Trial Outcomes & Findings for XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) China Single-Arm Study (NCT NCT01894152)
NCT ID: NCT01894152
Last Updated: 2020-05-26
Results Overview
Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) Myocardial Infarction (MI): * Q wave MI: Development of new, pathological Q wave on the ECG. * Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. This study has no primary or secondary endpoints, all endpoints are of equal weight.
COMPLETED
2002 participants
≤ 7 days after index procedure (Hospitalization)
2020-05-26
Participant Flow
A total of 2140 patients were registered from 35 centres in China. First patients was enrolled on July 12, 2013 \& enrollment was completed on Sep11, 2014 through the Interactive Voice Response System (IVRS) excluding those without consent and those without stent implants \& duplicate entries. Thus the analysis population includes 2002 participants .
Of the 2140 registered subjects,138 subjects withdrew from the study due to incomplete consent forms, no implanted study stents and repeated entry in voice interactive selection system. Among the final analysis population (n=2002), a total of 151 subjects failed to complete the follow-up period.
Participant milestones
| Measure |
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
|
|---|---|
|
Overall Study
STARTED
|
2002
|
|
Overall Study
COMPLETED
|
1851
|
|
Overall Study
NOT COMPLETED
|
151
|
Reasons for withdrawal
| Measure |
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
|
|---|---|
|
Overall Study
No DMR and no Stent thrombosis
|
151
|
Baseline Characteristics
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS) China Single-Arm Study
Baseline characteristics by cohort
| Measure |
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
n=2002 Participants
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1286 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
716 Participants
n=5 Participants
|
|
Age, Continuous
|
60.42 years
STANDARD_DEVIATION 10.72 • n=5 Participants
|
|
Sex: Female, Male
Female
|
501 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1501 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2002 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
2002 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: ≤ 7 days after index procedure (Hospitalization)Population: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) Myocardial Infarction (MI): * Q wave MI: Development of new, pathological Q wave on the ECG. * Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. This study has no primary or secondary endpoints, all endpoints are of equal weight.
Outcome measures
| Measure |
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
n=1851 Participants
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
|
|---|---|
|
Number of Participants With Cardiac Death and All Myocardial Infarction (MI) (Q-wave and Non-Q Wave) Composite Endpoint
|
7 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0 through 1885 DaysPopulation: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) Myocardial Infarction (MI): * Q wave MI: Development of new, pathological Q wave on the ECG. * Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. This study has no primary or secondary endpoints, all endpoints are of equal weight.
Outcome measures
| Measure |
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
n=1851 Participants
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
|
|---|---|
|
Number of Participants With Cardiac Death and All Myocardial Infarction (MI) (Q-wave and Non-Q Wave) Composite Endpoint
|
114 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: ≤ 7 days after index procedure (Hospitalization)Population: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
All deaths include Cardiac death, Cardiovascular death and Non-cardiovascular death. Myocardial Infarction (MI): * Q wave MI: Development of new, pathological Q wave on the ECG. * Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. This study has no primary or secondary endpoints, all endpoints are of equal weight.
Outcome measures
| Measure |
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
n=1851 Participants
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
|
|---|---|
|
Number of All Deaths, Myocardial Infarction, Any Repetitive Revascularization Composite Endpoints
|
8 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0 through 1885 DaysPopulation: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
All deaths include Cardiac death, Cardiovascular death and Non-cardiovascular death. Myocardial Infarction (MI): * Q wave MI: Development of new, pathological Q wave on the ECG. * Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. This study has no primary or secondary endpoints, all endpoints are of equal weight.
Outcome measures
| Measure |
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
n=1851 Participants
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
|
|---|---|
|
Number of All Deaths, Myocardial Infarction, Any Repetitive Revascularization Composite Endpoints
|
330 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: ≤ 7 days after index procedure (Hospitalization)Population: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) Myocardial Infarction (MI): Patient diagnosed with myocardial infarction, but its relation with target vessel not clear, therefore considered target vessel myocardial infarction. * Q wave MI: Development of new, pathological Q wave on the ECG. * Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. This study has no primary or secondary endpoints, all endpoints are of equal weight.
Outcome measures
| Measure |
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
n=1851 Participants
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
|
|---|---|
|
Number of Participants With Cardiogenic Death, Target Vessel Blood Flow Myocardial Infarction, Target Lesion Revascularization Composite Endpoint
|
5 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0 through 1885 DaysPopulation: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) Myocardial Infarction (MI): Patient diagnosed with myocardial infarction, but its relation with target vessel not clear, therefore considered target vessel myocardial infarction. * Q wave MI: Development of new, pathological Q wave on the ECG. * Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. This study has no primary or secondary endpoints, all endpoints are of equal weight.
Outcome measures
| Measure |
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
n=1851 Participants
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
|
|---|---|
|
Number of Participants With Cardiogenic Death, Target Vessel Blood Flow Myocardial Infarction, Target Lesion Revascularization Composite Endpoint
|
120 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: ≤ 7 days after index procedure (Hospitalization)Population: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
All deaths include Cardiac death, Cardiovascular death and Non-cardiovascular death. Myocardial Infarction (MI): * Q wave MI: Development of new, pathological Q wave on the ECG. * Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. This study has no primary or secondary endpoints, all endpoints are of equal weight.
