequency
|
Treatment Satisfaction
|
Perception of Disease/Quality of Life
|
|---|---|---|---|---|---|
|
Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG)
|
1.1 percentage of participants
Interval 0.86 to 1.33
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at 180 daysPopulation: Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
Outcome measures
| Measure |
Subjects Receiving the XIENCE V EECSS
n=7854 Participants
|
Angina Stability
|
Angina Frequency
|
Treatment Satisfaction
|
Perception of Disease/Quality of Life
|
|---|---|---|---|---|---|
|
Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG)
|
5.0 percentage of participants
Interval 4.53 to 5.51
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at 1 yearPopulation: Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
Outcome measures
| Measure |
Subjects Receiving the XIENCE V EECSS
n=7522 Participants
|
Angina Stability
|
Angina Frequency
|
Treatment Satisfaction
|
Perception of Disease/Quality of Life
|
|---|---|---|---|---|---|
|
Revascularization (Target Lesion, Target Vessel [TVR], and Non-target Vessel) (PCI and CABG)
|
9.2 percentage of participants
Interval 8.54 to 9.86
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at 14 daysPopulation: Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
by TIMI flow
Outcome measures
| Measure |
Subjects Receiving the XIENCE V EECSS
n=7990 Participants
|
Angina Stability
|
Angina Frequency
|
Treatment Satisfaction
|
Perception of Disease/Quality of Life
|
|---|---|---|---|---|---|
|
Major Bleeding Complications
|
0.6 percentage of participants
Interval 0.45 to 0.81
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at 30 daysPopulation: Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
by TIMI flow
Outcome measures
| Measure |
Subjects Receiving the XIENCE V EECSS
n=7944 Participants
|
Angina Stability
|
Angina Frequency
|
Treatment Satisfaction
|
Perception of Disease/Quality of Life
|
|---|---|---|---|---|---|
|
Major Bleeding Complications
|
0.7 percentage of participants
Interval 0.53 to 0.91
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at 180 daysPopulation: Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
by TIMI flow
Outcome measures
| Measure |
Subjects Receiving the XIENCE V EECSS
n=7763 Participants
|
Angina Stability
|
Angina Frequency
|
Treatment Satisfaction
|
Perception of Disease/Quality of Life
|
|---|---|---|---|---|---|
|
Major Bleeding Complications
|
1.8 percentage of participants
Interval 1.47 to 2.07
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at 1 yearPopulation: Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
by TIMI flow
Outcome measures
| Measure |
Subjects Receiving the XIENCE V EECSS
n=7346 Participants
|
Angina Stability
|
Angina Frequency
|
Treatment Satisfaction
|
Perception of Disease/Quality of Life
|
|---|---|---|---|---|---|
|
Major Bleeding Complications
|
2.8 percentage of participants
Interval 2.4 to 3.16
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at 14 daysPopulation: Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.
Patient is included if medications (both aspirin and thienopyridine) were taken for at least 1 day during the visit window. The visit window for 14-day visit is 7-21 days, 30-day visit is 23-37 days, 180-day visit is 166-194 days, 1-year visit is 323-407 days, and 2-year visit is 688-772 days. Adjunctive antiplatelet therapy includes: Aspirin \& Thienopyridines (Clopidogrel/Ticlopidine/Prasugrel). Compliance refers to subjects following prescribed instructions for taking these medications. Therapy interruptions refer to any intervals during which the subject stops taking one or all of the prescribed medications.
Outcome measures
| Measure |
Subjects Receiving the XIENCE V EECSS
n=8039 Participants
|
Angina Stability
|
Angina Frequency
|
Treatment Satisfaction
|
Perception of Disease/Quality of Life
|
|---|---|---|---|---|---|
|
Dual Antiplatelet Medication Usage
|
89.4 percentage of participants
Interval 88.67 to 90.03
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at 30 daysPopulation: Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.
Patient is included if medications (both aspirin and thienopyridine) were taken for at least 1 day during the visit window. The visit window for 14-day visit is 7-21 days, 30-day visit is 23-37 days, 180-day visit is 166-194 days, 1-year visit is 323-407 days, and 2-year visit is 688-772 days. Adjunctive antiplatelet therapy includes: Aspirin \& Thienopyridines (Clopidogrel/Ticlopidine/Prasugrel). Compliance refers to subjects following prescribed instructions for taking these medications. Therapy interruptions refer to any intervals during which the subject stops taking one or all of the prescribed medications.
