Trial Outcomes & Findings for SPIRIT V: A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Coronary Artery Lesions (Diabetic Sub-Study) (NCT NCT01171820)
NCT ID: NCT01171820
Last Updated: 2016-06-27
Results Overview
In-stent minimal lumen diameter (MLD) post-procedure minus (-) in-stent MLD at follow-up
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
324 participants
Primary outcome timeframe
270 days
Results posted on
2016-06-27
Participant Flow
324 subjects were recruited at 32 sites. Eligible subjects invited to participate, in-hospital or in-clinic and required to provide signed informed consent prior to enrollment. Final eligibility based on angiographic inclusion criteria prior to the intended procedure. Dates of recruitment: April 28, 2007 to October 6, 2008.
Subjects were randomized via telephone randomization and stratified by insulin treatment status, number of lesions treated-single vs. multiple. Randomization only occurred after verification of the inclusion/exclusion criteria and successful pre-dilatation. See the Eligibility Criteria (inclusion/exclusion criteria) for details.
Participant milestones
| Measure |
TAXUS® Liberté™
Patients receiving the TAXUS® Liberté™ stent during PCI
|
XIENCE V® EECSS
Patients receiving the XIENCE V® EECSS stent during percutaneous coronary intervention (PCI)
|
|---|---|---|
|
Overall Study
STARTED
|
106
|
218
|
|
Overall Study
COMPLETED
|
100
|
212
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
Reasons for withdrawal
| Measure |
TAXUS® Liberté™
Patients receiving the TAXUS® Liberté™ stent during PCI
|
XIENCE V® EECSS
Patients receiving the XIENCE V® EECSS stent during percutaneous coronary intervention (PCI)
|
|---|---|---|
|
Overall Study
Death
|
3
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
1-Year Missed Visit
|
1
|
1
|
Baseline Characteristics
SPIRIT V: A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Coronary Artery Lesions (Diabetic Sub-Study)
Baseline characteristics by cohort
| Measure |
TAXUS® Liberté™
n=106 Participants
Patients receiving the TAXUS® Liberté™ stent during PCI
|
XIENCE V® EECSS
n=218 Participants
Patients receiving the XIENCE V® EECSS stent during PCI
|
Total
n=324 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
49 Participants
n=93 Participants
|
102 Participants
n=4 Participants
|
151 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
57 Participants
n=93 Participants
|
116 Participants
n=4 Participants
|
173 Participants
n=27 Participants
|
|
Age, Continuous
|
65.75 years
STANDARD_DEVIATION 8.95 • n=93 Participants
|
65.32 years
STANDARD_DEVIATION 9.61 • n=4 Participants
|
65.46 years
STANDARD_DEVIATION 9.39 • n=27 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=93 Participants
|
66 Participants
n=4 Participants
|
101 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
71 Participants
n=93 Participants
|
152 Participants
n=4 Participants
|
223 Participants
n=27 Participants
|
|
Region of Enrollment
France
|
2 participants
n=93 Participants
|
7 participants
n=4 Participants
|
9 participants
n=27 Participants
|
|
Region of Enrollment
Thailand
|
0 participants
n=93 Participants
|
2 participants
n=4 Participants
|
2 participants
n=27 Participants
|
|
Region of Enrollment
Spain
|
57 participants
n=93 Participants
|
87 participants
n=4 Participants
|
144 participants
n=27 Participants
|
|
Region of Enrollment
Poland
|
8 participants
n=93 Participants
|
17 participants
n=4 Participants
|
25 participants
n=27 Participants
|
|
Region of Enrollment
Malaysia
|
1 participants
n=93 Participants
|
13 participants
n=4 Participants
|
14 participants
n=27 Participants
|
|
Region of Enrollment
Austria
|
2 participants
n=93 Participants
|
8 participants
n=4 Participants
|
10 participants
n=27 Participants
|
|
Region of Enrollment
Israel
|
1 participants
n=93 Participants
|
1 participants
n=4 Participants
|
2 participants
n=27 Participants
|
|
Region of Enrollment
Netherlands
|
1 participants
n=93 Participants
|
12 participants
n=4 Participants
|
13 participants
n=27 Participants
|
|
Region of Enrollment
Germany
|
14 participants
n=93 Participants
|
22 participants
n=4 Participants
|
36 participants
n=27 Participants
|
|
Region of Enrollment
United Kingdom
|
3 participants
n=93 Participants
|
6 participants
n=4 Participants
|
9 participants
n=27 Participants
|
|
Region of Enrollment
Italy
|
17 participants
n=93 Participants
|
43 participants
n=4 Participants
|
60 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 270 daysPopulation: Analysis based on intention to treat (ITT) population. Patients were required to have angiographic follow-up to provide this endpoint information. Some patients not completing the study, did not have this follow up.