Outcome measures
| Measure |
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
n=1851 Participants
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
|
|---|---|
|
Number of Participants With Composite Rate of All Deaths and Myocardial Infarctions (MI)
|
8 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0 through 1885 DaysPopulation: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
All deaths include Cardiac death, Cardiovascular death and Non-cardiovascular death. Myocardial Infarction (MI): * Q wave MI: Development of new, pathological Q wave on the ECG. * Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves. This study has no primary or secondary endpoints, all endpoints are of equal weight.
Outcome measures
| Measure |
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
n=1851 Participants
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
|
|---|---|
|
Number of Participants With Composite Rate of All Deaths and Myocardial Infarctions (MI)
|
156 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: ≤ 7 days after index procedure (Hospitalization)Population: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR). This study has no primary or secondary endpoints, all endpoints are of equal weight.
Outcome measures
| Measure |
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
n=1851 Participants
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
|
|---|---|
|
Number of Participants With Target Lesion Failure (TLF)
|
5 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0 through 1885 DaysPopulation: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR). This study has no primary or secondary endpoints, all endpoints are of equal weight.
Outcome measures
| Measure |
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
n=1851 Participants
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
|
|---|---|
|
Number of Participants With Target Lesion Failure (TLF)
|
100 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: ≤ 7 days after index procedure (Hospitalization)Population: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or ischemia-driven Target Vessel Revascularization (ID-TVR). This study has no primary or secondary endpoints, all endpoints are of equal weight.
Outcome measures
| Measure |
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
n=1851 Participants
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
|
|---|---|
|
Number of Participants With Target Vessel Failure (ID-TVF) (Cardiac Death, All Myocardial Infarctions and Ischemia-driven Target Vessel Revascularization)
|
7 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0 through 1885 DaysPopulation: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or ischemia-driven Target Vessel Revascularization (ID-TVR). This study has no primary or secondary endpoints, all endpoints are of equal weight.
Outcome measures
| Measure |
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
n=1851 Participants
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
|
|---|---|
|
Number of Participants With Target Vessel Failure (ID-TVF) (Cardiac Death, All Myocardial Infarctions and Ischemia-driven Target Vessel Revascularization)
|
180 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: ≤ 7 days after index procedure (Hospitalization)Population: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) This study as no primary or secondary endpoints, all endpoints are of equal weight. \- Non-cardiac death is defined as a death not due to cardiac causes (as defined above). This study has no primary or secondary endpoints, all endpoints are of equal weight.
Outcome measures
| Measure |
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
n=1851 Participants
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
|
|---|---|
|
Number of All Death (Cardiac, Vascular, and Non-cardiovascular)
|
3 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0 through 1885 DaysPopulation: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
Cardiac death is defined as any death in which a cardiac cause cannot be excluded. (This includes but is not limited to acute myocardial infarction, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality,cerebrovascular accident within 30 days of the procedure or cerebrovascular accident suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery.) This study as no primary or secondary endpoints, all endpoints are of equal weight. \- Non-cardiac death is defined as a death not due to cardiac causes (as defined above). This study has no primary or secondary endpoints, all endpoints are of equal weight.
Outcome measures
| Measure |
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
n=1851 Participants
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
|
|---|---|
|
Number of All Death (Cardiac, Vascular, and Non-cardiovascular)
|
91 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: ≤ 7 days after index procedure (Hospitalization)Population: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
Myocardial Infarction (MI) * Q wave MI Development of new, pathological Q wave on the ECG * Non-Q wave MI Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves This study has no primary or secondary endpoints, all endpoints are of equal weight.
Outcome measures
| Measure |
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
n=1851 Participants
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
|
|---|---|
|
Number of Participants With All Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave)
|
6 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0 through 1885 DaysPopulation: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
Myocardial Infarction (MI) * Q wave MI Development of new, pathological Q wave on the ECG * Non-Q wave MI Elevation of CK levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves This study has no primary or secondary endpoints, all endpoints are of equal weight.
Outcome measures
| Measure |
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
n=1851 Participants
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
|
|---|---|
|
Number of Participants With All Myocardial Infarction (MI) (Including Q-wave and Non-Q-wave)
|
75 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: ≤ 7 days after index procedure (Hospitalization)Population: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. This study has no primary or secondary endpoints, all endpoints are of equal weight.
Outcome measures
| Measure |
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
n=1851 Participants
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
|
|---|---|
|
Number of Participants With All Target Vessel Revascularization (TVR)
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0 through 1885 DaysPopulation: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
Target Vessel Revascularization is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. This study has no primary or secondary endpoints, all endpoints are of equal weight.