Outcome measures
| Measure |
Subjects Receiving the XIENCE V EECSS
n=8039 Participants
|
Angina Stability
|
Angina Frequency
|
Treatment Satisfaction
|
Perception of Disease/Quality of Life
|
|---|---|---|---|---|---|
|
Dual Antiplatelet Medication Usage
|
89.2 percentage of participants
Interval 88.45 to 89.82
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at 180 daysPopulation: Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.
Patient is included if medications (both aspirin and thienopyridine) were taken for at least 1 day during the visit window. The visit window for 14-day visit is 7-21 days, 30-day visit is 23-37 days, 180-day visit is 166-194 days, 1-year visit is 323-407 days, and 2-year visit is 688-772 days. Adjunctive antiplatelet therapy includes: Aspirin \& Thienopyridines (Clopidogrel/Ticlopidine/Prasugrel). Compliance refers to subjects following prescribed instructions for taking these medications. Therapy interruptions refer to any intervals during which the subject stops taking one or all of the prescribed medications.
Outcome measures
| Measure |
Subjects Receiving the XIENCE V EECSS
n=8039 Participants
|
Angina Stability
|
Angina Frequency
|
Treatment Satisfaction
|
Perception of Disease/Quality of Life
|
|---|---|---|---|---|---|
|
Dual Antiplatelet Medication Usage
|
86.4 percentage of participants
Interval 85.6 to 87.11
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at 1 yearPopulation: Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.
Patient is included if medications (both aspirin and thienopyridine) were taken for at least 1 day during the visit window. The visit window for 14-day visit is 7-21 days, 30-day visit is 23-37 days, 180-day visit is 166-194 days, 1-year visit is 323-407 days, and 2-year visit is 688-772 days. Adjunctive antiplatelet therapy includes: Aspirin \& Thienopyridines (Clopidogrel/Ticlopidine/Prasugrel). Compliance refers to subjects following prescribed instructions for taking these medications. Therapy interruptions refer to any intervals during which the subject stops taking one or all of the prescribed medications.
Outcome measures
| Measure |
Subjects Receiving the XIENCE V EECSS
n=8039 Participants
|
Angina Stability
|
Angina Frequency
|
Treatment Satisfaction
|
Perception of Disease/Quality of Life
|
|---|---|---|---|---|---|
|
Dual Antiplatelet Medication Usage
|
79.9 percentage of participants
Interval 79.03 to 80.79
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled.
Defined as patients who had at least 1 day without using either aspirin or thienopyridine from 1 to 407 days post index procedure.
Outcome measures
| Measure |
Subjects Receiving the XIENCE V EECSS
n=6886 Participants
|
Angina Stability
|
Angina Frequency
|
Treatment Satisfaction
|
Perception of Disease/Quality of Life
|
|---|---|---|---|---|---|
|
Dual Antiplatelet Therapy Non-compliance Through 1 Year
|
18.0 percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at 30 daysPopulation: Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
MI= Academic Research Consortium (ARC) defined
Outcome measures
| Measure |
Subjects Receiving the XIENCE V EECSS
n=7963 Participants
|
Angina Stability
|
Angina Frequency
|
Treatment Satisfaction
|
Perception of Disease/Quality of Life
|
|---|---|---|---|---|---|
|
Composite Rate of Cardiac Death and MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Clinically-indicated Target Lesion Revascularization (CI-TLR) (PCI and CABG) (This Composite Endpoint is Also Denoted as TLF)
|
3.5 percentage of participants
Interval 3.06 to 3.88
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at 180 daysPopulation: Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
MI= Academic Research Consortium (ARC) defined
Outcome measures
| Measure |
Subjects Receiving the XIENCE V EECSS
n=7854 Participants
|
Angina Stability
|
Angina Frequency
|
Treatment Satisfaction
|
Perception of Disease/Quality of Life
|
|---|---|---|---|---|---|
|
Composite Rate of Cardiac Death and MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Clinically-indicated Target Lesion Revascularization (CI-TLR) (PCI and CABG) (This Composite Endpoint is Also Denoted as TLF)
|
6.2 percentage of participants
Interval 5.71 to 6.8
