Trial Outcomes & Findings for ABSORB III Randomized Controlled Trial (RCT) (NCT NCT01751906)
NCT ID: NCT01751906
Last Updated: 2023-10-11
Results Overview
TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TV-MI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR).
COMPLETED
NA
2008 participants
1 year
2023-10-11
Participant Flow
The first Lead-In subject (Lead-In Group ) was registered on Dec 28, 2012. A total of 2008 patients (Primary Analysis Group) were randomized into Absorb BVS arm (n = 1322) and Xience arm (n = 686) at 193 study sites between March 22, 2013 \& April 3,2014 and the last 5 year follow-up visit was on May 31, 2019.
Of total 13,789 eligible population,11,781 patients were excluded due to, 1. Not meeting general eligibility criteria only (n=567); 2. Not meeting angiographic eligibility criteria only (n=10,690); 3. Not meeting both 1 and 2 (n=64); 4. Other reasons (n=460).
Participant milestones
| Measure |
Absorb BVS
Subjects receiving Absorb BVS
Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm
* Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.
* The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.
Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
XIENCE
Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition
XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).
* Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm
* Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition
* For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices
To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
|---|---|---|
|
Overall Study
STARTED
|
1322
|
686
|
|
Overall Study
COMPLETED
|
1059
|
555
|
|
Overall Study
NOT COMPLETED
|
263
|
131
|
Reasons for withdrawal
| Measure |
Absorb BVS
Subjects receiving Absorb BVS
Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm
* Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.
* The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.
Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
XIENCE
Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition
XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).
* Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm
* Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition
* For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices
To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
151
|
68
|
|
Overall Study
Withdrawal by Subject
|
22
|
18
|
|
Overall Study
Physician Decision
|
5
|
2
|
|
Overall Study
Death
|
84
|
43
|
|
Overall Study
Denied on premises for follow-up by law
|
1
|
0
|
Baseline Characteristics
The number of participants analyzed includes subjects who were available at that time of analysis
Baseline characteristics by cohort
| Measure |
Absorb BVS
n=1322 Participants
Subjects receiving Absorb BVS
Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm
* Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.
* The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.
Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
XIENCE
n=686 Participants
Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition
XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).
* Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm
* Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition
* For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices
To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
Total
n=2008 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.5 years
STANDARD_DEVIATION 10.6 • n=1322 Participants
|
63.6 years
STANDARD_DEVIATION 10.3 • n=686 Participants
|
63.5 years
STANDARD_DEVIATION 10.5 • n=2008 Participants
|
|
Sex: Female, Male
Female
|
388 Participants
n=1322 Participants
|
205 Participants
n=686 Participants
|
593 Participants
n=2008 Participants
|
|
Sex: Female, Male
Male
|
934 Participants
n=1322 Participants
|
481 Participants
n=686 Participants
|
1415 Participants
n=2008 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
50 Participants
n=1322 Participants
|
23 Participants
n=686 Participants
|
73 Participants
n=2008 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
1250 Participants
n=1322 Participants
|
652 Participants
n=686 Participants
|
1902 Participants
n=2008 Participants
|
|
Race/Ethnicity, Customized
Unknown or not reported
|
22 Participants
n=1322 Participants
|
11 Participants
n=686 Participants
|
33 Participants
n=2008 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
8 Participants
n=1322 Participants
|
2 Participants
n=686 Participants
|
10 Participants
n=2008 Participants
|
|
Race/Ethnicity, Customized
Asian
|
20 Participants
n=1322 Participants
|
13 Participants
n=686 Participants
|
33 Participants
n=2008 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
8 Participants
n=1322 Participants
|
1 Participants
n=686 Participants
|
9 Participants
n=2008 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
70 Participants
n=1322 Participants
|
34 Participants
n=686 Participants
|
104 Participants
n=2008 Participants
|
|
Race/Ethnicity, Customized
White
|
1152 Participants
n=1322 Participants
|
606 Participants
n=686 Participants
|
1758 Participants
n=2008 Participants
|
|
Region of Enrollment
United States
|
1318 Participants
n=1322 Participants
|
683 Participants
n=686 Participants
|
2001 Participants
n=2008 Participants
|
|
Region of Enrollment
Australia
|
4 Participants
n=1322 Participants
|
3 Participants
n=686 Participants
|
7 Participants
n=2008 Participants
|
|
Hypertension Requiring Medication
|
1071 Participants
n=1322 Participants
|
553 Participants
n=686 Participants
|
1624 Participants
n=2008 Participants
|
|
Dyslipidemia Requiring Medication
|
1009 Participants
n=1322 Participants
|
533 Participants
n=686 Participants
|
1542 Participants
n=2008 Participants
|
|
Prior Coronary Intervention
|
512 Participants
n=1322 Participants • The number of participants analyzed includes subjects who were available at that time of analysis
|
260 Participants
n=684 Participants • The number of participants analyzed includes subjects who were available at that time of analysis
|
772 Participants
n=2006 Participants • The number of participants analyzed includes subjects who were available at that time of analysis
|
|
Stable Angina
|
757 Participants
n=1321 Participants • The number of participants analyzed includes subjects who were available at that time of analysis
|
417 Participants
n=686 Participants • The number of participants analyzed includes subjects who were available at that time of analysis
|
1174 Participants
n=2007 Participants • The number of participants analyzed includes subjects who were available at that time of analysis
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Intent-To-Treat Population set (ITT). The number of participants analyzed includes subjects who had available follow up data at that time frame.
TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TV-MI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Outcome measures
| Measure |
Absorb BVS
n=1313 Participants
Subjects receiving Absorb BVS
Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm
* Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.
* The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.
Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
XIENCE
n=677 Participants
Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition
XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).
* Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm
* Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition
* For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices
To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
|---|---|---|
|
Number of Cardiac Death/TV-MI/ID-TLR (TLF)
|
102 Participants
|
41 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: The analysis will exclude angina following the index procedure through discharge, not to exceed a period of 7 days. ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
Angina is defined as the first adverse event resulting in the site diagnosis of angina.
Outcome measures
| Measure |
Absorb BVS
n=1303 Participants
Subjects receiving Absorb BVS
Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm
* Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.
* The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.
Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
XIENCE
n=678 Participants
Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition
XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).
* Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm
* Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition
* For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices
To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
|---|---|---|
|
Number of Participants With Powered Secondary Endpoint: Angina
|
238 Participants
|
125 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: ITT population. Analysis population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through 1 year without any DMR event (all death, all MI (regardless of MI definition), all revascularization, respectively).
This powered secondary endpoint is intended to assess all revascularization at 1 year and test for superiority of Absorb BVS to XIENCE. All revascularizations are comprised of TLR, TVR excluding TLR, and non-TVR.
Outcome measures
| Measure |
Absorb BVS
n=1313 Participants
Subjects receiving Absorb BVS
Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm
* Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.
* The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.
Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
XIENCE
n=677 Participants
Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition
XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).
* Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm
* Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition
* For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices
To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
|---|---|---|
|
Number of Participants With Powered Secondary Endpoint: All Revascularization
|
120 Participants
|
55 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: For ID-TVR, Fisher's exact test is used for superiority testing based on the ITT population. This analysis will include \~2000 subjects. ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame
This powered secondary endpoint is intended to assess all ID-TVR at 1 year and test for superiority of Absorb BVS to XIENCE.
Outcome measures
| Measure |
Absorb BVS
n=1313 Participants
Subjects receiving Absorb BVS
Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm
* Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.
* The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.
Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
XIENCE
n=677 Participants
Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition
XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).
* Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm
* Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition
* For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices
To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
|---|---|---|
|
Number of Participants With Powered Secondary Endpoint: Ischemia Driven Target Vessel Revascularization (ID-TVR)
|
66 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: On day 0 (the day of procedure)Population: Intent-To-Treat Population set (ITT). The number of participants analyzed includes subjects who had available follow up data at that time frame.
Successful delivery and deployment of the study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system with attainment of final in-scaffold/stent residual stenosis of less than 30% by quantitative coronary angiography (QCA) (by visual estimation if QCA unavailable). When bailout scaffold/stent is used, the success or failure of the bailout scaffold/stent delivery and deployment is not one of the criteria for device success.
Outcome measures
| Measure |
Absorb BVS
n=1355 Target Lesions
Subjects receiving Absorb BVS
Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm
* Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.
* The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.
Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
XIENCE
n=704 Target Lesions
Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition
XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).
* Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm
* Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition
* For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices
To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
|---|---|---|
|
Acute Success- Device Success (Lesion Level Analysis)
|
94.3 Percentage of lesions
|
99.3 Percentage of lesions
|
SECONDARY outcome
Timeframe: On day 0 (the day of procedure)Population: Intent-To-Treat Population set (ITT). The number of participants analyzed includes subjects who had available follow up data at that time frame.
Achievement of final in-scaffold/stent residual stenosis of less than 30% by QCA (by visual estimation if QCA unavailable) with successful delivery and deployment of at least one study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system for all target lesions without the occurrence of cardiac death, target vessel MI or repeat TLR during the hospital stay (maximum of 7 days).
Outcome measures
| Measure |
Absorb BVS
n=1311 Participants
Subjects receiving Absorb BVS
Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm
* Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.
* The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.
Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
XIENCE
n=678 Participants
Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition
XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).
* Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm
* Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition
* For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices
To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
|---|---|---|
|
Acute Success: Procedural Success (Subject Level Analysis)
|
1240 Participants
|
652 Participants
|
SECONDARY outcome
Timeframe: 0 to 5 yearsPopulation: ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.
DEATH (Per ARC Circulation) : All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Outcome measures
| Measure |
Absorb BVS
n=1187 Participants
Subjects receiving Absorb BVS
Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm
* Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.
* The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.
Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
XIENCE
n=612 Participants
Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition
XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).
* Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm
* Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition
* For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices
To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
|---|---|---|
|
Number of Death (Cardiac, Vascular, Non-cardiovascular)
|
85 Participants
|
44 Participants
|
SECONDARY outcome
Timeframe: 0 to 5 yearsPopulation: ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.
* Attributable to target vessel (TV-MI) * Not attributable to target vessel (NTV-MI)
Outcome measures
| Measure |
Absorb BVS
n=1187 Participants
Subjects receiving Absorb BVS
Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm
* Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.
* The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.
Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
XIENCE
n=612 Participants
Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition
XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).
* Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm
* Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition
* For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices
To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
|---|---|---|
|
Number of Participants With All Myocardial Infarction (MI)
|
159 Participants
|
69 Participants
|
SECONDARY outcome
Timeframe: 0 to 5 yearsPopulation: ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven (ID-TLR) or not ischemia driven (NID-TLR) by the investigator prior to repeat angiography. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent.
Outcome measures
| Measure |
Absorb BVS
n=1187 Participants
Subjects receiving Absorb BVS
Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm
* Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.
* The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.
Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
XIENCE
n=612 Participants
Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition
XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).
* Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm
* Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition
* For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices
To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
|---|---|---|
|
Number of Participants With All Target Lesion Revascularization (TLR)
|
118 Participants
|
51 Participants
|
SECONDARY outcome
Timeframe: 0 to 5 yearsPopulation: ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Outcome measures
| Measure |
Absorb BVS
n=1187 Participants
Subjects receiving Absorb BVS
Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm
* Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.
* The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.
Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
XIENCE
n=612 Participants
Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition
XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).
* Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm
* Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition
* For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices
To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
|---|---|---|
|
Number of Participants With All Target Vessel Revascularization (TVR) Excluding Target Lesion Revascularization (TLR)
|
108 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: 0 to 5 yearsPopulation: ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.
All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.
Outcome measures
| Measure |
Absorb BVS
n=1187 Participants
Subjects receiving Absorb BVS
Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm
* Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.
* The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.
Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
XIENCE
n=612 Participants
Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition
XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).
* Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm
* Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition
* For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices
To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
|---|---|---|
|
Number of Participants With All Revascularization
|
255 Participants
|
114 Participants
|
SECONDARY outcome
Timeframe: 0 to 5 yearsPopulation: ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.
All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI
Outcome measures
| Measure |
Absorb BVS
n=1187 Participants
Subjects receiving Absorb BVS
Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm
* Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.
* The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.
Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
XIENCE
n=612 Participants
Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition
XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).
* Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm
* Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition
* For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices
To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
|---|---|---|
|
Number of Death/All MI
|
230 Participants
|
101 Participants
|
SECONDARY outcome
Timeframe: 0 to 5 yearsPopulation: ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.
All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI
Outcome measures
| Measure |
Absorb BVS
n=1187 Participants
Subjects receiving Absorb BVS
Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm
* Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.
* The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.
Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
XIENCE
n=612 Participants
Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition
XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).
* Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm
* Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition
* For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices
To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
|---|---|---|
|
Number of Cardiac Death/All MI
|
185 Participants
|
81 Participants
|
SECONDARY outcome
Timeframe: 0 to 5 yearsPopulation: ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Outcome measures
| Measure |
Absorb BVS
n=1187 Participants
Subjects receiving Absorb BVS
Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm
* Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.
* The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.
Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
XIENCE
n=612 Participants
Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition
XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).
* Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm
* Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition
* For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices
To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
|---|---|---|
|
Number of Cardiac Death/TV-MI/ID-TLR (TLF)
|
220 Participants
|
98 Participants
|
SECONDARY outcome
Timeframe: 0 to 5 yearsPopulation: ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Outcome measures
| Measure |
Absorb BVS
n=1187 Participants
Subjects receiving Absorb BVS
Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm
* Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.
* The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.
Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
XIENCE
n=612 Participants
Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition
XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).
* Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm
* Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition
* For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices
To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
|---|---|---|
|
Number of Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)
|
245 Participants
|
113 Participants
|
SECONDARY outcome
Timeframe: 0 to 5 yearsPopulation: ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Outcome measures
| Measure |
Absorb BVS
n=1187 Participants
Subjects receiving Absorb BVS
Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm
* Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.
* The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.
Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
XIENCE
n=612 Participants
Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition
XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).
* Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm
* Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition
* For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices
To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
|---|---|---|
|
Number of Participants With Target Vessel Failure (TVF)
|
290 Participants
|
128 Participants
|
SECONDARY outcome
Timeframe: 0 to 5 yearsPopulation: ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
Outcome measures
| Measure |
Absorb BVS
n=1187 Participants
Subjects receiving Absorb BVS
Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm
* Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.
* The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.
Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
XIENCE
n=612 Participants
Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition
XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).
* Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm
* Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition
* For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices
To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
|---|---|---|
|
Number of Death/All MI/All Revascularization (DMR)
|
378 Participants
|
168 Participants
|
SECONDARY outcome
Timeframe: ≤ 1 DayPopulation: Analyzed population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any Stent/Scaffold Thrombosis event. ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing : Acute : 0 - 24 hours post stent implantation; Subacute : \>24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : \>1 year post stent implantation. Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of Any unexplained death within the first 30 days or Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.
Outcome measures
| Measure |
Absorb BVS
n=1319 Participants
Subjects receiving Absorb BVS
Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm
* Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.
* The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.
Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
XIENCE
n=686 Participants
Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition
XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).
* Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm
* Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition
* For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices
To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
|---|---|---|
|
Number of Participants With Acute Stent/Scaffold Thrombosis (Per ARC Definition)
Definite/Probable
|
3 Participants
|
4 Participants
|
|
Number of Participants With Acute Stent/Scaffold Thrombosis (Per ARC Definition)
Definite
|
3 Participants
|
4 Participants
|
|
Number of Participants With Acute Stent/Scaffold Thrombosis (Per ARC Definition)
Probable
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 0 to 30 DaysPopulation: Analyzed population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any Stent/Scaffold Thrombosis event. ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing : Acute : 0 - 24 hours post stent implantation; Subacute : \>24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : \>1 year post stent implantation. Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of Any unexplained death within the first 30 days or Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.
Outcome measures
| Measure |
Absorb BVS
n=1314 Participants
Subjects receiving Absorb BVS
Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm
* Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.
* The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.
Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
XIENCE
n=686 Participants
Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition
XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).
* Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm
* Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition
* For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices
To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
|---|---|---|
|
Number of Participants With Acute/Subacute Stent/Scaffold Thrombosis (Per ARC Definition)
Definite/Probable
|
14 Participants
|
5 Participants
|
|
Number of Participants With Acute/Subacute Stent/Scaffold Thrombosis (Per ARC Definition)
Definite
|
12 Participants
|
5 Participants
|
|
Number of Participants With Acute/Subacute Stent/Scaffold Thrombosis (Per ARC Definition)
Probable
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: >1 to 30 DaysPopulation: Analyzed population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any Stent/Scaffold Thrombosis event. ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing : Acute : 0 - 24 hours post stent implantation; Subacute : \>24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : \>1 year post stent implantation. Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of Any unexplained death within the first 30 days or Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.
Outcome measures
| Measure |
Absorb BVS
n=1314 Participants
Subjects receiving Absorb BVS
Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm
* Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.
* The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.
Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
XIENCE
n=686 Participants
Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition
XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).
* Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm
* Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition
* For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices
To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
|---|---|---|
|
Number of Participants With Subacute Stent/Scaffold Thrombosis
Definite
|
10 Participants
|
1 Participants
|
|
Number of Participants With Subacute Stent/Scaffold Thrombosis
Probable
|
2 Participants
|
0 Participants
|
|
Number of Participants With Subacute Stent/Scaffold Thrombosis
Definite/Probable
|
12 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 31 to 365 DaysPopulation: Analyzed population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any Stent/Scaffold Thrombosis event. ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing : Acute : 0 - 24 hours post stent implantation; Subacute : \>24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : \>1 year post stent implantation. Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of * Any unexplained death within the first 30 days or * Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.
Outcome measures
| Measure |
Absorb BVS
n=1289 Participants
Subjects receiving Absorb BVS
Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm
* Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.
* The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.
Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
XIENCE
n=672 Participants
Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition
XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).
* Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm
* Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition
* For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices
To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
|---|---|---|
|
Number of Participants With Late Stent/Scaffold Thrombosis (Per ARC Definition)
Definite/Probable
|
6 Participants
|
0 Participants
|
|
Number of Participants With Late Stent/Scaffold Thrombosis (Per ARC Definition)
Definite
|
6 Participants
|
0 Participants
|
|
Number of Participants With Late Stent/Scaffold Thrombosis (Per ARC Definition)
Probable
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 366 to 393 DaysPopulation: Analyzed population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any Stent/Scaffold Thrombosis event. ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing : Acute : 0 - 24 hours post stent implantation; Subacute : \>24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : \>1 year post stent implantation. Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of * Any unexplained death within the first 30 days or * Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.
Outcome measures
| Measure |
Absorb BVS
n=1289 Participants
Subjects receiving Absorb BVS
Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm
* Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.
* The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.
Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
XIENCE
n=672 Participants
Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition
XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).
* Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm
* Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition
* For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices
To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
|---|---|---|
|
Number of Participants With Very Late Stent /Scaffold Thrombosis (Per ARC Definition)
Definite/Probable
|
0 Participants
|
0 Participants
|
|
Number of Participants With Very Late Stent /Scaffold Thrombosis (Per ARC Definition)
Definite
|
0 Participants
|
0 Participants
|
|
Number of Participants With Very Late Stent /Scaffold Thrombosis (Per ARC Definition)
Probable
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 0 to 1853 DaysPopulation: Analyzed population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any Stent/Scaffold Thrombosis event. ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing : Acute : 0 - 24 hours post stent implantation; Subacute : \>24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : \>1 year post stent implantation. Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of * Any unexplained death within the first 30 days or * Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.
Outcome measures
| Measure |
Absorb BVS
n=1072 Participants
Subjects receiving Absorb BVS
Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm
* Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.
* The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.
Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
XIENCE
n=558 Participants
Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition
XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).
* Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm
* Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition
* For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices
To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
|---|---|---|
|
Number of Participants With Cumulative Stent/Scaffold Thrombosis
Definite/Probable
|
32 Participants
|
7 Participants
|
|
Number of Participants With Cumulative Stent/Scaffold Thrombosis
Definite
|
30 Participants
|
7 Participants
|
|
Number of Participants With Cumulative Stent/Scaffold Thrombosis
Probable
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: < or = 1 dayPopulation: ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.
Angiographic endpoint Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen.
Outcome measures
| Measure |
Absorb BVS
n=1380 Target Lesions
Subjects receiving Absorb BVS
Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm
* Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.
* The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.
Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
XIENCE
n=708 Target Lesions
Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition
XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).
* Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm
* Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition
* For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices
To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
|---|---|---|
|
Pre-Procedure Minimum Lumen Diameter (MLD)
|
0.92 Millimeter
Standard Deviation 0.37
|
0.90 Millimeter
Standard Deviation 0.34
|
SECONDARY outcome
Timeframe: < or = 1 dayPopulation: ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.
Percent Diameter Stenosis is defined as the value calculated as 100 \* (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).
Outcome measures
| Measure |
Absorb BVS
n=1380 Target Lesions
Subjects receiving Absorb BVS
Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm
* Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.
* The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.
Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
XIENCE
n=708 Target Lesions
Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition
XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).
* Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm
* Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition
* For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices
To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
|---|---|---|
|
Pre-Procedure Percent Diameter Stenosis (%DS)
|
65.25 Percent Diameter stenosis
Standard Deviation 12.48
|
65.90 Percent Diameter stenosis
Standard Deviation 11.66
|
SECONDARY outcome
Timeframe: ≤ 7 days post index procedurePopulation: ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.
Angiographic endpoint. Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. In- Segment is defined as, within the margins of the stent or scaffold and 5 mm proximal and 5 mm distal to the stent or scaffold.
Outcome measures
| Measure |
Absorb BVS
n=1374 Target Lesions
Subjects receiving Absorb BVS
Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm
* Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.
* The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.
Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
XIENCE
n=706 Target Lesions
Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition
XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).
* Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm
* Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition
* For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices
To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
|---|---|---|
|
Post-Procedure In-Segment Minimum Lumen Diameter (MLD)
|
2.15 Millimeter
Standard Deviation 0.41
|
2.14 Millimeter
Standard Deviation 0.43
|
SECONDARY outcome
Timeframe: ≤ 7 days post index procedurePopulation: ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.
Angiographic endpoint. Percent Diameter Stenosis is defined as the value calculated as 100 \* (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA). In- Segment is defined as, within the margins of the stent or scaffold and 5 mm proximal and 5 mm distal to the stent or scaffold.
Outcome measures
| Measure |
Absorb BVS
n=1374 Target Lesions
Subjects receiving Absorb BVS
Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm
* Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.
* The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.
Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
XIENCE
n=706 Target Lesions
Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition
XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).
* Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm
* Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition
* For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices
To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
|---|---|---|
|
Post-Procedure In-Segment Percent Diameter Stenosis (%DS)
|
20.04 Percent Diameter stenosis
Standard Deviation 7.94
|
19.82 Percent Diameter stenosis
Standard Deviation 8.20
|
SECONDARY outcome
Timeframe: ≤ 7 days post index procedurePopulation: ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.
Angiographic endpoint. Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. In- Segment is defined as, within the margins of the stent or scaffold and 5 mm proximal and 5 mm distal to the stent or scaffold
Outcome measures
| Measure |
Absorb BVS
n=1373 Target Lesions
Subjects receiving Absorb BVS
Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm
* Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.
* The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.
Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
XIENCE
n=706 Target Lesions
Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition
XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).
* Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm
* Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition
* For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices
To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
|---|---|---|
|
Post-Procedure In-Device Minimum Lumen Diameter (MLD)
|
2.37 Millimeter
Standard Deviation 0.40
|
2.49 Millimeter
Standard Deviation 0.40
|
SECONDARY outcome
Timeframe: ≤ 7 days post index procedurePopulation: ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.
Angiographic endpoint. Percent Diameter Stenosis is defined as the value calculated as 100 \* (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).
Outcome measures
| Measure |
Absorb BVS
n=1369 Target Lesions
Subjects receiving Absorb BVS
Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm
* Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.
* The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.
Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
XIENCE
n=702 Target Lesions
Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition
XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).
* Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm
* Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition
* For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices
To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
|---|---|---|
|
Post-Procedure In-Device Percent Diameter Stenosis (%DS)
|
11.62 Percent Diameter stenosis
Standard Deviation 8.77
|
6.41 Percent Diameter stenosis
Standard Deviation 8.91
|
SECONDARY outcome
Timeframe: ≤ 7 days post index procedurePopulation: ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.
The acute gain was defined as the difference between post- and pre procedural minimal lumen diameter (MLD).
Outcome measures
| Measure |
Absorb BVS
n=1372 Target Lesions
Subjects receiving Absorb BVS
Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm
* Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.
* The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.
Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
XIENCE
n=706 Target Lesions
Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition
XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).
* Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm
* Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition
* For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices
To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
|---|---|---|
|
Post-Procedure In-Device Acute Gain
|
1.45 mm
Standard Deviation 0.45
|
1.59 mm
Standard Deviation 0.44
|
SECONDARY outcome
Timeframe: From Post procedure to 3 YearsPopulation: The full analysis set (FAS) population is defined as the patients wherein the target lesion was treated with the assigned device.
* Mean lumen area measured after nitrate infusions, superiority test, \~300 pooled subjects. * Pooled IVUS subjects (\~300 subjects): 150 subjects from the Imaging Cohort of ABSORB III RCT and 150 subjects from ABSORB Japan RCT.
Outcome measures
| Measure |
Absorb BVS
n=119 Lesions
Subjects receiving Absorb BVS
Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm
* Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.
* The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.
Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
XIENCE
n=65 Lesions
Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition
XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).
* Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm
* Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition
* For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices
To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
|---|---|---|
|
Powered Imaging Cohort Secondary Endpoint: The Instent/Scaffold Mean Lumen Area Change, From Post Procedure to 3 Years by Intravascular Ultrasound (IVUS)
|
-0.30 mm^2
Standard Deviation 1.32
|
-0.60 mm^2
Standard Deviation 0.91
|
SECONDARY outcome
Timeframe: 3 YearsPopulation: The full analysis set (FAS) population is defined as the patients wherein the target lesion was treated with the assigned device
All OCT endpoints will be collected for within the device and within the treated segment: Descriptive analysis of strut, lesion and vessel morphology Mean neointimal area (NIA) - Apposed to the vessel wall with neointimal coverage Apposed to vessel wall without neointimal coverage Incomplete apposition to vessel wall with neointimal coverage Incomplete apposition to vessel wall without neointimal coverage Lumen area/volume stenosis % Mean/minimal device area Mean/minimal luminal area/volume Mean strut area/volume Persisting incomplete apposition, late incomplete apposition at 3 years (if analyzable) OCT analysis for subjects with jailed side branch Descriptive analyses from 3-dimensional OCT reconstructions
Outcome measures
| Measure |
Absorb BVS
n=21 Leisions
Subjects receiving Absorb BVS
Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm
* Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.
* The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.
Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
XIENCE
n=10 Leisions
Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition
XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).
* Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm
* Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition
* For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices
To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
|---|---|---|
|
Optical Coherence Tomography (OCT) Endpoint: Mean Neointimal Area (NIA)
|
1.12 mm^2
Standard Deviation 0.48
|
1.19 mm^2
Standard Deviation 0.61
|
SECONDARY outcome
Timeframe: 3 YearsPopulation: The full analysis set (FAS) population is defined as the patients wherein the target lesion was treated with the assigned device.
All OCT endpoints will be collected for within the device and within the treated segment: Descriptive analysis of strut, lesion and vessel morphology Mean neointimal area (NIA) - Apposed to the vessel wall with neointimal coverage Apposed to vessel wall without neointimal coverage Incomplete apposition to vessel wall with neointimal coverage Incomplete apposition to vessel wall without neointimal coverage Lumen area/volume stenosis % Mean/minimal device area Mean/minimal luminal area/volume Mean strut area/volume Persisting incomplete apposition, late incomplete apposition at 3 years (if analyzable) OCT analysis for subjects with jailed side branch Descriptive analyses from 3-dimensional OCT reconstructions
Outcome measures
| Measure |
Absorb BVS
n=33 Leisions
Subjects receiving Absorb BVS
Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm
* Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.
* The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.
Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
XIENCE
n=16 Leisions
Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition
XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).
* Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm
* Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition
* For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices
To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
|---|---|---|
|
Optical Coherence Tomography (OCT) Endpoint: Mean Device Area, Adluminal
Post-procedure
|
6.89 mm^2
Standard Deviation 1.98
|
7.25 mm^2
Standard Deviation 1.51
|
|
Optical Coherence Tomography (OCT) Endpoint: Mean Device Area, Adluminal
3 Years
|
7.70 mm^2
Standard Deviation 2.54
|
7.24 mm^2
Standard Deviation 1.90
|
SECONDARY outcome
Timeframe: 3 YearsPopulation: The full analysis set (FAS) population is defined as the patients wherein the target lesion was treated with the assigned device.
All OCT endpoints will be collected for within the device and within the treated segment: Descriptive analysis of strut, lesion and vessel morphology Mean neointimal area (NIA) - Apposed to the vessel wall with neointimal coverage Apposed to vessel wall without neointimal coverage Incomplete apposition to vessel wall with neointimal coverage Incomplete apposition to vessel wall without neointimal coverage Lumen area/volume stenosis % Mean/minimal device area Mean/minimal luminal area/volume Mean strut area/volume Persisting incomplete apposition, late incomplete apposition at 3 years (if analyzable) OCT analysis for subjects with jailed side branch Descriptive analyses from 3-dimensional OCT reconstructions
Outcome measures
| Measure |
Absorb BVS
n=33 Leisions
Subjects receiving Absorb BVS
Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm
* Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.
* The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.
Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
XIENCE
n=16 Leisions
Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition
XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).
* Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm
* Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition
* For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices
To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
|---|---|---|
|
Optical Coherence Tomography (OCT) Endpoint: Mean Lumen Area
3 Years
|
6.67 mm^2
Standard Deviation 2.36
|
6.06 mm^2
Standard Deviation 1.73
|
|
Optical Coherence Tomography (OCT) Endpoint: Mean Lumen Area
Post-procedure
|
7.99 mm^2
Standard Deviation 2.12
|
7.50 mm^2
Standard Deviation 1.46
|
SECONDARY outcome
Timeframe: 3 YearsPopulation: The full analysis set (FAS) population is defined as the patients wherein the target lesion was treated with the assigned device.
All OCT endpoints will be collected for within the device and within the treated segment: Descriptive analysis of strut, lesion and vessel morphology Mean neointimal area (NIA) - Apposed to the vessel wall with neointimal coverage Apposed to vessel wall without neointimal coverage Incomplete apposition to vessel wall with neointimal coverage Incomplete apposition to vessel wall without neointimal coverage Lumen area/volume stenosis % Mean/minimal device area Mean/minimal luminal area/volume Mean strut area/volume Persisting incomplete apposition, late incomplete apposition at 3 years (if analyzable) OCT analysis for subjects with jailed side branch Descriptive analyses from 3-dimensional OCT reconstructions
Outcome measures
| Measure |
Absorb BVS
n=33 Leisions
Subjects receiving Absorb BVS
Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm
* Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.
* The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.
Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
XIENCE
n=16 Leisions
Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition
XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).
* Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm
* Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition
* For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices
To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
|---|---|---|
|
Optical Coherence Tomography (OCT) Endpoint: Minimal Lumen Area
Post-procedure
|
6.47 mm^2
Standard Deviation 1.82
|
6.07 mm^2
Standard Deviation 1.46
|
|
Optical Coherence Tomography (OCT) Endpoint: Minimal Lumen Area
3 Years
|
4.95 mm^2
Standard Deviation 1.78
|
4.54 mm^2
Standard Deviation 1.40
|
SECONDARY outcome
Timeframe: 3 YearsPopulation: The full analysis set (FAS) population is defined as the patients wherein the target lesion was treated with the assigned device.
All OCT endpoints will be collected for within the device and within the treated segment: Descriptive analysis of strut, lesion and vessel morphology Mean neointimal area (NIA) - Apposed to the vessel wall with neointimal coverage Apposed to vessel wall without neointimal coverage Incomplete apposition to vessel wall with neointimal coverage Incomplete apposition to vessel wall without neointimal coverage Lumen area/volume stenosis % Mean/minimal device area Mean/minimal luminal area/volume Mean strut area/volume Persisting incomplete apposition, late incomplete apposition at 3 years (if analyzable) OCT analysis for subjects with jailed side branch Descriptive analyses from 3-dimensional OCT reconstructions
Outcome measures
| Measure |
Absorb BVS
n=33 Leisions
Subjects receiving Absorb BVS
Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm
* Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.