In-stent minimal lumen diameter (MLD) post-procedure minus (-) in-stent MLD at follow-up
Outcome measures
| Measure |
TAXUS® Liberté™
n=110 lesions
Patients receiving the TAXUS® Liberté™ stent during PCI
|
XIENCE V® EECSS
n=249 lesions
Patients receiving the XIENCE V® EECSS stent during PCI
|
|---|---|---|
|
In-stent Late Loss (LL)
|
0.39 millimeters
Standard Deviation 0.49
|
0.19 millimeters
Standard Deviation 0.37
|
SECONDARY outcome
Timeframe: immediately post-procedurePopulation: Analysis based on intention to treat (ITT) population.
Successful delivery and deployment of the study stent (in overlapping stent setting a successful delivery and deployment of the first and second study stent) at the intended target lesion and successful withdrawal of the stent delivery system with attainment of final residual stenosis of less than 50% of the target lesion by quantitative coronary angiography (QCA) (by visual estimation if QCA unavailable), without use of a device outside the assigned treatment strategy.
Outcome measures
| Measure |
TAXUS® Liberté™
n=133 Lesions
Patients receiving the TAXUS® Liberté™ stent during PCI
|
XIENCE V® EECSS
n=289 Lesions
Patients receiving the XIENCE V® EECSS stent during PCI
|
|---|---|---|
|
Clinical Device Success (Per-lesion)
|
98.50 Percentage of lesions
Interval 94.67 to 99.82
|
97.58 Percentage of lesions
Interval 95.07 to 99.02
|
SECONDARY outcome
Timeframe: immediately post-procedurePopulation: The sample size for clinical procedure success is based on the number of evaluable patients, for whom data is available to define clinical procedure success.
Successful delivery and deployment of the study stent or stents at the intended target lesion and successful withdrawal of the stent delivery system with attainment of final residual stenosis of less than 50% of the target lesion by quantitative coronary angiography (QCA) (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of cardiac death, MI attributed to the target vessel and/or CI-TLR during the hospital stay with a maximum of first seven days post index procedure. In multiple lesion setting each lesion must meet clinical procedure success.
Outcome measures
| Measure |
TAXUS® Liberté™
n=102 Participants
Patients receiving the TAXUS® Liberté™ stent during PCI
|
XIENCE V® EECSS
n=212 Participants
Patients receiving the XIENCE V® EECSS stent during PCI
|
|---|---|---|
|
Clinical Procedure Success (Per-patient)
|
93.14 Percentage of participants
Interval 86.37 to 97.2
|
96.70 Percentage of participants
Interval 93.32 to 98.66
|
SECONDARY outcome
Timeframe: 270 daysPopulation: Analysis based on intention to treat (ITT) population. Patients were required to have angiographic follow-up to provide this endpoint information. Some patients not completing the study, did not have this follow up. The number of analyzed represents number of patients randomized.
In-segment minimal lumen diameter (MLD) post-procedure minus (-) in segment MLD at follow-up
Outcome measures
| Measure |
TAXUS® Liberté™
n=109 lesions
Patients receiving the TAXUS® Liberté™ stent during PCI
|
XIENCE V® EECSS
n=249 lesions
Patients receiving the XIENCE V® EECSS stent during PCI
|
|---|---|---|
|
In-segment Late Loss
|
0.22 millimeters
Standard Deviation 0.45
|
0.12 millimeters
Standard Deviation 0.42
|
SECONDARY outcome
Timeframe: 270 dayPopulation: Analysis based on intention to treat (ITT) population. Patients were required to have angiographic follow-up to provide this endpoint information. Some patients not completing the study, did not have this follow up. The number of analyzed represents number of patients randomized.
Proximal Minimum Lumen Diameter (MLD) post-procedure minus proximal MLD at follow-up
Outcome measures
| Measure |
TAXUS® Liberté™
n=106 Participants
Patients receiving the TAXUS® Liberté™ stent during PCI
|
XIENCE V® EECSS
n=241 lesions
Patients receiving the XIENCE V® EECSS stent during PCI
|
|---|---|---|
|
Proximal Late Loss
|
0.17 millimeters
Standard Deviation 0.33
|
0.13 millimeters
Standard Deviation 0.39
|
SECONDARY outcome
Timeframe: 270 daysPopulation: Analysis based on intention to treat (ITT) population. Patients were required to have angiographic follow-up to provide this endpoint information. Some patients not completing the study, did not have this follow up. The number of analyzed represents number of patients randomized.
Distal Minimum Lumen Diameter (MLD) post-procedure minus distal MLD at follow-up
Outcome measures
| Measure |
TAXUS® Liberté™
n=107 lesions
Patients receiving the TAXUS® Liberté™ stent during PCI
|
XIENCE V® EECSS
n=247 lesions
Patients receiving the XIENCE V® EECSS stent during PCI
|
|---|---|---|
|
Distal Late Loss
|
0.0 millimeters
Standard Deviation 0.34
|
0.0 millimeters
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: 270 daysPopulation: Analysis based on intention to treat (ITT) population. Patients were required to have angiographic follow-up to provide this endpoint information. Some patients not completing the study, did not have this follow up. The number of analyzed represents number of patients randomized.