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at 1 yearPopulation: Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. First Enrollment Phase and Second Enrollment Phase Pooled. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
MI= Academic Research Consortium (ARC) defined
Outcome measures
| Measure |
Subjects Receiving the XIENCE V EECSS
n=7522 Participants
|
Angina Stability
|
Angina Frequency
|
Treatment Satisfaction
|
Perception of Disease/Quality of Life
|
|---|---|---|---|---|---|
|
Composite Rate of Cardiac Death and MI (Q-wave and Non Q-wave) Attributed to the Target Vessel, and Clinically-indicated Target Lesion Revascularization (CI-TLR) (PCI and CABG) (This Composite Endpoint is Also Denoted as TLF)
|
9.4 percentage of participants
Interval 8.75 to 10.08
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at baselinePopulation: First enrollment phase of \~5,000 patients only. Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease: Anginal Stability: whether a patient's symptoms are changing over time. Anginal Frequency: how often a patient is having symptoms now Physical Limitation: how much a patient's condition is hampering his ability to do what he wants to do. Treatment Satisfaction: how well a patient understands her care and what she thinks of it. Disease Perception: the overall impact of a patient's condition on a patient's interpersonal relationships and state of mind. Each dimension is assigns each response an ordinal value, beginning with 1 for the response at the lowest level of functioning, and summing across items within each of the 5 scales. Scale scores then transformed to 0-100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100.
Outcome measures
| Measure |
Subjects Receiving the XIENCE V EECSS
n=4483 Participants
|
Angina Stability
|
Angina Frequency
|
Treatment Satisfaction
|
Perception of Disease/Quality of Life
|
|---|---|---|---|---|---|
|
Patient Health Status, Physical Limitations Assessed Using the SAQ (Seattle Angina Questionaire)
|
70.0 units on the SAQ scale
Standard Deviation 25.5
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at 180 daysPopulation: First enrollment phase of \~5,000 patients only. Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease: Anginal Stability: whether a patient's symptoms are changing over time. Anginal Frequency: how often a patient is having symptoms now Physical Limitation: how much a patient's condition is hampering his ability to do what he wants to do. Treatment Satisfaction: how well a patient understands her care and what she thinks of it. Disease Perception: the overall impact of a patient's condition on a patient's interpersonal relationships and state of mind. Each dimension is assigns each response an ordinal value, beginning with 1 for the response at the lowest level of functioning, and summing across items within each of the 5 scales. Scale scores then transformed to 0-100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100.
Outcome measures
| Measure |
Subjects Receiving the XIENCE V EECSS
n=3648 Participants
|
Angina Stability
|
Angina Frequency
|
Treatment Satisfaction
|
Perception of Disease/Quality of Life
|
|---|---|---|---|---|---|
|
Patient Health Status, Physical Limitations Assessed Using the SAQ (Seattle Angina Questionaire)
|
75.8 units on the SAQ scale
Standard Deviation 24.9
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at 1 yearPopulation: First enrollment phase of \~5,000 patients only. Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease: Anginal Stability: whether a patient's symptoms are changing over time. Anginal Frequency: how often a patient is having symptoms now Physical Limitation: how much a patient's condition is hampering his ability to do what he wants to do. Treatment Satisfaction: how well a patient understands her care and what she thinks of it. Disease Perception: the overall impact of a patient's condition on a patient's interpersonal relationships and state of mind. Each dimension is assigns each response an ordinal value, beginning with 1 for the response at the lowest level of functioning, and summing across items within each of the 5 scales. Scale scores then transformed to 0-100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100.