Outcome measures
| Measure |
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
n=1851 Participants
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
|
|---|---|
|
Number of Participants With All Target Vessel Revascularization (TVR)
|
26 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: ≤ 7 days after index procedure (Hospitalization)Population: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
This study has no primary or secondary endpoints, all endpoints are of equal weight. All Revascularization includes Coronary artery bypass grafting and Percutaneous coronary intervention
Outcome measures
| Measure |
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
n=1851 Participants
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
|
|---|---|
|
Number of Participants With All Revascularization (Target Lesion, Target Vessel, and Non-target Vessel) (PCI and Coronary Artery Bypass Graft [CABG])
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0 through 1885 DaysPopulation: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
This study has no primary or secondary endpoints, all endpoints are of equal weight. All Revascularization includes Coronary artery bypass grafting and Percutaneous coronary intervention
Outcome measures
| Measure |
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
n=1851 Participants
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
|
|---|---|
|
Number of Participants With All Revascularization (Target Lesion, Target Vessel, and Non-target Vessel) (PCI and Coronary Artery Bypass Graft [CABG])
|
223 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0 to 1 dayPopulation: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
This study has no primary or secondary endpoints, all endpoints are of equal weight. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Extremely late scaffold/stent thrombosis: \>1 year post stent implantation"
Outcome measures
| Measure |
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
n=1851 Participants
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
|
|---|---|
|
Number of Participants With Acute Stent Thrombosis
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: > 1 day to 30 daysPopulation: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
This study has no primary or secondary endpoints, all endpoints are of equal weight. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Extremely late scaffold/stent thrombosis: \>1 year post stent implantation"
Outcome measures
| Measure |
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
n=1851 Participants
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
|
|---|---|
|
Number of Participants With Sub-acute Stent Thrombosis
|
2 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0 - 30 daysPopulation: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
This study has no primary or secondary endpoints, all endpoints are of equal weight. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Extremely late scaffold/stent thrombosis: \>1 year post stent implantation"
Outcome measures
| Measure |
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
n=1851 Participants
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
|
|---|---|
|
Number of Participants With Early Stent Thrombosis
|
2 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 31 to 365 daysPopulation: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
This study has no primary or secondary endpoints, all endpoints are of equal weight. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Extremely late scaffold/stent thrombosis: \>1 year post stent implantation"
Outcome measures
| Measure |
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
n=1851 Participants
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
|
|---|---|
|
Number of Participants With Late Stent Thrombosis
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: > 365 daysPopulation: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
This study has no primary or secondary endpoints, all endpoints are of equal weight. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Extremely late scaffold/stent thrombosis: \>1 year post stent implantation"
Outcome measures
| Measure |
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
n=1851 Participants
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
|
|---|---|
|
Number of Participants With Very Late Stent Thrombosis
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0 to 1885 daysPopulation: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
This study has no primary or secondary endpoints, all endpoints are of equal weight. Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Extremely late scaffold/stent thrombosis: \>1 year post stent implantation"
Outcome measures
| Measure |
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
n=1851 Participants
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
|
|---|---|
|
Number of Participants With Overall Stent Thrombosis
|
3 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: ≤ 7 days after index procedure (Hospitalization)Population: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
This study has no primary or secondary endpoints, all endpoints are of equal weight. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Outcome measures
| Measure |
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
n=1851 Participants
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
|
|---|---|
|
Number of Participants With Target Vessel ARC MI
|
2 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0 to 1885 daysPopulation: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
This study has no primary or secondary endpoints, all endpoints are of equal weight. Myocardial Infarction (MI): Q wave MI: Development of new, pathological Q wave on the ECG. Non-Q wave MI: Elevation of Creatine kinase (CK) levels to ≥ two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves.
Outcome measures
| Measure |
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
n=1851 Participants
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
|
|---|---|
|
Number of Participants With Target Vessel ARC MI
|
23 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: ≤ 7 days after index procedure (Hospitalization)Population: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
This study has no primary or secondary endpoints, all endpoints are of equal weight. All TVR (TLR and TVR, non-target lesion)
Outcome measures
| Measure |
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
n=1851 Participants
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
|
|---|---|
|
Number of Participants With All TVR (TLR and TVR, Non-target Lesion)
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0 to 1885 daysPopulation: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
This study has no primary or secondary endpoints, all endpoints are of equal weight. All TVR (TLR and TVR, non-target lesion)
Outcome measures
| Measure |
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
n=1851 Participants
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
|
|---|---|
|
Number of Participants With All TVR (TLR and TVR, Non-target Lesion)
|
84 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: ≤ 7 days after index procedure (Hospitalization)Population: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
This study has no primary or secondary endpoints, all endpoints are of equal weight.
Outcome measures
| Measure |
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
n=1851 Participants
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
|
|---|---|
|
Number of Participants With All TLR
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0 to 1885 daysPopulation: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
This study has no primary or secondary endpoints, all endpoints are of equal weight.
Outcome measures
| Measure |
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
n=1851 Participants
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
|
|---|---|
|
Number of Participants With All TLR
|
58 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: ≤ 7 days after index procedure (Hospitalization)Population: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
This study has no primary or secondary endpoints, all endpoints are of equal weight. Revascularization includes TLR, TVR, non-target lesion, and non TVR.
Outcome measures
| Measure |
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
n=1851 Participants
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
|
|---|---|
|
Number of Participants With ID-TLR
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0 to 1885 daysPopulation: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
This study has no primary or secondary endpoints, all endpoints are of equal weight. Revascularization includes TLR, TVR, non-target lesion, and non TVR.
