Trial Outcomes & Findings for SPIRIT IV Clinical Trial: Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System (NCT NCT00307047)
NCT ID: NCT00307047
Last Updated: 2012-11-07
Results Overview
Percentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
3687 participants
Primary outcome timeframe
1 year
Results posted on
2012-11-07
Participant Flow
Subjects enrolled into this trial were comprised of male and female subjects from the general interventional cardiology population. Recruitment may have, but was not limited to a hospital or an interventional cardiology clinic. The enrollment period was August 10, 2006 through July 30, 2008.
Patients who met inclusion/exclusion criteria were offered participation in the study, and randomized until the total trial population was reached.
Participant milestones
| Measure |
XIENCE V®
Patients recieving the XIENCE V® stent
|
TAXUS™ EXPRESS 2™
Patients receiving the TAXUS™ EXPRESS 2™ stent
|
|---|---|---|
|
Overall Study
STARTED
|
2458
|
1229
|
|
Overall Study
COMPLETED
|
2389
|
1180
|
|
Overall Study
NOT COMPLETED
|
69
|
49
|
Reasons for withdrawal
| Measure |
XIENCE V®
Patients recieving the XIENCE V® stent
|
TAXUS™ EXPRESS 2™
Patients receiving the TAXUS™ EXPRESS 2™ stent
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
35
|
24
|
|
Overall Study
Withdrawal by Subject
|
6
|
6
|
|
Overall Study
Physician Decision
|
1
|
2
|
|
Overall Study
Lost to follow-up for other reasons
|
0
|
1
|
|
Overall Study
All death, all MI, all Revascularization
|
27
|
16
|
Baseline Characteristics
SPIRIT IV Clinical Trial: Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System
Baseline characteristics by cohort
| Measure |
XIENCE V®
n=2458 Participants
Patients recieving the XIENCE V® stent
|
TAXUS™ EXPRESS 2™
n=1229 Participants
Patients receiving the TAXUS™ EXPRESS 2™ stent
|
Total
n=3687 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1373 Participants
n=5 Participants
|
677 Participants
n=7 Participants
|
2050 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1085 Participants
n=5 Participants
|
552 Participants
n=7 Participants
|
1637 Participants
n=5 Participants
|
|
Age Continuous
|
63.25 years
STANDARD_DEVIATION 10.52 • n=5 Participants
|
63.34 years
STANDARD_DEVIATION 10.23 • n=7 Participants
|
63.28 years
STANDARD_DEVIATION 10.42 • n=5 Participants
|
|
Sex: Female, Male
Female
|
793 Participants
n=5 Participants
|
396 Participants
n=7 Participants
|
1189 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1665 Participants
n=5 Participants
|
833 Participants
n=7 Participants
|
2498 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2458 participants
n=5 Participants
|
1229 participants
n=7 Participants
|
3687 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearPercentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).
Outcome measures
| Measure |
XIENCE V®
n=2416 Participants
Patients recieving the XIENCE V® stent
|
TAXUS™ EXPRESS 2™
n=1195 Participants
Patients receiving the TAXUS™ EXPRESS 2™ stent
|
|---|---|---|
|
Ischemia Driven Target Lesion Failure (TLF)
|
4.2 Percentage of participants
|
6.8 Percentage of participants
|
SECONDARY outcome
Timeframe: 30 daysDefined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR
Outcome measures
| Measure |
XIENCE V®
n=2451 Participants
Patients recieving the XIENCE V® stent
|
TAXUS™ EXPRESS 2™
n=1222 Participants
Patients receiving the TAXUS™ EXPRESS 2™ stent
|
|---|---|---|
|
Ischemia Driven Target Vessel Failure (TVF)
|
1.9 percentage of participants
|
3.1 percentage of participants
|
SECONDARY outcome
Timeframe: 180 daysDefined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR
Outcome measures
| Measure |
XIENCE V®
n=2435 Participants
Patients recieving the XIENCE V® stent
|
TAXUS™ EXPRESS 2™
n=1208 Participants
Patients receiving the TAXUS™ EXPRESS 2™ stent
|
|---|---|---|
|
Ischemia Driven Target Vessel Failure (TVF)
|
3.4 percentage of participants
|
6.2 percentage of participants
|
SECONDARY outcome
Timeframe: 270 daysDefined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR
Outcome measures
| Measure |
XIENCE V®
n=2419 Participants
Patients recieving the XIENCE V® stent
|
TAXUS™ EXPRESS 2™
n=1201 Participants
Patients receiving the TAXUS™ EXPRESS 2™ stent
|
|---|---|---|
|
Ischemia Driven Target Vessel Failure (TVF)
|
4.6 percentage of participants
|
7.2 percentage of participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: ITT, @ 1 yr
Defined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR
Outcome measures
| Measure |
XIENCE V®
n=2416 Participants
Patients recieving the XIENCE V® stent
|
TAXUS™ EXPRESS 2™
n=1195 Participants
Patients receiving the TAXUS™ EXPRESS 2™ stent
|
|---|---|---|
|
Ischemia Driven Target Vessel Failure (TVF)
|
5.6 percentage of participants
|
7.9 percentage of participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: ITT, @ 2 years
Defined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR
Outcome measures
| Measure |
XIENCE V®
n=2388 Participants
Patients recieving the XIENCE V® stent
|
TAXUS™ EXPRESS 2™
n=1190 Participants
Patients receiving the TAXUS™ EXPRESS 2™ stent
|
|---|---|---|
|
Ischemia Driven Target Vessel Failure (TVF)
|
9.6 percentage of participants
|
11.8 percentage of participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: ITT, @ 3 years
Defined as the composite endpoint comprised of cardiac death (CD), myocardial infarction (MI), TLR, and TVR
Outcome measures
| Measure |
XIENCE V®
n=2348 Participants
Patients recieving the XIENCE V® stent
|
TAXUS™ EXPRESS 2™
n=1158 Participants
Patients receiving the TAXUS™ EXPRESS 2™ stent
|
|---|---|---|
|
Ischemia Driven Target Vessel Failure (TVF)
|
13.3 percentage of participants
|
14.5 percentage of participants
|
SECONDARY outcome
Timeframe: 30 daysPopulation: ITT population.
Revascularization of a target lesion associated with any of the following: * positive functional ischemia study * ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) * angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study
Outcome measures
| Measure |
XIENCE V®
n=2451 Participants
Patients recieving the XIENCE V® stent
|
TAXUS™ EXPRESS 2™
n=1222 Participants
Patients receiving the TAXUS™ EXPRESS 2™ stent
|
|---|---|---|
|
Ischemia Driven Target Lesion Revascularization (TLR)
|
0.4 percentage of participants
|
1.1 percentage of participants
|
SECONDARY outcome
Timeframe: 180 daysPopulation: ITT population
Revascularization of a target lesion associated with any of the following: * positive functional ischemia study * ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) * angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study
Outcome measures
| Measure |
XIENCE V®
n=2435 Participants
Patients recieving the XIENCE V® stent
|
TAXUS™ EXPRESS 2™
n=1208 Participants
Patients receiving the TAXUS™ EXPRESS 2™ stent
|
|---|---|---|
|
Ischemia Driven Target Lesion Revascularization (TLR)
|
1.1 percentage of participants
|
3.2 percentage of participants
|
SECONDARY outcome
Timeframe: 270 daysPopulation: ITT population
Revascularization of a target lesion associated with any of the following: * positive functional ischemia study * ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) * angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study
Outcome measures
| Measure |
XIENCE V®
n=2419 Participants
Patients recieving the XIENCE V® stent
|
TAXUS™ EXPRESS 2™
n=1201 Participants
Patients receiving the TAXUS™ EXPRESS 2™ stent
|
|---|---|---|
|
Ischemia Driven Target Lesion Revascularization (TLR)
|
1.9 percentage of participants
|
4.1 percentage of participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: ITT population.
Revascularization of a target lesion associated with any of the following: * positive functional ischemia study * ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) * angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study
Outcome measures
| Measure |
XIENCE V®
n=2416 Participants
Patients recieving the XIENCE V® stent
|
TAXUS™ EXPRESS 2™
n=1195 Participants
Patients receiving the TAXUS™ EXPRESS 2™ stent
|
|---|---|---|
|
Ischemia Driven Target Lesion Revascularization (TLR)
|
2.5 percentage of participants
Interval 1.94 to 3.23
|
4.6 percentage of participants
Interval 3.49 to 5.95
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: ITT population.
Revascularization of a target lesion associated with any of the following: * positive functional ischemia study * ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) * angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study
Outcome measures
| Measure |
XIENCE V®
n=2388 Participants
Patients recieving the XIENCE V® stent
|
TAXUS™ EXPRESS 2™
n=1190 Participants
Patients receiving the TAXUS™ EXPRESS 2™ stent
|
|---|---|---|
|
Ischemia Driven Target Lesion Revascularization (TLR)
|
4.4 percentage of participants
|
6.9 percentage of participants
|
SECONDARY outcome
Timeframe: 3 yearsPopulation: ITT population.