Outcome measures
| Measure |
Subjects Receiving the XIENCE V EECSS
n=3457 Participants
|
Angina Stability
|
Angina Frequency
|
Treatment Satisfaction
|
Perception of Disease/Quality of Life
|
|---|---|---|---|---|---|
|
Patient Health Status, Physical Limitations Assessed Using the SAQ (Seattle Angina Questionaire)
|
76.0 units on the SAQ scale
Standard Deviation 24.9
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: at baselinePopulation: First enrollment phase of \~5,000 patients only. Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease: Anginal Stability: whether a patient's symptoms are changing over time. Anginal Frequency: how often a patient is having symptoms now Physical Limitation: how much a patient's condition is hampering his ability to do what he wants to do. Treatment Satisfaction: how well a patient understands her care and what she thinks of it. Disease Perception: the overall impact of a patient's condition on a patient's interpersonal relationships and state of mind. Each dimension is assigns each response an ordinal value, beginning with 1 for the response at the lowest level of functioning, and summing across items within each of the 5 scales. Scale scores then transformed to 0-100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100.
Outcome measures
| Measure |
Subjects Receiving the XIENCE V EECSS
n=4483 Participants
|
Angina Stability
n=4681 Participants
|
Angina Frequency
n=4767 Participants
|
Treatment Satisfaction
n=4736 Participants
|
Perception of Disease/Quality of Life
n=4661 Participants
|
|---|---|---|---|---|---|
|
SAQ (Seattle Angina Questionaire)
|
70.0 units on the SAQ scale
Standard Deviation 25.5
|
42.0 units on the SAQ scale
Standard Deviation 27.6
|
73.1 units on the SAQ scale
Standard Deviation 25.1
|
98.1 units on the SAQ scale
Standard Deviation 12.7
|
55.3 units on the SAQ scale
Standard Deviation 25.8
|
SECONDARY outcome
Timeframe: 180 daysPopulation: First enrollment phase of \~5,000 patients only. Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease: Anginal Stability: whether a patient's symptoms are changing over time. Anginal Frequency: how often a patient is having symptoms now Physical Limitation: how much a patient's condition is hampering his ability to do what he wants to do. Treatment Satisfaction: how well a patient understands her care and what she thinks of it. Disease Perception: the overall impact of a patient's condition on a patient's interpersonal relationships and state of mind. Each dimension is assigns each response an ordinal value, beginning with 1 for the response at the lowest level of functioning, and summing across items within each of the 5 scales. Scale scores then transformed to 0-100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100.
Outcome measures
| Measure |
Subjects Receiving the XIENCE V EECSS
n=3648 Participants
|
Angina Stability
n=3896 Participants
|
Angina Frequency
n=3903 Participants
|
Treatment Satisfaction
n=3839 Participants
|
Perception of Disease/Quality of Life
n=3773 Participants
|
|---|---|---|---|---|---|
|
SAQ (Seattle Angina Questionaire)
|
75.8 units on the SAQ scale
Standard Deviation 24.9
|
57.3 units on the SAQ scale
Standard Deviation 20.2
|
90.1 units on the SAQ scale
Standard Deviation 17.1
|
91.4 units on the SAQ scale
Standard Deviation 14.5
|
76.8 units on the SAQ scale
Standard Deviation 21.5
|
SECONDARY outcome
Timeframe: 1 yearPopulation: First enrollment phase of \~5,000 patients only. Enrolled population is defined in the protocol as patients who received only XIENCE V EECSS during the index procedure. The analysis population at clinical follow-up visits may have changed due to early termination from the study by the patient or physician.
SAQ: 19-item, 5-6-point Likert, questionnaire measuring 5 dimensions of coronary artery disease: Anginal Stability: whether a patient's symptoms are changing over time. Anginal Frequency: how often a patient is having symptoms now Physical Limitation: how much a patient's condition is hampering his ability to do what he wants to do. Treatment Satisfaction: how well a patient understands her care and what she thinks of it. Disease Perception: the overall impact of a patient's condition on a patient's interpersonal relationships and state of mind. Each dimension is assigns each response an ordinal value, beginning with 1 for the response at the lowest level of functioning, and summing across items within each of the 5 scales. Scale scores then transformed to 0-100 range by subtracting the lowest possible scale score, dividing by the range of the scale and multiplying by 100.
