Trial Outcomes & Findings for TAXUS Libertē Post Approval Study (NCT NCT00997503)
NCT ID: NCT00997503
Last Updated: 2015-08-07
Results Overview
Cardiac death or myocardial infarction in the TAXUS Liberte Post-Approval Study enrolled population. For pooled data from the TAXUS Liberté and TAXUS Express patient populations, please see the citations.
Recruitment status
COMPLETED
Target enrollment
4199 participants
Primary outcome timeframe
12 months
Results posted on
2015-08-07
Participant Flow
Participant milestones
| Measure |
TAXUS Libertē: Overall Enrolled Population
Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
|
|---|---|
|
Overall Study
STARTED
|
4199
|
|
Overall Study
12 Months
|
4059
|
|
Overall Study
COMPLETED
|
3926
|
|
Overall Study
NOT COMPLETED
|
273
|
Reasons for withdrawal
| Measure |
TAXUS Libertē: Overall Enrolled Population
Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
|
|---|---|
|
Overall Study
Death
|
53
|
|
Overall Study
Withdrawal by Subject
|
76
|
|
Overall Study
Lost to Follow-up
|
33
|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Physician Decision
|
10
|
|
Overall Study
Missed 12-month follow-up
|
85
|
|
Overall Study
Other reason
|
13
|
Baseline Characteristics
TAXUS Libertē Post Approval Study
Baseline characteristics by cohort
| Measure |
TAXUS Liberté Post-Approval Study Enrolled Population
n=4199 Participants
Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
|
|---|---|
|
Age, Continuous
|
59.8 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1161 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3038 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
181 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
3623 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
23 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black, or African Heritage
|
323 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
8 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
16 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
43 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4199 participants
n=5 Participants
|
|
Weight
|
92.9 kilograms
STANDARD_DEVIATION 20.7 • n=5 Participants
|
|
Smoking Status
Current
|
1272 participants
n=5 Participants
|
|
Smoking Status
Previous
|
1451 participants
n=5 Participants
|
|
Smoking Status
Never
|
1387 participants
n=5 Participants
|
|
Smoking Status
Unknown
|
89 participants
n=5 Participants
|
|
History of Hyperlipidemia Requiring Medication
|
2950 participants
n=5 Participants
|
|
History of Hypertension Requiring Medication
|
3130 participants
n=5 Participants
|
|
Diabetic (Medically Treated)
|
1289 participants
n=5 Participants
|
|
Family History of Coronary Artery Disease (CAD)
|
2466 participants
n=5 Participants
|
|
History of Atrial Fibrillation
|
143 participants
n=5 Participants
|
|
History of Coronary Artery Bypass Graft (CABG)
|
559 participants
n=5 Participants
|
|
History of Percutaneous Coronary Intervention (PCI)
|
1411 participants
n=5 Participants
|
|
History of Congestive Heart Failure (CHF)
|
254 participants
n=5 Participants
|
|
Current Stable Angina
|
1320 participants
n=5 Participants
|
|
Current Unstable Angina
|
1385 participants
n=5 Participants
|
|
Current Silent Ischemia
|
310 participants
n=5 Participants
|
|
Current Myocardial Infarction (MI)
|
1040 participants
n=5 Participants
|
|
Experiencing Cardiogenic Shock
|
17 participants
n=5 Participants
|
|
History of Multivessel Disease
|
1464 participants
n=5 Participants
|
|
History of Left Main Disease
|
155 participants
n=5 Participants
|
|
History of Transient Ischemic Attack (TIA)
|
4 participants
n=5 Participants
|
|
History of Stroke
|
4 participants
n=5 Participants
|
|
Current Renal Dysfunction
|
185 participants
n=5 Participants
|
|
History of Peripheral Vascular Disease
|
284 participants
n=5 Participants
|
|
History of Major Bleeding
|
32 participants
n=5 Participants
|
|
De Novo Lesion
|
5421 lesions
n=5 Participants
|
|
Culprit Lesion for ST Elevation Myocardial Infarction (STEMI)
|
386 lesions
n=5 Participants
|
|
Restenosis
Restenosis - Drug Eluting Stent (DES)
|
168 lesions
n=5 Participants
|
|
Restenosis
Restenosis - Bare Metal Stent (BMS)
|
82 lesions
n=5 Participants
|
|
Restenosis
Restenotic Lesion (No Stent)
|
31 lesions
n=5 Participants
|
|
Chronic Total Occlusion
|
70 lesions
n=5 Participants
|
|
Ostial Lesion
|
216 lesions
n=5 Participants
|
|
Post Brachytherapy
|
5 lesions
n=5 Participants
|
|
Bifurcated Lesion
|
336 lesions
n=5 Participants
|
|
Reference Vessel Diameter (RVD)
|
2.99 millimeters
STANDARD_DEVIATION 0.5 • n=5 Participants
|
|
Lesion Length
|
16 millimeters
STANDARD_DEVIATION 9.5 • n=5 Participants
|
|
Pre-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow
0
|
501 lesions
n=5 Participants
|
|
Pre-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow
1
|
197 lesions
n=5 Participants
|
|
Pre-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow
2
|
679 lesions
n=5 Participants
|
|
Pre-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow
3
|
4283 lesions
n=5 Participants
|
|
Lesion Classification: American College of Cardiology (ACC)/ American Heart Association (AHA)
Type A
|
1132 lesions
n=5 Participants
|
|
Lesion Classification: American College of Cardiology (ACC)/ American Heart Association (AHA)
Type B1
|
2298 lesions
n=5 Participants
|
|
Lesion Classification: American College of Cardiology (ACC)/ American Heart Association (AHA)
Type B2
|
1162 lesions
n=5 Participants
|
|
Lesion Classification: American College of Cardiology (ACC)/ American Heart Association (AHA)
Type C
|
1068 lesions
n=5 Participants
|
|
Lesion Calcification
None
|
3630 lesions
n=5 Participants
|
|
Lesion Calcification
Mild
|
1398 lesions
n=5 Participants
|
|
Lesion Calcification
Moderate
|
482 lesions
n=5 Participants
|
|
Lesion Calcification
Severe
|
150 lesions
n=5 Participants
|
|
Pre-Procedure Target Lesion Percent Diameter Stenosis (%DS)
|
85.3 percemt
STANDARD_DEVIATION 11.7 • n=5 Participants
|
|
Vessel Tortuosity
None
|
3912 lesions
n=5 Participants
|
|
Vessel Tortuosity
Mild
|
1261 lesions
n=5 Participants
|
|
Vessel Tortuosity
Moderate
|
431 lesions
n=5 Participants
|
|
Vessel Tortuosity
Severe
|