Revascularization of a target lesion associated with any of the following: * positive functional ischemia study * ischemic symptoms and angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) * angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study
Outcome measures
| Measure |
XIENCE V®
n=2348 Participants
Patients recieving the XIENCE V® stent
|
TAXUS™ EXPRESS 2™
n=1158 Participants
Patients receiving the TAXUS™ EXPRESS 2™ stent
|
|---|---|---|
|
Ischemia Driven Target Lesion Revascularization (TLR)
|
6.3 percentage of participants
|
7.9 percentage of participants
|
SECONDARY outcome
Timeframe: 30 daysRevascularization of a lesion within the target vessel associated with any of the following: * positive functional ischemia study * ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) * angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study
Outcome measures
| Measure |
XIENCE V®
n=2451 Participants
Patients recieving the XIENCE V® stent
|
TAXUS™ EXPRESS 2™
n=1222 Participants
Patients receiving the TAXUS™ EXPRESS 2™ stent
|
|---|---|---|
|
Ischemia Driven Target Vessel Revascularization (TVR)
|
0.7 percentage of participants
|
1.6 percentage of participants
|
SECONDARY outcome
Timeframe: 180 daysRevascularization of a lesion within the target vessel associated with any of the following: * positive functional ischemia study * ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) * angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study
Outcome measures
| Measure |
XIENCE V®
n=2435 Participants
Patients recieving the XIENCE V® stent
|
TAXUS™ EXPRESS 2™
n=1208 Participants
Patients receiving the TAXUS™ EXPRESS 2™ stent
|
|---|---|---|
|
Ischemia Driven Target Vessel Revascularization (TVR)
|
1.9 percentage of participants
|
4.3 percentage of participants
|
SECONDARY outcome
Timeframe: 270 daysRevascularization of a lesion within the target vessel associated with any of the following: * positive functional ischemia study * ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) * angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study
Outcome measures
| Measure |
XIENCE V®
n=2419 Participants
Patients recieving the XIENCE V® stent
|
TAXUS™ EXPRESS 2™
n=1201 Participants
Patients receiving the TAXUS™ EXPRESS 2™ stent
|
|---|---|---|
|
Ischemia Driven Target Vessel Revascularization (TVR)
|
3.0 percentage of participants
|
5.3 percentage of participants
|
SECONDARY outcome
Timeframe: 1 yearRevascularization of a lesion within the target vessel associated with any of the following: * positive functional ischemia study * ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) * angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study
Outcome measures
| Measure |
XIENCE V®
n=2416 Participants
Patients recieving the XIENCE V® stent
|
TAXUS™ EXPRESS 2™
n=1195 Participants
Patients receiving the TAXUS™ EXPRESS 2™ stent
|
|---|---|---|
|
Ischemia Driven Target Vessel Revascularization (TVR)
|
3.9 percentage of participants
|
5.9 percentage of participants
|
SECONDARY outcome
Timeframe: 2 yearsRevascularization of a lesion within the target vessel associated with any of the following: * positive functional ischemia study * ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) * angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study
Outcome measures
| Measure |
XIENCE V®
n=2388 Participants
Patients recieving the XIENCE V® stent
|
TAXUS™ EXPRESS 2™
n=1190 Participants
Patients receiving the TAXUS™ EXPRESS 2™ stent
|
|---|---|---|
|
Ischemia Driven Target Vessel Revascularization (TVR)
|
7.0 percentage of participants
|
8.9 percentage of participants
|
SECONDARY outcome
Timeframe: 3 yearsRevascularization of a lesion within the target vessel associated with any of the following: * positive functional ischemia study * ischemic symptoms and an angiographic minimal lumen diameter stenosis ≥ 50% by core laboratory quantitative coronary angiography (QCA) * angiographic diameter stenosis ≥ 70% by core laboratory QCA without either ischemic symptoms or a positive functional study
Outcome measures
| Measure |
XIENCE V®
n=2348 Participants
Patients recieving the XIENCE V® stent
|
TAXUS™ EXPRESS 2™
n=1158 Participants
Patients receiving the TAXUS™ EXPRESS 2™ stent
|
|---|---|---|
|
Ischemia Driven Target Vessel Revascularization (TVR)
|
10.1 percentage of participants
|
10.6 percentage of participants
|
SECONDARY outcome
Timeframe: 30 daysPatients determined to have had a MACE event, defined as one of the following events: Cardiac death, myocardial infarction, and TLR
Outcome measures
| Measure |
XIENCE V®
n=2451 Participants
Patients recieving the XIENCE V® stent
|
TAXUS™ EXPRESS 2™
n=1222 Participants
Patients receiving the TAXUS™ EXPRESS 2™ stent
|
|---|---|---|
|
Ischemia Driven Major Adverse Cardiac Events (MACE)
|
1.6 Percentage of participants
|
2.7 Percentage of participants
|
SECONDARY outcome
Timeframe: 180 daysPatients determined to have had a MACE event, defined as one of the following events: Cardiac death, myocardial infarction, and TLR
Outcome measures
| Measure |
XIENCE V®
n=2435 Participants
Patients recieving the XIENCE V® stent
|
TAXUS™ EXPRESS 2™
n=1208 Participants
Patients receiving the TAXUS™ EXPRESS 2™ stent
|
|---|---|---|
|
Ischemia Driven Major Adverse Cardiac Events (MACE)
|
2.6 Percentage of participants
|
5.3 Percentage of participants
|
SECONDARY outcome
Timeframe: 270 daysPatients determined to have had a MACE event, defined as one of the following events: Cardiac death, myocardial infarction, and TLR
Outcome measures
| Measure |
XIENCE V®
n=2419 Participants
Patients recieving the XIENCE V® stent
|
TAXUS™ EXPRESS 2™
n=1201 Participants
Patients receiving the TAXUS™ EXPRESS 2™ stent
|
|---|---|---|
|
Ischemia Driven Major Adverse Cardiac Events (MACE)
|
3.5 Percentage of participants
|
6.2 Percentage of participants
|
SECONDARY outcome
Timeframe: 1 yearsPatients determined to have had a MACE event, defined as one of the following events: Cardiac death, myocardial infarction, and TLR
Outcome measures
| Measure |
XIENCE V®
n=2416 Participants
Patients recieving the XIENCE V® stent
|
TAXUS™ EXPRESS 2™
n=1195 Participants
Patients receiving the TAXUS™ EXPRESS 2™ stent
|
|---|---|---|
|
Ischemia Driven Major Adverse Cardiac Events (MACE)
|
4.2 Percentage of participants
|
6.9 Percentage of participants
|
SECONDARY outcome
Timeframe: 2 yearsPatients determined to have had a MACE event, defined as one of the following events: Cardiac death, myocardial infarction, and TLR
Outcome measures
| Measure |
XIENCE V®
n=2388 Participants
Patients recieving the XIENCE V® stent
|
TAXUS™ EXPRESS 2™
n=1190 Participants
Patients receiving the TAXUS™ EXPRESS 2™ stent
|
|---|---|---|
|
Ischemia Driven Major Adverse Cardiac Events (MACE)
|
7.2 Percentage of participants
|
10.2 Percentage of participants
|
SECONDARY outcome
Timeframe: 3 yearsPatients determined to have had a MACE event, defined as one of the following events: Cardiac death, myocardial infarction, and TLR
Outcome measures
| Measure |
XIENCE V®
n=2348 Participants
Patients recieving the XIENCE V® stent
|
TAXUS™ EXPRESS 2™
n=1158 Participants
Patients receiving the TAXUS™ EXPRESS 2™ stent
|
|---|---|---|
|
Ischemia Driven Major Adverse Cardiac Events (MACE)
|
9.8 Percentage of participants
|
12.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Acute: At time of index procedurePopulation: clinical device success is computed per lesion
Successful delivery and deployment of the first implanted study stent (in overlapping stent setting a successful delivery and deployment of the first and second study 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 QCA (by visual estimation if QCA unavailable). Bailout subjects will be included as device success only if the above criteria for clinical device are met.
Outcome measures
| Measure |
XIENCE V®
n=3058 Participants
Patients recieving the XIENCE V® stent
|
TAXUS™ EXPRESS 2™
n=1551 Participants
Patients receiving the TAXUS™ EXPRESS 2™ stent
|
|---|---|---|
|
Acute Success (Clinical Device)
|
92.0 Percent of success
|
90.7 Percent of success
|
SECONDARY outcome
Timeframe: Acute: At time of index procedurePopulation: Clinical procedure success is computed per subject
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 QCA (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of major adverse cardiac event (MACE) during the hospital stay with a maximum of first seven days following the index procedure. In multiple lesion setting all lesions must meet clinical procedure success.