Outcome measures
| Measure |
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
n=1851 Participants
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
|
|---|---|
|
Number of Participants With ID-TLR
|
37 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: ≤ 7 days after index procedure (Hospitalization)Population: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
This study has no primary or secondary endpoints, all endpoints are of equal weight. Revascularization includes TLR, TVR, non-target lesion, and non TVR.
Outcome measures
| Measure |
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
n=1851 Participants
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
|
|---|---|
|
Number of Participants With ID-TVR, Non-target Lesion
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0 to 1885 daysPopulation: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
This study has no primary or secondary endpoints, all endpoints are of equal weight. Revascularization includes TLR, TVR, non-target lesion, and non TVR.
Outcome measures
| Measure |
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
n=1851 Participants
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
|
|---|---|
|
Number of Participants With ID-TVR, Non-target Lesion
|
22 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: ≤ 7 days after index procedure (Hospitalization)Population: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
This study has no primary or secondary endpoints, all endpoints are of equal weight. Revascularization includes TLR, TVR, non-target lesion, and non TVR.
Outcome measures
| Measure |
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
n=1851 Participants
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
|
|---|---|
|
Number of Participants With ID-TVR (TLR and TVR, Non-target Lesion)
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0 to 1885 daysPopulation: Full Analysis Set (FAS). Full Analysis Set includes all patients who had implanted XIENCE PRIME EECSS stent in the start-up procedures. The analysis population includes patients with DMR composite event (deaths, myocardial infarctions, revascularization cases) or stent thrombosis or complete follow-up at given point in time.
This study has no primary or secondary endpoints, all endpoints are of equal weight. Revascularization includes TLR, TVR, non-target lesion, and non TVR.
Outcome measures
| Measure |
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
n=1851 Participants
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
|
|---|---|
|
Number of Participants With ID-TVR (TLR and TVR, Non-target Lesion)
|
59 Participants
|
Adverse Events
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
Serious adverse events
| Measure |
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
n=2002 participants at risk
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
|
|---|---|
|
General disorders
WEAK
|
0.05%
1/2002 • 5 years
|
|
Hepatobiliary disorders
ACUTE PANCREATITIS
|
0.05%
1/2002 • 5 years
|
|
Hepatobiliary disorders
CONSTRICTIVE PERICARDITIS
|
0.05%
1/2002 • 5 years
|
|
Hepatobiliary disorders
HEMORRHAGE OF LIVER
|
0.05%
1/2002 • 5 years
|
|
Hepatobiliary disorders
LIVER FAILURE
|
0.10%
2/2002 • 5 years
|
|
Injury, poisoning and procedural complications
NON-TARGET VESSEL PCI
|
0.05%
1/2002 • 5 years
|
|
Injury, poisoning and procedural complications
PCI POSTOPERATIVE UPPER GASTROINTESTINAL BLEEDING
|
0.05%
1/2002 • 5 years
|
|
Injury, poisoning and procedural complications
POSTOPERATIVE PCI
|
0.05%
1/2002 • 5 years
|
|
Injury, poisoning and procedural complications
REVASCULARIZATION
|
0.35%
7/2002 • 5 years
|
|
Injury, poisoning and procedural complications
REVASCULARIZATION OF LCX
|
0.05%
1/2002 • 5 years
|
|
Injury, poisoning and procedural complications
REVIEW AFTER PCI
|
0.05%
1/2002 • 5 years
|
|
Injury, poisoning and procedural complications