56 lesions
n=5 Participants
|
|
Lesion Location (Vessel)
Right Coronary Artery (RCA)
|
1943 lesions
n=5 Participants
|
|
Lesion Location (Vessel)
Left Anterior Descending (LAD) Coronary Artery
|
2198 lesions
n=5 Participants
|
|
Lesion Location (Vessel)
Left Circumflex (LCX) Coronary Artery
|
1306 lesions
n=5 Participants
|
|
Lesion Location (Vessel)
Left Main (LM) Coronary Artery
|
46 lesions
n=5 Participants
|
|
Lesion Location (Vessel)
Arterial or Vein Graft
|
167 lesions
n=5 Participants
|
|
Thrombus Present (Pre-Procedure)
Yes
|
478 lesions
n=5 Participants
|
|
Thrombus Present (Pre-Procedure)
Possibly
|
273 lesions
n=5 Participants
|
|
Thrombus Present (Pre-Procedure)
No
|
4840 lesions
n=5 Participants
|
|
Thrombus Present (Pre-Procedure)
Unknown
|
69 lesions
n=5 Participants
|
|
Acute Coronary Syndrome (ACS) Present
|
1194 procedures
n=5 Participants
|
|
Pre-dilatation Performed
|
3044 procedures
n=5 Participants
|
|
Number of Lesions Treated Per Patient
|
1.3 lesions
STANDARD_DEVIATION 0.7 • n=5 Participants
|
|
Number of Vessels Treated Per Patient
|
1.1 vessels
STANDARD_DEVIATION 0.4 • n=5 Participants
|
|
Study Stents Implanted Per Patient
|
1.5 stents
STANDARD_DEVIATION 0.8 • n=5 Participants
|
|
Post-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow
0
|
0 lesions
n=5 Participants
|
|
Post-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow
1
|
1 lesions
n=5 Participants
|
|
Post-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow
2
|
42 lesions
n=5 Participants
|
|
Post-Procedure Thrombolysis In Myocardial Infarction (TIMI) Flow
3
|
5617 lesions
n=5 Participants
|
|
Post-Procedure Target Lesion Percent Diameter Stenosis (%DS)
|
1.3 percentage of diameter stenosis
STANDARD_DEVIATION 4.2 • n=5 Participants
|
|
Thrombus Present (Post-Procedure)
Yes
|
27 lesions
n=5 Participants
|
|
Thrombus Present (Post-Procedure)
Possibly
|
45 lesions
n=5 Participants
|
|
Thrombus Present (Post-Procedure)
No
|
5588 lesions
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.
Cardiac death or myocardial infarction in the TAXUS Liberte Post-Approval Study enrolled population. For pooled data from the TAXUS Liberté and TAXUS Express patient populations, please see the citations.
Outcome measures
| Measure |
TAXUS Libertē Post-Approval Study Enrolled Population
n=4059 Participants
There were a total of 4,199 patients in the TAXUS Libertē Post-Approval Study that received at least one TAXUS Liberte stent.
|
|---|---|
|
Cardiac Death or Myocardial Infarction
|
2.1 percentage of participants
|
SECONDARY outcome
Timeframe: 1-2 yearsPopulation: To be analyzed in this secondary analysis, a subject needed to have an endpoint event between 1-2 years or sufficient follow-up through 2-years. There were 448 subjects that did not meet the criteria for this analysis.
Stent Thrombosis (protocol definition): The occurrence of any of the following: 1. Clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis: Angiographic documentation of acute complete occlusion (TIMI flow 0 or 1) of a previously successfully treated artery (TIMI flow 2 to 3 immediately after stent placement and diameter stenosis less than or equal to 30%) and/or Angiographic documentation of a flow limiting thrombus within or adjacent to a previously successfully treated lesion 2. Acute MI in the distribution of the treated vessel. 3. Death within the first 30 days post index procedure (without other obvious cause) is considered a surrogate for stent thrombosis when angiography is not available.
Outcome measures
| Measure |
TAXUS Libertē Post-Approval Study Enrolled Population
n=3751 Participants
There were a total of 4,199 patients in the TAXUS Libertē Post-Approval Study that received at least one TAXUS Liberte stent.
|
|---|---|
|
Incremental Rate of Stent Thrombosis (Protocol Definition)
|
1.3 percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: To be included, subject was a medically treated diabetic at the time of enrollment. Also, subjects met the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure. There were 2945 subjects that did not meet the criteria for this analysis.
Target vessel failure (TVF) for TAXUS Libertē Post-Approval Study medically-treated diabetic population. For pooled data from the TAXUS Liberté population, please see the citations
Outcome measures
| Measure |
TAXUS Libertē Post-Approval Study Enrolled Population
n=1254 Participants
There were a total of 4,199 patients in the TAXUS Libertē Post-Approval Study that received at least one TAXUS Liberte stent.
|
|---|---|
|
Target Vessel Failure (TVF) for the Medically-Treated Diabetic Population
|
6.1 percentage of participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.
* MACCE defined as the composite of cardiac death, myocardial infarction, target vessel revascularization and stroke. * Binary rate
Outcome measures
| Measure |
TAXUS Libertē Post-Approval Study Enrolled Population
n=4132 Participants
There were a total of 4,199 patients in the TAXUS Libertē Post-Approval Study that received at least one TAXUS Liberte stent.
|
|---|---|
|
Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE)
|
4.7 percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.
* MACCE defined as the composite of cardiac death, myocardial infarction, target vessel revascularization and stroke. * Binary rate
Outcome measures
| Measure |
TAXUS Libertē Post-Approval Study Enrolled Population
n=4059 Participants
There were a total of 4,199 patients in the TAXUS Libertē Post-Approval Study that received at least one TAXUS Liberte stent.
|
|---|---|
|
Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE)
|
7.8 percentage of participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.
MACCE defined as the composite of cardiac death, myocardial infarction, target vessel revascularization and stroke.
Outcome measures
| Measure |
TAXUS Libertē Post-Approval Study Enrolled Population
n=4132 Participants
There were a total of 4,199 patients in the TAXUS Libertē Post-Approval Study that received at least one TAXUS Liberte stent.
|
|---|---|
|
Rate of Major Adverse Cardiac & Cerebrovascular Events (MACCE): Study Stent Related
|
3.1 percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.