Outcome measures
| Measure |
XIENCE V®
n=2434 Participants
Patients recieving the XIENCE V® stent
|
TAXUS™ EXPRESS 2™
n=1216 Participants
Patients receiving the TAXUS™ EXPRESS 2™ stent
|
|---|---|---|
|
Acute Success (Clinical Procedure)
|
98.6 Percentage of success
|
98.1 Percentage of success
|
SECONDARY outcome
Timeframe: 30 daysOutcome measures
| Measure |
XIENCE V®
n=2451 Participants
Patients recieving the XIENCE V® stent
|
TAXUS™ EXPRESS 2™
n=1222 Participants
Patients receiving the TAXUS™ EXPRESS 2™ stent
|
|---|---|---|
|
All Myocardial Infarction (MI)
|
1.5 Percentage of participants
|
2.1 Percentage of participants
|
SECONDARY outcome
Timeframe: 180 daysOutcome measures
| Measure |
XIENCE V®
n=2435 Participants
Patients recieving the XIENCE V® stent
|
TAXUS™ EXPRESS 2™
n=1208 Participants
Patients receiving the TAXUS™ EXPRESS 2™ stent
|
|---|---|---|
|
All MI
|
1.6 Percentage of participants
|
2.9 Percentage of participants
|
SECONDARY outcome
Timeframe: 270 daysOutcome measures
| Measure |
XIENCE V®
n=2419 Participants
Patients recieving the XIENCE V® stent
|
TAXUS™ EXPRESS 2™
n=1201 Participants
Patients receiving the TAXUS™ EXPRESS 2™ stent
|
|---|---|---|
|
All MI
|
1.8 Percentage of participants
|
3.0 Percentage of participants
|
SECONDARY outcome
Timeframe: 1 yearOutcome measures
| Measure |
XIENCE V®
n=2416 Participants
Patients recieving the XIENCE V® stent
|
TAXUS™ EXPRESS 2™
n=1195 Participants
Patients receiving the TAXUS™ EXPRESS 2™ stent
|
|---|---|---|
|
All MI
|
1.9 Percentage of participants
|
3.1 Percentage of participants
|
SECONDARY outcome
Timeframe: 2 yearsOutcome measures
| Measure |
XIENCE V®
n=2388 Participants
Patients recieving the XIENCE V® stent
|
TAXUS™ EXPRESS 2™
n=1190 Participants
Patients receiving the TAXUS™ EXPRESS 2™ stent
|
|---|---|---|
|
All MI
|
2.6 Percentage of participants
|
3.9 Percentage of participants
|
SECONDARY outcome
Timeframe: 3 yearsOutcome measures
| Measure |
XIENCE V®
n=2348 Participants
Patients recieving the XIENCE V® stent
|
TAXUS™ EXPRESS 2™
n=1158 Participants
Patients receiving the TAXUS™ EXPRESS 2™ stent
|
|---|---|---|
|
All MI
|
3.1 Percentage of participants
|
4.7 Percentage of participants
|
SECONDARY outcome
Timeframe: 30 daysOutcome measures
| Measure |
XIENCE V®
n=2451 Participants
Patients recieving the XIENCE V® stent
|
TAXUS™ EXPRESS 2™
n=1222 Participants
Patients receiving the TAXUS™ EXPRESS 2™ stent
|
|---|---|---|
|
All Cause Mortality
|
0.0 Percentage of participants
|
0.2 Percentage of participants
|
SECONDARY outcome
Timeframe: 180 daysOutcome measures
| Measure |
XIENCE V®
n=2435 Participants
Patients recieving the XIENCE V® stent
|
TAXUS™ EXPRESS 2™
n=1208 Participants
Patients receiving the TAXUS™ EXPRESS 2™ stent
|
|---|---|---|
|
All Cause Mortality
|
0.5 Percentage of participants
|
0.6 Percentage of participants
|
SECONDARY outcome
Timeframe: 270 daysOutcome measures
| Measure |
XIENCE V®
n=2419 Participants
Patients recieving the XIENCE V® stent
|
TAXUS™ EXPRESS 2™
n=1201 Participants
Patients receiving the TAXUS™ EXPRESS 2™ stent
|
|---|---|---|
|
All Cause Mortality
|
0.7 Percentage of participants
|
0.9 Percentage of participants
|
SECONDARY outcome
Timeframe: 1 yearOutcome measures
| Measure |
XIENCE V®
n=2416 Participants
Patients recieving the XIENCE V® stent
|
TAXUS™ EXPRESS 2™
n=1195 Participants
Patients receiving the TAXUS™ EXPRESS 2™ stent
|
|---|---|---|
|
All Cause Mortality
|
1.0 Percentage of participants
|
1.3 Percentage of participants
|
SECONDARY outcome
Timeframe: 2 yearsOutcome measures
| Measure |
XIENCE V®
n=2388 Participants
Patients recieving the XIENCE V® stent
|
TAXUS™ EXPRESS 2™
n=1190 Participants
Patients receiving the TAXUS™ EXPRESS 2™ stent
|
|---|---|---|
|
All Cause Mortality
|
2.1 Percentage of participants
|
2.7 Percentage of participants
|
SECONDARY outcome
Timeframe: 3 yearsOutcome measures
| Measure |
XIENCE V®
n=2348 Participants
Patients recieving the XIENCE V® stent
|
TAXUS™ EXPRESS 2™
n=1158 Participants
Patients receiving the TAXUS™ EXPRESS 2™ stent
|
|---|---|---|
|
All Cause Mortality
|
3.4 Percentage of participants
|
5.2 Percentage of participants
|
SECONDARY outcome
Timeframe: 30 daysOutcome measures
| Measure |
XIENCE V®
n=2451 Participants
Patients recieving the XIENCE V® stent
|
TAXUS™ EXPRESS 2™
n=1222 Participants
Patients receiving the TAXUS™ EXPRESS 2™ stent
|
|---|---|---|
|
Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)
|
2.4 Percentage of participants
|
3.6 Percentage of participants
|
SECONDARY outcome
Timeframe: 180 daysOutcome measures
| Measure |
XIENCE V®
n=2435 Participants
Patients recieving the XIENCE V® stent
|
TAXUS™ EXPRESS 2™
n=1208 Participants
Patients receiving the TAXUS™ EXPRESS 2™ stent
|
|---|---|---|
|
Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)
|
5.5 Percentage of participants
|
7.5 Percentage of participants
|
SECONDARY outcome
Timeframe: 270 daysOutcome measures
| Measure |
XIENCE V®
n=2419 Participants
Patients recieving the XIENCE V® stent
|
TAXUS™ EXPRESS 2™
n=1201 Participants
Patients receiving the TAXUS™ EXPRESS 2™ stent
|
|---|---|---|
|
Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)
|
7.2 Percentage of participants
|
9.3 Percentage of participants
|
SECONDARY outcome
Timeframe: 1 yearOutcome measures
| Measure |
XIENCE V®
n=2416 Participants
Patients recieving the XIENCE V® stent
|
TAXUS™ EXPRESS 2™
n=1195 Participants
Patients receiving the TAXUS™ EXPRESS 2™ stent
|
|---|---|---|
|
Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)
|
9.0 Percentage of participants
|
10.5 Percentage of participants
|
SECONDARY outcome
Timeframe: 2 yearsOutcome measures
| Measure |
XIENCE V®
n=2388 Participants
Patients recieving the XIENCE V® stent
|
TAXUS™ EXPRESS 2™
n=1190 Participants
Patients receiving the TAXUS™ EXPRESS 2™ stent
|
|---|---|---|
|
Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)
|
15.5 Percentage of participants
|
16.2 Percentage of participants
|
SECONDARY outcome
Timeframe: 3 yearsOutcome measures
| Measure |
XIENCE V®
n=2348 Participants
Patients recieving the XIENCE V® stent
|
TAXUS™ EXPRESS 2™
n=1158 Participants
Patients receiving the TAXUS™ EXPRESS 2™ stent
|
|---|---|---|
|
Composite Endpoint of All Deaths, All MI, All Revascularizations (DMR)
|
21.4 Percentage of participants
|
22.5 Percentage of participants
|
SECONDARY outcome
Timeframe: 0-30 daysARC: Academic Research Consortium-defines ST as a cumulative value at the different time points and with the different seperate time points. Time 0 is defined as the time point after the guiding catheter has been removed. Acute\*: 0-24 hours post implantation Subacute\*: \>24 hours-30 days post Late†: 30 days-1 year post Very late stent thrombosis†: \>1 year post \* Acute/subacute can also be replaced by early ST. Early ST (0-30 days) is currently used in the community. † Including "primary" as well as "secondary" late ST; "secondary" late ST is after a target segment revascularization.
Outcome measures
| Measure |
XIENCE V®
n=2451 Participants
Patients recieving the XIENCE V® stent
|
TAXUS™ EXPRESS 2™
n=1221 Participants
Patients receiving the TAXUS™ EXPRESS 2™ stent
|
|---|---|---|
|
Definite + Probable Stent Thrombosis Rate Based on Academic Research Consortium (ARC) Definition
|
0.16 Percentage of participants
|
0.74 Percentage of participants
|
SECONDARY outcome
Timeframe: 31-393 daysARC: Academic Research Consortium-defines ST as a cumulative value at the different time points and with the different seperate time points. Time 0 is defined as the time point after the guiding catheter has been removed. Acute\*: 0-24 hours post implantation Subacute\*: \>24 hours-30 days post Late†: 30 days-1 year post Very late stent thrombosis†: \>1 year post \* Acute/subacute can also be replaced by early ST. Early ST (0-30 days) is currently used in the community. † Including "primary" as well as "secondary" late ST; "secondary" late ST is after a target segment revascularization.