Percent of patients with a follow-up percent diameter stenosis of ≥ 50% per QCA.
Outcome measures
| Measure |
TAXUS® Liberté™
n=115 lesions
Patients receiving the TAXUS® Liberté™ stent during PCI
|
XIENCE V® EECSS
n=261 lesions
Patients receiving the XIENCE V® EECSS stent during PCI
|
|---|---|---|
|
In-stent Angiographic Binary Restenosis Rate
|
6.1 Percentage of participants
Interval 2.48 to 12.14
|
3.1 Percentage of participants
Interval 1.33 to 5.95
|
SECONDARY outcome
Timeframe: 270 daysPopulation: Analysis based on intention to treat (ITT) population. Patients were required to have angiographic follow-up to provide this endpoint information. Some patients not completing the study, did not have this follow up. The number of analyzed represents number of patients randomized.
Percent of patients with a follow-up percent diameter stenosis of ≥ 50% per QCA.
Outcome measures
| Measure |
TAXUS® Liberté™
n=110 lesions
Patients receiving the TAXUS® Liberté™ stent during PCI
|
XIENCE V® EECSS
n=255 lesions
Patients receiving the XIENCE V® EECSS stent during PCI
|
|---|---|---|
|
In-segment Angiographic Binary Restenosis Rate
|
6.4 Percentage of participants
Interval 2.6 to 12.67
|
7.5 Percentage of participants
Interval 4.55 to 11.39
|
SECONDARY outcome
Timeframe: 270 daysPopulation: Analysis based on intention to treat (ITT) population. Patients were required to have angiographic follow-up to provide this endpoint information. Some patients not completing the study, did not have this follow up. The number of analyzed represents number of patients randomized.
This number represents the average of percent diameter stenosis found on examination of all the lesions analyzed. This value calculated as 100 \* (1 - minimum lumen diameter/reference vessel diameter) (MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.
Outcome measures
| Measure |
TAXUS® Liberté™
n=115 lesions
Patients receiving the TAXUS® Liberté™ stent during PCI
|
XIENCE V® EECSS
n=261 lesions
Patients receiving the XIENCE V® EECSS stent during PCI
|
|---|---|---|
|
In-stent Percent Diameter Stenosis (% DS)
|
20.70 Percent diameter stenosis
Standard Deviation 16.02
|
14.33 Percent diameter stenosis
Standard Deviation 13.34
|
SECONDARY outcome
Timeframe: 270 daysPopulation: Analysis based on intention to treat (ITT) population. Patients were required to have angiographic follow-up to provide this endpoint information. Some patients not completing the study, did not have this follow up. The number of analyzed represents number of patients randomized.
This number represents the average of percent diameter stenosis found on examination of all the lesions analyzed. This value calculated as 100 \* (1 - MLD/RVD) using the mean values from two orthogonal views (when possible) by QCA.
Outcome measures
| Measure |
TAXUS® Liberté™
n=110 lesions
Patients receiving the TAXUS® Liberté™ stent during PCI
|
XIENCE V® EECSS
n=255 lesions
Patients receiving the XIENCE V® EECSS stent during PCI
|
|---|---|---|
|
In-segment Percent Diameter Stenosis (% DS)
|
23.87 Percent diameter stenosis
Standard Deviation 15.25
|
22.42 Percent diameter stenosis
Standard Deviation 15.05
|
SECONDARY outcome
Timeframe: 0 to 37 daysPopulation: Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.
The Clinical Event Committee will adjudicate the events according to the definitions developed by the Academic Research Consortium (ARC), as published in Circulation (Cutlip, D.E., et al., Clinical End Points in Coronary Stent Trials: A Case for Standardized Definitions. Circulation, 2007. 115: p. 2344-2351.) Stent thrombosis was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of stent thrombosis; probable: unexplained death ≤30 days or any MI that is related to acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis; and possible: unexplained death \>30 days after stent placement.
Outcome measures
| Measure |
TAXUS® Liberté™
n=106 Participants
Patients receiving the TAXUS® Liberté™ stent during PCI
|
XIENCE V® EECSS
n=218 Participants
Patients receiving the XIENCE V® EECSS stent during PCI
|
|---|---|---|
|
Adjudicated Stent Thrombosis (Confirmed/Definite, Probable, Possible)
|
0.94 Percentage of participants
Interval 0.02 to 5.14
|
0.00 Percentage of participants
Interval 0.0 to 1.68
|
SECONDARY outcome
Timeframe: 254 daysPopulation: Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.