* MACCE defined as the composite of cardiac death, myocardial infarction, target vessel revascularization and stroke. * Binary rate
Outcome measures
| Measure |
TAXUS Libertē Post-Approval Study Enrolled Population
n=4059 Participants
There were a total of 4,199 patients in the TAXUS Libertē Post-Approval Study that received at least one TAXUS Liberte stent.
|
|---|---|
|
Rate of Major Adverse Cardiac and Cerebrovascular Events (MACCE): Study Stent Related
|
4.9 percentage of participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.
* MACE defined as the composite of cardiac death, myocardial infarction and target vessel revascularization. * Binary rate
Outcome measures
| Measure |
TAXUS Libertē Post-Approval Study Enrolled Population
n=4132 Participants
There were a total of 4,199 patients in the TAXUS Libertē Post-Approval Study that received at least one TAXUS Liberte stent.
|
|---|---|
|
Rate of Major Adverse Cardiac Events (MACE)
|
4.3 percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.
* MACE defined as the composite of cardiac death, myocardial infarction and target vessel revascularization. * Binary rate
Outcome measures
| Measure |
TAXUS Libertē Post-Approval Study Enrolled Population
n=4059 Participants
There were a total of 4,199 patients in the TAXUS Libertē Post-Approval Study that received at least one TAXUS Liberte stent.
|
|---|---|
|
Rate of Major Adverse Cardiac Events (MACE)
|
7.3 percentage of participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.
* MACE defined as the composite of cardiac death, myocardial infarction and target vessel revascularization. * Binary rate
Outcome measures
| Measure |
TAXUS Libertē Post-Approval Study Enrolled Population
n=4132 Participants
There were a total of 4,199 patients in the TAXUS Libertē Post-Approval Study that received at least one TAXUS Liberte stent.
|
|---|---|
|
Rate of Major Adverse Cardiac Events (MACE): Study Stent Related
|
3.1 percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.
* MACE defined as the composite of cardiac death, myocardial infarction and target vessel revascularization. * Binary rate
Outcome measures
| Measure |
TAXUS Libertē Post-Approval Study Enrolled Population
n=4059 Participants
There were a total of 4,199 patients in the TAXUS Libertē Post-Approval Study that received at least one TAXUS Liberte stent.
|
|---|---|
|
Rate of Major Adverse Cardiac Events (MACE): Study Stent Related
|
4.9 percentage of participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.
* Target vessel failure is defined as any revascularization of the target vessel, MI (Q- and non-Q wave) related to the target vessel, or death related to the target vessel. * Binary Rate
Outcome measures
| Measure |
TAXUS Libertē Post-Approval Study Enrolled Population
n=4132 Participants
There were a total of 4,199 patients in the TAXUS Libertē Post-Approval Study that received at least one TAXUS Liberte stent.
|
|---|---|
|
Rate of Target Vessel Failure (TVF)
|
3.9 percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.
* Target vessel failure is defined as any revascularization of the target vessel, MI (Q- and non-Q wave) related to the target vessel, or death related to the target vessel. * Binary rate
Outcome measures
| Measure |
TAXUS Libertē Post-Approval Study Enrolled Population
n=4059 Participants
There were a total of 4,199 patients in the TAXUS Libertē Post-Approval Study that received at least one TAXUS Liberte stent.
|
|---|---|
|
Rate of Target Vessel Failure (TVF)
|
6.4 percentage of participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.
\- Binary Rate
Outcome measures
| Measure |
TAXUS Libertē Post-Approval Study Enrolled Population
n=4132 Participants
There were a total of 4,199 patients in the TAXUS Libertē Post-Approval Study that received at least one TAXUS Liberte stent.
|
|---|---|
|
Rate of Cardiac Death or Myocardial Infarction (MI)
|
1.4 percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.
\- Binary Rate
Outcome measures
| Measure |
TAXUS Libertē Post-Approval Study Enrolled Population
n=4059 Participants
There were a total of 4,199 patients in the TAXUS Libertē Post-Approval Study that received at least one TAXUS Liberte stent.
|
|---|---|
|
Rate of Cardiac Death or Myocardial Infarction (MI)
|
2.1 percentage of participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.
-Binary rate
Outcome measures
| Measure |
TAXUS Libertē Post-Approval Study Enrolled Population
n=4132 Participants
There were a total of 4,199 patients in the TAXUS Libertē Post-Approval Study that received at least one TAXUS Liberte stent.
|
|---|---|
|
Rate of All Cause Death
|
0.7 percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.
-Binary rate
Outcome measures
| Measure |
TAXUS Libertē Post-Approval Study Enrolled Population
n=4059 Participants
There were a total of 4,199 patients in the TAXUS Libertē Post-Approval Study that received at least one TAXUS Liberte stent.
|
|---|---|
|
Rate of All Cause Death
|
1.4 percentage of participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.
-Binary rate
Outcome measures
| Measure |
TAXUS Libertē Post-Approval Study Enrolled Population
n=4132 Participants
There were a total of 4,199 patients in the TAXUS Libertē Post-Approval Study that received at least one TAXUS Liberte stent.
|
|---|---|
|
Rate of Cardiac Death
|
0.4 percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.
-Binary rate
Outcome measures
| Measure |
TAXUS Libertē Post-Approval Study Enrolled Population
n=4059 Participants
There were a total of 4,199 patients in the TAXUS Libertē Post-Approval Study that received at least one TAXUS Liberte stent.
|
|---|---|
|
Rate of Cardiac Death
|
0.9 percentage of participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.
-Binary rate
Outcome measures
| Measure |
TAXUS Libertē Post-Approval Study Enrolled Population
n=4132 Participants
There were a total of 4,199 patients in the TAXUS Libertē Post-Approval Study that received at least one TAXUS Liberte stent.
|
|---|---|
|
Rate of Cardiac Death: Study Stent Related
|
0.1 percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.
-Binary rate
Outcome measures
| Measure |
TAXUS Libertē Post-Approval Study Enrolled Population
n=4059 Participants
There were a total of 4,199 patients in the TAXUS Libertē Post-Approval Study that received at least one TAXUS Liberte stent.
|
|---|---|
|
Rate of Cardiac Death: Study Stent Related
|
0.1 percentage of participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.
-Binary rate
Outcome measures
| Measure |
TAXUS Libertē Post-Approval Study Enrolled Population
n=4132 Participants
There were a total of 4,199 patients in the TAXUS Libertē Post-Approval Study that received at least one TAXUS Liberte stent.
|
|---|---|
|
Rate of Myocardial Infarction (MI)
|
1.0 percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.