Outcome measures
| Measure |
XIENCE V®
n=2391 Participants
Patients recieving the XIENCE V® stent
|
TAXUS™ EXPRESS 2™
n=1181 Participants
Patients receiving the TAXUS™ EXPRESS 2™ stent
|
|---|---|---|
|
Definite + Probable Stent Thrombosis Rate Based on ARC Definition
|
0.13 Percentage of participants
|
0.42 Percentage of participants
|
SECONDARY outcome
Timeframe: 0 -393 daysARC: Academic Research Consortium-defines ST as a cumulative value at the different time points and with the different seperate time points. Time 0 is defined as the time point after the guiding catheter has been removed. Acute\*: 0-24 hours post implantation Subacute\*: \>24 hours-30 days post Late†: 30 days-1 year post Very late stent thrombosis†: \>1 year post \* Acute/subacute can also be replaced by early ST. Early ST (0-30 days) is currently used in the community. † Including "primary" as well as "secondary" late ST; "secondary" late ST is after a target segment revascularization.
Outcome measures
| Measure |
XIENCE V®
n=2391 Participants
Patients recieving the XIENCE V® stent
|
TAXUS™ EXPRESS 2™
n=1181 Participants
Patients receiving the TAXUS™ EXPRESS 2™ stent
|
|---|---|---|
|
Definite + Probable Stent Thrombosis Rate Based on ARC Definition
|
0.29 Percentage of participants
|
1.10 Percentage of participants
|
SECONDARY outcome
Timeframe: 0-758 daysARC: Academic Research Consortium-defines ST as a cumulative value at the different time points and with the different seperate time points. Time 0 is defined as the time point after the guiding catheter has been removed. Acute\*: 0-24 hours post implantation Subacute\*: \>24 hours-30 days post Late†: 30 days-1 year post Very late stent thrombosis†: \>1 year post \* Acute/subacute can also be replaced by early ST. Early ST (0-30 days) is currently used in the community. † Including "primary" as well as "secondary" late ST; "secondary" late ST is after a target segment revascularization.
Outcome measures
| Measure |
XIENCE V®
n=2313 Participants
Patients recieving the XIENCE V® stent
|
TAXUS™ EXPRESS 2™
n=1135 Participants
Patients receiving the TAXUS™ EXPRESS 2™ stent
|
|---|---|---|
|
Definite + Probable Stent Thrombosis Rate Based on ARC Definition
|
0.48 Percentage of participants
|
1.32 Percentage of participants
|
SECONDARY outcome
Timeframe: 0-1123 daysARC: Academic Research Consortium-defines ST as a cumulative value at the different time points and with the different seperate time points. Time 0 is defined as the time point after the guiding catheter has been removed. Acute\*: 0-24 hours post implantation Subacute\*: \>24 hours-30 days post Late†: 30 days-1 year post Very late stent thrombosis†: \>1 year post \* Acute/subacute can also be replaced by early ST. Early ST (0-30 days) is currently used in the community. † Including "primary" as well as "secondary" late ST; "secondary" late ST is after a target segment revascularization.
Outcome measures
| Measure |
XIENCE V®
n=2263 Participants
Patients recieving the XIENCE V® stent
|
TAXUS™ EXPRESS 2™
n=1098 Participants
Patients receiving the TAXUS™ EXPRESS 2™ stent
|
|---|---|---|
|
Definite + Probable Stent Thrombosis Rate Based on ARC Definition
|
0.62 Percentage of participants
|
1.73 Percentage of participants
|
SECONDARY outcome
Timeframe: 0-30 daysST will be categorized as acute (≤ 1day), subacute (\>1 day to ≤ 30 days) and late (\>30 days) and will be defined as any of the following: * Clinical presentation of acute coronary syndrome with angiographic evidence of ST * In the absence of angiography, any unexplained death, or acute MI (S-T segment elevation or new Q-wave)\* in the distribution of the target lesion within 30 days \*(Non-specific S-T/T changes, and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.
Outcome measures
| Measure |
XIENCE V®
n=2451 Participants
Patients recieving the XIENCE V® stent
|
TAXUS™ EXPRESS 2™
n=1221 Participants
Patients receiving the TAXUS™ EXPRESS 2™ stent
|
|---|---|---|
|
Protocol Defined Stent Thrombosis Rate
|
0.12 Percentage of participants
|
0.57 Percentage of participants
|
SECONDARY outcome
Timeframe: 31-393 daysST will be categorized as acute (≤ 1day), subacute (\>1 day to ≤ 30 days) and late (\>30 days) and will be defined as any of the following: * Clinical presentation of acute coronary syndrome with angiographic evidence of ST * In the absence of angiography, any unexplained death, or acute MI (S-T segment elevation or new Q-wave)\* in the distribution of the target lesion within 30 days \*(Non-specific S-T/T changes, and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.
Outcome measures
| Measure |
XIENCE V®
n=2389 Participants
Patients recieving the XIENCE V® stent
|
TAXUS™ EXPRESS 2™
n=1181 Participants
Patients receiving the TAXUS™ EXPRESS 2™ stent
|
|---|---|---|
|
Protocol Defined Stent Thrombosis Rate
|
0.04 Percentage of participants
|
0.34 Percentage of participants
|
SECONDARY outcome
Timeframe: 0-393 daysST will be categorized as acute (≤ 1day), subacute (\>1 day to ≤ 30 days) and late (\>30 days) and will be defined as any of the following: * Clinical presentation of acute coronary syndrome with angiographic evidence of ST * In the absence of angiography, any unexplained death, or acute MI (S-T segment elevation or new Q-wave)\* in the distribution of the target lesion within 30 days \*(Non-specific S-T/T changes, and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.
Outcome measures
| Measure |
XIENCE V®
n=2389 Participants
Patients recieving the XIENCE V® stent
|
TAXUS™ EXPRESS 2™
n=1181 Participants
Patients receiving the TAXUS™ EXPRESS 2™ stent
|
|---|---|---|
|
Protocol Defined Stent Thrombosis Rate
|
0.17 Percentage of participants
|
0.85 Percentage of participants
|
SECONDARY outcome
Timeframe: 0-758 daysST will be categorized as acute (≤ 1day), subacute (\>1 day to ≤ 30 days) and late (\>30 days) and will be defined as any of the following: * Clinical presentation of acute coronary syndrome with angiographic evidence of ST * In the absence of angiography, any unexplained death, or acute MI (S-T segment elevation or new Q-wave)\* in the distribution of the target lesion within 30 days \*(Non-specific S-T/T changes, and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.
Outcome measures
| Measure |
XIENCE V®
n=2313 Participants
Patients recieving the XIENCE V® stent
|
TAXUS™ EXPRESS 2™
n=1137 Participants
Patients receiving the TAXUS™ EXPRESS 2™ stent
|
|---|---|---|
|
Protocol Defined Stent Thrombosis Rate
|
0.52 Percentage of participants
|
1.23 Percentage of participants
|
SECONDARY outcome
Timeframe: 0-1123 daysST will be categorized as acute (≤ 1day), subacute (\>1 day to ≤ 30 days) and late (\>30 days) and will be defined as any of the following: * Clinical presentation of acute coronary syndrome with angiographic evidence of ST * In the absence of angiography, any unexplained death, or acute MI (S-T segment elevation or new Q-wave)\* in the distribution of the target lesion within 30 days \*(Non-specific S-T/T changes, and cardiac enzyme elevations do not suffice) Any thromboses that occur less than 30 days after the index procedure will not be counted as restenosis.