STENT THROMBOSIS
|
0.15%
3/2002 • 5 years
|
|
Injury, poisoning and procedural complications
STENT RESTENOSIS
|
0.05%
1/2002 • 5 years
|
|
Injury, poisoning and procedural complications
TOXIC MULTIPLE NEUROPATHY CAUSED BY DRUG
|
0.05%
1/2002 • 5 years
|
|
Investigations
CORONARY HEART DISEASE AND POST- PCI
|
0.15%
3/2002 • 5 years
|
|
Investigations
CORONARY HEART DISEASE REEXAMINATION
|
0.10%
2/2002 • 5 years
|
|
Investigations
CORONORY ANGIOGRAPHY(NOS)
|
0.05%
1/2002 • 5 years
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
0.15%
3/2002 • 5 years
|
|
Metabolism and nutrition disorders
DIABETIC KETOACIDOSIS CAUSE THE DEATH
|
0.05%
1/2002 • 5 years
|
|
Metabolism and nutrition disorders
HYPERGLYCEMIA
|
0.10%
2/2002 • 5 years
|
|
Metabolism and nutrition disorders
HYPERTHYREOSIS
|
0.05%
1/2002 • 5 years
|
|
Musculoskeletal and connective tissue disorders
GOUT
|
0.05%
1/2002 • 5 years
|
|
Musculoskeletal and connective tissue disorders
PATHOLOGICAL FRACTURE
|
0.05%
1/2002 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
0.05%
1/2002 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CANCER
|
0.10%
2/2002 • 5 years
|
|
Blood and lymphatic system disorders
ANEMIA
|
0.05%
1/2002 • 5 years
|
|
Blood and lymphatic system disorders
BLOOD DISEASE
|
0.05%
1/2002 • 5 years
|
|
Blood and lymphatic system disorders
MASSIVE ABDOMINAL HEMORRHAGE
|
0.05%
1/2002 • 5 years
|
|
Cardiac disorders
CHEST PAIN-CARDIAC
|
0.80%
16/2002 • 5 years
|
|
Cardiac disorders
CHEST PAIN AND CHEST TIGHTNESS (CHD)
|
0.20%
4/2002 • 5 years
|
|
Cardiac disorders
ACUTE CORONARY SYNDROME
|
0.35%
7/2002 • 5 years
|
|
Cardiac disorders
ACUTE HEART FAILURE
|
0.15%
3/2002 • 5 years
|
|
Cardiac disorders
ACUTE NON - ST SEGMENT ELEVATION MYOCARDIAL INFARCTION
|
0.30%
6/2002 • 5 years
|
|
Cardiac disorders
ACUTE ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION
|
0.05%
1/2002 • 5 years
|
|
Cardiac disorders
ANGINA PECTORIS
|
2.4%
49/2002 • 5 years
|
|
Cardiac disorders
UNSTABLE ANGINA PECTORIS
|
8.4%
169/2002 • 5 years
|
|
Cardiac disorders
CHEST TIGHTNESS-CARDIAC
|
0.45%
9/2002 • 5 years
|
|
Cardiac disorders
ARRHYTHMIA
|
0.50%
10/2002 • 5 years
|
|
Cardiac disorders
ARRHYTHMIA PERMANENT PACEMAKER IMPLANTATION
|
0.05%
1/2002 • 5 years
|
|
Cardiac disorders
ARRHYTHMIA, ATRIAL FIBRILLATION
|
0.05%
1/2002 • 5 years
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.65%
13/2002 • 5 years
|
|
Cardiac disorders
ATRIAL FLUTTER
|
0.10%
2/2002 • 5 years
|
|
Cardiac disorders
ATRIAL PREMATURE BEAT
|
0.05%
1/2002 • 5 years
|
|
Cardiac disorders
VENTRICULAR PREMATURE BEAT
|
0.15%
3/2002 • 5 years
|
|
Cardiac disorders
CORONARY HEART DISEASE
|
11.8%
236/2002 • 5 years
|
|
Cardiac disorders
CARDIAC ARREST
|
0.05%
1/2002 • 5 years
|
|
Cardiac disorders
CARDIAC DYSFUNCTION
|
0.05%
1/2002 • 5 years
|
|
Cardiac disorders
CARDIAC ENLARGEMENT
|
0.05%
1/2002 • 5 years
|
|
Cardiac disorders
CARDIAC INSUFFICIENCY
|
0.05%
1/2002 • 5 years
|
|
Cardiac disorders
CARDIAC RESPIRATORY ARREST
|
0.05%
1/2002 • 5 years
|
|
Cardiac disorders
CARDIAC TAMPONADE
|
0.05%
1/2002 • 5 years
|
|
Cardiac disorders
CHRONIC CORONARY INSUFFICIENCY
|
0.05%
1/2002 • 5 years
|
|
Cardiac disorders
HEART FAILURE
|
1.2%
24/2002 • 5 years
|
|
Cardiac disorders
CONGENITAL ATRIAL SEPTAL DEFECT
|
0.05%
1/2002 • 5 years
|
|
Cardiac disorders
CORONARY ATHEROSCLEROTIC CARDIOPATHY
|
0.65%
13/2002 • 5 years
|
|
Cardiac disorders
CORONARY HEART DISEASE DEATH
|
0.10%
2/2002 • 5 years
|
|
Cardiac disorders
EXTRASYSTOLE
|
0.05%
1/2002 • 5 years
|
|
Cardiac disorders
HEART PALPITATIONS
|
0.05%
1/2002 • 5 years
|
|
Cardiac disorders
HYDROPERICARDIUM
|
0.10%
2/2002 • 5 years
|
|
Cardiac disorders
ISCHEMIC CARDIOMYOPATHY
|
0.15%
3/2002 • 5 years
|
|
Cardiac disorders
LETHAL MYOCARDIAL INFARCTION
|
0.10%
2/2002 • 5 years
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
3.3%
66/2002 • 5 years
|
|
Cardiac disorders