The Clinical Event Committee will adjudicate the events according to the definitions developed by the Academic Research Consortium (ARC), as published in Circulation (Cutlip, D.E., et al., Clinical End Points in Coronary Stent Trials: A Case for Standardized Definitions. Circulation, 2007. 115: p. 2344-2351.) Stent thrombosis was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of stent thrombosis; probable: unexplained death ≤30 days or any MI that is related to acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis; and possible: unexplained death \>30 days after stent placement.
Outcome measures
| Measure |
TAXUS® Liberté™
n=106 Participants
Patients receiving the TAXUS® Liberté™ stent during PCI
|
XIENCE V® EECSS
n=217 Participants
Patients receiving the XIENCE V® EECSS stent during PCI
|
|---|---|---|
|
Adjudicated Stent Thrombosis (Confirmed/Definite, Probable, Possible)
|
2.83 Percentage of participants
Interval 0.59 to 8.05
|
0.46 Percentage of participants
Interval 0.01 to 2.54
|
SECONDARY outcome
Timeframe: 365 daysPopulation: Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.
The Clinical Event Committee will adjudicate the events according to the definitions developed by the Academic Research Consortium (ARC), as published in Circulation (Cutlip, D.E., et al., Clinical End Points in Coronary Stent Trials: A Case for Standardized Definitions. Circulation, 2007. 115: p. 2344-2351.) Stent thrombosis was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of stent thrombosis; probable: unexplained death ≤30 days or any MI that is related to acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis; and possible: unexplained death \>30 days after stent placement.
Outcome measures
| Measure |
TAXUS® Liberté™
n=104 Participants
Patients receiving the TAXUS® Liberté™ stent during PCI
|
XIENCE V® EECSS
n=215 Participants
Patients receiving the XIENCE V® EECSS stent during PCI
|
|---|---|---|
|
Adjudicated Stent Thrombosis (Confirmed/Definite, Probable, Possible)
|
2.88 Percentage of participants
Interval 0.6 to 8.2
|
0.47 Percentage of participants
Interval 0.01 to 2.56
|
SECONDARY outcome
Timeframe: 37 daysPopulation: Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion was defined as the treated segment from 5 mm proximal and 5 mm distal to the stent. TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel was defined as the entire major coronary vessel proximal and distal to the target lesion, including upstream and downstream branches and the target lesion itself. A revascularization is considered clinically indicated if angiography at follow-up shows a %DS ≥ 50% and if one of the following occurs: history of recurrent angina pectoris due to the target vessel; signs of ischemia at rest or during exercise test due to target vessel; abnormal results of any invasive diagnostic test; TLR or TVR with a % DS ≥ 70% even in the absence of the above mentioned ischemic signs.
Outcome measures
| Measure |
TAXUS® Liberté™
n=106 Participants
Patients receiving the TAXUS® Liberté™ stent during PCI
|
XIENCE V® EECSS
n=218 Participants
Patients receiving the XIENCE V® EECSS stent during PCI
|
|---|---|---|
|
Adjudicated Revascularizations (Target Lesion Revascularization (TLR)/ Target Vessel Revascularization (TVR)/Any Revascularization) Both Clinically-indicated and Not Clinically-indicated.
|
2.83 Percentage of participants
Interval 0.59 to 8.05
|
1.38 Percentage of participants
Interval 0.28 to 3.97
|
SECONDARY outcome
Timeframe: 254 daysPopulation: Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion was defined as the treated segment from 5 mm proximal and 5 mm distal to the stent. TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel was defined as the entire major coronary vessel proximal and distal to the target lesion, including upstream and downstream branches and the target lesion itself. A revascularization is considered clinically indicated if angiography at follow-up shows a %DS ≥ 50% and if one of the following occurs: history of recurrent angina pectoris due to the target vessel; signs of ischemia at rest or during exercise test due to target vessel; abnormal results of any invasive diagnostic test; TLR or TVR with a % DS ≥ 70% even in the absence of the above mentioned ischemic signs.
Outcome measures
| Measure |
TAXUS® Liberté™
n=106 Participants
Patients receiving the TAXUS® Liberté™ stent during PCI
|
XIENCE V® EECSS
n=217 Participants
Patients receiving the XIENCE V® EECSS stent during PCI
|
|---|---|---|
|
Adjudicated Revascularizations (Target Lesion Revascularization (TLR)/ Target Vessel Revascularization (TVR)/Any Revascularization) Both Clinically-indicated and Not Clinically-indicated.
|
4.72 Percentage of participants
Interval 1.55 to 10.67
|
6.45 Percentage of participants
Interval 3.57 to 10.59
|
SECONDARY outcome
Timeframe: 393 daysPopulation: Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. The target lesion was defined as the treated segment from 5 mm proximal and 5 mm distal to the stent. TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel was defined as the entire major coronary vessel proximal and distal to the target lesion, including upstream and downstream branches and the target lesion itself. A revascularization is considered clinically indicated if angiography at follow-up shows a %DS ≥ 50% and if one of the following occurs: history of recurrent angina pectoris due to the target vessel; signs of ischemia at rest or during exercise test due to target vessel; abnormal results of any invasive diagnostic test; TLR or TVR with a % DS ≥ 70% even in the absence of the above mentioned ischemic signs.