Outcome measures
| Measure |
XIENCE V®
n=2266 Participants
Patients recieving the XIENCE V® stent
|
TAXUS™ EXPRESS 2™
n=1104 Participants
Patients receiving the TAXUS™ EXPRESS 2™ stent
|
|---|---|---|
|
Protocol Defined Stent Thrombosis Rate
|
0.79 Percentage of participants
|
1.99 Percentage of participants
|
SECONDARY outcome
Timeframe: 30 daysOutcome measures
| Measure |
XIENCE V®
n=2451 Participants
Patients recieving the XIENCE V® stent
|
TAXUS™ EXPRESS 2™
n=1222 Participants
Patients receiving the TAXUS™ EXPRESS 2™ stent
|
|---|---|---|
|
Cardiac Death or Target Vessel MI Rate
|
1.5 Percentage of participants
|
2.1 Percentage of participants
|
SECONDARY outcome
Timeframe: 180 daysOutcome measures
| Measure |
XIENCE V®
n=2435 Participants
Patients recieving the XIENCE V® stent
|
TAXUS™ EXPRESS 2™
n=1208 Participants
Patients receiving the TAXUS™ EXPRESS 2™ stent
|
|---|---|---|
|
Cardiac Death or Target Vessel MI Rate
|
1.8 Percentage of participants
|
2.8 Percentage of participants
|
SECONDARY outcome
Timeframe: 270 daysOutcome measures
| Measure |
XIENCE V®
n=2419 Participants
Patients recieving the XIENCE V® stent
|
TAXUS™ EXPRESS 2™
n=1201 Participants
Patients receiving the TAXUS™ EXPRESS 2™ stent
|
|---|---|---|
|
Cardiac Death or Target Vessel MI Rate
|
2.1 Percentage of participants
|
3.0 Percentage of participants
|
SECONDARY outcome
Timeframe: 1 yearOutcome measures
| Measure |
XIENCE V®
n=2416 Participants
Patients recieving the XIENCE V® stent
|
TAXUS™ EXPRESS 2™
n=1195 Participants
Patients receiving the TAXUS™ EXPRESS 2™ stent
|
|---|---|---|
|
Cardiac Death or Target Vessel MI Rate
|
2.2 Percentage of participants
|
3.2 Percentage of participants
|
SECONDARY outcome
Timeframe: 2 yearsOutcome measures
| Measure |
XIENCE V®
n=2388 Participants
Patients recieving the XIENCE V® stent
|
TAXUS™ EXPRESS 2™
n=1190 Participants
Patients receiving the TAXUS™ EXPRESS 2™ stent
|
|---|---|---|
|
Cardiac Death or Target Vessel MI Rate
|
3.2 Percentage of participants
|
4.3 Percentage of participants
|
SECONDARY outcome
Timeframe: 3 yearsOutcome measures
| Measure |
XIENCE V®
n=2348 Participants
Patients recieving the XIENCE V® stent
|
TAXUS™ EXPRESS 2™
n=1158 Participants
Patients receiving the TAXUS™ EXPRESS 2™ stent
|
|---|---|---|
|
Cardiac Death or Target Vessel MI Rate
|
4.1 Percentage of participants
|
5.5 Percentage of participants
|
SECONDARY outcome
Timeframe: 30 daysPercentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).
Outcome measures
| Measure |
XIENCE V®
n=2451 Participants
Patients recieving the XIENCE V® stent
|
TAXUS™ EXPRESS 2™
n=1222 Participants
Patients receiving the TAXUS™ EXPRESS 2™ stent
|
|---|---|---|
|
Ischemia Driven Target Lesion Failure (TLF)
|
1.6 Percentage of participants
|
2.7 Percentage of participants
|
SECONDARY outcome
Timeframe: 180 daysPercentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).
Outcome measures
| Measure |
XIENCE V®
n=2435 Participants
Patients recieving the XIENCE V® stent
|
TAXUS™ EXPRESS 2™
n=1208 Participants
Patients receiving the TAXUS™ EXPRESS 2™ stent
|
|---|---|---|
|
Ischemia Driven Target Lesion Failure (TLF)
|
2.5 Percentage of participants
|
5.1 Percentage of participants
|
SECONDARY outcome
Timeframe: 270 daysPercentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).
Outcome measures
| Measure |
XIENCE V®
n=2419 Participants
Patients recieving the XIENCE V® stent
|
TAXUS™ EXPRESS 2™
n=1201 Participants
Patients receiving the TAXUS™ EXPRESS 2™ stent
|
|---|---|---|
|
Ischemia Driven Target Lesion Failure (TLF)
|
3.4 Percentage of participants
|
6.1 Percentage of participants
|
SECONDARY outcome
Timeframe: 2 yearsPercentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).
Outcome measures
| Measure |
XIENCE V®
n=2388 Participants
Patients recieving the XIENCE V® stent
|
TAXUS™ EXPRESS 2™
n=1190 Participants
Patients receiving the TAXUS™ EXPRESS 2™ stent
|
|---|---|---|
|
Ischemia Driven Target Lesion Failure (TLF)
|
7.0 Percentage of participants
|
10.0 Percentage of participants
|
SECONDARY outcome
Timeframe: 3 yearsPercentage of participants with the determination of TLF. TLF is the composite of cardiac death, target vessel myocardial infarction, and ischemic driven target lesion revascularization (TLR).
Outcome measures
| Measure |
XIENCE V®
n=2348 Participants
Patients recieving the XIENCE V® stent
|
TAXUS™ EXPRESS 2™
n=1158 Participants
Patients receiving the TAXUS™ EXPRESS 2™ stent
|
|---|---|---|
|
Ischemia Driven Target Lesion Failure (TLF)
|
9.5 Percentage of participants
|
11.9 Percentage of participants
|
Adverse Events
XIENCE V®
Serious events: 913 serious events
Other events: 762 other events
Deaths: 0 deaths
TAXUS™ EXPRESS 2™
Serious events: 468 serious events
Other events: 407 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
XIENCE V®
n=2436 participants at risk
Patients recieving the XIENCE V® stent
|
TAXUS™ EXPRESS 2™
n=1214 participants at risk
Patients receiving the TAXUS™ EXPRESS 2™ stent
|
|---|---|---|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.08%
2/2436 • Number of events 2 • 1 year
|
0.25%
3/1214 • Number of events 3 • 1 year
|
|
Gastrointestinal disorders
Colonic polyp
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Surgical and medical procedures
Colostomy closure
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Investigations
Computerised tomogram
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Confusional state
|
0.16%
4/2436 • Number of events 4 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Psychiatric disorders
Conversion disorder
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Nervous system disorders
Convulsion
|
0.12%
3/2436 • Number of events 3 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Surgical and medical procedures
Coronary angioplasty
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Surgical and medical procedures
Coronary arterial stent insertion
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
|
0.00%
0/2436 • 1 year
|
0.16%
2/1214 • Number of events 2 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.45%
11/2436 • Number of events 11 • 1 year
|
0.58%
7/1214 • Number of events 7 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma stage unspecified
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign renal neoplasm
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Gastrointestinal disorders
Colitis
|
0.08%
2/2436 • Number of events 2 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Cardiac disorders
Cardiac perforation
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.08%
2/2436 • Number of events 2 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Gastrointestinal disorders
Abdominal hernia obstructive
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Abdominal pain
|
0.53%
13/2436 • Number of events 13 • 1 year
|
0.58%
7/1214 • Number of events 7 • 1 year
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.16%
4/2436 • Number of events 4 • 1 year
|
0.16%
2/1214 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Abdominal symptom
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Infections and infestations
Abscess fungal
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Infections and infestations
Abscess neck
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Cardiac disorders
Acute coronary syndrome
|
0.12%
3/2436 • Number of events 3 • 1 year
|
0.16%
2/1214 • Number of events 2 • 1 year
|
|
Cardiac disorders
Acute myocardial infarction
|
0.37%
9/2436 • Number of events 11 • 1 year
|
0.41%
5/1214 • Number of events 5 • 1 year
|
|
Psychiatric disorders
Acute prerenal failure
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Reproductive system and breast disorders
Acute respiratory distress syndrome
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Infections and infestations
Acute sinusitis
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
General disorders
Adverse drug reaction
|
0.08%
2/2436 • Number of events 2 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Nervous system disorders
Amnesia
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Blood and lymphatic system disorders
Anaemia
|
0.70%
17/2436 • Number of events 17 • 1 year
|
0.91%
11/1214 • Number of events 12 • 1 year
|
|
Immune system disorders
Anaphylactic reaction
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Cardiac disorders
Angina pectoris
|
12.5%
304/2436 • Number of events 406 • 1 year
|
12.6%
153/1214 • Number of events 196 • 1 year
|
|
Cardiac disorders
Angina unstable
|
0.08%
2/2436 • Number of events 2 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.12%
3/2436 • Number of events 3 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Ankylosing spondylitis
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Anxiety
|
0.12%
3/2436 • Number of events 3 • 1 year
|
0.16%
2/1214 • Number of events 2 • 1 year
|
|
Vascular disorders
Aortic aneurysm
|
0.12%
3/2436 • Number of events 3 • 1 year
|
0.25%
3/1214 • Number of events 4 • 1 year
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Vascular disorders
Aortic dissection
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Cardiac disorders
Aortic stenosis
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Cardiac disorders
Aortic valve incompetence
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Cardiac disorders
Aortic valve stenosis
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 2 • 1 year
|
|
Infections and infestations
Appendicitis
|
0.25%
6/2436 • Number of events 6 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Gastrointestinal disorders
Appendicitis perforated
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Arachnoid cyst
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Cardiac disorders
Arrhythmia
|
2.5%
60/2436 • Number of events 70 • 1 year
|
3.5%
43/1214 • Number of events 48 • 1 year
|
|
Surgical and medical procedures
Arterial bypass operation
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Surgical and medical procedures
Arterial stent insertion
|
0.08%
2/2436 • Number of events 2 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Vascular disorders
Arterial thrombosis
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Investigations
Arteriogram coronary
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Vascular disorders
Arteriosclerosis
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Cardiac disorders
Arteriospasm coronary
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Vascular disorders
Arteriovenous fistula
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.29%
7/2436 • Number of events 7 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.16%
4/2436 • Number of events 5 • 1 year
|
0.25%
3/1214 • Number of events 4 • 1 year
|
|
Infections and infestations
Arthritis infective
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Investigations
Arthroscopy
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Asbestosis
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
General disorders
Asthenia
|
0.08%
2/2436 • Number of events 2 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/2436 • 1 year
|
0.16%
2/1214 • Number of events 2 • 1 year
|
|
Nervous system disorders
Ataxia
|
0.08%
2/2436 • Number of events 2 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Cardiac disorders
Atrial fibrillation
|
0.37%
9/2436 • Number of events 9 • 1 year
|
0.33%
4/1214 • Number of events 4 • 1 year
|
|
Cardiac disorders
Atrial flutter
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
|
0.04%
1/2436 • Number of events 4 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.49%
12/2436 • Number of events 12 • 1 year
|
0.66%
8/1214 • Number of events 9 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Hepatobiliary disorders
Bile duct stone
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Hepatobiliary disorders
Biliary colic
|
0.08%
2/2436 • Number of events 2 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Hepatobiliary disorders
Biliary dilatation
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.16%
4/2436 • Number of events 6 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Renal and urinary disorders