* The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.
Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
XIENCE
n=16 Leisions
Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition
XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).
* Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm
* Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition
* For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices
To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
|---|---|---|
|
Optical Coherence Tomography (OCT) Endpoint: Percentage of Malapposition Struts
Post-procedure
|
7.42 Percentage of Malapposition Struts
Standard Deviation 5.49
|
7.64 Percentage of Malapposition Struts
Standard Deviation 6.26
|
|
Optical Coherence Tomography (OCT) Endpoint: Percentage of Malapposition Struts
3 Years
|
0.32 Percentage of Malapposition Struts
Standard Deviation 0.99
|
0.07 Percentage of Malapposition Struts
Standard Deviation 0.22
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.
Overall health status assessed using the EuroQoL 5D (EQ-5D™). EQ-5D: * Scale range: 0 to 1 * Higher values represent better outcomes * Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Subscale scores are summed to obtain total/overall health status. A scoring algorithm was used to combine the sub-scores from each of the 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), and generate a single index ranging from 0 to 1
Outcome measures
| Measure |
Absorb BVS
n=1249 Participants
Subjects receiving Absorb BVS
Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm
* Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.
* The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.
Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
XIENCE
n=651 Participants
Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition
XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).
* Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm
* Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition
* For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices
To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
|---|---|---|
|
Patient Reported Outcomes (PRO): Overall Health Status
|
0.77 score on a scale
Standard Deviation 0.2
|
0.77 score on a scale
Standard Deviation 0.20
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 monthPopulation: ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.
Overall health status assessed using the EuroQoL 5D (EQ-5D™). EQ-5D: * Scale range: 0 to 1 * Higher values represent better outcomes * Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Subscale scores are summed to obtain total/overall health status. A scoring algorithm was used to combine the sub-scores from each of the 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), and generate a single index ranging from 0 to 1
Outcome measures
| Measure |
Absorb BVS
n=1231 Participants
Subjects receiving Absorb BVS
Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm
* Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.
* The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.
Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
XIENCE
n=647 Participants
Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition
XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).
* Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm
* Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition
* For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices
To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
|---|---|---|
|
Patient Reported Outcomes (PRO): Overall Health Status
|
0.85 score on a scale
Standard Deviation 0.18
|
0.85 score on a scale
Standard Deviation 0.18
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.
Overall health status assessed using the EuroQoL 5D (EQ-5D™). EQ-5D: * Scale range: 0 to 1 * Higher values represent better outcomes * Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Subscale scores are summed to obtain total/overall health status. A scoring algorithm was used to combine the sub-scores from each of the 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), and generate a single index ranging from 0 to 1
Outcome measures
| Measure |
Absorb BVS
n=1087 Participants
Subjects receiving Absorb BVS
Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm
* Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.
* The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.
Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
XIENCE
n=567 Participants
Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition
XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).
* Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm
* Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition
* For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices
To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
|---|---|---|
|
Patient Reported Outcomes (PRO): Overall Health Status
|
0.83 score on a scale
Standard Deviation 0.20
|
0.83 score on a scale
Standard Deviation 0.19
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.
Anxiety assessed using the Generalized Anxiety Disorder scale (GAD-7). GAD-7: * Scale range: 0 to 21 * Lower values represent better outcomes * No subscales
Outcome measures
| Measure |
Absorb BVS
n=1009 Participants
Subjects receiving Absorb BVS
Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm
* Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.
* The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.
Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
XIENCE
n=530 Participants
Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition
XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).
* Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm
* Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition
* For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices
To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
|---|---|---|
|
Patient Reported Outcomes (PRO): Anxiety
|
5.92 score on a scale
Standard Deviation 5.86
|
6.34 score on a scale
Standard Deviation 6.07
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 monthPopulation: ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.
Anxiety assessed using the Generalized Anxiety Disorder scale (GAD-7). GAD-7: * Scale range: 0 to 21 * Lower values represent better outcomes * No subscales
Outcome measures
| Measure |
Absorb BVS
n=1067 Participants
Subjects receiving Absorb BVS
Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm
* Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.
* The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.
Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
XIENCE
n=556 Participants
Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition
XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).
* Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm
* Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition
* For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices
To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
|---|---|---|
|
Patient Reported Outcomes (PRO): Anxiety
|
3.39 score on a scale
Standard Deviation 4.64
|
3.33 score on a scale
Standard Deviation 4.61
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.
Anxiety assessed using the Generalized Anxiety Disorder scale (GAD-7). GAD-7: * Scale range: 0 to 21 * Lower values represent better outcomes * No subscales
Outcome measures
| Measure |
Absorb BVS
n=911 Participants
Subjects receiving Absorb BVS
Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm
* Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.
* The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.
Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
XIENCE
n=482 Participants
Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition
XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).
* Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm
* Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition
* For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices
To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
|---|---|---|
|
Patient Reported Outcomes (PRO): Anxiety
|
3.92 score on a scale
Standard Deviation 4.99
|
4.04 score on a scale
Standard Deviation 5.08
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.
Disease-Specific quality of life assessed using the Seattle Angina Questionnaire (SAQ) Seattle Angina Questionnaire (SAQ): Each scale is transformed to a score of 0 to 100, where higher scores indicate better function (eg, less physical limitation, less angina, and better quality of life).
Outcome measures
| Measure |
Absorb BVS
n=1195 Participants
Subjects receiving Absorb BVS
Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm
* Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.
* The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.
Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
XIENCE
n=617 Participants
Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition
XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).
* Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm
* Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition
* For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices
To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
|---|---|---|
|
Patient Reported Outcomes (PRO): Disease-Specific Quality of Life
|
67.67 score on a scale
Standard Deviation 20.20
|
67.11 score on a scale
Standard Deviation 19.17
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 monthPopulation: ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.
Disease-Specific quality of life in hospital baseline and at 1 year assessed using the Seattle Angina Questionnaire (SAQ). Seattle Angina Questionnaire (SAQ): Each scale is transformed to a score of 0 to 100, where higher scores indicate better function (eg, less physical limitation, less angina, and better quality of life).
Outcome measures
| Measure |
Absorb BVS
n=1131 Participants
Subjects receiving Absorb BVS
Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm
* Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.
* The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.
Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
XIENCE
n=589 Participants
Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition
XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).
* Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm
* Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition
* For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices
To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
|---|---|---|
|
Patient Reported Outcomes (PRO): Disease-Specific Quality of Life
|
87.10 score on a scale
Standard Deviation 14.27
|
86.98 score on a scale
Standard Deviation 14.16
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.
Disease-Specific quality of life in hospital baseline and at 1 year assessed using the Seattle Angina Questionnaire (SAQ). Seattle Angina Questionnaire (SAQ): Each scale is transformed to a score of 0 to 100, where higher scores indicate better function (eg, less physical limitation, less angina, and better quality of life).
Outcome measures
| Measure |
Absorb BVS
n=1014 Participants
Subjects receiving Absorb BVS
Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm
* Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.
* The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.
Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
XIENCE
n=514 Participants
Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition
XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).
* Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm
* Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition
* For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices
To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
|---|---|---|
|
Patient Reported Outcomes (PRO): Disease-Specific Quality of Life
|
87.05 score on a scale
Standard Deviation 13.91
|
86.42 score on a scale
Standard Deviation 14.45
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.
Dyspnea severity assessed using the Rose Dyspnea Scale (RDS). Rose Dyspnea Scale: * Scale range: 0 to 4 * Lower values represent better outcomes (higher scores indicate worse dyspnea) * No subscales
Outcome measures
| Measure |
Absorb BVS
n=1242 Participants
Subjects receiving Absorb BVS
Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm
* Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.
* The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.
Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
XIENCE
n=651 Participants
Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition
XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).
* Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm
* Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition
* For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices
To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
|---|---|---|
|
Patient Reported Outcomes (PRO): Dyspnea Severity
|
1.66 score on a scale
Standard Deviation 1.48
|
1.65 score on a scale
Standard Deviation 1.46
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 monthPopulation: ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.
Dyspnea severity assessed using the Rose Dyspnea Scale (RDS). Rose Dyspnea Scale: * Scale range: 0 to 4 * Lower values represent better outcomes (higher scores indicate worse dyspnea) * No subscales
Outcome measures
| Measure |
Absorb BVS
n=1220 Participants
Subjects receiving Absorb BVS
Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm
* Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.
* The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.
Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
XIENCE
n=636 Participants
Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition
XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).
* Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm
* Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition
* For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices
To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
|---|---|---|
|
Patient Reported Outcomes (PRO): Dyspnea Severity
|
0.81 score on a scale
Standard Deviation 1.24
|
0.88 score on a scale
Standard Deviation 1.29
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 monthsPopulation: ITT population. The number of participants analyzed includes subjects who had available follow-up data at that time frame. The analysis excludes subjects who are truly lost to follow-up.
Dyspnea severity assessed using the Rose Dyspnea Scale (RDS). Rose Dyspnea Scale: * Scale range: 0 to 4 * Lower values represent better outcomes (higher scores indicate worse dyspnea) * No subscales
Outcome measures
| Measure |
Absorb BVS
n=1080 Participants
Subjects receiving Absorb BVS
Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm
* Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.
* The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.
Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
XIENCE
n=568 Participants
Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition
XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).
* Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm
* Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition
* For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices
To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
|---|---|---|
|
Patient Reported Outcomes (PRO): Dyspnea Severity
|
0.94 score on a scale
Standard Deviation 1.26
|
0.99 score on a scale
Standard Deviation 1.30
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3-4 yearsPopulation: ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.
TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TVMI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Outcome measures
| Measure |
Absorb BVS
n=1202 Participants
Subjects receiving Absorb BVS
Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm
* Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.
* The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.
Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
XIENCE
n=610 Participants
Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition
XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).
* Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm
* Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition
* For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices
To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
|---|---|---|
|
Landmark Analysis on TLF and Components
|
38 Participants
|
16 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3-5 yearsPopulation: ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.
TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TVMI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Outcome measures
| Measure |
Absorb BVS
n=1108 Participants
Subjects receiving Absorb BVS
Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm
* Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.
* The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.
Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
XIENCE
n=580 Participants
Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition
XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).
* Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm
* Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition
* For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices
To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
|---|---|---|
|
Landmark Analysis on TLF and Components
|
60 Participants
|
38 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3-4 yearsPopulation: Analyzed population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any Stent/Scaffold Thrombosis event. ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing : Acute : 0 - 24 hours post stent implantation; Subacute : \>24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : \>1 year post stent implantation. Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of * Any unexplained death within the first 30 days or * Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.
Outcome measures
| Measure |
Absorb BVS
n=1180 Participants
Subjects receiving Absorb BVS
Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm
* Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.
* The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.
Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
XIENCE
n=607 Participants
Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition
XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).
* Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm
* Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition
* For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices
To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
|---|---|---|
|
Landmark Analysis on Cumulative Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable)
Definite
|
1 Participants
|
1 Participants
|
|
Landmark Analysis on Cumulative Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable)
Probable
|
0 Participants
|
0 Participants
|
|
Landmark Analysis on Cumulative Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable)
Definite/Probable
|
1 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3-5 yearsPopulation: Analyzed population excludes subjects who are truly lost-to-follow-up, defined as subjects who are terminated through a given time point without any Stent/Scaffold Thrombosis event. ITT population. The number of participants analyzed includes subjects who had available follow up data at that time frame.
Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the Catheterization lab. Timing : Acute : 0 - 24 hours post stent implantation; Subacute : \>24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : \>1 year post stent implantation. Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of * Any unexplained death within the first 30 days or * Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.
Outcome measures
| Measure |
Absorb BVS
n=1059 Participants
Subjects receiving Absorb BVS
Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm
* Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.
* The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.
Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
XIENCE
n=556 Participants
Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition
XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).
* Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm
* Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition
* For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices
To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
|---|---|---|
|
Landmark Analysis on Cumulative Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable)
Definite/Probable
|
1 Participants
|
2 Participants
|
|
Landmark Analysis on Cumulative Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable)
Definite
|
1 Participants
|
2 Participants
|
|
Landmark Analysis on Cumulative Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable)
Probable
|
0 Participants
|
0 Participants
|
Adverse Events
Absorb BVS
XIENCE
Serious adverse events
| Measure |
Absorb BVS
n=1322 participants at risk
Subjects receiving Absorb BVS
Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm
* Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.
* The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.
Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
XIENCE
n=686 participants at risk
Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition
XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).
* Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm
* Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition
* For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices
To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.53%
7/1322 • 5 years
|
1.0%
7/686 • 5 years
|
|
Blood and lymphatic system disorders
ANAEMIA OF CHRONIC DISEASE
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Blood and lymphatic system disorders
COAGULOPATHY
|
0.00%
0/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Blood and lymphatic system disorders
HAEMORRHAGIC ANAEMIA
|
0.15%
2/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Blood and lymphatic system disorders
HEPARIN-INDUCED THROMBOCYTOPENIA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Blood and lymphatic system disorders
IRON DEFICIENCY ANEMIA
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Blood and lymphatic system disorders
LEUKOCYTOSIS
|
0.15%
2/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Blood and lymphatic system disorders
LYMPHADENOPATHY
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Blood and lymphatic system disorders
MICROCYTIC ANAEMIA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Blood and lymphatic system disorders
NORMOCHROMIC NORMOCYTIC ANAEMIA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Cardiac disorders
ACUTE CORONARY SYNDROME
|
0.45%
6/1322 • 5 years
|
0.73%
5/686 • 5 years
|
|
Cardiac disorders
ACUTE LEFT VENTRICULAR FAILURE
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
3.7%
49/1322 • 5 years
|
3.1%
21/686 • 5 years
|
|
Cardiac disorders
ANGINA PECTORIS
|
12.2%
161/1322 • 5 years
|
12.7%
87/686 • 5 years
|
|
Cardiac disorders
ANGINA UNSTABLE
|
5.1%
68/1322 • 5 years
|
4.1%
28/686 • 5 years
|
|
Cardiac disorders
AORTIC VALVE DISEASE
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Cardiac disorders
AORTIC VALVE STENOSIS
|
0.45%
6/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Cardiac disorders
ARRHYTHMIA
|
0.08%
1/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Cardiac disorders
ARTERIOSCLEROSIS CORONARY ARTERY
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Cardiac disorders
ARTERIOSPASM CORONARY
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
3.9%
52/1322 • 5 years
|
3.1%
21/686 • 5 years
|
|
Cardiac disorders
ATRIAL FLUTTER
|
0.45%
6/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Cardiac disorders
ATRIAL TACHYCARDIA
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Cardiac disorders
ATRIOVENTRICULAR BLOCK
|
0.23%
3/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Cardiac disorders
ATRIOVENTRICULAR BLOCK COMPLETE
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Cardiac disorders
ATRIOVENTRICULAR BLOCK SECOND DEGREE
|
0.30%
4/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Cardiac disorders
BRADYCARDIA
|
0.68%
9/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Cardiac disorders
BUNDLE BRANCH BLOCK
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Cardiac disorders
CARDIAC ARREST
|
0.76%
10/1322 • 5 years
|
0.87%
6/686 • 5 years
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.61%
8/1322 • 5 years
|
0.58%
4/686 • 5 years
|
|
Cardiac disorders
CARDIAC FAILURE ACUTE
|
0.38%
5/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Cardiac disorders
CARDIAC FAILURE CHRONIC
|
0.15%
2/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
2.4%
32/1322 • 5 years
|
3.6%
25/686 • 5 years
|
|
Cardiac disorders
CARDIAC TAMPONADE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Cardiac disorders
CARDIAC VALVE DISEASE
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Cardiac disorders
CARDIO-RESPIRATORY ARREST
|
0.15%
2/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Cardiac disorders
CARDIOGENIC SHOCK
|
0.08%
1/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Cardiac disorders
CARDIOMYOPATHY
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Cardiac disorders
CARDIORENAL SYNDROME
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Cardiac disorders
CHRONIC LEFT VENTRICULAR FAILURE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Cardiac disorders
CONDUCTION DISORDER
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Cardiac disorders
CONGESTIVE CARDIOMYOPATHY
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
2.9%
38/1322 • 5 years
|
3.5%
24/686 • 5 years
|
|
Cardiac disorders
CORONARY ARTERY DISSECTION
|
1.7%
22/1322 • 5 years
|
1.7%
12/686 • 5 years
|
|
Cardiac disorders
CORONARY ARTERY EMBOLISM
|
0.15%
2/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Cardiac disorders
CORONARY ARTERY OCCLUSION
|
0.30%
4/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Cardiac disorders
CORONARY ARTERY PERFORATION
|
0.38%
5/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Cardiac disorders
CORONARY ARTERY STENOSIS
|
1.5%
20/1322 • 5 years
|
1.9%
13/686 • 5 years
|
|
Cardiac disorders
CORONARY OSTIAL STENOSIS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Cardiac disorders
DRESSLER'S SYNDROME
|
0.00%
0/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Cardiac disorders
IN-STENT CORONARY ARTERY RESTENOSIS
|
0.30%
4/1322 • 5 years
|
0.73%
5/686 • 5 years
|
|
Cardiac disorders
INTRACARDIAC THROMBUS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Cardiac disorders
ISCHAEMIC CARDIOMYOPATHY
|
0.23%
3/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Cardiac disorders
LEFT VENTRICULAR DYSFUNCTION
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Cardiac disorders
MITRAL VALVE INCOMPETENCE
|
0.38%
5/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
3.9%
52/1322 • 5 years
|
3.4%
23/686 • 5 years
|
|
Cardiac disorders
MYOCARDIAL ISCHAEMIA
|
0.23%
3/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Cardiac disorders
PALPITATIONS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Cardiac disorders
PERICARDIAL EFFUSION
|
0.38%
5/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Cardiac disorders
PERICARDITIS
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Cardiac disorders
PRINZMETAL ANGINA
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Cardiac disorders
SICK SINUS SYNDROME
|
0.45%
6/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Cardiac disorders
SINUS ARRHYTHMIA
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Cardiac disorders
SINUS BRADYCARDIA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Cardiac disorders
SUPRAVENTRICULAR TACHYCARDIA
|
0.38%
5/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Cardiac disorders
TACHYCARDIA
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Cardiac disorders
TORSADE DE POINTES
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Cardiac disorders
VENTRICULAR ARRHYTHMIA
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Cardiac disorders
VENTRICULAR EXTRASYSTOLES
|
0.23%
3/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Cardiac disorders
VENTRICULAR FIBRILLATION
|
0.38%
5/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Cardiac disorders
VENTRICULAR TACHYCARDIA
|
0.61%
8/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Congenital, familial and genetic disorders
CYSTIC LYMPHANGIOMA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Congenital, familial and genetic disorders
PULMONARY ARTERIOVENOUS FISTULA
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Ear and labyrinth disorders
VERTIGO
|
0.38%
5/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Eye disorders
AMAUROSIS FUGAX
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Eye disorders
CATARACT
|
0.00%
0/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Eye disorders
CATARACT NUCLEAR
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Eye disorders
DIPLOPIA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Eye disorders
GLAUCOMA
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Eye disorders
MACULAR OEDEMA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Eye disorders
PAPILLOEDEMA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Eye disorders
POSTERIOR CAPSULE OPACIFICATION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Eye disorders
RETINAL DETACHMENT
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Eye disorders
RETINAL HAEMORRHAGE
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Eye disorders
VISION BLURRED
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Gastrointestinal disorders
ABDOMINAL HERNIA
|
0.23%
3/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Gastrointestinal disorders
ABDOMINAL HERNIA OBSTRUCTIVE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.23%
3/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.15%
2/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Gastrointestinal disorders
ABDOMINAL WALL HAEMATOMA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Gastrointestinal disorders
ALCOHOLIC PANCREATITIS
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Gastrointestinal disorders
COELIAC ARTERY STENOSIS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Gastrointestinal disorders
COLITIS
|
0.15%
2/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Gastrointestinal disorders
COLITIS ISCHAEMIC
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Gastrointestinal disorders
CROHN'S DISEASE
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Gastrointestinal disorders
DENTAL CARIES
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Gastrointestinal disorders
DIABETIC GASTROPARESIS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.23%
3/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Gastrointestinal disorders
DIVERTICULUM
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Gastrointestinal disorders
DIVERTICULUM INTESTINAL HAEMORRHAGIC
|
0.15%
2/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Gastrointestinal disorders
DUODENAL ULCER
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Gastrointestinal disorders
DUODENAL ULCER HAEMORRHAGE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Gastrointestinal disorders
DYSPHAGIA
|
0.38%
5/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Gastrointestinal disorders
ENTEROVESICAL FISTULA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Gastrointestinal disorders
FAECALOMA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Gastrointestinal disorders
GASTRIC HAEMORRHAGE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Gastrointestinal disorders
GASTRIC ULCER
|
0.15%
2/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Gastrointestinal disorders
GASTRIC ULCER HAEMORRHAGE
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Gastrointestinal disorders
GASTRITIS
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Gastrointestinal disorders
GASTROINTESTINAL ANGIODYSPLASIA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
0.98%
13/1322 • 5 years
|
1.9%
13/686 • 5 years
|
|
Gastrointestinal disorders
GASTROINTESTINAL ULCER HAEMORRHAGE
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
0.38%
5/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Gastrointestinal disorders
HAEMATEMESIS
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Gastrointestinal disorders
HAEMATOCHEZIA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Gastrointestinal disorders
HAEMORRHOIDAL HAEMORRHAGE
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Gastrointestinal disorders
HIATUS HERNIA
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Gastrointestinal disorders
ILEUS
|
0.08%
1/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Gastrointestinal disorders
IMPAIRED GASTRIC EMPTYING
|
0.23%
3/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Gastrointestinal disorders
INGUINAL HERNIA
|
0.15%
2/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Gastrointestinal disorders
INTESTINAL MASS
|
0.15%
2/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
0.00%
0/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Gastrointestinal disorders
IRRITABLE BOWEL SYNDROME
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Gastrointestinal disorders
LARGE INTESTINE PERFORATION
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Gastrointestinal disorders
LOWER GASTROINTESTINAL HAEMORRHAGE
|
0.15%
2/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Gastrointestinal disorders
MALLORY-WEISS SYNDROME
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Gastrointestinal disorders
MELAENA
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Gastrointestinal disorders
MOUTH HAEMORRHAGE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Gastrointestinal disorders
OESOPHAGEAL ACHALASIA
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Gastrointestinal disorders
OESOPHAGITIS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Gastrointestinal disorders
PANCREATIC CYST
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Gastrointestinal disorders
PANCREATITIS
|
0.08%
1/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Gastrointestinal disorders
PANCREATITIS ACUTE
|
0.15%
2/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Gastrointestinal disorders
RECTAL HAEMORRHAGE
|
0.15%
2/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Gastrointestinal disorders
RETROPERITONEAL HAEMORRHAGE
|
0.23%
3/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
0.23%
3/1322 • 5 years
|
0.87%
6/686 • 5 years
|
|
Gastrointestinal disorders
SMALL INTESTINAL PERFORATION
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Gastrointestinal disorders
UMBILICAL HERNIA
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Gastrointestinal disorders
UMBILICAL HERNIA, OBSTRUCTIVE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Gastrointestinal disorders
UPPER GASTROINTESTINAL HAEMORRHAGE
|
0.23%
3/1322 • 5 years
|
0.58%
4/686 • 5 years
|
|
General disorders
ABASIA
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
General disorders
ADVERSE DRUG REACTION
|
0.23%
3/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
General disorders
ASTHENIA
|
0.38%
5/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
General disorders
CARDIAC DEATH
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
General disorders
CATHETER SITE HAEMATOMA
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
General disorders
CATHETER SITE HAEMORRHAGE
|
0.08%
1/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
General disorders
CATHETER SITE PAIN
|
0.00%
0/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
General disorders
CHEST DISCOMFORT
|
0.76%
10/1322 • 5 years
|
1.2%
8/686 • 5 years
|
|
General disorders
CHEST PAIN
|
3.0%
40/1322 • 5 years
|
2.6%
18/686 • 5 years
|
|
General disorders
DEATH
|
0.76%
10/1322 • 5 years
|
0.87%
6/686 • 5 years
|
|
General disorders
DEVICE ELECTRICAL FINDING
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
General disorders
DEVICE FAILURE
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
General disorders
DEVICE MALFUNCTION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
General disorders
DEVICE OCCLUSION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
General disorders
DROWNING
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
General disorders
DRUG INTOLERANCE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
General disorders
DRUG WITHDRAWAL SYNDROME
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
General disorders
HERNIA
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
General disorders
HERNIA OBSTRUCTIVE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
General disorders
IMPAIRED HEALING
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
General disorders
MEDICAL DEVICE SITE REACTION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
General disorders
MULTI-ORGAN FAILURE
|
0.08%
1/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
6.4%
84/1322 • 5 years
|
7.4%
51/686 • 5 years
|
|
General disorders
OEDEMA PERIPHERAL
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
General disorders
PAIN
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
General disorders
PELVIC MASS
|
0.00%
0/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
General disorders
PYREXIA
|
0.45%
6/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
General disorders
SUDDEN CARDIAC DEATH
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
General disorders
SURGICAL FAILURE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
General disorders
SYSTEMIC INFLAMMATORY RESPONSE SYNDROME
|
0.23%
3/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
General disorders
THROMBOSIS IN DEVICE
|
0.68%
9/1322 • 5 years
|
0.87%
6/686 • 5 years
|
|
Hepatobiliary disorders
BILE DUCT STONE
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Hepatobiliary disorders
CHOLANGITIS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.23%
3/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Hepatobiliary disorders
CHOLECYSTITIS ACUTE
|
0.15%
2/1322 • 5 years
|
0.58%
4/686 • 5 years
|
|
Hepatobiliary disorders
CHOLECYSTITIS CHRONIC
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.53%
7/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Hepatobiliary disorders
GALLBLADDER DISORDER
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Hepatobiliary disorders
HEPATIC LESION
|
0.15%
2/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Hepatobiliary disorders
PORTAL VEIN THROMBOSIS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Immune system disorders
ALLERGY TO ARTHROPOD STING
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Infections and infestations
ABDOMINAL ABSCESS
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Infections and infestations
ABSCESS NECK
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
APPENDICITIS
|
0.30%
4/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Infections and infestations
APPENDICITIS PERFORATED
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
ARTHRITIS BACTERIAL
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
ARTHRITIS INFECTIVE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
BACTERAEMIA
|
0.30%
4/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
BACTERIAL INFECTION
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Infections and infestations
BACTERIAL SEPSIS
|
0.00%
0/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Infections and infestations
BREAST CELLULITIS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
BRONCHITIS
|
0.76%
10/1322 • 5 years
|
0.87%
6/686 • 5 years
|
|
Infections and infestations
BRONCHITIS VIRAL
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
CATHETER SITE ABSCESS
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
CATHETER SITE CELLULITIS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
CATHETER SITE INFECTION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
CELLULITIS
|
0.83%
11/1322 • 5 years
|
1.6%
11/686 • 5 years
|
|
Infections and infestations
CHOLECYSTITIS INFECTIVE
|
0.00%
0/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Infections and infestations
CLOSTRIDIAL INFECTION
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Infections and infestations
CLOSTRIDIUM DIFFICILE COLITIS
|
0.15%
2/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Infections and infestations
CYSTITIS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
DIABETIC FOOT INFECTION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
DIVERTICULITIS
|
0.38%
5/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Infections and infestations
ENDOCARDITIS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
ENTEROCOCCAL SEPSIS
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Infections and infestations
ESCHERICHIA BACTERAEMIA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
FUNGAL INFECTION
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Infections and infestations
GANGRENE
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Infections and infestations
GASTROENTERITIS
|
0.45%
6/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
0.08%
1/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Infections and infestations
GENITAL INFECTION FEMALE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
HERPES ZOSTER
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Infections and infestations
HIV INFECTION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
IMPLANT SITE INFECTION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
INFECTED DERMAL CYST
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
INFECTED SKIN ULCER
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Infections and infestations
INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
INFLUENZA
|
0.23%
3/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Infections and infestations
KIDNEY INFECTION
|
0.23%
3/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
LOBAR PNEUMONIA
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Infections and infestations
LOCALISED INFECTION
|
0.00%
0/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Infections and infestations
LUNG ABSCESS
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Infections and infestations
MENINGITIS ASEPTIC
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
METAPNEUMOVIRUS INFECTION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
MYCOBACTERIUM ABSCESSUS INFECTION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
ORAL FUNGAL INFECTION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
ORCHITIS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
OSTEOMYELITIS
|
0.23%
3/1322 • 5 years
|
0.58%
4/686 • 5 years
|
|
Infections and infestations
PERITONITIS
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Infections and infestations
PERITONSILLAR ABSCESS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
PNEUMONIA
|
1.9%
25/1322 • 5 years
|
2.8%
19/686 • 5 years
|
|
Infections and infestations
PNEUMONIA ADENOVIRAL
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
PNEUMONIA BACTERIAL
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
PNEUMONIA NECROTISING
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
PNEUMONIA PRIMARY ATYPICAL
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
PNEUMONIA STAPHYLOCOCCAL
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
POST PROCEDURAL CELLULITIS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
POST PROCEDURAL INFECTION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
POST PROCEDURAL PNEUMONIA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
POSTOPERATIVE WOUND INFECTION