-Binary rate
Outcome measures
| Measure |
TAXUS Libertē Post-Approval Study Enrolled Population
n=4059 Participants
There were a total of 4,199 patients in the TAXUS Libertē Post-Approval Study that received at least one TAXUS Liberte stent.
|
|---|---|
|
Rate of Myocardial Infarction (MI)
|
1.4 percentage of participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.
-Binary rate
Outcome measures
| Measure |
TAXUS Libertē Post-Approval Study Enrolled Population
n=4132 Participants
There were a total of 4,199 patients in the TAXUS Libertē Post-Approval Study that received at least one TAXUS Liberte stent.
|
|---|---|
|
Rate of Myocardial Infarction (MI): Study Stent Related
|
0.9 percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.
-Binary rate
Outcome measures
| Measure |
TAXUS Libertē Post-Approval Study Enrolled Population
n=4059 Participants
There were a total of 4,199 patients in the TAXUS Libertē Post-Approval Study that received at least one TAXUS Liberte stent.
|
|---|---|
|
Rate of Myocardial Infarction (MI): Study Stent Related
|
1.0 percentage of participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.
-Binary rate
Outcome measures
| Measure |
TAXUS Libertē Post-Approval Study Enrolled Population
n=4132 Participants
There were a total of 4,199 patients in the TAXUS Libertē Post-Approval Study that received at least one TAXUS Liberte stent.
|
|---|---|
|
Rate of Target Vessel Reintervention (TVR)
|
3.3 percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.
-Binary rate
Outcome measures
| Measure |
TAXUS Libertē Post-Approval Study Enrolled Population
n=4059 Participants
There were a total of 4,199 patients in the TAXUS Libertē Post-Approval Study that received at least one TAXUS Liberte stent.
|
|---|---|
|
Rate of Target Vessel Reintervention (TVR)
|
5.8 percentage of participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.
-Binary rate
Outcome measures
| Measure |
TAXUS Libertē Post-Approval Study Enrolled Population
n=4132 Participants
There were a total of 4,199 patients in the TAXUS Libertē Post-Approval Study that received at least one TAXUS Liberte stent.
|
|---|---|
|
Rate of Target Vessel Reintervention (TVR): Study Stent Related
|
2.5 percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.
-Binary rate
Outcome measures
| Measure |
TAXUS Libertē Post-Approval Study Enrolled Population
n=4059 Participants
There were a total of 4,199 patients in the TAXUS Libertē Post-Approval Study that received at least one TAXUS Liberte stent.
|
|---|---|
|
Rate of Target Vessel Reintervention (TVR): Study Stent Related
|
4.3 percentage of participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.
-Binary Rate
Outcome measures
| Measure |
TAXUS Libertē Post-Approval Study Enrolled Population
n=4132 Participants
There were a total of 4,199 patients in the TAXUS Libertē Post-Approval Study that received at least one TAXUS Liberte stent.
|
|---|---|
|
Rate of Stroke
|
0.4 percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.
-Binary Rate
Outcome measures
| Measure |
TAXUS Libertē Post-Approval Study Enrolled Population
n=4059 Participants
There were a total of 4,199 patients in the TAXUS Libertē Post-Approval Study that received at least one TAXUS Liberte stent.
|
|---|---|
|
Rate of Stroke
|
0.5 percentage of participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.
* Major Bleeding defined as the composite of severe or moderate bleeding complication (based upon GUSTO classification). * Binary rate
Outcome measures
| Measure |
TAXUS Libertē Post-Approval Study Enrolled Population
n=4132 Participants
There were a total of 4,199 patients in the TAXUS Libertē Post-Approval Study that received at least one TAXUS Liberte stent.
|
|---|---|
|
Rate of Major Bleeding
|
2.3 percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.
* Major Bleeding defined as the composite of severe or moderate bleeding complication (based upon GUSTO classification). * Binary rate
Outcome measures
| Measure |
TAXUS Libertē Post-Approval Study Enrolled Population
n=4059 Participants
There were a total of 4,199 patients in the TAXUS Libertē Post-Approval Study that received at least one TAXUS Liberte stent.
|
|---|---|
|
Rate of Major Bleeding
|
3.6 percentage of participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.
* ARC - Academic Research Consortium * Binary rate
Outcome measures
| Measure |
TAXUS Libertē Post-Approval Study Enrolled Population
n=4132 Participants
There were a total of 4,199 patients in the TAXUS Libertē Post-Approval Study that received at least one TAXUS Liberte stent.
|
|---|---|
|
Rate of Stent Thrombosis (ARC Definite + Probable)
|
0.6 percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.
* ARC - Academic Research Consortium * Binary Rate
Outcome measures
| Measure |
TAXUS Libertē Post-Approval Study Enrolled Population
n=4059 Participants
There were a total of 4,199 patients in the TAXUS Libertē Post-Approval Study that received at least one TAXUS Liberte stent.
|
|---|---|
|
Rate of Stent Thrombosis (ARC Definite + Probable)
|
0.8 percentage of participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: There were 67 patients that were not eligible for the 6-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.
-Binary rate The occurrence of any of the following: 1. Clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis: Angiographic documentation of acute complete occlusion (TIMI flow 0 or 1) of a previously successfully treated artery (TIMI flow 2 to 3 immediately after stent placement and diameter stenosis less than or equal to 30%) and/or Angiographic documentation of a flow limiting thrombus within or adjacent to a previously successfully treated lesion 2. Acute MI in the distribution of the treated vessel. 3. Death within the first 30 days post index procedure (without other obvious cause) is considered a surrogate for stent thrombosis when angiography is not available.
Outcome measures
| Measure |
TAXUS Libertē Post-Approval Study Enrolled Population
n=4132 Participants
There were a total of 4,199 patients in the TAXUS Libertē Post-Approval Study that received at least one TAXUS Liberte stent.
|
|---|---|
|
Rate of Stent Thrombosis (Protocol Definition)
|
0.6 percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: There were 140 patients that were not eligible for the 12-month analyses, as they did not meet the following criteria: either a minimum number of days of follow-up of 335 days or an endpoint event up to 365 days post-stent implant procedure.