Outcome measures
| Measure |
Subjects Receiving the XIENCE V EECSS
n=3457 Participants
|
Angina Stability
n=3689 Participants
|
Angina Frequency
n=3694 Participants
|
Treatment Satisfaction
n=3630 Participants
|
Perception of Disease/Quality of Life
n=3574 Participants
|
|---|---|---|---|---|---|
|
SAQ (Seattle Angina Questionaire)
|
76.0 units on the SAQ scale
Standard Deviation 24.9
|
54.3 units on the SAQ scale
Standard Deviation 18.3
|
90.7 units on the SAQ scale
Standard Deviation 17.0
|
92.2 units on the SAQ scale
Standard Deviation 14.0
|
78.0 units on the SAQ scale
Standard Deviation 21.1
|
Adverse Events
Subjects Receiving the XIENCE V EECSS
Serious events: 1656 serious events
Other events: 478 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Subjects Receiving the XIENCE V EECSS
n=4952 participants at risk
|
|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
0.26%
13/4952 • Number of events 13 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Cardiac disorders
Acute myocardial infarction
|
1.3%
64/4952 • Number of events 67 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Cardiac disorders
Acute pulmonary edema
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Cardiac disorders
Angina pectoris
|
10.3%
510/4952 • Number of events 632 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Cardiac disorders
Angina unstable
|
1.0%
50/4952 • Number of events 57 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Cardiac disorders
Aortic valve disease
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Cardiac disorders
Arrhythmia
|
0.14%
7/4952 • Number of events 7 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Cardiac disorders
Arteriospasm coronary
|
0.04%
2/4952 • Number of events 2 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Cardiac disorders
Atrial fibrillation
|
1.0%
51/4952 • Number of events 58 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Cardiac disorders
Atrial flutter
|
0.28%
14/4952 • Number of events 18 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Cardiac disorders
Atrial thrombosis
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Cardiac disorders
Atrioventricular block
|
0.04%
2/4952 • Number of events 2 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.04%
2/4952 • Number of events 2 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Cardiac disorders
Bradycardia
|
0.32%
16/4952 • Number of events 16 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Cardiac disorders
Cardiac arrest
|
0.34%
17/4952 • Number of events 17 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Cardiac disorders
Cardiac failure
|
0.28%
14/4952 • Number of events 16 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Cardiac disorders
Cardiac failure acute
|
0.06%
3/4952 • Number of events 3 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Cardiac disorders
Cardiac failure congestive
|
1.7%
83/4952 • Number of events 120 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Cardiac disorders
Cardiac tamponade
|
0.08%
4/4952 • Number of events 4 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.18%
9/4952 • Number of events 9 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Cardiac disorders
Cardiogenic shock
|
0.12%
6/4952 • Number of events 6 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Cardiac disorders
Cardiomyopathy
|
0.18%
9/4952 • Number of events 9 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.04%
2/4952 • Number of events 2 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Cardiac disorders
Coronary artery dissection
|
0.28%
14/4952 • Number of events 14 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Cardiac disorders
Coronary artery disease
|
0.38%
19/4952 • Number of events 19 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Cardiac disorders
Coronary artery perforation
|
0.02%
1/4952 • Number of events 2 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.08%
4/4952 • Number of events 4 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Cardiac disorders
Coronary artery thrombosis
|
0.08%
4/4952 • Number of events 4 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Cardiac disorders
Electromechanical dissociation
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.08%
4/4952 • Number of events 4 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.08%
4/4952 • Number of events 4 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Cardiac disorders
Low cardiac output syndrome
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Cardiac disorders
Mitral valve calcification
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.12%
6/4952 • Number of events 7 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Cardiac disorders
Mitral valve stenosis
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Cardiac disorders
Myocardial infarction
|
0.63%
31/4952 • Number of events 31 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.28%
14/4952 • Number of events 15 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Cardiac disorders
Palpitations
|
0.08%
4/4952 • Number of events 4 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Cardiac disorders
Pericardial effusion
|
0.06%
3/4952 • Number of events 4 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Cardiac disorders
Pericardial haemorrhage
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Cardiac disorders
Post procedural myocardial infarction
|
0.06%
3/4952 • Number of events 3 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Cardiac disorders
Sick sinus syndrome
|
0.24%
12/4952 • Number of events 12 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Cardiac disorders
Sinus arrest
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Cardiac disorders
Sinus arrhythmia
|
0.04%
2/4952 • Number of events 2 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Cardiac disorders
Sinus bradycardia
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Cardiac disorders
Sudden cardiac death
|
0.04%
2/4952 • Number of events 2 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.08%
4/4952 • Number of events 4 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Cardiac disorders
Tachycardia
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Cardiac disorders
Ventricular dysfunction
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.18%
9/4952 • Number of events 9 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.48%