Bladder mass
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Surgical and medical procedures
Bladder neoplasm surgery
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Renal and urinary disorders
Bladder prolapse
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Investigations
Blood creatine phosphokinase increased
|
0.08%
2/2436 • Number of events 2 • 1 year
|
0.25%
3/1214 • Number of events 3 • 1 year
|
|
Investigations
Blood creatine phosphokinase mb increased
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Investigations
Blood creatinine increased
|
0.08%
2/2436 • Number of events 2 • 1 year
|
0.16%
2/1214 • Number of events 2 • 1 year
|
|
Investigations
Blood glucose flactuation
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Investigations
Blood glucose increased
|
0.08%
2/2436 • Number of events 2 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Investigations
Blood potassium decreased
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Investigations
Blood urine present
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Investigations
Body temperature increased
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone neoplasm
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Brachial plexus injury
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Cardiac disorders
Bradycardia
|
0.29%
7/2436 • Number of events 7 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain cancer metastatic
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.08%
2/2436 • Number of events 2 • 1 year
|
0.16%
2/1214 • Number of events 2 • 1 year
|
|
Infections and infestations
Breast cellulitis
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Infections and infestations
Bronchitis
|
0.16%
4/2436 • Number of events 4 • 1 year
|
0.16%
2/1214 • Number of events 2 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Cachexia
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Renal and urinary disorders
Calculus ureteric
|
0.08%
2/2436 • Number of events 2 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoid tumour of the duodenum
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Cardiac disorders
Cardiac arrest
|
0.16%
4/2436 • Number of events 4 • 1 year
|
0.00%
0/1214 • 1 year
|
|
General disorders
Cardiac death
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Investigations
Cardiac enzymes increased
|
0.16%
4/2436 • Number of events 4 • 1 year
|
0.33%
4/1214 • Number of events 4 • 1 year
|
|
Cardiac disorders
Cardiac failure congestive
|
1.2%
30/2436 • Number of events 44 • 1 year
|
1.2%
15/1214 • Number of events 19 • 1 year
|
|
Surgical and medical procedures
Cardiac pacemaker insertion
|
0.08%
2/2436 • Number of events 2 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Investigations
Cardiac stress test abnormal
|
0.12%
3/2436 • Number of events 3 • 1 year
|
0.25%
3/1214 • Number of events 3 • 1 year
|
|
Cardiac disorders
Cardiac tamponade
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Investigations
Cardiac ventriculogram abnormal
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.08%
2/2436 • Number of events 2 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Vascular disorders
Carotid artery disease
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Vascular disorders
Carotid artery occlusion
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Vascular disorders
Carotid artery stenosis
|
0.37%
9/2436 • Number of events 9 • 1 year
|
0.41%
5/1214 • Number of events 6 • 1 year
|
|
Surgical and medical procedures
Carotid artery stent insertion
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Surgical and medical procedures
Carotid endarterectomy
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Eye disorders
Cataract
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
General disorders
Catheter site haematoma
|
0.57%
14/2436 • Number of events 16 • 1 year
|
0.58%
7/1214 • Number of events 7 • 1 year
|
|
General disorders
Catheter site haemorrhage
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
General disorders
Catheter site infection
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
General disorders
Catheter site pain
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 2 • 1 year
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
0.49%
12/2436 • Number of events 12 • 1 year
|
0.41%
5/1214 • Number of events 9 • 1 year
|
|
Injury, poisoning and procedural complications
Central line infection
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Nervous system disorders
Cerebral ventricle dilatation
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Nervous system disorders
Cerebrovascular accident
|
0.57%
14/2436 • Number of events 14 • 1 year
|
0.99%
12/1214 • Number of events 12 • 1 year
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Surgical and medical procedures
Chemotherapy
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
General disorders
Chest discomfort
|
0.33%
8/2436 • Number of events 8 • 1 year
|
0.33%
4/1214 • Number of events 4 • 1 year
|
|
General disorders
Chest pain
|
1.9%
47/2436 • Number of events 54 • 1 year
|
2.0%
24/1214 • Number of events 29 • 1 year
|
|
Hepatobiliary disorders
Cholangitis
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Surgical and medical procedures
Cholecystectomy
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.16%
2/1214 • Number of events 2 • 1 year
|
|
Hepatobiliary disorders
Cholecystitis
|
0.08%
2/2436 • Number of events 2 • 1 year
|
0.25%
3/1214 • Number of events 3 • 1 year
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.33%
8/2436 • Number of events 8 • 1 year
|
0.33%
4/1214 • Number of events 4 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.90%
22/2436 • Number of events 27 • 1 year
|
0.82%
10/1214 • Number of events 11 • 1 year
|
|
Infections and infestations
Clostridial infection
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Infections and infestations
Clostridium difficile colitis
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Surgical and medical procedures
Coronary artery bypass
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Surgical and medical procedures
Coronary artery bypass graft
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Cardiac disorders
Coronary artery dissection
|
0.70%
17/2436 • Number of events 18 • 1 year
|
1.1%
13/1214 • Number of events 13 • 1 year
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/2436 • 1 year
|
0.16%
2/1214 • Number of events 2 • 1 year
|
|
Cardiac disorders
Coronary artery perforation
|
0.16%
4/2436 • Number of events 4 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Injury, poisoning and procedural complications
Coronary artery reocclusion
|
0.08%
2/2436 • Number of events 2 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Cardiac disorders
Coronary artery stenosis
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Cardiac disorders
Coronary artery thrombosis
|
0.08%
2/2436 • Number of events 2 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Surgical and medical procedures
Coronary revascularisation
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Crohn's disease
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
General disorders
Cyst
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Vascular disorders
Deep vein thrombosis
|
0.29%
7/2436 • Number of events 7 • 1 year
|
0.16%
2/1214 • Number of events 2 • 1 year
|
|
Metabolism and nutrition disorders
Dehydration
|
0.29%
7/2436 • Number of events 7 • 1 year
|
0.25%
3/1214 • Number of events 4 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Dementia alzheimer's type
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Depression
|
0.12%
3/2436 • Number of events 3 • 1 year
|
0.25%
3/1214 • Number of events 3 • 1 year
|
|
Injury, poisoning and procedural complications
Device failure
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.16%
2/1214 • Number of events 2 • 1 year
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.08%
2/2436 • Number of events 2 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Diabetes mellitus poor control
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Metabolism and nutrition disorders
Diabetic foot
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Diabetic retinal oedema
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Diabetic ulcer
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Diarrhoea
|
0.25%
6/2436 • Number of events 6 • 1 year
|
0.16%
2/1214 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Gastrointestinal disorders
Diverticulitis
|
0.21%
5/2436 • Number of events 5 • 1 year
|
0.25%
3/1214 • Number of events 4 • 1 year
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Dizziness
|
0.49%
12/2436 • Number of events 12 • 1 year
|
0.49%
6/1214 • Number of events 6 • 1 year
|
|
Psychiatric disorders
Drug abuse
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Gastrointestinal disorders
Dyspepsia
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Gastrointestinal disorders
Dysphagia
|
0.16%
4/2436 • Number of events 4 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.82%
20/2436 • Number of events 22 • 1 year
|
0.58%
7/1214 • Number of events 8 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.08%
2/2436 • Number of events 2 • 1 year
|
0.49%
6/1214 • Number of events 6 • 1 year
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Gastrointestinal disorders
Enteritis
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Infections and infestations
Enterococcal infection
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Vascular disorders
Epistaxis
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.16%
2/1214 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Erosive duodenitis
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Injury, poisoning and procedural complications
Face injury
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Facial palsy
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Fall
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Vascular disorders
Femoral arterial stenosis
|
0.16%
4/2436 • Number of events 7 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Vascular disorders
Femoral artery occlusion
|
0.16%
4/2436 • Number of events 4 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.12%
3/2436 • Number of events 3 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Investigations
Fibrin d dimer increased
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
General disorders
Flank pain
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Surgical and medical procedures
Fluid replacement
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Injury, poisoning and procedural complications
Fracture nonunion
|
0.08%
2/2436 • Number of events 2 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Hepatobiliary disorders
Gallbladder disorder
|
0.00%
0/2436 • 1 year
|
0.41%
5/1214 • Number of events 6 • 1 year
|
|
Infections and infestations
Gangrene
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.08%
1/1214 • Number of events 3 • 1 year
|
|
Surgical and medical procedures
Gastric banding
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Surgical and medical procedures
Gastric bypass
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Gastric disorder
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Gastritis
|
0.16%
4/2436 • Number of events 4 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Gastrointestinal disorders
Gastroduodenitis
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Infections and infestations
Gastroenteritis
|
0.12%
3/2436 • Number of events 3 • 1 year
|
0.25%
3/1214 • Number of events 3 • 1 year
|
|
Infections and infestations
Gastroenteritis viral
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Vascular disorders
Gastrointestinal haemorrhage
|
1.9%
47/2436 • Number of events 57 • 1 year
|
1.6%
20/1214 • Number of events 26 • 1 year
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.25%
6/2436 • Number of events 6 • 1 year
|
0.25%
3/1214 • Number of events 3 • 1 year
|
|
Gastrointestinal disorders
Gastrooesophagitis
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Eye disorders