-Binary rate The occurrence of any of the following: 1. Clinical presentation of acute coronary syndrome with angiographic evidence of stent thrombosis: Angiographic documentation of acute complete occlusion (TIMI flow 0 or 1) of a previously successfully treated artery (TIMI flow 2 to 3 immediately after stent placement and diameter stenosis less than or equal to 30%) and/or Angiographic documentation of a flow limiting thrombus within or adjacent to a previously successfully treated lesion 2. Acute MI in the distribution of the treated vessel. 3. Death within the first 30 days post index procedure (without other obvious cause) is considered a surrogate for stent thrombosis when angiography is not available.
Outcome measures
| Measure |
TAXUS Libertē Post-Approval Study Enrolled Population
n=4059 Participants
There were a total of 4,199 patients in the TAXUS Libertē Post-Approval Study that received at least one TAXUS Liberte stent.
|
|---|---|
|
Rate of Stent Thrombosis (Protocol Definition)
|
0.9 percentage of participants
|
Adverse Events
TAXUS Liberté: Overall Enrolled Population
Serious events: 1232 serious events
Other events: 293 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TAXUS Liberté: Overall Enrolled Population
n=4199 participants at risk
Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
|
|---|---|
|
Cardiac disorders
Angina pectoris
|
6.0%
253/4199 • Number of events 278 • 1 year
|
|
Cardiac disorders
Angina unstable
|
2.4%
100/4199 • Number of events 113 • 1 year
|
|
Cardiac disorders
Coronary artery disease
|
1.8%
77/4199 • Number of events 79 • 1 year
|
|
Cardiac disorders
Cardiac failure congestive
|
1.1%
48/4199 • Number of events 62 • 1 year
|
|
Cardiac disorders
Coronary artery stenosis
|
1.2%
50/4199 • Number of events 51 • 1 year
|
|
Cardiac disorders
Acute myocardial infarction
|
1.1%
46/4199 • Number of events 50 • 1 year
|
|
Cardiac disorders
Myocardial infarction
|
1.1%
45/4199 • Number of events 48 • 1 year
|
|
Cardiac disorders
Atrial fibrillation
|
0.52%
22/4199 • Number of events 26 • 1 year
|
|
Cardiac disorders
Coronary artery thrombosis
|
0.50%
21/4199 • Number of events 24 • 1 year
|
|
Cardiac disorders
Ventricular tachycardia
|
0.38%
16/4199 • Number of events 16 • 1 year
|
|
Cardiac disorders
Cardiac arrest
|
0.36%
15/4199 • Number of events 15 • 1 year
|
|
Cardiac disorders
Coronary artery dissection
|
0.33%
14/4199 • Number of events 15 • 1 year
|
|
Cardiac disorders
Ischaemic cardiomyopathy
|
0.29%
12/4199 • Number of events 12 • 1 year
|
|
Cardiac disorders
Myocardial ischaemia
|
0.29%
12/4199 • Number of events 12 • 1 year
|
|
Cardiac disorders
Bradycardia
|
0.26%
11/4199 • Number of events 11 • 1 year
|
|
Cardiac disorders
Ventricular fibrillation
|
0.24%
10/4199 • Number of events 10 • 1 year
|
|
Cardiac disorders
Acute coronary syndrome
|
0.14%
6/4199 • Number of events 6 • 1 year
|
|
Cardiac disorders
Cardiac failure
|
0.14%
6/4199 • Number of events 6 • 1 year
|
|
Cardiac disorders
Coronary artery occlusion
|
0.12%
5/4199 • Number of events 5 • 1 year
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.12%
5/4199 • Number of events 5 • 1 year
|
|
Cardiac disorders
Atrioventricular block complete
|
0.10%
4/4199 • Number of events 4 • 1 year
|
|
Cardiac disorders
Sick sinus syndrome
|
0.10%
4/4199 • Number of events 4 • 1 year
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.07%
3/4199 • Number of events 3 • 1 year
|
|
Cardiac disorders
Cardiac failure chronic
|
0.07%
3/4199 • Number of events 3 • 1 year
|
|
Cardiac disorders
Cardiorespiratory arrest
|
0.07%
3/4199 • Number of events 3 • 1 year
|
|
Cardiac disorders
Cardiomyopathy
|
0.07%
3/4199 • Number of events 3 • 1 year
|
|
Cardiac disorders
Congestive myopathy
|
0.07%
3/4199 • Number of events 3 • 1 year
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.07%
3/4199 • Number of events 3 • 1 year
|
|
Cardiac disorders
Arteriospasm coronary
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Cardiac disorders
Atrioventricular block
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Cardiac disorders
Cardiac tamponade
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Cardiac disorders
Cardiogenic Shock
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Cardiac disorders
Coronary artery perforation
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Cardiac disorders
Mitral valve incompetence
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Cardiac disorders
Palpitations
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Cardiac disorders
Aortic Valve Stenosis
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Cardiac disorders
Atrial tachycardia
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Cardiac disorders
Cardiac aneurysm
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Cardiac disorders
Cardiac disorder
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Cardiac disorders
Cardiac failure acute
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Cardiac disorders
Conduction Disorder
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Cardiac disorders
Hypertensive heart disease
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Cardiac disorders
Hypertrophic cardiomyopathy
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Cardiac disorders
Intracardiac thrombus
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Cardiac disorders
Left ventricular failure
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Cardiac disorders
Microvascular angina
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Cardiac disorders
Pericarditis
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Cardiac disorders
Postural orthostatic tachycardia syndrome
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Cardiac disorders
Sinus tachycardia
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Cardiac disorders
Tachycardia
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Cardiac disorders
Ventricle Rupture
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Cardiac disorders
Ventricular dysfunction
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
General disorders
Non-cardiac chest pain
|
3.8%
160/4199 • Number of events 183 • 1 year
|
|
General disorders
Chest pain
|
0.48%
20/4199 • Number of events 23 • 1 year
|
|
General disorders
Catheter site haemorrhage
|
0.14%
6/4199 • Number of events 7 • 1 year
|
|
General disorders
Adverse drug reaction
|
0.14%
6/4199 • Number of events 6 • 1 year
|
|
General disorders
Catheter site haematoma
|
0.14%
6/4199 • Number of events 6 • 1 year
|
|
General disorders
Death
|
0.10%
4/4199 • Number of events 4 • 1 year
|
|
General disorders
Asthenia
|
0.07%
3/4199 • Number of events 3 • 1 year
|
|
General disorders
Chest discomfort
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
General disorders
Impaired healing
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
General disorders
Multi-organ failure
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
General disorders
Pyrexia
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
General disorders
Catheter site discharge
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
General disorders
Catheter site pain
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.2%
51/4199 • Number of events 57 • 1 year
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.24%
10/4199 • Number of events 10 • 1 year
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.21%
9/4199 • Number of events 9 • 1 year
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.19%
8/4199 • Number of events 8 • 1 year
|
|
Gastrointestinal disorders
Gastritis
|
0.17%
7/4199 • Number of events 7 • 1 year
|
|
Gastrointestinal disorders
Pancreatitis
|
0.14%
6/4199 • Number of events 6 • 1 year
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.07%
3/4199 • Number of events 5 • 1 year
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.12%
5/4199 • Number of events 5 • 1 year
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.12%
5/4199 • Number of events 5 • 1 year
|
|
Gastrointestinal disorders
Abdominal pain
|
0.10%
4/4199 • Number of events 4 • 1 year
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.10%
4/4199 • Number of events 4 • 1 year
|
|
Gastrointestinal disorders
Haematemesis
|
0.10%
4/4199 • Number of events 4 • 1 year
|
|
Cardiac disorders
Gastritis Haemorrhagic
|
0.07%
3/4199 • Number of events 3 • 1 year
|
|
Gastrointestinal disorders
Peptic ulcer
|
0.07%
3/4199 • Number of events 3 • 1 year
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Diabetic gastroparesis
|
0.02%
1/4199 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Gastritis erosive
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Abdominal distension
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Colitis
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Diarrhoea
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Diverticulum