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Infections and infestations
RESPIRATORY SYNCYTIAL VIRUS INFECTION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
SEPSIS
|
1.1%
14/1322 • 5 years
|
1.5%
10/686 • 5 years
|
|
Infections and infestations
SEPSIS SYNDROME
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
SEPTIC ENCEPHALOPATHY
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Infections and infestations
SEPTIC SHOCK
|
0.15%
2/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Infections and infestations
SPINAL CORD INFECTION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
STAPHYLOCOCCAL BACTERAEMIA
|
0.00%
0/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Infections and infestations
STAPHYLOCOCCAL INFECTION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.68%
9/1322 • 5 years
|
1.0%
7/686 • 5 years
|
|
Infections and infestations
URINARY TRACT INFECTION BACTERIAL
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Infections and infestations
UROSEPSIS
|
0.23%
3/1322 • 5 years
|
0.58%
4/686 • 5 years
|
|
Infections and infestations
VIRAL INFECTION
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
VIRAL LABYRINTHITIS
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Infections and infestations
WOUND INFECTION
|
0.08%
1/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Infections and infestations
WOUND INFECTION BACTERIAL
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Infections and infestations
WOUND INFECTION STAPHYLOCOCCAL
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Injury, poisoning and procedural complications
ACETABULUM FRACTURE
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Injury, poisoning and procedural complications
ALCOHOL POISONING
|
0.15%
2/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Injury, poisoning and procedural complications
ANAEMIA POSTOPERATIVE
|
0.23%
3/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Injury, poisoning and procedural complications
ANKLE FRACTURE
|
0.08%
1/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Injury, poisoning and procedural complications
BURNS THIRD DEGREE
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Injury, poisoning and procedural complications
CARDIAC PROCEDURE COMPLICATION
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Injury, poisoning and procedural complications
CEREBRAL HAEMORRHAGE TRAUMATIC
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
CLAVICLE FRACTURE
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Injury, poisoning and procedural complications
COLON INJURY
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
CONCUSSION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
CONTRAST MEDIA ALLERGY
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
CORONARY ARTERY RESTENOSIS
|
3.9%
51/1322 • 5 years
|
2.2%
15/686 • 5 years
|
|
Injury, poisoning and procedural complications
CRANIOCEREBRAL INJURY
|
0.23%
3/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
CYSTITIS RADIATION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
DEEP VEIN THROMBOSIS POSTOPERATIVE
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
EXPOSURE TO TOXIC AGENT
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
FALL
|
0.68%
9/1322 • 5 years
|
1.0%
7/686 • 5 years
|
|
Injury, poisoning and procedural complications
FEMORAL NECK FRACTURE
|
0.00%
0/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Injury, poisoning and procedural complications
FEMUR FRACTURE
|
0.23%
3/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
FOOT FRACTURE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
GASTROINTESTINAL ANASTOMOTIC LEAK
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Injury, poisoning and procedural complications
HAND FRACTURE
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Injury, poisoning and procedural complications
HEAD INJURY
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Injury, poisoning and procedural complications
HIP FRACTURE
|
0.30%
4/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Injury, poisoning and procedural complications
HUMERUS FRACTURE
|
0.00%
0/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Injury, poisoning and procedural complications
ILIOTIBIAL BAND SYNDROME
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Injury, poisoning and procedural complications
IN-STENT ARTERIAL RESTENOSIS
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Injury, poisoning and procedural complications
IN-STENT CORONARY ARTERY RESTENOSIS
|
0.53%
7/1322 • 5 years
|
0.73%
5/686 • 5 years
|
|
Injury, poisoning and procedural complications
INCISIONAL HERNIA
|
0.23%
3/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
INJURY
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
JOINT DISLOCATION
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Injury, poisoning and procedural complications
LACERATION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
LIGAMENT RUPTURE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
LIMB INJURY
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Injury, poisoning and procedural complications
LIMB TRAUMATIC AMPUTATION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
MENISCUS LESION
|
0.30%
4/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Injury, poisoning and procedural complications
MULTIPLE FRACTURES
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
MULTIPLE INJURIES
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
MUSCLE RUPTURE
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Injury, poisoning and procedural complications
PELVIC FRACTURE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
PLAQUE SHIFT
|
0.08%
1/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Injury, poisoning and procedural complications
POST CONCUSSION SYNDROME
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL HAEMATOMA
|
0.08%
1/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL HAEMORRHAGE
|
0.08%
1/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL MYOCARDIAL INFARCTION
|
0.53%
7/1322 • 5 years
|
0.73%
5/686 • 5 years
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL STROKE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
POST-TRAUMATIC PAIN
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
POSTOPERATIVE ADHESION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
PROCEDURAL COMPLICATION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
PROCEDURAL DIZZINESS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
PROCEDURAL HEADACHE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
PROCEDURAL HYPOTENSION
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Injury, poisoning and procedural complications
PROCEDURAL VOMITING
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
RADIUS FRACTURE
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Injury, poisoning and procedural complications
RESPIRATORY FUME INHALATION DISORDER
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
RIB FRACTURE
|
0.15%
2/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Injury, poisoning and procedural complications
ROAD TRAFFIC ACCIDENT
|
0.30%
4/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
SEROMA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
SKULL FRACTURE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
SNAKE BITE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
SPINAL COMPRESSION FRACTURE
|
0.30%
4/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Injury, poisoning and procedural complications
SPINAL FRACTURE
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
SPLENIC RUPTURE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
STERNAL FRACTURE
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Injury, poisoning and procedural complications
SUBDURAL HAEMATOMA
|
0.45%
6/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Injury, poisoning and procedural complications
TENDON INJURY
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Injury, poisoning and procedural complications
TENDON RUPTURE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
THERMAL BURN
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
THORACIC VERTEBRAL FRACTURE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
TIBIA FRACTURE
|
0.00%
0/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Injury, poisoning and procedural complications
TRAUMATIC HAEMATOMA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
TRAUMATIC HAEMORRHAGE
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Injury, poisoning and procedural complications
ULNA FRACTURE
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Injury, poisoning and procedural complications
UPPER LIMB FRACTURE
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
URINARY RETENTION POSTOPERATIVE
|
0.23%
3/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
VASCULAR GRAFT OCCLUSION
|
0.15%
2/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Injury, poisoning and procedural complications
VASCULAR PSEUDOANEURYSM
|
0.53%
7/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Injury, poisoning and procedural complications
WOUND
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
WOUND EVISCERATION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
WOUND HAEMORRHAGE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
WRIST FRACTURE
|
0.15%
2/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Investigations
BIOPSY LUNG
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Investigations
BLOOD CREATINE INCREASED
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Investigations
BLOOD CREATINE PHOSPHOKINASE MB INCREASED
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Investigations
BLOOD CREATININE INCREASED
|
0.23%
3/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Investigations
BLOOD PRESSURE INCREASED
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Investigations
BLOOD PRESSURE SYSTOLIC INCREASED
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Investigations
CARDIAC ENZYMES INCREASED
|
0.30%
4/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Investigations
CARDIAC STRESS TEST ABNORMAL
|
0.08%
1/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Investigations
COMPUTERISED TOMOGRAM ABNORMAL
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Investigations
COMPUTERISED TOMOGRAM THORAX ABNORMAL
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Investigations
EJECTION FRACTION DECREASED
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Investigations
ELECTROCARDIOGRAM ST SEGMENT ELEVATION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Investigations
HAEMOGLOBIN DECREASED
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Investigations
HEART RATE INCREASED
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Investigations
OXYGEN CONSUMPTION INCREASED
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Investigations
TROPONIN INCREASED
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Investigations
WHITE BLOOD CELL COUNT INCREASED
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.53%
7/1322 • 5 years
|
0.73%
5/686 • 5 years
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Metabolism and nutrition disorders
DIABETIC KETOACIDOSIS
|
0.38%
5/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Metabolism and nutrition disorders
FAILURE TO THRIVE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Metabolism and nutrition disorders
FLUID OVERLOAD
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
0.45%
6/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
0.00%
0/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
0.30%
4/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.23%
3/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.23%
3/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Metabolism and nutrition disorders
HYPOVOLAEMIA
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Metabolism and nutrition disorders
LACTIC ACIDOSIS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Metabolism and nutrition disorders
METABOLIC ACIDOSIS
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Metabolism and nutrition disorders
OBESITY
|
0.45%
6/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.38%
5/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
0.30%
4/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.23%
3/1322 • 5 years
|
0.58%
4/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
BURSITIS
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
CHONDROCALCINOSIS PYROPHOSPHATE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
COSTOCHONDRITIS
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
DUPUYTREN'S CONTRACTURE
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
EXOSTOSIS
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
FLANK PAIN
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
FRACTURE NONUNION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
0.68%
9/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
JOINT EFFUSION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
LUMBAR SPINAL STENOSIS
|
0.53%
7/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
0.15%
2/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
0.30%
4/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL DISORDER
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
0.08%
1/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
2.0%
26/1322 • 5 years
|
2.0%
14/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
OSTEOPENIA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
OSTEOPOROSIS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.30%
4/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
PAIN IN JAW
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
RHABDOMYOLYSIS
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
RHEUMATOID ARTHRITIS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
ROTATOR CUFF SYNDROME
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
SACROILIITIS
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
SPINAL OSTEOARTHRITIS
|
0.23%
3/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
SPONDYLITIS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
SPONDYLOLISTHESIS
|
0.23%
3/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
TENDINOUS CONTRACTURE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
VERTEBRAL FORAMINAL STENOSIS
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ACUTE MYELOID LEUKAEMIA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ACUTE MYELOID LEUKAEMIA RECURRENT
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ADENOCARCINOMA
|
0.15%
2/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ADENOCARCINOMA PANCREAS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-CELL LYMPHOMA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-CELL LYMPHOMA STAGE IV
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
|
0.08%
1/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BENIGN OVARIAN TUMOUR
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BILE DUCT CANCER
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BLADDER CANCER
|
0.23%
3/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BLADDER CANCER RECURRENT
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BLADDER CANCER STAGE IV
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BLADDER NEOPLASM
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BRAIN NEOPLASM
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
0.38%
5/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER STAGE III
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CERVIX CARCINOMA
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CHRONIC LYMPHOCYTIC LEUKAEMIA
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
COLON ADENOMA
|
0.15%
2/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
COLON CANCER
|
0.15%
2/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
DIFFUSE LARGE B-CELL LYMPHOMA
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
GASTRIC CANCER
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
GLIOBLASTOMA
|
0.00%
0/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HEAD AND NECK CANCER
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HEAD AND NECK CANCER METASTATIC
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HEPATIC CANCER METASTATIC
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HEPATIC NEOPLASM MALIGNANT
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HYPOPHARYNGEAL CANCER
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LEUKAEMIA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LEUKAEMIA RECURRENT
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LIP AND/OR ORAL CAVITY CANCER
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG ADENOCARCINOMA
|
0.23%
3/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG CANCER METASTATIC
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG NEOPLASM
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG NEOPLASM MALIGNANT
|
0.45%
6/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG SQUAMOUS CELL CARCINOMA STAGE III
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG SQUAMOUS CELL CARCINOMA STAGE UNSPECIFIED
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LYMPHOMA
|
0.30%
4/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT MELANOMA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MENINGIOMA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO LIVER
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO LUNG
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO LYMPH NODES
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO SPINE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTATIC MALIGNANT MELANOMA
|
0.23%
3/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTATIC NEOPLASM
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MULTIPLE MYELOMA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NEOPLASM MALIGNANT
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NON-HODGKIN'S LYMPHOMA
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NON-SMALL CELL LUNG CANCER
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
OESOPHAGEAL CARCINOMA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ORAL NEOPLASM
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
OROPHARYNGEAL CANCER STAGE UNSPECIFIED
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
OVARIAN CANCER METASTATIC
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
OVARIAN EPITHELIAL CANCER
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PANCREATIC CARCINOMA
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PERICARDIAL EFFUSION MALIGNANT
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER
|
0.83%
11/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RECTAL CANCER
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RENAL CANCER
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RENAL CELL CARCINOMA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RENAL NEOPLASM
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SINONASAL PAPILLOMA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SKIN CANCER
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SMALL CELL LUNG CANCER LIMITED STAGE
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SMALL CELL LUNG CANCER STAGE UNSPECIFIED
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA
|
0.23%
3/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA OF SKIN
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TRANSITIONAL CELL CARCINOMA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
URETERIC CANCER
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
UTERINE CANCER
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
VULVAL CANCER STAGE 0
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Nervous system disorders
ALTERED STATE OF CONSCIOUSNESS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Nervous system disorders
APHASIA
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Nervous system disorders
ARACHNOIDITIS
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Nervous system disorders
AUTONOMIC NERVOUS SYSTEM IMBALANCE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Nervous system disorders
CAROTID ARTERY DISEASE
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Nervous system disorders
CAROTID ARTERY STENOSIS
|
0.83%
11/1322 • 5 years
|
1.0%
7/686 • 5 years
|
|
Nervous system disorders
CARPAL TUNNEL SYNDROME
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Nervous system disorders
CENTRAL NERVOUS SYSTEM LESION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Nervous system disorders
CEREBELLAR INFARCTION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Nervous system disorders
CEREBRAL HAEMORRHAGE
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Nervous system disorders
CEREBRAL INFARCTION
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
1.4%
19/1322 • 5 years
|
2.2%
15/686 • 5 years
|
|
Nervous system disorders
CEREBROVASCULAR DISORDER
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Nervous system disorders
CERVICOBRACHIAL SYNDROME
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Nervous system disorders
COMPLICATED MIGRAINE
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Nervous system disorders
CONVULSION
|
0.23%
3/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Nervous system disorders
DIABETIC NEUROPATHY
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Nervous system disorders
DIZZINESS
|
0.45%
6/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Nervous system disorders
DYSARTHRIA
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Nervous system disorders
EMBOLIC STROKE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Nervous system disorders
ENCEPHALOPATHY
|
0.15%
2/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Nervous system disorders
GUILLAIN-BARRE SYNDROME
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Nervous system disorders
HAEMORRHAGE INTRACRANIAL
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Nervous system disorders
HAEMORRHAGIC STROKE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Nervous system disorders
HEADACHE
|
0.15%
2/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Nervous system disorders
HEMIPARESIS
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Nervous system disorders
HEMIPLEGIC MIGRAINE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Nervous system disorders
HEPATIC ENCEPHALOPATHY