Gaze palsy
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Gastrointestinal disorders
Gingivitis
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Endocrine disorders
Goitre
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Vascular disorders
Haematemesis
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Vascular disorders
Haematochezia
|
0.04%
1/2436 • Number of events 2 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Vascular disorders
Haematoma
|
0.16%
4/2436 • Number of events 4 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Renal and urinary disorders
Haematuria
|
0.21%
5/2436 • Number of events 7 • 1 year
|
0.25%
3/1214 • Number of events 3 • 1 year
|
|
Vascular disorders
Haemoptysis
|
0.00%
0/2436 • 1 year
|
0.16%
2/1214 • Number of events 2 • 1 year
|
|
Vascular disorders
Haemorrhage
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.25%
6/2436 • Number of events 6 • 1 year
|
0.16%
2/1214 • Number of events 2 • 1 year
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Head and neck cancer
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Head injury
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Nervous system disorders
Headache
|
0.16%
4/2436 • Number of events 4 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Infections and infestations
Helicobacter gastritis
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hemiparesis
|
0.08%
2/2436 • Number of events 2 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Investigations
Hepatic enzyme increased
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
General disorders
Hernia
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.08%
2/2436 • Number of events 2 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Surgical and medical procedures
Hip arthroplasty
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.16%
4/2436 • Number of events 4 • 1 year
|
0.16%
2/1214 • Number of events 2 • 1 year
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.12%
3/2436 • Number of events 3 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Reproductive system and breast disorders
Hydrocele
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Renal and urinary disorders
Hydronephrosis
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.08%
2/2436 • Number of events 2 • 1 year
|
0.00%
0/1214 • 1 year
|
|
General disorders
Hyperhidrosis
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.08%
2/2436 • Number of events 2 • 1 year
|
0.16%
2/1214 • Number of events 2 • 1 year
|
|
Endocrine disorders
Hyperparathyroidism
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Vascular disorders
Hypertension
|
0.45%
11/2436 • Number of events 11 • 1 year
|
0.33%
4/1214 • Number of events 4 • 1 year
|
|
Vascular disorders
Hypertensive crisis
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.16%
2/1214 • Number of events 2 • 1 year
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/2436 • 1 year
|
0.16%
2/1214 • Number of events 2 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hypoaesthesia
|
0.08%
2/2436 • Number of events 2 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Nervous system disorders
Hypoaesthesia facial
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.16%
4/2436 • Number of events 5 • 1 year
|
0.16%
2/1214 • Number of events 2 • 1 year
|
|
Vascular disorders
Hypotension
|
0.53%
13/2436 • Number of events 13 • 1 year
|
0.25%
3/1214 • Number of events 3 • 1 year
|
|
Vascular disorders
Hypovolaemic shock
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.08%
2/2436 • Number of events 2 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Vascular disorders
Iliac artery occlusion
|
0.08%
2/2436 • Number of events 2 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
General disorders
Impaired healing
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 2 • 1 year
|
|
Surgical and medical procedures
Implantable defibrillator insertion
|
0.08%
2/2436 • Number of events 2 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Implantable defibrillator malfunction
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Surgical and medical procedures
Implantable defibrillator replacement
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Injury, poisoning and procedural complications
In-stent coronary artery restenosis
|
0.16%
4/2436 • Number of events 4 • 1 year
|
0.16%
2/1214 • Number of events 2 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Increased upper airway secretion
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Infections and infestations
Infected sebaceous cyst
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Infections and infestations
Influenza
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Gastrointestinal disorders
Inguinal hernia, obstructive
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Injury, poisoning and procedural complications
Injury
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Injury, poisoning and procedural complications
Intentional overdose
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Vascular disorders
Intermittent claudication
|
0.08%
2/2436 • Number of events 2 • 1 year
|
0.16%
2/1214 • Number of events 2 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.08%
2/2436 • Number of events 2 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Gastrointestinal disorders
Intestinal malrotation
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Gastrointestinal disorders
Intestinal mass
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Cardiac disorders
Intracardiac thrombus
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.08%
2/2436 • Number of events 2 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Hepatobiliary disorders
Ischaemic hepatitis
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Infections and infestations
Klebsiella bacteraemia
|
0.08%
2/2436 • Number of events 2 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.12%
3/2436 • Number of events 3 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Vascular disorders
Labile hypertension
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Investigations
Laboratory test abnormal
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Infections and infestations
Labyrinthitis
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Injury, poisoning and procedural complications
Limb traumatic amputation
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Investigations
Liver function test abnormal
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Infections and infestations
Localised infection
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.08%
2/2436 • Number of events 2 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Surgical and medical procedures
Lung lobectomy
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Blood and lymphatic system disorders
Lymphadenopathy mediastinal
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant urinary tract neoplasm
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Injury, poisoning and procedural complications
Mechanical complication of implant
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Investigations
Mediastinoscopy
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Vascular disorders
Melaena
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Psychiatric disorders
Mental status changes
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic squamous cell carcinoma
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Cardiac disorders
Mitral valve incompetence
|
0.08%
2/2436 • Number of events 2 • 1 year
|
0.00%
0/1214 • 1 year
|
|
General disorders
Multi-organ failure
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.16%
2/1214 • Number of events 2 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
0.08%
2/2436 • Number of events 3 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Cardiac disorders
Myocardial infarction
|
2.4%
58/2436 • Number of events 62 • 1 year
|
3.5%
42/1214 • Number of events 43 • 1 year
|
|
Cardiac disorders
Myocardial ischemia
|
1.9%
46/2436 • Number of events 49 • 1 year
|
1.5%
18/1214 • Number of events 20 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
0.12%
3/2436 • Number of events 3 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.08%
2/2436 • Number of events 2 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Surgical and medical procedures
Nephrectomy
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.21%
5/2436 • Number of events 6 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Nervous system disorders
Nervous system disorder
|
0.00%
0/2436 • 1 year
|
0.16%
2/1214 • Number of events 2 • 1 year
|
|
General disorders
Non-cardiac chest pain
|
2.3%
57/2436 • Number of events 82 • 1 year
|
2.3%
28/1214 • Number of events 30 • 1 year
|
|
Blood and lymphatic system disorders
Normochromic normocytic anemia
|
0.08%
2/2436 • Number of events 2 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Metabolism and nutrition disorders
Obesity
|
0.08%
2/2436 • Number of events 2 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Nervous system disorders
Occipital neuralgia
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Investigations
Occult blood positive
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
General disorders
Oedema peripheral
|
0.08%
2/2436 • Number of events 2 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.08%
2/2436 • Number of events 2 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Gastrointestinal disorders
Oesophageal obstruction
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Gastrointestinal disorders
Oesophageal pain
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.08%
2/2436 • Number of events 2 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Gastrointestinal disorders
Oesophagitis
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.16%
2/1214 • Number of events 2 • 1 year
|
|
Vascular disorders
Orthostatic hypotension
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.62%
15/2436 • Number of events 15 • 1 year
|
0.41%
5/1214 • Number of events 5 • 1 year
|
|
Infections and infestations
Osteomyelitis
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.16%
2/1214 • Number of events 5 • 1 year
|
|
General disorders
Pain
|
0.12%
3/2436 • Number of events 3 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.21%
5/2436 • Number of events 5 • 1 year
|
0.25%
3/1214 • Number of events 3 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Cardiac disorders
Palpitations
|
0.00%
0/2436 • 1 year
|
0.25%
3/1214 • Number of events 3 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.08%
2/2436 • Number of events 2 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Gastrointestinal disorders
Pancreatitis
|
0.12%
3/2436 • Number of events 4 • 1 year
|
0.25%
3/1214 • Number of events 3 • 1 year
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.16%
2/1214 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Pancreatitis necrotising
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Surgical and medical procedures
Parathyroid gland operation
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Surgical and medical procedures
Percutaneous coronary intervention
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Cardiac disorders
Pericardial effusion
|
0.08%
2/2436 • Number of events 2 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Vascular disorders
Peripheral ischaemia
|
0.33%
8/2436 • Number of events 10 • 1 year
|
0.16%
2/1214 • Number of events 3 • 1 year
|
|
Vascular disorders
Peripheral vascular disorder
|
0.29%
7/2436 • Number of events 7 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Vascular disorders
Peritoneal haemorrhage
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal fistula
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Surgical and medical procedures
Physiotherapy
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Investigations
Platelet count decreased
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural disorder
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.37%
9/2436 • Number of events 10 • 1 year
|
0.33%