Outcome measures
| Measure |
TAXUS® Liberté™
n=104 Participants
Patients receiving the TAXUS® Liberté™ stent during PCI
|
XIENCE V® EECSS
n=215 Participants
Patients receiving the XIENCE V® EECSS stent during PCI
|
|---|---|---|
|
Adjudicated Revascularizations (Target Lesion Revascularization (TLR)/ Target Vessel Revascularization (TVR)/Any Revascularization) Both Clinically-indicated and Not Clinically-indicated.
|
14.42 Percentage of participants
Interval 8.3 to 22.67
|
20.93 Percentage of participants
Interval 15.7 to 26.99
|
SECONDARY outcome
Timeframe: 37 daysPopulation: Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.
Cardiac death: Any death due to proximate cardiac cause (eg, myocardial infarction, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, and all procedure related deaths, including those related to concomitant treatment, will be classified as cardiac death. MI- due to target vessel: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel. Clinical-indicated Target Lesion Revascularization (CI-TLR): TLR with evidence of diameter stenosis ≥ 50% determined by QCA; or in the case of any one of the following: new recurrent history of angina pectoris, ischemic signs, abnormal results in diagnostic tests, or TLR \>=70% in the absence of the above signs.
Outcome measures
| Measure |
TAXUS® Liberté™
n=106 Participants
Patients receiving the TAXUS® Liberté™ stent during PCI
|
XIENCE V® EECSS
n=218 Participants
Patients receiving the XIENCE V® EECSS stent during PCI
|
|---|---|---|
|
Adjudicated Composite Endpoint of Cardiac Death, Myocardial Infarction (MI) Attributed to the Target Vessel and Clinical-indicated Target Lesion Revascularization (CI-TLR)
|
7.55 Percentage of participants
Interval 3.31 to 14.33
|
2.29 Percentage of participants
Interval 0.75 to 5.27
|
SECONDARY outcome
Timeframe: 254 daysPopulation: Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.
Cardiac death: Any death due to proximate cardiac cause (eg, myocardial infarction, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, and all procedure related deaths, including those related to concomitant treatment, will be classified as cardiac death. MI- due to target vessel: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel. Clinical-indicated Target Lesion Revascularization (CI-TLR): TLR with evidence of diameter stenosis ≥ 50% determined by QCA; or in the case of any one of the following: new recurrent history of angina pectoris, ischemic signs, abnormal results in diagnostic tests, or TLR \>=70% in the absence of the above signs.
Outcome measures
| Measure |
TAXUS® Liberté™
n=106 Participants
Patients receiving the TAXUS® Liberté™ stent during PCI
|
XIENCE V® EECSS
n=217 Participants
Patients receiving the XIENCE V® EECSS stent during PCI
|
|---|---|---|
|
Adjudicated Composite Endpoint of Cardiac Death, Myocardial Infarction (MI) Attributed to the Target Vessel and Clinical-indicated Target Lesion Revascularization (CI-TLR)
|
9.43 Percentage of participants
Interval 4.62 to 16.67
|
5.53 Percentage of participants
Interval 2.89 to 9.46
|
SECONDARY outcome
Timeframe: 393 daysPopulation: Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.
Cardiac death: Any death due to proximate cardiac cause (eg, myocardial infarction, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, and all procedure related deaths, including those related to concomitant treatment, will be classified as cardiac death. MI- due to target vessel: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel. Clinical-indicated Target Lesion Revascularization (CI-TLR): TLR with evidence of diameter stenosis ≥ 50% determined by QCA; or in the case of any one of the following: new recurrent history of angina pectoris, ischemic signs, abnormal results in diagnostic tests, or TLR \>=70% in the absence of the above signs.
Outcome measures
| Measure |
TAXUS® Liberté™
n=104 Participants
Patients receiving the TAXUS® Liberté™ stent during PCI
|
XIENCE V® EECSS
n=215 Participants
Patients receiving the XIENCE V® EECSS stent during PCI
|
|---|---|---|
|
Adjudicated Composite Endpoint of Cardiac Death, Myocardial Infarction (MI) Attributed to the Target Vessel and Clinical-indicated Target Lesion Revascularization (CI-TLR)
|
12.50 Percentage of participants
Interval 6.83 to 20.43
|
11.16 Percentage of participants
Interval 7.28 to 16.15
|
SECONDARY outcome
Timeframe: 37 daysPopulation: Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.