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Nervous system disorders
HYPOAESTHESIA
|
0.08%
1/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Nervous system disorders
HYPOXIC-ISCHAEMIC ENCEPHALOPATHY
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Nervous system disorders
ISCHAEMIC STROKE
|
0.38%
5/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Nervous system disorders
LATERAL MEDULLARY SYNDROME
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Nervous system disorders
LOSS OF CONSCIOUSNESS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Nervous system disorders
LUMBAR RADICULOPATHY
|
0.15%
2/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Nervous system disorders
METABOLIC ENCEPHALOPATHY
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Nervous system disorders
MIGRAINE
|
0.15%
2/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Nervous system disorders
MYELOMALACIA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Nervous system disorders
NEUROLOGICAL SYMPTOM
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Nervous system disorders
NYSTAGMUS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Nervous system disorders
PARAESTHESIA
|
0.30%
4/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Nervous system disorders
POLYNEUROPATHY ALCOHOLIC
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Nervous system disorders
POST-TRAUMATIC HEADACHE
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Nervous system disorders
PRESYNCOPE
|
0.38%
5/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Nervous system disorders
RADICULITIS
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Nervous system disorders
RADICULITIS CERVICAL
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Nervous system disorders
SPONDYLITIC MYELOPATHY
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Nervous system disorders
SUBARACHNOID HAEMORRHAGE
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Nervous system disorders
SUBDURAL HYGROMA
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Nervous system disorders
SYNCOPE
|
1.8%
24/1322 • 5 years
|
1.9%
13/686 • 5 years
|
|
Nervous system disorders
THALAMIC INFARCTION
|
0.23%
3/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Nervous system disorders
THROMBOTIC STROKE
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
0.83%
11/1322 • 5 years
|
0.87%
6/686 • 5 years
|
|
Nervous system disorders
UNRESPONSIVE TO STIMULI
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Nervous system disorders
URAEMIC ENCEPHALOPATHY
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Nervous system disorders
VERTEBRAL ARTERY OCCLUSION
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Nervous system disorders
VITH NERVE PARALYSIS
|
0.15%
2/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Psychiatric disorders
ACUTE STRESS DISORDER
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Psychiatric disorders
ADJUSTMENT DISORDER WITH MIXED DISTURBANCE OF EMOTION AND CONDUCT
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Psychiatric disorders
ALCOHOL ABUSE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Psychiatric disorders
ALCOHOL WITHDRAWAL SYNDROME
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Psychiatric disorders
ANXIETY
|
0.15%
2/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Psychiatric disorders
BIPOLAR DISORDER
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Psychiatric disorders
COMPLETED SUICIDE
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Psychiatric disorders
DELIRIUM
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Psychiatric disorders
DELIRIUM TREMENS
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Psychiatric disorders
DEPRESSION SUICIDAL
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Psychiatric disorders
HALLUCINATION, VISUAL
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Psychiatric disorders
INTENTIONAL SELF-INJURY
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Psychiatric disorders
MAJOR DEPRESSION
|
0.15%
2/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Psychiatric disorders
MENTAL STATUS CHANGES
|
0.38%
5/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Psychiatric disorders
PANIC ATTACK
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Psychiatric disorders
SUICIDAL IDEATION
|
0.00%
0/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Renal and urinary disorders
CALCULUS URETERIC
|
0.08%
1/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Renal and urinary disorders
HAEMATURIA
|
0.23%
3/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Renal and urinary disorders
HYDRONEPHROSIS
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.53%
7/1322 • 5 years
|
1.0%
7/686 • 5 years
|
|
Renal and urinary disorders
RENAL ARTERY STENOSIS
|
0.08%
1/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Renal and urinary disorders
RENAL DISORDER
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.38%
5/1322 • 5 years
|
0.58%
4/686 • 5 years
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
0.91%
12/1322 • 5 years
|
1.7%
12/686 • 5 years
|
|
Renal and urinary disorders
RENAL FAILURE CHRONIC
|
0.15%
2/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Renal and urinary disorders
RENAL IMPAIRMENT
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Renal and urinary disorders
RENAL TUBULAR NECROSIS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Renal and urinary disorders
STRESS URINARY INCONTINENCE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Renal and urinary disorders
URINARY RETENTION
|
0.30%
4/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Reproductive system and breast disorders
BENIGN PROSTATIC HYPERPLASIA
|
0.23%
3/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Reproductive system and breast disorders
FALLOPIAN TUBE CYST
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Reproductive system and breast disorders
PELVIC HAEMATOMA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Reproductive system and breast disorders
UTERINE POLYP
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Reproductive system and breast disorders
VAGINAL HAEMORRHAGE
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Reproductive system and breast disorders
VULVA CYST
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE PULMONARY OEDEMA
|
0.00%
0/1322 • 5 years
|
0.58%
4/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE
|
1.2%
16/1322 • 5 years
|
1.0%
7/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
ASPIRATION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
2.1%
28/1322 • 5 years
|
1.5%
10/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
2.5%
33/1322 • 5 years
|
1.9%
13/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
0.38%
5/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
0.08%
1/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
HYPERVENTILATION
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
0.15%
2/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
INTERSTITIAL LUNG DISEASE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
MEDIASTINAL MASS
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
NASAL POLYPS
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
NON-CARDIOGENIC PULMONARY OEDEMA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
ORGANISING PNEUMONIA
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.30%
4/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
PLEURITIC PAIN
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA ASPIRATION
|
0.00%
0/1322 • 5 years
|
0.58%
4/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
0.15%
2/1322 • 5 years
|
0.73%
5/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.68%
9/1322 • 5 years
|
1.0%
7/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY OEDEMA
|
0.23%
3/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY ARREST
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.98%
13/1322 • 5 years
|
1.2%
8/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
TRACHEAL STENOSIS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Skin and subcutaneous tissue disorders
DIABETIC FOOT
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Skin and subcutaneous tissue disorders
SKIN ULCER
|
0.30%
4/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Surgical and medical procedures
AORTIC ANEURYSM REPAIR
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Surgical and medical procedures
CHOLECYSTECTOMY
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Surgical and medical procedures
COLOSTOMY
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Surgical and medical procedures
CORONARY ARTERY BYPASS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Surgical and medical procedures
HIP ARTHROPLASTY
|
0.23%
3/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Surgical and medical procedures
INGUINAL HERNIA REPAIR
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Surgical and medical procedures
KNEE ARTHROPLASTY
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Surgical and medical procedures
LEG AMPUTATION
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Surgical and medical procedures
MEDICAL DEVICE REMOVAL
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Surgical and medical procedures
NEPHRECTOMY
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Surgical and medical procedures
SPINAL FUSION SURGERY
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Surgical and medical procedures
TENDON OPERATION
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Surgical and medical procedures
TRANSURETHRAL PROSTATECTOMY
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Vascular disorders
ACCELERATED HYPERTENSION
|
0.23%
3/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Vascular disorders
AORTIC ANEURYSM
|
0.45%
6/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Vascular disorders
AORTIC DISSECTION
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Vascular disorders
AORTIC INTRAMURAL HAEMATOMA
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Vascular disorders
AORTIC STENOSIS
|
0.30%
4/1322 • 5 years
|
0.73%
5/686 • 5 years
|
|
Vascular disorders
ARTERIAL SPASM
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Vascular disorders
ARTERIOSCLEROSIS
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Vascular disorders
BLOOD PRESSURE INADEQUATELY CONTROLLED
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Vascular disorders
CIRCULATORY COLLAPSE
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.83%
11/1322 • 5 years
|
0.58%
4/686 • 5 years
|
|
Vascular disorders
FEMORAL ARTERIAL STENOSIS
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Vascular disorders
HAEMATOMA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Vascular disorders
HYPERTENSION
|
0.61%
8/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Vascular disorders
HYPERTENSIVE CRISIS
|
0.23%
3/1322 • 5 years
|
0.73%
5/686 • 5 years
|
|
Vascular disorders
HYPOTENSION
|
0.38%
5/1322 • 5 years
|
0.58%
4/686 • 5 years
|
|
Vascular disorders
ILIAC ARTERY STENOSIS
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Vascular disorders
INTERMITTENT CLAUDICATION
|
0.61%
8/1322 • 5 years
|
1.0%
7/686 • 5 years
|
|
Vascular disorders
MALIGNANT HYPERTENSION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Vascular disorders
ORTHOSTATIC HYPOTENSION
|
0.15%
2/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Vascular disorders
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE
|
0.23%
3/1322 • 5 years
|
1.2%
8/686 • 5 years
|
|
Vascular disorders
PERIPHERAL ISCHAEMIA
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Vascular disorders
PERIPHERAL VASCULAR DISORDER
|
0.53%
7/1322 • 5 years
|
0.87%
6/686 • 5 years
|
|
Vascular disorders
SUBCLAVIAN ARTERY OCCLUSION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Vascular disorders
SUBCLAVIAN ARTERY STENOSIS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Vascular disorders
SUBCLAVIAN STEAL SYNDROME
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Vascular disorders
THROMBOSIS
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Vascular disorders
VASOSPAM
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Vascular disorders
VENOUS INSUFFICIENCY
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
Other adverse events
| Measure |
Absorb BVS
n=1322 participants at risk
Subjects receiving Absorb BVS
Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm
* Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.
* The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.
Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
XIENCE
n=686 participants at risk
Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition
XIENCE: Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).
* Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm
* Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition
* For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices
To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MENINGIOMA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO LIVER
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO LUNG
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO LYMPH NODES
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO SPINE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTATIC MALIGNANT MELANOMA
|
0.23%
3/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTATIC NEOPLASM
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MULTIPLE MYELOMA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NEOPLASM MALIGNANT
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NEURILEMMOMA MALIGNANT
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NON-HODGKIN'S LYMPHOMA
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NON-SMALL CELL LUNG CANCER
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Blood and lymphatic system disorders
ANAEMIA
|
1.6%
21/1322 • 5 years
|
2.3%
16/686 • 5 years
|
|
Blood and lymphatic system disorders
ANAEMIA OF CHRONIC DISEASE
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Blood and lymphatic system disorders
COAGULOPATHY
|
0.00%
0/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Blood and lymphatic system disorders
HAEMORRHAGIC ANAEMIA
|
0.15%
2/1322 • 5 years
|
0.58%
4/686 • 5 years
|
|
Blood and lymphatic system disorders
HAEMORRHAGIC DIATHESIS
|
0.15%
2/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Blood and lymphatic system disorders
HEPARIN-INDUCED THROMBOCYTOPENIA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Blood and lymphatic system disorders
IRON DEFICIENCY ANAEMIA
|
0.23%
3/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Blood and lymphatic system disorders
LEUKOCYTOSIS
|
0.38%
5/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Blood and lymphatic system disorders
LYMPHADENITIS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Blood and lymphatic system disorders
LYMPHADENOPATHY
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Blood and lymphatic system disorders
MICROCYTIC ANAEMIA
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Blood and lymphatic system disorders
NORMOCHROMIC NORMOCYTIC ANAEMIA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Blood and lymphatic system disorders
SPLENIC INFARCTION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.15%
2/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Cardiac disorders
ACUTE CORONARY SYNDROME
|
0.45%
6/1322 • 5 years
|
0.73%
5/686 • 5 years
|
|
Cardiac disorders
ACUTE LEFT VENTRICULAR FAILURE
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
3.7%
49/1322 • 5 years
|
3.2%
22/686 • 5 years
|
|
Cardiac disorders
ANGINA PECTORIS
|
28.8%
381/1322 • 5 years
|
29.4%
202/686 • 5 years
|
|
Cardiac disorders
ANGINA UNSTABLE
|
5.8%
77/1322 • 5 years
|
4.2%
29/686 • 5 years
|
|
Cardiac disorders
AORTIC VALVE DISEASE
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Cardiac disorders
AORTIC VALVE INCOMPETENCE
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Cardiac disorders
AORTIC VALVE STENOSIS
|
0.61%
8/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Cardiac disorders
ARRHYTHMIA
|
0.08%
1/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Cardiac disorders
ARTERIOSCLEROSIS CORONARY ARTERY
|
0.30%
4/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Cardiac disorders
ARTERIOSPASM CORONARY
|
0.30%
4/1322 • 5 years
|
0.58%
4/686 • 5 years
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
7.2%
95/1322 • 5 years
|
6.1%
42/686 • 5 years
|
|
Cardiac disorders
ATRIAL FLUTTER
|
0.83%
11/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Cardiac disorders
ATRIAL HYPERTROPHY
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Cardiac disorders
ATRIAL TACHYCARDIA
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Cardiac disorders
ATRIAL THROMBOSIS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Cardiac disorders
ATRIOVENTRICULAR BLOCK
|
0.45%
6/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Cardiac disorders
ATRIOVENTRICULAR BLOCK COMPLETE
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Cardiac disorders
ATRIOVENTRICULAR BLOCK SECOND DEGREE
|
0.38%
5/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Cardiac disorders
BRADYCARDIA
|
2.3%
31/1322 • 5 years
|
1.9%
13/686 • 5 years
|
|
Cardiac disorders
BUNDLE BRANCH BLOCK
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Cardiac disorders
BUNDLE BRANCH BLOCK LEFT
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Cardiac disorders
BUNDLE BRANCH BLOCK RIGHT
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Cardiac disorders
CARDIAC ARREST
|
0.76%
10/1322 • 5 years
|
0.87%
6/686 • 5 years
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.61%
8/1322 • 5 years
|
0.58%
4/686 • 5 years
|
|
Cardiac disorders
CARDIAC FAILURE ACUTE
|
0.38%
5/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Cardiac disorders
CARDIAC FAILURE CHRONIC
|
0.15%
2/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
3.0%
39/1322 • 5 years
|
4.4%
30/686 • 5 years
|
|
Cardiac disorders
CARDIAC FLUTTER
|
0.15%
2/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Cardiac disorders
CARDIAC TAMPONADE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Cardiac disorders
CARDIAC VALVE DISEASE
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Cardiac disorders
CARDIO-RESPIRATORY ARREST
|
0.15%
2/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Cardiac disorders
CARDIOGENIC SHOCK
|
0.08%
1/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Cardiac disorders
CARDIOMEGALY
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Cardiac disorders
CARDIOMYOPATHY
|
0.08%
1/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Cardiac disorders
CARDIORENAL SYNDROME
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Cardiac disorders
CHRONIC LEFT VENTRICULAR FAILURE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Cardiac disorders
CONDUCTION DISORDER
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Cardiac disorders
CONGESTIVE CARDIOMYOPATHY
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
3.3%
44/1322 • 5 years
|
4.1%
28/686 • 5 years
|
|
Cardiac disorders
CORONARY ARTERY DISSECTION
|
6.4%
85/1322 • 5 years
|
8.2%
56/686 • 5 years
|
|
Cardiac disorders
CORONARY ARTERY EMBOLISM
|
0.23%
3/1322 • 5 years
|
0.58%
4/686 • 5 years
|
|
Cardiac disorders
CORONARY ARTERY OCCLUSION
|
0.38%
5/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Cardiac disorders
CORONARY ARTERY PERFORATION
|
0.53%
7/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Cardiac disorders
CORONARY ARTERY STENOSIS
|
1.7%
23/1322 • 5 years
|
2.0%
14/686 • 5 years
|
|
Cardiac disorders
CORONARY NO-REFLOW PHENOMENON
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Cardiac disorders
CORONARY OSTIAL STENOSIS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Cardiac disorders
CYANOSIS
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Cardiac disorders
DIASTOLIC DYSFUNCTION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Cardiac disorders
DRESSLER'S SYNDROME
|
0.00%
0/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Cardiac disorders
EXTRASYSTOLES
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Cardiac disorders
HEART VALVE INCOMPETENCE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Cardiac disorders
HYPERTROPHIC CARDIOMYOPATHY
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Cardiac disorders
IN-STENT CORONARY ARTERY RESTENOSIS
|
0.30%
4/1322 • 5 years
|
0.73%
5/686 • 5 years
|
|
Cardiac disorders
INTRACARDIAC THROMBUS
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Cardiac disorders
ISCHAEMIC CARDIOMYOPATHY
|
0.30%
4/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Cardiac disorders
LEFT VENTRICULAR DYSFUNCTION
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Cardiac disorders
LEFT VENTRICULAR HYPERTROPHY
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Cardiac disorders
MITRAL VALVE INCOMPETENCE
|
0.61%
8/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
4.1%
54/1322 • 5 years
|
3.5%
24/686 • 5 years
|
|
Cardiac disorders
MYOCARDIAL ISCHAEMIA
|
0.45%
6/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Cardiac disorders
NODAL ARRHYTHMIA
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Cardiac disorders
NODAL RHYTHM
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Cardiac disorders
PALPITATIONS
|
2.4%
32/1322 • 5 years
|
2.5%
17/686 • 5 years
|
|
Cardiac disorders
PERICARDIAL EFFUSION
|
0.45%
6/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Cardiac disorders
PERICARDITIS
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Cardiac disorders
PRINZMETAL ANGINA
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Cardiac disorders
SICK SINUS SYNDROME
|
0.45%
6/1322 • 5 years
|
0.58%
4/686 • 5 years
|
|
Cardiac disorders
SINUS ARREST
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Cardiac disorders
SINUS ARRHYTHMIA
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Cardiac disorders
SINUS BRADYCARDIA
|
0.23%
3/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Cardiac disorders
SINUS TACHYCARDIA
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Cardiac disorders
SUPRAVENTRICULAR EXTRASYSTOLES
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Cardiac disorders
SUPRAVENTRICULAR TACHYCARDIA
|
0.91%
12/1322 • 5 years
|
0.73%
5/686 • 5 years
|
|
Cardiac disorders
TACHYCARDIA
|
0.91%