OLD MYOCARDIAL INFARCTION
|
0.35%
7/2002 • 5 years
|
|
Cardiac disorders
MYOCARDIAL BRIDGE
|
0.05%
1/2002 • 5 years
|
|
Cardiac disorders
NON-TARGET VESSEL REVASCULARIZATION
|
0.25%
5/2002 • 5 years
|
|
Cardiac disorders
PRECORDIAL DISTRESS
|
0.10%
2/2002 • 5 years
|
|
Cardiac disorders
SICK SINUS SYNDROME
|
0.05%
1/2002 • 5 years
|
|
Cardiac disorders
TACHYCARDIA-BRADYCARDIA SYNDROME
|
0.05%
1/2002 • 5 years
|
|
Cardiac disorders
TARGET LESION REVASCULARIZATION
|
0.05%
1/2002 • 5 years
|
|
Cardiac disorders
TRANSIENT ISCHEMIC ATTACK
|
0.05%
1/2002 • 5 years
|
|
Cardiac disorders
TVR or TLR
|
1.0%
21/2002 • 5 years
|
|
Cardiac disorders
VENTRICULAR FIBRILLATION
|
0.10%
2/2002 • 5 years
|
|
Cardiac disorders
CHRONIC HEART FAILURE
|
0.05%
1/2002 • 5 years
|
|
Eye disorders
BINOCULAR CATARACT
|
0.05%
1/2002 • 5 years
|
|
Eye disorders
LEFT EYE SENILE CATARACT
|
0.05%
1/2002 • 5 years
|
|
Eye disorders
RIGHT EYE CATARACT
|
0.05%
1/2002 • 5 years
|
|
Eye disorders
TRACTIONAL RETINAL DETACHMENT
|
0.05%
1/2002 • 5 years
|
|
Eye disorders
RIGHT EYE SENILE CATARACT (MATURE PERIOD)
|
0.05%
1/2002 • 5 years
|
|
Gastrointestinal disorders
UPPER GASTROINTESTINAL HEMORRHAGE
|
0.40%
8/2002 • 5 years
|
|
Gastrointestinal disorders
GASTROINTESTINAL HEMORRHAGE
|
0.95%
19/2002 • 5 years
|
|
Gastrointestinal disorders
BLACK STOOL
|
0.05%
1/2002 • 5 years
|
|
Gastrointestinal disorders
CHRONIC GASTRITIS
|
0.10%
2/2002 • 5 years
|
|
Gastrointestinal disorders
CHRONIC NON-ATROPHIC GASTRITIS WITH BILE REFLUX
|
0.05%
1/2002 • 5 years
|
|
Gastrointestinal disorders
CHRONIC NON-ATROPHIC GASTRITIS WITH EROSION
|
0.05%
1/2002 • 5 years
|
|
Gastrointestinal disorders
GASTRIC ULCER
|
0.05%
1/2002 • 5 years
|
|
Gastrointestinal disorders
GASTRIC ULCER WITH BLEEDING
|
0.15%
3/2002 • 5 years
|
|
Gastrointestinal disorders
LEFT INGUINAL HERNIA
|
0.05%
1/2002 • 5 years
|
|
General disorders
CHEST PAIN
|
2.9%
58/2002 • 5 years
|
|
General disorders
CHEST PAIN AND CHEST TIGHTNESS
|
0.40%
8/2002 • 5 years
|
|
General disorders
CHEST TIGHTNESS
|
3.1%
63/2002 • 5 years
|
|
General disorders
BREASTBONE HIND TIGHTENING FEELING
|
0.05%
1/2002 • 5 years
|
|
General disorders
CHEST BLEEDING
|
0.05%
1/2002 • 5 years
|
|
General disorders
CHEST DISCOMFORT
|
0.15%
3/2002 • 5 years
|
|
General disorders
CHEST DISTRESS
|
0.35%
7/2002 • 5 years
|
|
General disorders
CHEST HEART PALPITATIONS
|
0.05%
1/2002 • 5 years
|
|
General disorders
DEATH
|
2.1%
42/2002 • 5 years
|
|
General disorders
DISCOMFORT IN THE ANTERIOR REGION OF THE HEART
|
0.05%
1/2002 • 5 years
|
|
General disorders
DIZZY
|
0.20%
4/2002 • 5 years
|
|
General disorders
EDEMA
|
0.05%
1/2002 • 5 years
|
|
General disorders
INTERMITTENT CHEST DISCOMFORT
|
0.05%
1/2002 • 5 years
|
|
General disorders
SYNCOPE
|
0.25%
5/2002 • 5 years
|
|
General disorders
MULTI-ORGAN FAILURE
|
0.05%
1/2002 • 5 years
|
|
General disorders
NECK DISCOMFORT
|
0.05%
1/2002 • 5 years
|
|
General disorders
PALPITATION
|
0.45%
9/2002 • 5 years
|
|
General disorders
THE AREA BEFORE THE HEART PALPITATIONS, SHORTNESS
|
0.05%
1/2002 • 5 years
|
|
General disorders
THE AREA BEFORE THE HEART TIGHTNESS
|
0.05%
1/2002 • 5 years
|
|
General disorders
THE LIMBS SWELLING
|
0.05%
1/2002 • 5 years
|
|
General disorders
TO TREAT OTHER VASCULAR LESIONS
|
0.05%
1/2002 • 5 years
|
|
General disorders
VERTIGO SYNDROME
|
0.05%
1/2002 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CANCER OF THE STOMACH
|
0.05%
1/2002 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CANCER METASTASIS
|
0.05%
1/2002 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
COLORECTAL CANCER
|
0.10%
2/2002 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
DESCENDING COLON TUMOR
|
0.05%
1/2002 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ESOPHAGEAL MALIGNANT TUMOR
|
0.05%
1/2002 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LIVER CANCER
|
0.05%