Death defined by the Academic Research Consortium is as follows: All death is considered to be cardiac death unless an unequivocal noncardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal noncardiac disease (eg, cancer, infection) should be classified as cardiac. Myocardial infarction: Myocardial Infarction Classification and Criteria for Diagnosis as defined by the Academic Research Consortium. Target Vessel Revascularization (TVR): 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.
Outcome measures
| Measure |
TAXUS® Liberté™
n=106 Participants
Patients receiving the TAXUS® Liberté™ stent during PCI
|
XIENCE V® EECSS
n=218 Participants
Patients receiving the XIENCE V® EECSS stent during PCI
|
|---|---|---|
|
Adjudicated Composite Endpoint of All Death, MI and Target Vessel Revascularization (TVR)
|
8.49 Percentage of participants
Interval 3.96 to 15.51
|
2.29 Percentage of participants
Interval 0.75 to 5.27
|
SECONDARY outcome
Timeframe: 254 daysPopulation: Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.
Death defined by the Academic Research Consortium is as follows: All death is considered to be cardiac death unless an unequivocal noncardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal noncardiac disease (eg, cancer, infection) should be classified as cardiac. Myocardial infarction: Myocardial Infarction Classification and Criteria for Diagnosis as defined by the Academic Research Consortium. Target Vessel Revascularization (TVR): 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.
Outcome measures
| Measure |
TAXUS® Liberté™
n=106 Participants
Patients receiving the TAXUS® Liberté™ stent during PCI
|
XIENCE V® EECSS
n=217 Participants
Patients receiving the XIENCE V® EECSS stent during PCI
|
|---|---|---|
|
Adjudicated Composite Endpoint of All Death, MI and Target Vessel Revascularization (TVR)
|
11.32 Percentage of participants
Interval 5.99 to 18.94
|
6.45 Percentage of participants
Interval 3.57 to 10.59
|
SECONDARY outcome
Timeframe: 393 daysPopulation: Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.
Death defined by the Academic Research Consortium is as follows: All death is considered to be cardiac death unless an unequivocal noncardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal noncardiac disease (eg, cancer, infection) should be classified as cardiac. Myocardial infarction: Myocardial Infarction Classification and Criteria for Diagnosis as defined by the Academic Research Consortium. Target Vessel Revascularization (TVR): 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.
Outcome measures
| Measure |
TAXUS® Liberté™
n=104 Participants
Patients receiving the TAXUS® Liberté™ stent during PCI
|
XIENCE V® EECSS
n=215 Participants
Patients receiving the XIENCE V® EECSS stent during PCI
|
|---|---|---|
|
Adjudicated Composite Endpoint of All Death, MI and Target Vessel Revascularization (TVR)
|
16.35 Percentage of participants
Interval 9.82 to 24.88
|
16.28 Percentage of participants
Interval 11.61 to 21.91
|
SECONDARY outcome
Timeframe: 37 daysPopulation: Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.
Death defined by the Academic Research Consortium is as follows: All death is considered to be cardiac death unless an unequivocal noncardiac cause can be established. MI- due to target vessel: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel. Any revascularization: TLR or TVR or non-TVR
Outcome measures
| Measure |
TAXUS® Liberté™
n=106 Participants
Patients receiving the TAXUS® Liberté™ stent during PCI
|
XIENCE V® EECSS
n=218 Participants
Patients receiving the XIENCE V® EECSS stent during PCI
|
|---|---|---|
|
Adjudicated Composite Endpoint of All Death, Any Myocardial Infarction (MI) and Any Revascularization (TLR/TVR/Non-TVR)
|
10.38 Percentage of participants
Interval 5.3 to 17.81
|
3.21 Percentage of participants
Interval 1.3 to 6.5
|
SECONDARY outcome
Timeframe: 254 daysPopulation: Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.
Death defined by the Academic Research Consortium is as follows: All death is considered to be cardiac death unless an unequivocal noncardiac cause can be established. MI- due to target vessel: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel. Any revascularization: TLR or TVR or non-TVR
Outcome measures
| Measure |
TAXUS® Liberté™
n=106 Participants
Patients receiving the TAXUS® Liberté™ stent during PCI
|
XIENCE V® EECSS
n=217 Participants
Patients receiving the XIENCE V® EECSS stent during PCI
|
|---|---|---|
|
Adjudicated Composite Endpoint of All Death, Any Myocardial Infarction (MI) and Any Revascularization (TLR/TVR/Non TVR)
|
14.15 Percentage of participants
Interval 8.14 to 22.26
|
9.68 Percentage of participants
Interval 6.09 to 14.41
|
SECONDARY outcome
Timeframe: 393 daysPopulation: Analysis based on intention to treat (ITT) population. The number of patients analyzed excludes subjects who were lost-to-follow-up.