4/1214 • Number of events 5 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Infections and infestations
Pneumonia
|
1.5%
37/2436 • Number of events 42 • 1 year
|
2.0%
24/1214 • Number of events 26 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Polyp
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Vascular disorders
Post procedural haemorrhage
|
0.12%
3/2436 • Number of events 3 • 1 year
|
0.58%
7/1214 • Number of events 7 • 1 year
|
|
Injury, poisoning and procedural complications
Postoperative abscess
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Nervous system disorders
Presyncope
|
0.08%
2/2436 • Number of events 2 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Vascular disorders
Presyncope
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Vascular disorders
Procedural hypotension
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.12%
3/2436 • Number of events 3 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Reproductive system and breast disorders
Prostatitis
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Infections and infestations
Pseudomembranous colitis
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.21%
5/2436 • Number of events 5 • 1 year
|
0.58%
7/1214 • Number of events 7 • 1 year
|
|
Vascular disorders
Pulmonary embolism
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.08%
2/2436 • Number of events 2 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Infections and infestations
Pyelonephritis
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
General disorders
Pyrexia
|
0.21%
5/2436 • Number of events 5 • 1 year
|
0.00%
0/1214 • 1 year
|
|
General disorders
Radiation associated pain
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.08%
2/2436 • Number of events 2 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.04%
1/2436 • Number of events 2 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Vascular disorders
Rectal haemorrhage
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Renal artery occlusion
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.21%
5/2436 • Number of events 5 • 1 year
|
0.16%
2/1214 • Number of events 2 • 1 year
|
|
Vascular disorders
Renal artery stenosis
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Surgical and medical procedures
Renal artery stent placement
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Renal and urinary disorders
Renal dysplasia
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Renal failure
|
0.21%
5/2436 • Number of events 6 • 1 year
|
0.41%
5/1214 • Number of events 5 • 1 year
|
|
Renal and urinary disorders
Renal failure acute
|
0.82%
20/2436 • Number of events 23 • 1 year
|
0.25%
3/1214 • Number of events 3 • 1 year
|
|
Renal and urinary disorders
Renal failure chronic
|
0.08%
2/2436 • Number of events 2 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Investigations
Renal function test abnormal
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Renal and urinary disorders
Renal hypertension
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Renal impairment
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Renal and urinary disorders
Renal mass
|
0.12%
3/2436 • Number of events 3 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal neoplasm
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Renal and urinary disorders
Renal tubular necrosis
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Renal and urinary disorders
Renal vessel disorder
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Vascular disorders
Renovascular hypertension
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Reperfusion injury
|
0.08%
2/2436 • Number of events 2 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.12%
3/2436 • Number of events 3 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.29%
7/2436 • Number of events 7 • 1 year
|
0.25%
3/1214 • Number of events 3 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Restrictive pulmonary disease
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Vascular disorders
Retroperitoneal haemorrhage
|
0.25%
6/2436 • Number of events 6 • 1 year
|
0.25%
3/1214 • Number of events 3 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/2436 • 1 year
|
0.16%
2/1214 • Number of events 2 • 1 year
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.16%
2/1214 • Number of events 2 • 1 year
|
|
Surgical and medical procedures
Rotator cuff repair
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Salivary gland mass
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Surgical and medical procedures
Salivary gland operation
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Scar pain
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Injury, poisoning and procedural complications
Scrotal hematoma
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Infections and infestations
Sepsis
|
0.08%
2/2436 • Number of events 2 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Infections and infestations
Septic shock
|
0.12%
3/2436 • Number of events 4 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Cardiac disorders
Sick sinus syndrome
|
0.08%
2/2436 • Number of events 2 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Cardiac disorders
Sinus bradycardia
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Infections and infestations
Sinusitis
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Skin and subcutaneous tissue disorders
Skin burning sensation
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Surgical and medical procedures
Skin neoplasm excision
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 2 • 1 year
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.12%
3/2436 • Number of events 3 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer metastatic
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer stage unspecified
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.08%
2/2436 • Number of events 2 • 1 year
|
0.16%
2/1214 • Number of events 2 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Spinal disorder
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Surgical and medical procedures
Spinal fusion surgery
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Surgical and medical procedures
Spinal laminectomy
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Surgical and medical procedures
Spinal operation
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Injury, poisoning and procedural complications
Splenic rupture
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Nervous system disorders
Spondylitic myelopathy
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Infections and infestations
Staphylococcal abscess
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Infections and infestations
Staphylococcal infection
|
0.12%
3/2436 • Number of events 3 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Skin and subcutaneous tissue disorders
Stasis dermatitis
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Injury, poisoning and procedural complications
Stent-graft endoleak
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Vascular disorders
Subarachnoid haemorrhage
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Vascular disorders
Subclavian steal syndrome
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Vascular disorders
Subdural hematoma
|
0.08%
2/2436 • Number of events 3 • 1 year
|
0.25%
3/1214 • Number of events 4 • 1 year
|
|
General disorders
Sudden death
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Psychiatric disorders
Suicidal ideation
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Surgical and medical procedures
Surgery
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
General disorders
Swelling
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Nervous system disorders
Syncope
|
0.70%
17/2436 • Number of events 17 • 1 year
|
0.58%
7/1214 • Number of events 8 • 1 year
|
|
Vascular disorders
Syncope vasovagal
|
0.08%
2/2436 • Number of events 2 • 1 year
|
0.16%
2/1214 • Number of events 2 • 1 year
|
|
General disorders
Systemic inflammatory response syndrome
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Throat cancer
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Throat tightness
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.08%
2/2436 • Number of events 2 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Injury, poisoning and procedural complications
Thrombosis in device
|
0.08%
2/2436 • Number of events 2 • 1 year
|
0.16%
2/1214 • Number of events 2 • 1 year
|
|
Endocrine disorders
Thyroid mass
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsil cancer
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Surgical and medical procedures
Transfusion
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Nervous system disorders
Transient ischaemic attack
|
0.45%
11/2436 • Number of events 11 • 1 year
|
0.58%
7/1214 • Number of events 7 • 1 year
|
|
Injury, poisoning and procedural complications
Traumatic brain injury
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Investigations
Troponin increased
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Nervous system disorders
Unresponsive to stimuli
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Surgical and medical procedures
Ureteral stent insertion
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Urinary tract disorder
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Infections and infestations
Urinary tract infection
|
0.33%
8/2436 • Number of events 8 • 1 year
|
0.49%
6/1214 • Number of events 6 • 1 year
|
|
Infections and infestations
Urosepsis
|
0.16%
4/2436 • Number of events 4 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Vascular disorders
Vascular occlusion
|
0.04%
1/2436 • Number of events 2 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Vascular disorders
Vascular pseudoaneurysm
|
0.86%
21/2436 • Number of events 21 • 1 year
|
0.58%
7/1214 • Number of events 7 • 1 year
|
|
Vascular disorders
Vasospasm
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Cardiac disorders
Ventricular fibrillation
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Cardiac disorders
Ventricular tachycardia
|
0.12%
3/2436 • Number of events 3 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Ear and labyrinth disorders
Vertigo
|
0.08%
2/2436 • Number of events 2 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
0.08%
2/2436 • Number of events 4 • 1 year
|
0.33%
4/1214 • Number of events 4 • 1 year
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Metabolism and nutrition disorders
Weight loss poor
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.04%
1/2436 • Number of events 1 • 1 year
|
0.00%
0/1214 • 1 year
|
|
Vascular disorders
Wound haemorrhage
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/2436 • 1 year
|
0.08%
1/1214 • Number of events 1 • 1 year
|
Other adverse events
| Measure |
XIENCE V®
n=2436 participants at risk
Patients recieving the XIENCE V® stent
|
TAXUS™ EXPRESS 2™
n=1214 participants at risk
Patients receiving the TAXUS™ EXPRESS 2™ stent
|
|---|---|---|
|
Cardiac disorders
Angina pectoris
|
16.3%
398/2436 • Number of events 493 • 1 year
|
16.3%
198/1214 • Number of events 236 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.9%
193/2436 • Number of events 194 • 1 year
|
10.7%
130/1214 • Number of events 139 • 1 year
|
|
General disorders
Catheter site haematoma
|
7.3%
177/2436 • Number of events 181 • 1 year
|
8.1%
98/1214 • Number of events 102 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.0%
121/2436 • Number of events 126 • 1 year
|
5.3%
64/1214 • Number of events 67 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Investigators will not use Trial related data without written consent of sponsor for any purpose other than Trial completion or generation of publication material. Publication or presentation of results from a trial site are not allowed until publication and/or presentation of multi-center results. Sponsor must receive materials at least 60 days prior to the proposed date of the presentation or the initial submission of proposed publication in order to be reviewed by the sponsor.
- Publication restrictions are in place
Restriction type: OTHER