1/2002 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LIVER CYST
|
0.05%
1/2002 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG CANCER
|
0.05%
1/2002 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LYMPHOMA
|
0.05%
1/2002 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATIC HYPERPLASIA
|
0.05%
1/2002 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PULMONARY HEMANGIOMA
|
0.05%
1/2002 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SACRAL TUMOR
|
0.05%
1/2002 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SMALL CELL LUNG CANCER
|
0.05%
1/2002 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
STOMACH CANCER
|
0.05%
1/2002 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BILATERAL OVARIAN CYSTS
|
0.05%
1/2002 • 5 years
|
|
Nervous system disorders
ACUTE BRAINSTEM INFARCTION
|
0.05%
1/2002 • 5 years
|
|
Nervous system disorders
ANGIONEUROEDEMA
|
0.05%
1/2002 • 5 years
|
|
Nervous system disorders
CEREBRAL INSUFFICIENCY
|
0.05%
1/2002 • 5 years
|
|
Nervous system disorders
CERVICAL HEADACHE
|
0.05%
1/2002 • 5 years
|
|
Nervous system disorders
DEATH(CEREBRAL INFARCTION AND CEREBRAL HERNIA)
|
0.05%
1/2002 • 5 years
|
|
Nervous system disorders
GUILLAIN-BARRE SYNDROME
|
0.05%
1/2002 • 5 years
|
|
Nervous system disorders
ISCHEMIC CEREBROVASCULAR DISEASE
|
0.05%
1/2002 • 5 years
|
|
Nervous system disorders
LACUNAR INFARCTION
|
0.10%
2/2002 • 5 years
|
|
Nervous system disorders
LEFT TEMPORAL LOBE BRAIN CONTUSION
|
0.05%
1/2002 • 5 years
|
|
Nervous system disorders
LUMBAR SPINAL STENOSIS
|
0.05%
1/2002 • 5 years
|
|
Nervous system disorders
STROKE
|
0.05%
1/2002 • 5 years
|
|
Nervous system disorders
SUBARACHNOID HEMORRHAGE
|
0.05%
1/2002 • 5 years
|
|
Renal and urinary disorders
BILATERAL URETERAL CALCULI
|
0.10%
2/2002 • 5 years
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.10%
2/2002 • 5 years
|
|
Renal and urinary disorders
RIGHT HYDRONEPHROSIS WITH URETERAL STRICTURE
|
0.05%
1/2002 • 5 years
|
|
Reproductive system and breast disorders
ENDOMETRIAL LESIONS
|
0.05%
1/2002 • 5 years
|
|
Reproductive system and breast disorders
OOPHORITIC CYST
|
0.05%
1/2002 • 5 years
|
|
Reproductive system and breast disorders
VAGINAL BLEEDING
|
0.05%
1/2002 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHIAL ASTHMA
|
0.10%
2/2002 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
SHORTNESS OF BREATH
|
0.25%
5/2002 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
ANHELATION
|
0.10%
2/2002 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
CHEST TIGHTNESS AND SHORTNESS OF BREATH
|
0.10%
2/2002 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
COPD
|
0.05%
1/2002 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
LEFT PLEURAL EFFUSION
|
0.05%
1/2002 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
LUNG INFECTION
|
0.10%
2/2002 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
MAXILLARY SINUSITIS
|
0.05%
1/2002 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
MIXED LUNG VENTILATION DYSFUNCTION
|
0.05%
1/2002 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA
|
0.25%
5/2002 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY FIBROSIS
|
0.05%
1/2002 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY INFECTION
|
0.15%
3/2002 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY MULTILOBE PNEUMONIA
|
0.05%
1/2002 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.05%
1/2002 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
SEVERE PNEUMONIA AND RESPIRATORY FAILURE
|
0.05%
1/2002 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
TYPE I RESPIRATORY FAILURE
|
0.05%
1/2002 • 5 years
|
|
Skin and subcutaneous tissue disorders
LACERATION OF SCALP SOFT TISSUE
|
0.05%
1/2002 • 5 years
|
|
Vascular disorders
ABDOMINAL ANEURYSM
|
0.05%
1/2002 • 5 years
|
|
Vascular disorders
ABNORMAL VESSELS IN CORONARY ARTERIES
|
0.05%
1/2002 • 5 years
|
|
Vascular disorders
ARTERIOSCLEROSIS OBLITERANS OF LOWER EXTREMITY