Death defined by the Academic Research Consortium is as follows: All death is considered to be cardiac death unless an unequivocal noncardiac cause can be established. MI- due to target vessel: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel. Any revascularization: TLR or TVR or non-TVR
Outcome measures
| Measure |
TAXUS® Liberté™
n=104 Participants
Patients receiving the TAXUS® Liberté™ stent during PCI
|
XIENCE V® EECSS
n=215 Participants
Patients receiving the XIENCE V® EECSS stent during PCI
|
|---|---|---|
|
Adjudicated Composite Endpoint of All Death, Any Myocardial Infarction (MI) and Any Revascularization (TLR/TVR/Non TVR)
|
23.08 Percentage of participants
Interval 15.38 to 32.36
|
24.19 Percentage of participants
Interval 18.62 to 30.48
|
Adverse Events
TAXUS® Liberté™
Serious events: 41 serious events
Other events: 13 other events
Deaths: 0 deaths
XIENCE V® EECSS
Serious events: 100 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TAXUS® Liberté™
n=105 participants at risk
Patients receiving the TAXUS® Liberté™ stent during PCI
|
XIENCE V® EECSS
n=215 participants at risk
Patients receiving the XIENCE V® EECSS stent during PCI
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/105 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.93%
2/215 • Number of events 3 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Cardiac disorders
Angina pectoris
|
12.4%
13/105 • Number of events 14 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
11.6%
25/215 • Number of events 29 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/105 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.47%
1/215 • Number of events 3 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Cardiac disorders
Arrhythmia
|
1.9%
2/105 • Number of events 2 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
1.9%
4/215 • Number of events 4 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/105 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.47%
1/215 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Cardiac disorders
Atrial septal defect
|
0.00%
0/105 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.47%
1/215 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/105 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.47%
1/215 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/105 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.47%
1/215 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.95%
1/105 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.47%
1/215 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/105 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.47%
1/215 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/105 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.47%
1/215 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Cardiac disorders
Coronary artery dissection
|
0.00%
0/105 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.93%
2/215 • Number of events 2 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Cardiac disorders
Coronary artery restenosis
|
0.00%
0/105 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.93%
2/215 • Number of events 2 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Cardiac disorders
Coronary artery stenosis
|
2.9%
3/105 • Number of events 3 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
6.0%
13/215 • Number of events 13 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Cardiac disorders
In-stent coronary artery restenosis
|
1.9%
2/105 • Number of events 2 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.93%
2/215 • Number of events 2 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Cardiac disorders
Myocardial infarction
|
8.6%
9/105 • Number of events 9 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
2.8%
6/215 • Number of events 8 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Cardiac disorders
Myocardial infarction, acute
|
0.00%
0/105 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.93%
2/215 • Number of events 2 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Cardiac disorders
Myocardial ischaemia
|
1.9%
2/105 • Number of events 2 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
1.9%
4/215 • Number of events 4 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.00%
0/105 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.47%
1/215 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/105 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.47%
1/215 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/105 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.47%
1/215 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Ear and labyrinth disorders
Vertigo
|
0.95%
1/105 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.00%
0/215 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/105 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.47%
1/215 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/105 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.47%
1/215 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
General disorders
Asthenia
|
0.00%
0/105 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.47%
1/215 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Gastrointestinal disorders
Catheter site haematoma
|
0.00%
0/105 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.47%
1/215 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
General disorders
Catheter site related reaction
|
0.00%
0/105 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.47%
1/215 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
General disorders
Chest pain
|
0.95%
1/105 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
1.4%
3/215 • Number of events 4 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
General disorders
Noncardiac chest pain
|
0.00%
0/105 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.47%
1/215 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/105 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.47%
1/215 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Infections and infestations
Abscess
|
0.00%
0/105 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.47%
1/215 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/105 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.47%
1/215 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Infections and infestations
Diverticulitis
|
0.95%
1/105 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.00%
0/215 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/105 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.47%
1/215 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Infections and infestations
Haematoma infection
|
0.95%
1/105 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.00%
0/215 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/105 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.47%
1/215 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Infections and infestations
Sepsis
|
0.00%
0/105 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.47%
1/215 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/105 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.47%
1/215 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Injury, poisoning and procedural complications
Arteriovenous graft thrombosis
|
0.00%
0/105 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.47%
1/215 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Injury, poisoning and procedural complications
Coronary artery restenosis
|
0.00%
0/105 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.47%
1/215 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/105 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.47%
1/215 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Injury, poisoning and procedural complications
Instent coronary artery restenosis
|
0.00%
0/105 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.47%
1/215 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/105 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.47%
1/215 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.95%
1/105 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.00%
0/215 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/105 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.47%
1/215 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/105 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.47%
1/215 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/105 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.47%
1/215 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
0.00%
0/105 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.47%
1/215 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Investigations
Cardiac stress test abnormal
|