24/4952 • Number of events 27 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
General disorders
Adverse drug reaction
|
0.04%
2/4952 • Number of events 2 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
General disorders
Asthenia
|
0.12%
6/4952 • Number of events 6 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
General disorders
Catheter site haematoma
|
0.32%
16/4952 • Number of events 16 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
General disorders
Catheter site haemorrhage
|
0.14%
7/4952 • Number of events 7 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
General disorders
Drug withdrawal syndrome
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
General disorders
Exercise tolerance decreased
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
General disorders
Fatigue
|
0.08%
4/4952 • Number of events 4 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
General disorders
Gait disturbance
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
General disorders
Generalised edema
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
General disorders
Infusion site phlebitis
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
General disorders
Multi-organ failure
|
0.04%
2/4952 • Number of events 2 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
General disorders
Non-cardiac chest pain
|
3.4%
167/4952 • Number of events 191 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
General disorders
Edema
|
0.04%
2/4952 • Number of events 2 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
General disorders
Edema peripheral
|
0.10%
5/4952 • Number of events 5 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
General disorders
Pain
|
0.04%
2/4952 • Number of events 2 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
General disorders
Pyrexia
|
0.18%
9/4952 • Number of events 10 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
General disorders
Sudden death
|
0.04%
2/4952 • Number of events 2 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Immune system disorders
Contrast media reaction
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Immune system disorders
Drug hypersensitivity
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Immune system disorders
Hypersensitivity
|
0.04%
2/4952 • Number of events 2 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Injury, poisoning and procedural complications
Coronary artery reocclusion
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Injury, poisoning and procedural complications
Coronary artery restenosis
|
0.04%
2/4952 • Number of events 2 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Injury, poisoning and procedural complications
Device dislocation
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Injury, poisoning and procedural complications
Implantable defibrillator malfunction
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Injury, poisoning and procedural complications
In-stent arterial restenosis
|
0.06%
3/4952 • Number of events 3 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Injury, poisoning and procedural complications
In-stent coronary artery restenosis
|
0.34%
17/4952 • Number of events 18 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Injury, poisoning and procedural complications
Incision site haemorrhage
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Injury, poisoning and procedural complications
Lead dislodgement
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Injury, poisoning and procedural complications
Mechanical complication of implant
|
0.04%
2/4952 • Number of events 2 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Injury, poisoning and procedural complications
Other injuries
|
1.1%
53/4952 • Number of events 59 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Injury, poisoning and procedural complications
Pacemaker complication
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhagen
|
0.08%
4/4952 • Number of events 4 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Injury, poisoning and procedural complications
Reperfusion injury
|
0.14%
7/4952 • Number of events 7 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Injury, poisoning and procedural complications
Stent-graft endoleak
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Injury, poisoning and procedural complications
Thrombosis in device
|
0.10%
5/4952 • Number of events 5 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Injury, poisoning and procedural complications
Vessel perforation
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Injury, poisoning and procedural complications
Weaning failure
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Nervous system disorders
Amnesia
|
0.04%
2/4952 • Number of events 2 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Nervous system disorders
Anoxic encephalopathy
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Nervous system disorders
Ataxia
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Nervous system disorders
Carotid sinus syndrome
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.04%
2/4952 • Number of events 2 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Nervous system disorders
Cerebral infarction
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.46%
23/4952 • Number of events 24 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Nervous system disorders
Complex partial seizures
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Nervous system disorders
Convulsion
|
0.08%
4/4952 • Number of events 4 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Nervous system disorders
Dementia
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Nervous system disorders
Dizziness
|
0.40%
20/4952 • Number of events 20 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Nervous system disorders
Dizziness postural
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Nervous system disorders
Dysarthria
|
0.04%
2/4952 • Number of events 2 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Nervous system disorders
Embolic cerebral infarction
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Nervous system disorders
Embolic stroke
|
0.08%
4/4952 • Number of events 4 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Nervous system disorders
Encephalopathy
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Nervous system disorders