12/1322 • 5 years
|
0.87%
6/686 • 5 years
|
|
Cardiac disorders
TORSADE DE POINTES
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Cardiac disorders
TRICUSPID VALVE INCOMPETENCE
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Cardiac disorders
VENTRICULAR ARRHYTHMIA
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Cardiac disorders
VENTRICULAR EXTRASYSTOLES
|
0.45%
6/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Cardiac disorders
VENTRICULAR FIBRILLATION
|
0.45%
6/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Cardiac disorders
VENTRICULAR TACHYCARDIA
|
1.1%
14/1322 • 5 years
|
0.87%
6/686 • 5 years
|
|
Congenital, familial and genetic disorders
ARTERIOVENOUS MALFORMATION
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Congenital, familial and genetic disorders
CYSTIC LYMPHANGIOMA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Congenital, familial and genetic disorders
MYOTONIC DYSTROPHY
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Congenital, familial and genetic disorders
PULMONARY ARTERIOVENOUS FISTULA
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Ear and labyrinth disorders
DEAFNESS
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Ear and labyrinth disorders
EAR PAIN
|
0.00%
0/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Ear and labyrinth disorders
EUSTACHIAN TUBE OBSTRUCTION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Ear and labyrinth disorders
MIXED DEAFNESS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Ear and labyrinth disorders
TINNITUS
|
0.08%
1/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Ear and labyrinth disorders
TYMPANIC MEMBRANE PERFORATION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Ear and labyrinth disorders
VERTIGO
|
0.98%
13/1322 • 5 years
|
1.0%
7/686 • 5 years
|
|
Endocrine disorders
ADRENAL MASS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Endocrine disorders
GOITRE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Endocrine disorders
HYPERTHYROIDISM
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Endocrine disorders
HYPOGONADISM
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Endocrine disorders
HYPOTHYROIDISM
|
0.45%
6/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Endocrine disorders
THYROID CYST
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Eye disorders
AGE-RELATED MACULAR DEGENERATION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Eye disorders
AMAUROSIS FUGAX
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Eye disorders
CATARACT
|
0.53%
7/1322 • 5 years
|
1.2%
8/686 • 5 years
|
|
Eye disorders
CATARACT NUCLEAR
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Eye disorders
CONJUNCTIVAL HAEMORRHAGE
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Eye disorders
CONJUNCTIVITIS
|
0.15%
2/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Eye disorders
DIABETIC RETINOPATHY
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Eye disorders
DIPLOPIA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Eye disorders
EYE PRURITUS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Eye disorders
EYE SWELLING
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Eye disorders
GAZE PALSY
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Eye disorders
GLAUCOMA
|
0.30%
4/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Eye disorders
MACULAR FIBROSIS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Eye disorders
MACULAR OEDEMA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Eye disorders
PAPILLOEDEMA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Eye disorders
POSTERIOR CAPSULE OPACIFICATION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Eye disorders
RETINAL DETACHMENT
|
0.15%
2/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Eye disorders
RETINAL HAEMORRHAGE
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Eye disorders
SCLERAL DISCOLOURATION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Eye disorders
SCLERAL HAEMORRHAGE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Eye disorders
VISION BLURRED
|
0.38%
5/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Eye disorders
VISUAL IMPAIRMENT
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
|
0.38%
5/1322 • 5 years
|
0.58%
4/686 • 5 years
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Gastrointestinal disorders
ABDOMINAL HERNIA
|
0.23%
3/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Gastrointestinal disorders
ABDOMINAL HERNIA OBSTRUCTIVE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Gastrointestinal disorders
ABDOMINAL MASS
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.98%
13/1322 • 5 years
|
1.9%
13/686 • 5 years
|
|
Gastrointestinal disorders
ABDOMINAL PAIN LOWER
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.61%
8/1322 • 5 years
|
1.0%
7/686 • 5 years
|
|
Gastrointestinal disorders
ABDOMINAL WALL HAEMATOMA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Gastrointestinal disorders
ALCOHOLIC PANCREATITIS
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Gastrointestinal disorders
BARRETT'S OESOPHAGUS
|
0.23%
3/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Gastrointestinal disorders
COELIAC ARTERY STENOSIS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Gastrointestinal disorders
COELIAC DISEASE
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Gastrointestinal disorders
COLITIS
|
0.30%
4/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Gastrointestinal disorders
COLITIS ISCHAEMIC
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Gastrointestinal disorders
COLONIC POLYP
|
0.23%
3/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.83%
11/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Gastrointestinal disorders
CROHN'S DISEASE
|
0.15%
2/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Gastrointestinal disorders
DENTAL CARIES
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Gastrointestinal disorders
DIABETIC GASTROPARESIS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Gastrointestinal disorders
DIARRHOEA
|
1.4%
18/1322 • 5 years
|
1.0%
7/686 • 5 years
|
|
Gastrointestinal disorders
DIVERTICULUM
|
0.23%
3/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Gastrointestinal disorders
DIVERTICULUM INTESTINAL
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Gastrointestinal disorders
DIVERTICULUM INTESTINAL HAEMORRHAGIC
|
0.15%
2/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Gastrointestinal disorders
DRY MOUTH
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Gastrointestinal disorders
DUODENAL ULCER
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Gastrointestinal disorders
DUODENAL ULCER HAEMORRHAGE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Gastrointestinal disorders
DUODENITIS
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Gastrointestinal disorders
DYSPEPSIA
|
1.1%
15/1322 • 5 years
|
0.58%
4/686 • 5 years
|
|
Gastrointestinal disorders
DYSPHAGIA
|
0.76%
10/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Gastrointestinal disorders
ENTEROVESICAL FISTULA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Gastrointestinal disorders
EROSIVE OESOPHAGITIS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Gastrointestinal disorders
ERUCTATION
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Gastrointestinal disorders
FAECAL INCONTINENCE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Gastrointestinal disorders
FAECALOMA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Gastrointestinal disorders
FAECES DISCOLOURED
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Gastrointestinal disorders
FLATULENCE
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Gastrointestinal disorders
FOOD POISONING
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Gastrointestinal disorders
FUNCTIONAL GASTROINTESTINAL DISORDER
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Gastrointestinal disorders
GASTRIC HAEMORRHAGE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Gastrointestinal disorders
GASTRIC ULCER
|
0.15%
2/1322 • 5 years
|
0.58%
4/686 • 5 years
|
|
Gastrointestinal disorders
GASTRIC ULCER HAEMORRHAGE
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Gastrointestinal disorders
GASTRITIS
|
0.45%
6/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Gastrointestinal disorders
GASTRITIS EROSIVE
|
0.23%
3/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Gastrointestinal disorders
GASTROINTESTINAL ANGIODYSPLASIA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Gastrointestinal disorders
GASTROINTESTINAL DISORDER
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
1.2%
16/1322 • 5 years
|
2.2%
15/686 • 5 years
|
|
Gastrointestinal disorders
GASTROINTESTINAL PAIN
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Gastrointestinal disorders
GASTROINTESTINAL ULCER HAEMORRHAGE
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
1.7%
23/1322 • 5 years
|
1.2%
8/686 • 5 years
|
|
Gastrointestinal disorders
HAEMATEMESIS
|
0.15%
2/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Gastrointestinal disorders
HAEMATOCHEZIA
|
0.30%
4/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Gastrointestinal disorders
HAEMORRHOIDAL HAEMORRHAGE
|
0.30%
4/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Gastrointestinal disorders
HIATUS HERNIA
|
0.68%
9/1322 • 5 years
|
0.58%
4/686 • 5 years
|
|
Gastrointestinal disorders
HYPOAESTHESIA ORAL
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Gastrointestinal disorders
ILEUS
|
0.08%
1/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Gastrointestinal disorders
IMPAIRED GASTRIC EMPTYING
|
0.23%
3/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Gastrointestinal disorders
INFREQUENT BOWEL MOVEMENTS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Gastrointestinal disorders
INGUINAL HERNIA
|
0.30%
4/1322 • 5 years
|
0.87%
6/686 • 5 years
|
|
Gastrointestinal disorders
INTESTINAL MASS
|
0.15%
2/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
0.00%
0/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Gastrointestinal disorders
IRRITABLE BOWEL SYNDROME
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Gastrointestinal disorders
LARGE INTESTINE PERFORATION
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Gastrointestinal disorders
LOWER GASTROINTESTINAL HAEMORRHAGE
|
0.23%
3/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Gastrointestinal disorders
MALLORY-WEISS SYNDROME
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Gastrointestinal disorders
MELAENA
|
0.15%
2/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Gastrointestinal disorders
MOUTH HAEMORRHAGE
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Gastrointestinal disorders
MOUTH ULCERATION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Gastrointestinal disorders
NAUSEA
|
1.4%
19/1322 • 5 years
|
1.9%
13/686 • 5 years
|
|
Gastrointestinal disorders
OESOPHAGEAL ACHALASIA
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Gastrointestinal disorders
OESOPHAGEAL FOOD IMPACTION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Gastrointestinal disorders
OESOPHAGEAL PAIN
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Gastrointestinal disorders
OESOPHAGEAL SPASM
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Gastrointestinal disorders
OESOPHAGEAL ULCER
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Gastrointestinal disorders
OESOPHAGITIS
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Gastrointestinal disorders
PANCREATIC CYST
|
0.08%
1/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Gastrointestinal disorders
PANCREATITIS
|
0.08%
1/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Gastrointestinal disorders
PANCREATITIS ACUTE
|
0.15%
2/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Gastrointestinal disorders
PANCREATITIS CHRONIC
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Gastrointestinal disorders
PEPTIC ULCER
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Gastrointestinal disorders
PROCTALGIA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Gastrointestinal disorders
RECTAL HAEMORRHAGE
|
0.61%
8/1322 • 5 years
|
1.2%
8/686 • 5 years
|
|
Gastrointestinal disorders
RECTAL PROLAPSE
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Gastrointestinal disorders
RETROPERITONEAL HAEMATOMA
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Gastrointestinal disorders
RETROPERITONEAL HAEMORRHAGE
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
0.23%
3/1322 • 5 years
|
0.87%
6/686 • 5 years
|
|
Gastrointestinal disorders
SMALL INTESTINAL PERFORATION
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Gastrointestinal disorders
STOMATITIS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Gastrointestinal disorders
TONGUE CYST
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Gastrointestinal disorders
TONGUE HAEMORRHAGE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Gastrointestinal disorders
TOOTH SOCKET HAEMORRHAGE
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Gastrointestinal disorders
UMBILICAL HERNIA
|
0.30%
4/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Gastrointestinal disorders
UMBILICAL HERNIA, OBSTRUCTIVE
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Gastrointestinal disorders
UPPER GASTROINTESTINAL HAEMORRHAGE
|
0.23%
3/1322 • 5 years
|
0.58%
4/686 • 5 years
|
|
Gastrointestinal disorders
VOMITING
|
0.98%
13/1322 • 5 years
|
1.5%
10/686 • 5 years
|
|
General disorders
ABASIA
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
General disorders
ADVERSE DRUG REACTION
|
5.6%
74/1322 • 5 years
|
6.1%
42/686 • 5 years
|
|
General disorders
ASTHENIA
|
0.91%
12/1322 • 5 years
|
0.58%
4/686 • 5 years
|
|
General disorders
BREAST COMPLICATION ASSOCIATED WITH DEVICE
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
General disorders
CARDIAC DEATH
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
General disorders
CATHETER SITE HAEMATOMA
|
2.3%
30/1322 • 5 years
|
2.0%
14/686 • 5 years
|
|
General disorders
CATHETER SITE HAEMORRHAGE
|
1.7%
22/1322 • 5 years
|
2.0%
14/686 • 5 years
|
|
General disorders
CATHETER SITE PAIN
|
2.2%
29/1322 • 5 years
|
2.2%
15/686 • 5 years
|
|
General disorders
CATHETER SITE RASH
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
General disorders
CATHETER SITE RELATED REACTION
|
0.68%
9/1322 • 5 years
|
0.58%
4/686 • 5 years
|
|
General disorders
CATHETER SITE SWELLING
|
0.38%
5/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
General disorders
CHEST DISCOMFORT
|
6.6%
87/1322 • 5 years
|
5.0%
34/686 • 5 years
|
|
General disorders
CHEST PAIN
|
6.0%
79/1322 • 5 years
|
7.1%
49/686 • 5 years
|
|
General disorders
CHILLS
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
General disorders
CYST
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
General disorders
DEATH
|
0.76%
10/1322 • 5 years
|
0.87%
6/686 • 5 years
|
|
General disorders
DEVICE ELECTRICAL FINDING
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
General disorders
DEVICE FAILURE
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
General disorders
DEVICE MALFUNCTION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
General disorders
DEVICE OCCLUSION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
General disorders
DISCOMFORT
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
General disorders
DROWNING
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
General disorders
DRUG INTOLERANCE
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
General disorders
DRUG WITHDRAWAL SYNDROME
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
General disorders
FACE OEDEMA
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
General disorders
FATIGUE
|
3.8%
50/1322 • 5 years
|
2.9%
20/686 • 5 years
|
|
General disorders
FEELING COLD
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
General disorders
GAIT DISTURBANCE
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
General disorders
GENERALISED OEDEMA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
General disorders
HERNIA
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
General disorders
HERNIA OBSTRUCTIVE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
General disorders
HERNIA PAIN
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
General disorders
IMPAIRED HEALING
|
0.00%
0/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
General disorders
IMPLANT SITE HAEMORRHAGE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
General disorders
IMPLANT SITE PAIN
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
General disorders
INFLUENZA LIKE ILLNESS
|
0.15%
2/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
General disorders
LOCAL SWELLING
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
General disorders
MALAISE
|
0.23%
3/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
General disorders
MASS
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
General disorders
MEDICAL DEVICE SITE REACTION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
General disorders
MULTI-ORGAN FAILURE
|
0.08%
1/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
20.5%
271/1322 • 5 years
|
17.8%
122/686 • 5 years
|
|
General disorders
OEDEMA
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
General disorders
OEDEMA PERIPHERAL
|
1.9%
25/1322 • 5 years
|
1.5%
10/686 • 5 years
|
|
General disorders
PAIN
|
0.68%
9/1322 • 5 years
|
0.87%
6/686 • 5 years
|
|
General disorders
PELVIC MASS
|
0.00%
0/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
General disorders
PYREXIA
|
0.68%
9/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
General disorders
SPINAL PAIN
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
General disorders
SUDDEN CARDIAC DEATH
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
General disorders
SURGICAL FAILURE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
General disorders
SWELLING
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
General disorders
SYSTEMIC INFLAMMATORY RESPONSE SYNDROME
|
0.23%
3/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
General disorders
THROMBOSIS IN DEVICE
|
1.1%
14/1322 • 5 years
|
0.87%
6/686 • 5 years
|
|
Hepatobiliary disorders
BILE DUCT STONE
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Hepatobiliary disorders
BILIARY COLIC
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Hepatobiliary disorders
CHOLANGITIS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.30%
4/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Hepatobiliary disorders
CHOLECYSTITIS ACUTE
|
0.15%
2/1322 • 5 years
|
0.58%
4/686 • 5 years
|
|
Hepatobiliary disorders
CHOLECYSTITIS CHRONIC
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.91%
12/1322 • 5 years
|
0.87%
6/686 • 5 years
|
|
Hepatobiliary disorders
GALLBLADDER DISORDER
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Hepatobiliary disorders
HEPATIC LESION
|
0.15%
2/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Hepatobiliary disorders
HEPATIC STEATOSIS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Hepatobiliary disorders
HEPATOMEGALY
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Hepatobiliary disorders
ISCHAEMIC HEPATITIS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Hepatobiliary disorders
PORTAL VEIN THROMBOSIS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Immune system disorders
ALLERGY TO ARTHROPOD STING
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Immune system disorders
ANAPHYLACTIC REACTION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Immune system disorders
CONTRAST MEDIA ALLERGY
|
0.15%
2/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Immune system disorders
DRUG HYPERSENSITIVITY
|
0.38%
5/1322 • 5 years
|
0.58%
4/686 • 5 years
|
|
Immune system disorders
FOOD ALLERGY
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Immune system disorders
HYPERSENSITIVITY
|
0.00%
0/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Immune system disorders
SEASONAL ALLERGY
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Infections and infestations
ABDOMINAL ABSCESS
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Infections and infestations
ABDOMINAL INFECTION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
ABSCESS NECK
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
ACUTE SINUSITIS
|
0.23%
3/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Infections and infestations
ACUTE TONSILLITIS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
APPENDICITIS
|
0.30%
4/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Infections and infestations
APPENDICITIS PERFORATED
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
ARTERIOVENOUS GRAFT SITE INFECTION
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Infections and infestations
ARTHRITIS BACTERIAL
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
ARTHRITIS INFECTIVE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
BACTERAEMIA
|
0.30%
4/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
BACTERIAL DISEASE CARRIER
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Infections and infestations
BACTERIAL INFECTION
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Infections and infestations
BACTERIAL SEPSIS
|
0.00%
0/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Infections and infestations
BREAST ABSCESS
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Infections and infestations
BREAST CELLULITIS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
BRONCHITIS
|
2.6%
34/1322 • 5 years
|
3.1%
21/686 • 5 years
|
|
Infections and infestations
BRONCHITIS VIRAL
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
BRONCHOPNEUMONIA
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Infections and infestations
CARBUNCLE
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Infections and infestations
CATHETER SITE ABSCESS
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
CATHETER SITE CELLULITIS
|
0.23%
3/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
CATHETER SITE INFECTION
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Infections and infestations
CELLULITIS
|
1.1%
15/1322 • 5 years
|
2.0%
14/686 • 5 years
|
|
Infections and infestations
CHOLECYSTITIS INFECTIVE
|
0.00%
0/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Infections and infestations
CLOSTRIDIAL INFECTION
|
0.30%
4/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Infections and infestations