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Entercolitis haemorrhagic
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Gastrointestinal ulcer
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Gastrointestinal ulcer haemorrhage
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Lip haemorrhage
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Localised intraabdominal fluid collection
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Melaena
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Oesophageal rupture
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Oesophageal ulcer haemorrhage
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Pancreatic cyst
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Pancreatic pseudocyst
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Pacreatitis chronic
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Peptic ulcer haemorrhage
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Peptic ulcer perforation
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Peritoneal haemorrhage
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Peritonitis
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Proctitis
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Rectal ulcer haemorrhage
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Small intestine perforation
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Infections and infestations
Pneumonia
|
0.69%
29/4199 • Number of events 30 • 1 year
|
|
Infections and infestations
Cellulitis
|
0.31%
13/4199 • Number of events 15 • 1 year
|
|
Infections and infestations
Bronchitis
|
0.17%
7/4199 • Number of events 7 • 1 year
|
|
Infections and infestations
Sepsis
|
0.17%
7/4199 • Number of events 7 • 1 year
|
|
Infections and infestations
Appendicitis
|
0.12%
5/4199 • Number of events 5 • 1 year
|
|
Infections and infestations
Diverticulitis
|
0.07%
3/4199 • Number of events 5 • 1 year
|
|
Infections and infestations
Abscess Limb
|
0.10%
4/4199 • Number of events 4 • 1 year
|
|
Infections and infestations
Gastroenteritis
|
0.07%
3/4199 • Number of events 3 • 1 year
|
|
Infections and infestations
Urinary Tract Infection
|
0.07%
3/4199 • Number of events 3 • 1 year
|
|
Infections and infestations
Cellulitis staphylococcal
|
0.02%
1/4199 • Number of events 2 • 1 year
|
|
Infections and infestations
Diabetic foot infection
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Infections and infestations
Gangrene
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Infections and infestations
Influenza
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Infections and infestations
Lobar pneumonia
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Infections and infestations
Osteomyelitis
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Infections and infestations
Septic shock
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Infections and infestations
Sinusitis
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Infections and infestations
Staphylococcal infection
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Infections and infestations
Urosepsis
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Infections and infestations
Wound infection
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Infections and infestations
Abdominal wall access
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Infections and infestations
Abdominal wall infection
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Infections and infestations
Abscess intestinal
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Infections and infestations
Bronchopneumonia
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Infections and infestations
Bronchopulmonary aspergillosis allergic
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Infections and infestations
Device related infection
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Infections and infestations
Empyema
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Infections and infestations
Fungal infection
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Infections and infestations
Groin infection
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Infections and infestations
Herpes zoster
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Infections and infestations
Infected lymphocyle
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Infections and infestations
Infected skin ulcer
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Infections and infestations
Infection
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Infections and infestations
Pneumonia bacterial
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Infections and infestations
Pyelonephritis
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Infections and infestations
Rectal abcess
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Infections and infestations
Scrotal abcess
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Infections and infestations
Sepsis syndrome
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Infections and infestations
Steptococcal sepsis
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Infections and infestations
Thrombophlebitis septic
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Infections and infestations
Tracheobronchitis
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Infections and infestations
Upper respiritory tract infection
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Nervous system disorders
Syncope
|
0.48%
20/4199 • Number of events 23 • 1 year
|
|
Nervous system disorders
Carotic artery stenosis
|
0.31%
13/4199 • Number of events 14 • 1 year
|
|
Nervous system disorders
Ischaemic stroke
|
0.26%
11/4199 • Number of events 11 • 1 year
|
|
Nervous system disorders
Transient ischaemic attack
|
0.19%
8/4199 • Number of events 8 • 1 year
|
|
Nervous system disorders
Presyncope
|
0.14%
6/4199 • Number of events 6 • 1 year
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.10%
4/4199 • Number of events 4 • 1 year
|
|
Nervous system disorders
Dizziness
|
0.07%
3/4199 • Number of events 3 • 1 year
|
|
Nervous system disorders
Embolic stroke
|
0.07%
3/4199 • Number of events 3 • 1 year
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.07%
3/4199 • Number of events 3 • 1 year
|
|
Nervous system disorders
Carotid sinus syndrome
|
0.02%
1/4199 • Number of events 2 • 1 year
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Nervous system disorders
Cerebral infarction
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Nervous system disorders
Convulsion
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Nervous system disorders
Neuropathy peripheral
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Nervous system disorders
Paraesthesia
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Nervous system disorders
Amnesia
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Nervous system disorders
Anoxic encephalopathy
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Nervous system disorders
Basilar artery thrombosis
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Nervous system disorders
Brain stem infarction
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Nervous system disorders
Burning sensation
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Nervous system disorders
Carotic artery occlusion
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Nervous system disorders
Cerebrovascular accident
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Nervous system disorders
Encephalopathy
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Nervous system disorders
Facial palsy
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Nervous system disorders
Hemianopia homonymous
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Nervous system disorders
Hemiparesis
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Nervous system disorders
Hydrocephalus
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Nervous system disorders
Hypertensive encephalopathy
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Nervous system disorders
Lacunar infarction
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Nervous system disorders
Rapiculopathy
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Nervous system disorders
Tarsal tunnel syndrome
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Nervous system disorders
Thrombotic stroke
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Nervous system disorders
Transient global amnesia
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Nervous system disorders
Vertobasilar insufficiency
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.19%
8/4199 • Number of events 11 • 1 year
|
|
Vascular disorders
Peripheral vascular disorder
|
0.24%
10/4199 • Number of events 10 • 1 year
|
|
Vascular disorders
Deep vein thrombosis
|
0.17%
7/4199 • Number of events 8 • 1 year
|
|
Vascular disorders
Hypertension
|