Facial palsy
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Nervous system disorders
Facial paresis
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Nervous system disorders
Grand mal convulsion
|
0.04%
2/4952 • Number of events 2 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Nervous system disorders
Headache
|
0.10%
5/4952 • Number of events 5 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Nervous system disorders
Hemiparesis
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Nervous system disorders
Hydrocephalus
|
0.04%
2/4952 • Number of events 2 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Nervous system disorders
Hypertensive encephalopathy
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Nervous system disorders
Hypoaesthesia
|
0.10%
5/4952 • Number of events 5 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Nervous system disorders
Hypoglycaemic encephalopathy
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Nervous system disorders
Ischaemic stroke
|
0.10%
5/4952 • Number of events 5 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Nervous system disorders
Lethargy
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Nervous system disorders
Moyamoya disease
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Nervous system disorders
Muscular weakness
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Nervous system disorders
Neuralgia
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Nervous system disorders
Neurological symptom
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Nervous system disorders
Neuromyelitis optica
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Nervous system disorders
Paraesthesia
|
0.06%
3/4952 • Number of events 3 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Nervous system disorders
Parkinson's disease
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Nervous system disorders
Presyncope
|
0.14%
7/4952 • Number of events 7 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Nervous system disorders
Spondylitic myelopathy
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.04%
2/4952 • Number of events 2 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Nervous system disorders
Syncope
|
0.75%
37/4952 • Number of events 38 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Nervous system disorders
Syncope vasovagal
|
0.06%
3/4952 • Number of events 3 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Nervous system disorders
Tension headache
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.38%
19/4952 • Number of events 20 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Nervous system disorders
Unresponsive to stimulie
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Nervous system disorders
Vertebrobasilar insufficiency
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Nervous system disorders
Vertigo
|
0.06%
3/4952 • Number of events 3 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders
|
1.0%
51/4952 • Number of events 61 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders
|
0.04%
2/4952 • Number of events 2 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Endocrine disorders
Endocrine disorders
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Eye disorders
Eye disorders
|
0.10%
5/4952 • Number of events 5 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
2.3%
114/4952 • Number of events 137 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Hepatobiliary disorders
Hepatobiliary disorders
|
0.57%
28/4952 • Number of events 30 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Infections and infestations
Infections and infestations
|
3.4%
170/4952 • Number of events 212 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Investigations
Investigations
|
1.2%
57/4952 • Number of events 63 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders
|
0.95%
47/4952 • Number of events 59 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
|
1.2%
58/4952 • Number of events 63 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
1.0%
51/4952 • Number of events 54 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Psychiatric disorders
Psychiatric disorders
|
0.40%
20/4952 • Number of events 21 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders
|
0.06%
3/4952 • Number of events 4 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
|
0.22%
11/4952 • Number of events 11 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Surgical and medical procedures
Surgical and medical procedures
|
0.93%
46/4952 • Number of events 47 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Renal and urinary disorders
Other renal and urinary disorders
|
0.85%
42/4952 • Number of events 45 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Renal and urinary disorders
Renal failure acute
|
0.63%
31/4952 • Number of events 31 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary edema
|
0.18%
9/4952 • Number of events 10 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.10%
5/4952 • Number of events 5 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.06%
3/4952 • Number of events 4 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.63%
31/4952 • Number of events 34 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.8%
91/4952 • Number of events 104 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.30%
15/4952 • Number of events 15 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea paroxysmal nocturnal
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.06%
3/4952 • Number of events 3 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Respiratory, thoracic and mediastinal disorders
Pickwickian syndrome
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.16%
8/4952 • Number of events 10 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.10%
5/4952 • Number of events 5 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.04%
2/4952 • Number of events 2 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.16%
8/4952 • Number of events 8 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.02%
1/4952 • Number of events 2 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.14%
7/4952 • Number of events 7 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory depression
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.04%
2/4952 • Number of events 3 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.16%