0.95%
1/105 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.93%
2/215 • Number of events 2 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Investigations
Ejection fraction decreased
|
1.9%
2/105 • Number of events 2 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.00%
0/215 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Investigations
Troponin T
|
0.95%
1/105 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.00%
0/215 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/105 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.47%
1/215 • Number of events 2 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Investigations
Diabetic foot
|
0.00%
0/105 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.47%
1/215 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/105 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.47%
1/215 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/105 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.93%
2/215 • Number of events 2 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.95%
1/105 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.00%
0/215 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Musculoskeletal and connective tissue disorders
Meniscus lesion
|
0.95%
1/105 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.00%
0/215 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/105 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.47%
1/215 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain neoplasm
|
0.00%
0/105 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.47%
1/215 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/105 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.93%
2/215 • Number of events 2 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer metastatic
|
0.00%
0/105 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.47%
1/215 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkins disease
|
0.95%
1/105 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.00%
0/215 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia
|
0.00%
0/105 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.47%
1/215 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip andor oral cavity cancer
|
0.00%
0/105 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.47%
1/215 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/105 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.47%
1/215 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Peritoneal carcinoma
|
0.00%
0/105 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.47%
1/215 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Nervous system disorders
Cerebellar infarction
|
0.00%
0/105 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.47%
1/215 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/105 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.47%
1/215 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Nervous system disorders
Ischaemic stroke
|
0.95%
1/105 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.47%
1/215 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/105 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.47%
1/215 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Nervous system disorders
Syncope vasovagal
|
0.00%
0/105 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.47%
1/215 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/105 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.93%
2/215 • Number of events 2 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/105 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.47%
1/215 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Renal and urinary disorders
Nephropathy
|
0.00%
0/105 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.47%
1/215 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.95%
1/105 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.00%
0/215 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/105 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
1.9%
4/215 • Number of events 5 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Renal and urinary disorders
Renal failure acute
|
0.95%
1/105 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.47%
1/215 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Renal and urinary disorders
Urinary retention
|
0.95%
1/105 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.00%
0/215 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/105 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
1.9%
4/215 • Number of events 4 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/105 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.47%
1/215 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.95%
1/105 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.47%
1/215 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Respiratory, thoracic and mediastinal disorders
Vocal cord disorder
|
0.00%
0/105 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.47%
1/215 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Surgical and medical procedures
Coronary angioplasty
|
0.00%
0/105 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.47%
1/215 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Surgical and medical procedures
Coronary arterial stent insertion
|
0.95%
1/105 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.00%
0/215 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Surgical and medical procedures
Coronary revascularisation
|
0.95%
1/105 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.93%
2/215 • Number of events 2 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Surgical and medical procedures
Diabetes mellitus management
|
0.00%
0/105 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.47%
1/215 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Vascular disorders
Coronary artery dissection
|
0.00%
0/105 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.47%
1/215 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Vascular disorders
Femoral arterial stenosis
|
0.00%
0/105 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.47%
1/215 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Vascular disorders
Haematoma
|
1.9%
2/105 • Number of events 2 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
1.4%
3/215 • Number of events 4 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Vascular disorders
Haemorrhage
|
0.95%
1/105 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.00%
0/215 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Vascular disorders
Hypertension
|
1.9%
2/105 • Number of events 2 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.93%
2/215 • Number of events 2 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/105 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.47%
1/215 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.95%
1/105 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.00%
0/215 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/105 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.47%
1/215 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.00%
0/105 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.93%
2/215 • Number of events 2 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Vascular disorders
Retroperitoneal haemorrhage
|
0.00%
0/105 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.47%
1/215 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Vascular disorders
Vascular pseudoaneurysm
|
0.95%
1/105 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
0.00%
0/215 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
Other adverse events
| Measure |
TAXUS® Liberté™
n=105 participants at risk
Patients receiving the TAXUS® Liberté™ stent during PCI
|
XIENCE V® EECSS
n=215 participants at risk
Patients receiving the XIENCE V® EECSS stent during PCI
|
|---|---|---|
|
Cardiac disorders
Angina pectoris
|
11.4%
12/105 • Number of events 13 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
6.5%
14/215 • Number of events 14 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
|
Cardiac disorders
Coronary artery dissection
|
0.95%
1/105 • Number of events 1 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
5.6%
12/215 • Number of events 12 • 1 year
There were 324 (218 XV, 106 TX) total patients in the dataset. To qualify as an At-Risk patient, the patient must have completed the study AND/OR have at least one adverse event. Applying this rule, the At-Risk population therefore totaled 215 XV and 105 TX and is not equal to the number of patients enrolled.
|
Additional Information
Robert Smith Jr, Ph.D., Sr Clinical Research Scientist
Abbott Vascular
Phone: 408-845-8265
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60