0.19%
8/4199 • Number of events 8 • 1 year
|
|
Vascular disorders
Hypotension
|
0.19%
8/4199 • Number of events 8 • 1 year
|
|
Vascular disorders
Intermittent claudication
|
0.14%
6/4199 • Number of events 7 • 1 year
|
|
Vascular disorders
Aortic stenosis
|
0.12%
5/4199 • Number of events 5 • 1 year
|
|
Vascular disorders
Orthostatic hypotension
|
0.12%
5/4199 • Number of events 5 • 1 year
|
|
Vascular disorders
Femoral arterial stenosis
|
0.10%
4/4199 • Number of events 4 • 1 year
|
|
Vascular disorders
Iliac artery stenosis
|
0.10%
4/4199 • Number of events 4 • 1 year
|
|
Vascular disorders
Peripheral ischaemia
|
0.10%
4/4199 • Number of events 4 • 1 year
|
|
Vascular disorders
Femoral artery occlusion
|
0.07%
3/4199 • Number of events 3 • 1 year
|
|
Vascular disorders
Haematoma
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Vascular disorders
Hypertensive crisis
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Vascular disorders
Malignant hypertension
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Vascular disorders
Peripheral artery aneurysm
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Vascular disorders
Vasospasm
|
0.02%
1/4199 • Number of events 2 • 1 year
|
|
Vascular disorders
Aortic aneurysm
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Vascular disorders
Arterial fibrosis
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Vascular disorders
Arterial haemorrhage
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Vascular disorders
Arterial stenosis
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Vascular disorders
Arterial stenosis limb
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Vascular disorders
Arterial thrombosis limb
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Vascular disorders
Arteriosclerosis
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Vascular disorders
Blue toe syndrome
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Vascular disorders
Haemorrhage
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Vascular disorders
Hypertensive emergency
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Vascular disorders
Iliac artery occlusion
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Vascular disorders
Peripheral artery dissection
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Vascular disorders
Subclavian artery stenosis
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Vascular disorders
Venous stenosis
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstruction pulmonary disease
|
0.31%
13/4199 • Number of events 17 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.29%
12/4199 • Number of events 15 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.24%
10/4199 • Number of events 10 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.21%
9/4199 • Number of events 9 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.14%
6/4199 • Number of events 7 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.14%
6/4199 • Number of events 6 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.05%
2/4199 • Number of events 3 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary alveolar haemorrhage
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Status asthmaticus
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.38%
16/4199 • Number of events 16 • 1 year
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.07%
3/4199 • Number of events 4 • 1 year
|
|
Injury, poisoning and procedural complications
Contusion
|
0.10%
4/4199 • Number of events 4 • 1 year
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.10%
4/4199 • Number of events 4 • 1 year
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.07%
3/4199 • Number of events 4 • 1 year
|
|
Injury, poisoning and procedural complications
Overdose
|
0.07%
3/4199 • Number of events 3 • 1 year
|
|
Injury, poisoning and procedural complications
Post procedural myocardial infarction
|
0.07%
3/4199 • Number of events 3 • 1 year
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Injury, poisoning and procedural complications
Device malfunction
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Injury, poisoning and procedural complications
Head injury
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Injury, poisoning and procedural complications
Anastamotic ulcer haemorrhage
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Burns third degree
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Contrast media reaction
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Device lead damage
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Incision site haematoma
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Incision site pain
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Laceration
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Mouth injury
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Poisoning
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Scrotal haematoma
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Splenic rupture
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Traumatic lung injury
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Vascular procedure complication
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
Anaemia
|
0.64%
27/4199 • Number of events 28 • 1 year
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.12%
5/4199 • Number of events 5 • 1 year
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.05%
2/4199 • Number of events 3 • 1 year
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
0.05%
2/4199 • Number of events 3 • 1 year
|
|
Blood and lymphatic system disorders
Thrombocytopenic purpura
|
0.02%
1/4199 • Number of events 2 • 1 year
|
|
Blood and lymphatic system disorders
Anaemic haemolytic autoimmune
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
Heparin-induced thrombocytopenia
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
Platelet aggregation inhibition
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Renal failure acute
|
0.40%
17/4199 • Number of events 18 • 1 year
|
|
Renal and urinary disorders
Renal failure
|
0.17%
7/4199 • Number of events 7 • 1 year
|
|
Renal and urinary disorders
Haematuria
|
0.14%
6/4199 • Number of events 6 • 1 year
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.07%
3/4199 • Number of events 3 • 1 year
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.07%
3/4199 • Number of events 3 • 1 year
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.02%
1/4199 • Number of events 2 • 1 year
|
|
Renal and urinary disorders
Pelvi-ureteric obstruction
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Renal and urinary disorders
Renal failure chronic
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Renal and urinary disorders
Renal impairment
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Renal and urinary disorders
Calculus ureteric
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Urethral haemorrhagic
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.17%
7/4199 • Number of events 7 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.10%
4/4199 • Number of events 5 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.10%
4/4199 • Number of events 4 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.07%
3/4199 • Number of events 3 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.07%
3/4199 • Number of events 3 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthrofibrosis
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.10%
4/4199 • Number of events 5 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.07%
3/4199 • Number of events 3 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of bladder
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal cancer metastatic
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer stage IV
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intestinal adenocarcenoma
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia recurrent
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma metastatic
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma stage IV
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma stage 1
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma stage III
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung squamous cell carcinoma stage unspecified
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer metastatic
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pharyngeal cancer stage unspecified
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer metastatic
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer carcinoma
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Dehydration
|
0.07%
3/4199 • Number of events 3 • 1 year
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.02%
1/4199 • Number of events 2 • 1 year
|
|
Metabolism and nutrition disorders
Gout
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Diabetic foot