|
0.05%
1/2002 • 5 years
|
|
Vascular disorders
ATHEROSCLEROSIS
|
0.05%
1/2002 • 5 years
|
|
Vascular disorders
CAROTID ARTERY OCCLUSION
|
0.05%
1/2002 • 5 years
|
|
Vascular disorders
CEREBRAL HEMORRHAGE
|
0.35%
7/2002 • 5 years
|
|
Vascular disorders
CEREBRAL INFARCTION
|
0.60%
12/2002 • 5 years
|
|
Vascular disorders
HYPERTENSION
|
0.35%
7/2002 • 5 years
|
|
Vascular disorders
INSUFFICIENT BLOOD SUPPLY TO THE CEREBRAL ARTERY
|
0.05%
1/2002 • 5 years
|
|
Vascular disorders
POSTERIOR CIRCULATION ISCHEMIA
|
0.25%
5/2002 • 5 years
|
|
Vascular disorders
PULMONARY EMBOLISM
|
0.05%
1/2002 • 5 years
|
|
Vascular disorders
SEQUELAE OF CEREBRAL INFARCTION
|
0.10%
2/2002 • 5 years
|
|
Vascular disorders
VASCULAR STENOSIS
|
0.05%
1/2002 • 5 years
|
|
Vascular disorders
VENTRICULAR ANEURYSM
|
0.10%
2/2002 • 5 years
|
Other adverse events
| Measure |
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
n=2002 participants at risk
XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS): Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
|
|---|---|
|
Blood and lymphatic system disorders
HEMORRHOIDAL BLEEDING
|
0.10%
2/2002 • 5 years
|
|
Cardiac disorders
ANGINA PECTORIS
|
0.50%
10/2002 • 5 years
|
|
Cardiac disorders
AURICULAR FIBRILLATION
|
0.05%
1/2002 • 5 years
|
|
Cardiac disorders
CHEST PAIN - CARDIAC
|
0.05%
1/2002 • 5 years
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.15%
3/2002 • 5 years
|
|
Cardiac disorders
HEART FAILURE
|
0.10%
2/2002 • 5 years
|
|
Cardiac disorders
MI
|
0.10%
2/2002 • 5 years
|
|
Cardiac disorders
PREMATURE BEAT
|
0.10%
2/2002 • 5 years
|
|
Cardiac disorders
REPERFUSION ARRHYTHMIA
|
0.10%
2/2002 • 5 years
|
|
Cardiac disorders
RESTING ANGINA
|
0.05%
1/2002 • 5 years
|
|
Cardiac disorders
UNSTABLE ANGINA
|
0.50%
10/2002 • 5 years
|
|
Eye disorders
BLEEDING IN EYES
|
0.15%
3/2002 • 5 years
|
|
Gastrointestinal disorders
DEFECATE HAEMORRHAGE
|
0.10%
2/2002 • 5 years
|
|
Gastrointestinal disorders
GASTRIC COLIC
|
0.05%
1/2002 • 5 years
|
|
Gastrointestinal disorders
GASTROINTESTINAL BLEEDING
|
0.40%
8/2002 • 5 years
|
|
Gastrointestinal disorders
UPSET STOMACH
|
0.10%
2/2002 • 5 years
|
|
General disorders
BLEEDING
|
0.05%
1/2002 • 5 years
|
|
General disorders
BLEEDING GUMS
|
0.30%
6/2002 • 5 years
|
|
General disorders
CHEST PAIN
|
0.25%
5/2002 • 5 years
|
|
General disorders
CHEST TIGHTEN AND CARDIOPALMUS
|
0.05%
1/2002 • 5 years
|
|
General disorders
CHEST TIGHTNESS
|
0.20%
4/2002 • 5 years
|
|
General disorders
DIZZY
|
0.05%
1/2002 • 5 years
|
|
General disorders
FEEL SUFFOCATED
|
0.05%
1/2002 • 5 years
|
|
General disorders
HEMORRHAGIC SPOT
|
0.05%
1/2002 • 5 years
|
|
General disorders
PALPITATION
|
0.15%
3/2002 • 5 years
|
|
General disorders
SHORT OF BREATH
|
0.05%
1/2002 • 5 years
|
|
General disorders
STOMACHACHE
|
0.05%
1/2002 • 5 years
|
|
General disorders
SYNCOPE
|
0.05%
1/2002 • 5 years
|
|
General disorders
TOOTHACHE
|
0.05%
1/2002 • 5 years
|
|
General disorders
|
0.05%
1/2002 • 5 years
|
|
Injury, poisoning and procedural complications
OM1 SEGMENT OCCLUDED
|
0.05%
1/2002 • 5 years
|
|
Investigations
CNI IS HIGHER THAN NORMAL VALUE
|
0.05%
1/2002 • 5 years
|
|
Investigations
ELEVATED TROPOLIN T
|
0.15%
3/2002 • 5 years
|
|
Investigations
ELEVATED TROPONIN I
|
0.30%
6/2002 • 5 years
|
|
Nervous system disorders
LACUNAR INFARCTION
|
0.05%
1/2002 • 5 years
|
|
Nervous system disorders
VAGAL REFLEX
|
0.05%
1/2002 • 5 years
|
|
Nervous system disorders
VERTEBRAL STENOSIS
|
0.05%
1/2002 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
NOSE BLEEDING
|
0.10%
2/2002 • 5 years
|
|
Skin and subcutaneous tissue disorders
SUBCUTANEOUS HEMORRHAGE
|
0.25%
5/2002 • 5 years
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
0.05%
1/2002 • 5 years
|
|
Skin and subcutaneous tissue disorders
SKIN ALLERGY
|
0.05%
1/2002 • 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place