8/4952 • Number of events 8 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Respiratory, thoracic and mediastinal disorders
Throat tightness
|
0.06%
3/4952 • Number of events 3 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Vascular disorders
Accelerated hypertension
|
0.04%
2/4952 • Number of events 2 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Vascular disorders
Aortic aneurysms
|
0.20%
10/4952 • Number of events 10 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Vascular disorders
Aortic dissection
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Vascular disorders
Aortic stenosis
|
0.08%
4/4952 • Number of events 4 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Vascular disorders
Arterial thrombosis limb
|
0.06%
3/4952 • Number of events 4 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Vascular disorders
Arteriosclerosis
|
0.18%
9/4952 • Number of events 9 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Vascular disorders
Arteriovenous malformation
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Vascular disorders
Carotid artery disease
|
0.10%
5/4952 • Number of events 5 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Vascular disorders
Carotid artery occlusion
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Vascular disorders
Carotid artery stenosis
|
0.34%
17/4952 • Number of events 19 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Vascular disorders
Deep vein thrombosis
|
0.16%
8/4952 • Number of events 9 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Vascular disorders
Epistaxis
|
0.06%
3/4952 • Number of events 3 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Vascular disorders
Femoral arterial stenosis
|
0.12%
6/4952 • Number of events 7 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Vascular disorders
Femoral artery occlusion
|
0.04%
2/4952 • Number of events 2 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Vascular disorders
Gastrointestinal haemorrhage
|
1.1%
54/4952 • Number of events 57 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Vascular disorders
Haematoma
|
0.06%
3/4952 • Number of events 3 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Vascular disorders
Haemoptysis
|
0.08%
4/4952 • Number of events 4 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Vascular disorders
Haemorrhage
|
0.04%
2/4952 • Number of events 2 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Vascular disorders
Hypertension
|
0.30%
15/4952 • Number of events 16 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Vascular disorders
Hypertensive crisis
|
0.04%
2/4952 • Number of events 2 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Vascular disorders
Hypotension
|
0.55%
27/4952 • Number of events 30 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Vascular disorders
Hypovolaemic shock
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Vascular disorders
Iliac artery occlusion
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Vascular disorders
Intermittent claudication
|
0.30%
15/4952 • Number of events 17 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Vascular disorders
Labile blood pressure
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Vascular disorders
Muscle haemorrhage
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Vascular disorders
Oesophageal varices haemorrhage
|
0.04%
2/4952 • Number of events 2 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Vascular disorders
Orthostatic hypotension
|
0.08%
4/4952 • Number of events 4 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.08%
4/4952 • Number of events 4 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Vascular disorders
Peripheral ischaemia
|
0.08%
4/4952 • Number of events 6 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.14%
7/4952 • Number of events 8 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Vascular disorders
Pulmonary hypertension
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Vascular disorders
Rectal haemorrhage
|
0.12%
6/4952 • Number of events 7 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Vascular disorders
Renal artery occlusion
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Vascular disorders
Renal artery stenosis
|
0.18%
9/4952 • Number of events 9 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Vascular disorders
Retroperitoneal haemorrhage
|
0.28%
14/4952 • Number of events 14 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Vascular disorders
Subclavian artery stenosis
|
0.04%
2/4952 • Number of events 2 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Vascular disorders
Thrombosis
|
0.04%
2/4952 • Number of events 2 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Vascular disorders
Upper gastrointestinal haemorrhage
|
0.20%
10/4952 • Number of events 10 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Vascular disorders
Vascular insufficiency
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Vascular disorders
Vascular pseudoaneurysm
|
0.36%
18/4952 • Number of events 18 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Vascular disorders
Aortic intramural haematoma
|
0.02%
1/4952 • Number of events 1 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.06%
3/4952 • Number of events 3 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
Other adverse events
| Measure |
Subjects Receiving the XIENCE V EECSS
n=4952 participants at risk
|
|---|---|
|
Cardiac disorders
Angina pectoris
|
9.7%
478/4952 • Number of events 556 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
General disorders
Non-cardiac chest pain
|
5.7%
280/4952 • Number of events 325 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
6.4%
316/4952 • Number of events 362 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Infections and infestations
Infections and infestations
|
5.2%
259/4952 • Number of events 311 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Investigations
Investigations
|
7.0%
349/4952 • Number of events 383 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
|
9.3%
459/4952 • Number of events 535 • 1 year
If a subject had more than one event, this subject has been counted only once. The number of participants at risk excludes subjects who were "early terminated" up to 365 days and who had no events through the given timepoint.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60