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Obesity
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.17%
7/4199 • Number of events 7 • 1 year
|
|
Hepatobiliary disorders
Cholecystitis
|
0.12%
5/4199 • Number of events 6 • 1 year
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.10%
4/4199 • Number of events 4 • 1 year
|
|
Hepatobiliary disorders
Biliary dyskinesia
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Hepatobiliary disorders
Bile duct stone
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Hepatobiliary disorders
Gallbladder disorder
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Mental status changes
|
0.12%
5/4199 • Number of events 5 • 1 year
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Psychiatric disorders
Suicidal ideation
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Psychiatric disorders
Anxiety
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Completed suicide
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Confusional state
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Psychiatric disorders
Psychotic disorder
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Investigations
Cardiac enzymes increased
|
0.10%
4/4199 • Number of events 4 • 1 year
|
|
Investigations
Haemoglobin decreased
|
0.10%
4/4199 • Number of events 4 • 1 year
|
|
Investigations
Bacteria stool identified
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Investigations
Blood glucose decreased
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Investigations
Cardiac stress test abnormal
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Investigations
Electrocardiogram abnormal
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Investigations
Troponin increased
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Immune system disorders
Drug hypersensitivity
|
0.10%
4/4199 • Number of events 4 • 1 year
|
|
Immune system disorders
Hypersensitivity
|
0.07%
3/4199 • Number of events 3 • 1 year
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.07%
3/4199 • Number of events 3 • 1 year
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Reproductive system and breast disorders
Vaginal prolapse
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Congenital, familial and genetic disorders
Haemorrhagic arteriovenous malformation
|
0.05%
2/4199 • Number of events 3 • 1 year
|
|
Congenital, familial and genetic disorders
Atrial septal defect
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Ear and labyrinth disorders
Vertigo
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Eye disorders
Retinal artery occlusion
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Eye disorders
Retinal detachment
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Endocrine disorders
Primary hypothyroidism
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.29%
12/4199 • Number of events 12 • 1 year
|
Other adverse events
| Measure |
TAXUS Liberté: Overall Enrolled Population
n=4199 participants at risk
Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
|
|---|---|
|
Cardiac disorders
Myocardial infarction
|
1.0%
43/4199 • Number of events 43 • 1 year
|
|
Cardiac disorders
Coronary artery disease
|
0.50%
21/4199 • Number of events 21 • 1 year
|
|
Cardiac disorders
Coronary artery dissection
|
0.17%
7/4199 • Number of events 7 • 1 year
|
|
Cardiac disorders
Acute myocardial infarction
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Cardiac disorders
Angina pectoris
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Cardiac disorders
Angina unstable
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Cardiac disorders
Coronary artery stenosis
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Cardiac disorders
Coronary artery thrombosis
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.1%
47/4199 • Number of events 47 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.21%
9/4199 • Number of events 9 • 1 year
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.19%
8/4199 • Number of events 8 • 1 year
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.10%
4/4199 • Number of events 4 • 1 year
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.07%
3/4199 • Number of events 3 • 1 year
|
|
Gastrointestinal disorders
Haematochezia
|
0.07%
3/4199 • Number of events 3 • 1 year
|
|
Gastrointestinal disorders
Melaena
|
0.07%
3/4199 • Number of events 3 • 1 year
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Diarrhoea
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
General disorders
Adverse drug reaction
|
0.48%
20/4199 • Number of events 20 • 1 year
|
|
General disorders
Catheter site haematoma
|
0.17%
7/4199 • Number of events 7 • 1 year
|
|
General disorders
Catheter site haemorrhage
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
General disorders
Chest pain
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
General disorders
Catheter site discharge
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
General disorders
Catheter site related reaction
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
General disorders
Chest discomfort
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
General disorders
Non-cardiac chest pain
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
General disorders
Puncture site haemorrhage
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Post-procedure myocardial infarction
|
0.21%
9/4199 • Number of events 9 • 1 year
|
|
Injury, poisoning and procedural complications
Contusion
|
0.19%
8/4199 • Number of events 8 • 1 year
|
|
Injury, poisoning and procedural complications
Animal scratch
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Tongue injury
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Vascular procedure complication
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Venous injury
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Immune system disorders
Drug hypersensitivity
|
0.45%
19/4199 • Number of events 19 • 1 year
|
|
Immune system disorders
Hypersensitivity
|
0.10%
4/4199 • Number of events 4 • 1 year
|
|
Vascular disorders
Haematoma
|
0.14%
6/4199 • Number of events 6 • 1 year
|
|
Vascular disorders
Haemorrhage
|
0.14%
6/4199 • Number of events 6 • 1 year
|
|
Vascular disorders
Arteriovenous fistula
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Vascular disorders
Venous stenosis
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Investigations
Cardiac enzymes increased
|
0.12%
5/4199 • Number of events 5 • 1 year
|
|
Investigations
Troponin increased
|
0.12%
5/4199 • Number of events 5 • 1 year
|
|
Investigations
Bleeding time prolonged
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Investigations
Blood creatine phosphokinase MB increased
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Investigations
Haemoglobin decreased
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Haematuria
|
0.24%
10/4199 • Number of events 10 • 1 year
|
|
Renal and urinary disorders
Haemorrhage urinary tract
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.07%
3/4199 • Number of events 3 • 1 year
|
|
Skin and subcutaneous tissue disorders
Skin haemorrhage
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Rash generalise
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
Anaemia
|
0.14%
6/4199 • Number of events 6 • 1 year
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Nervous system disorders
Transient ischaemic attack
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Nervous system disorders
Dizziness
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Nervous system disorders
Headache
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Nervous system disorders
Ischaemic stroke
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Eye disorders
Conjunctival haemorrhage
|
0.05%
2/4199 • Number of events 2 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.02%
1/4199 • Number of events 2 • 1 year
|
|
Eye disorders
Hyphaema
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Reproductive system and breast disorders
Haematospermia
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Reproductive system and breast disorders
Scrotal haematocoele
|
0.02%
1/4199 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer recurrent
|
0.02%
1/4199 • Number of events 1 • 1 year
|
Additional Information
Peter Maurer, Director of Clinical Trials
Boston Scientific Corporation
Phone: 1-508-683-6678
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee During the term of the agreement and for a period of one year thereafter, the PI must submit to Boston Scientific each paper, summary, abstract or outline that he intends to present or publish relating to the study, and will not submit or present any proposed publication to a publisher or other party prior to the expiration of 45 days from the date such Proposed Publication is submitted to Boston Scientific.
- Publication restrictions are in place
Restriction type: OTHER