CLOSTRIDIUM DIFFICILE COLITIS
|
0.23%
3/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Infections and infestations
CYSTITIS
|
0.15%
2/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Infections and infestations
DIABETIC FOOT INFECTION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
DIVERTICULITIS
|
0.38%
5/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Infections and infestations
EAR INFECTION
|
0.23%
3/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
ENDOCARDITIS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
ENTEROCOCCAL SEPSIS
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Infections and infestations
ESCHERICHIA BACTERAEMIA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
ESCHERICHIA URINARY TRACT INFECTION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
EYELID INFECTION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
FOLLICULITIS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
FUNGAL INFECTION
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Infections and infestations
FURUNCLE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
GANGRENE
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Infections and infestations
GASTROENTERITIS
|
0.76%
10/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
0.30%
4/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Infections and infestations
GENITAL INFECTION FEMALE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
GROIN ABSCESS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
HELICOBACTER INFECTION
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
HEPATITIS C
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
HERPES ZOSTER
|
0.53%
7/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Infections and infestations
HERPES ZOSTER OPHTHALMIC
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
HIV INFECTION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
IMPLANT SITE INFECTION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
INFECTED DERMAL CYST
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
INFECTED SKIN ULCER
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Infections and infestations
INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
INFLUENZA
|
0.61%
8/1322 • 5 years
|
1.2%
8/686 • 5 years
|
|
Infections and infestations
KIDNEY INFECTION
|
0.30%
4/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
LARYNGITIS
|
0.15%
2/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Infections and infestations
LOBAR PNEUMONIA
|
0.23%
3/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Infections and infestations
LOCALISED INFECTION
|
0.00%
0/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Infections and infestations
LUNG ABSCESS
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Infections and infestations
MENINGITIS ASEPTIC
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
METAPNEUMOVIRUS INFECTION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
MYCOBACTERIUM ABSCESSUS INFECTION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
NASOPHARYNGITIS
|
0.45%
6/1322 • 5 years
|
0.73%
5/686 • 5 years
|
|
Infections and infestations
ONYCHOMYCOSIS
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
ORAL FUNGAL INFECTION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
ORCHITIS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
OSTEOMYELITIS
|
0.23%
3/1322 • 5 years
|
0.58%
4/686 • 5 years
|
|
Infections and infestations
OTITIS EXTERNA
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Infections and infestations
OTITIS MEDIA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
OTITIS MEDIA ACUTE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
PARONYCHIA
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
PERITONITIS
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Infections and infestations
PERITONSILLAR ABSCESS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
PHARYNGITIS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
PHARYNGITIS STREPTOCOCCAL
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Infections and infestations
PILONIDAL CYST
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Infections and infestations
PNEUMONIA
|
2.5%
33/1322 • 5 years
|
3.9%
27/686 • 5 years
|
|
Infections and infestations
PNEUMONIA ADENOVIRAL
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
PNEUMONIA BACTERIAL
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
PNEUMONIA NECROTISING
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
PNEUMONIA PRIMARY ATYPICAL
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
PNEUMONIA STAPHYLOCOCCAL
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
POST PROCEDURAL CELLULITIS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
POST PROCEDURAL INFECTION
|
0.23%
3/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
POST PROCEDURAL PNEUMONIA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
POSTOPERATIVE WOUND INFECTION
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Infections and infestations
PROSTATE INFECTION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
PYELONEPHRITIS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
RESPIRATORY SYNCYTIAL VIRUS INFECTION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Infections and infestations
SEPSIS
|
1.1%
15/1322 • 5 years
|
1.5%
10/686 • 5 years
|
|
Infections and infestations
SEPSIS SYNDROME
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
SEPTIC ENCEPHALOPATHY
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Infections and infestations
SEPTIC SHOCK
|
0.15%
2/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Infections and infestations
SINUSITIS
|
0.83%
11/1322 • 5 years
|
1.5%
10/686 • 5 years
|
|
Infections and infestations
SPINAL CORD INFECTION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
STAPHYLOCOCCAL BACTERAEMIA
|
0.00%
0/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Infections and infestations
STAPHYLOCOCCAL INFECTION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
SUBCUTANEOUS ABSCESS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
TINEA PEDIS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Infections and infestations
TOOTH ABSCESS
|
0.15%
2/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
1.9%
25/1322 • 5 years
|
0.87%
6/686 • 5 years
|
|
Infections and infestations
URINARY TRACT INFECTION
|
2.4%
32/1322 • 5 years
|
3.4%
23/686 • 5 years
|
|
Infections and infestations
URINARY TRACT INFECTION BACTERIAL
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Infections and infestations
UROSEPSIS
|
0.23%
3/1322 • 5 years
|
0.58%
4/686 • 5 years
|
|
Infections and infestations
VIRAL INFECTION
|
0.30%
4/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Infections and infestations
VIRAL LABYRINTHITIS
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Infections and infestations
VIRAL UPPER RESPIRATORY TRACT INFECTION
|
0.08%
1/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Infections and infestations
WOUND INFECTION
|
0.15%
2/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Infections and infestations
WOUND INFECTION BACTERIAL
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Infections and infestations
WOUND INFECTION STAPHYLOCOCCAL
|
0.08%
1/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Injury, poisoning and procedural complications
ACCIDENT
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Injury, poisoning and procedural complications
ACCIDENTAL OVERDOSE
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
ACETABULUM FRACTURE
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Injury, poisoning and procedural complications
ALCOHOL POISONING
|
0.23%
3/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Injury, poisoning and procedural complications
ANAEMIA POSTOPERATIVE
|
0.38%
5/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Injury, poisoning and procedural complications
ANIMAL BITE
|
0.15%
2/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Injury, poisoning and procedural complications
ANKLE FRACTURE
|
0.08%
1/1322 • 5 years
|
0.58%
4/686 • 5 years
|
|
Injury, poisoning and procedural complications
ANXIETY POSTOPERATIVE
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Injury, poisoning and procedural complications
ARTHROPOD BITE
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
ARTHROPOD STING
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Injury, poisoning and procedural complications
ASBESTOSIS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
AVULSION FRACTURE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
BURNS THIRD DEGREE
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Injury, poisoning and procedural complications
CARDIAC FUNCTION DISTURBANCE POSTOPERATIVE
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Injury, poisoning and procedural complications
CARDIAC PROCEDURE COMPLICATION
|
0.30%
4/1322 • 5 years
|
0.58%
4/686 • 5 years
|
|
Injury, poisoning and procedural complications
CATHETER SITE HAEMATOMA
|
0.76%
10/1322 • 5 years
|
1.2%
8/686 • 5 years
|
|
Injury, poisoning and procedural complications
CEREBRAL HAEMORRHAGE TRAUMATIC
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
CLAVICLE FRACTURE
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Injury, poisoning and procedural complications
COLON INJURY
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
CONCUSSION
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Injury, poisoning and procedural complications
CONTRAST MEDIA ALLERGY
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Injury, poisoning and procedural complications
CONTUSION
|
1.9%
25/1322 • 5 years
|
0.87%
6/686 • 5 years
|
|
Injury, poisoning and procedural complications
CORNEAL ABRASION
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Injury, poisoning and procedural complications
CORONARY ARTERY RESTENOSIS
|
3.9%
51/1322 • 5 years
|
2.2%
15/686 • 5 years
|
|
Injury, poisoning and procedural complications
CRANIOCEREBRAL INJURY
|
0.23%
3/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Injury, poisoning and procedural complications
CYSTITIS RADIATION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
DEEP VEIN THROMBOSIS POSTOPERATIVE
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
DRUG ADMINISTRATION ERROR
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
EXCORIATION
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
EXPOSURE TO TOXIC AGENT
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
FACIAL BONES FRACTURE
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Injury, poisoning and procedural complications
FALL
|
2.1%
28/1322 • 5 years
|
2.9%
20/686 • 5 years
|
|
Injury, poisoning and procedural complications
FEMORAL NECK FRACTURE
|
0.00%
0/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Injury, poisoning and procedural complications
FEMUR FRACTURE
|
0.23%
3/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
FOOT FRACTURE
|
0.30%
4/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Injury, poisoning and procedural complications
FOREIGN BODY
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Injury, poisoning and procedural complications
GASTROINTESTINAL ANASTOMOTIC LEAK
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Injury, poisoning and procedural complications
HAEMATURIA TRAUMATIC
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
HAND FRACTURE
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Injury, poisoning and procedural complications
HEAD INJURY
|
0.08%
1/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Injury, poisoning and procedural complications
HIP FRACTURE
|
0.30%
4/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Injury, poisoning and procedural complications
HUMERUS FRACTURE
|
0.23%
3/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Injury, poisoning and procedural complications
ILIOTIBIAL BAND SYNDROME
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Injury, poisoning and procedural complications
IN-STENT ARTERIAL RESTENOSIS
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Injury, poisoning and procedural complications
IN-STENT CORONARY ARTERY RESTENOSIS
|
0.61%
8/1322 • 5 years
|
0.87%
6/686 • 5 years
|
|
Injury, poisoning and procedural complications
INCISION SITE PRURITUS
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Injury, poisoning and procedural complications
INCISIONAL HERNIA
|
0.23%
3/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
INJURY
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
JOINT DISLOCATION
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Injury, poisoning and procedural complications
JOINT INJURY
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
LACERATION
|
0.53%
7/1322 • 5 years
|
0.58%
4/686 • 5 years
|
|
Injury, poisoning and procedural complications
LIGAMENT RUPTURE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
LIGAMENT SPRAIN
|
0.08%
1/1322 • 5 years
|
0.87%
6/686 • 5 years
|
|
Injury, poisoning and procedural complications
LIMB INJURY
|
0.23%
3/1322 • 5 years
|
0.58%
4/686 • 5 years
|
|
Injury, poisoning and procedural complications
LIMB TRAUMATIC AMPUTATION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
LOWER LIMB FRACTURE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
MENISCUS LESION
|
0.61%
8/1322 • 5 years
|
0.58%
4/686 • 5 years
|
|
Injury, poisoning and procedural complications
MOUTH INJURY
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Injury, poisoning and procedural complications
MULTIPLE FRACTURES
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
MULTIPLE INJURIES
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
MUSCLE RUPTURE
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Injury, poisoning and procedural complications
MUSCLE STRAIN
|
0.15%
2/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Injury, poisoning and procedural complications
PELVIC FRACTURE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
PERIORBITAL HAEMATOMA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
PLAQUE SHIFT
|
0.30%
4/1322 • 5 years
|
0.87%
6/686 • 5 years
|
|
Injury, poisoning and procedural complications
POST CONCUSSION SYNDROME
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL CONSTIPATION
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL DISCOMFORT
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL HAEMATOMA
|
0.23%
3/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL HAEMORRHAGE
|
0.45%
6/1322 • 5 years
|
0.58%
4/686 • 5 years
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL MYOCARDIAL INFARCTION
|
0.91%
12/1322 • 5 years
|
1.0%
7/686 • 5 years
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL STROKE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL SWELLING
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Injury, poisoning and procedural complications
POST-TRAUMATIC NECK SYNDROME
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Injury, poisoning and procedural complications
POST-TRAUMATIC PAIN
|
0.30%
4/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Injury, poisoning and procedural complications
POSTOPERATIVE ADHESION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
POSTOPERATIVE FEVER
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
PROCEDURAL COMPLICATION
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
PROCEDURAL DIZZINESS
|
0.08%
1/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Injury, poisoning and procedural complications
PROCEDURAL HEADACHE
|
0.38%
5/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Injury, poisoning and procedural complications
PROCEDURAL HYPERTENSION
|
0.76%
10/1322 • 5 years
|
0.58%
4/686 • 5 years
|
|
Injury, poisoning and procedural complications
PROCEDURAL HYPOTENSION
|
0.98%
13/1322 • 5 years
|
1.0%
7/686 • 5 years
|
|
Injury, poisoning and procedural complications
PROCEDURAL NAUSEA
|
0.61%
8/1322 • 5 years
|
0.58%
4/686 • 5 years
|
|
Injury, poisoning and procedural complications
PROCEDURAL PAIN
|
0.23%
3/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Injury, poisoning and procedural complications
PROCEDURAL VOMITING
|
0.23%
3/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
RADIUS FRACTURE
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Injury, poisoning and procedural complications
RESPIRATORY FUME INHALATION DISORDER
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
RIB FRACTURE
|
0.30%
4/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Injury, poisoning and procedural complications
ROAD TRAFFIC ACCIDENT
|
0.76%
10/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Injury, poisoning and procedural complications
SCAPULA FRACTURE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
SEROMA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
SKULL FRACTURE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
SNAKE BITE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
SOFT TISSUE INJURY
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
SPINAL COMPRESSION FRACTURE
|
0.45%
6/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Injury, poisoning and procedural complications
SPINAL FRACTURE
|
0.15%
2/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Injury, poisoning and procedural complications
SPLENIC RUPTURE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
STERNAL FRACTURE
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Injury, poisoning and procedural complications
SUBDURAL HAEMATOMA
|
0.45%
6/1322 • 5 years
|
0.58%
4/686 • 5 years
|
|
Injury, poisoning and procedural complications
SUTURE RELATED COMPLICATION
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Injury, poisoning and procedural complications
TENDON INJURY
|
0.00%
0/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Injury, poisoning and procedural complications
TENDON RUPTURE
|
0.08%
1/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Injury, poisoning and procedural complications
THERMAL BURN
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
THORACIC VERTEBRAL FRACTURE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
TIBIA FRACTURE
|
0.00%
0/1322 • 5 years
|
0.58%
4/686 • 5 years
|
|
Injury, poisoning and procedural complications
TOXICITY TO VARIOUS AGENTS
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Injury, poisoning and procedural complications
TRAUMATIC HAEMATOMA
|
0.38%
5/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Injury, poisoning and procedural complications
TRAUMATIC HAEMORRHAGE
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Injury, poisoning and procedural complications
ULNA FRACTURE
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Injury, poisoning and procedural complications
UPPER LIMB FRACTURE
|
0.30%
4/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
URINARY RETENTION POSTOPERATIVE
|
0.38%
5/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Injury, poisoning and procedural complications
VASCULAR ACCESS COMPLICATION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
VASCULAR GRAFT OCCLUSION
|
0.15%
2/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Injury, poisoning and procedural complications
VASCULAR PSEUDOANEURYSM
|
0.76%
10/1322 • 5 years
|
0.87%
6/686 • 5 years
|
|
Injury, poisoning and procedural complications
WOUND
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
WOUND EVISCERATION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Injury, poisoning and procedural complications
WOUND HAEMORRHAGE
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Injury, poisoning and procedural complications
WRIST FRACTURE
|
0.23%
3/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Investigations
ANGIOGRAM
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Investigations
ARTERIOGRAM CORONARY ABNORMAL
|
0.08%
1/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Investigations
BIOPSY LUNG
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Investigations
BLOOD ALKALINE PHOSPHATASE INCREASED
|
0.23%
3/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Investigations
BLOOD CREATINE INCREASED
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Investigations
BLOOD CREATINE PHOSPHOKINASE INCREASED
|
0.91%
12/1322 • 5 years
|
1.2%
8/686 • 5 years
|
|
Investigations
BLOOD CREATINE PHOSPHOKINASE MB INCREASED
|
11.6%
153/1322 • 5 years
|
10.5%
72/686 • 5 years
|
|
Investigations
BLOOD CREATININE INCREASED
|
0.38%
5/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Investigations
BLOOD GLUCOSE DECREASED
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Investigations
BLOOD GLUCOSE INCREASED
|
0.30%
4/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Investigations
BLOOD HOMOCYSTEINE INCREASED
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Investigations
BLOOD IRON DECREASED
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Investigations
BLOOD MAGNESIUM DECREASED
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Investigations
BLOOD POTASSIUM DECREASED
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Investigations
BLOOD PRESSURE DECREASED
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Investigations
BLOOD PRESSURE INCREASED
|
0.91%
12/1322 • 5 years
|
0.58%
4/686 • 5 years
|
|
Investigations
BLOOD PRESSURE ORTHOSTATIC ABNORMAL
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Investigations
BLOOD PRESSURE SYSTOLIC INCREASED
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Investigations
BLOOD TESTOSTERONE DECREASED
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Investigations
BLOOD THYROID STIMULATING HORMONE DECREASED
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Investigations
BLOOD TRIGLYCERIDES INCREASED
|
0.23%
3/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Investigations
BLOOD URIC ACID INCREASED
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Investigations
BLOOD URINE PRESENT
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Investigations
BONE DENSITY ABNORMAL
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Investigations
BREATH SOUNDS ABNORMAL
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Investigations
CARDIAC ENZYMES INCREASED
|
7.9%
104/1322 • 5 years
|
6.6%
45/686 • 5 years
|
|
Investigations
CARDIAC MURMUR
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Investigations
CARDIAC STRESS TEST ABNORMAL
|
0.68%
9/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Investigations
CAROTID BRUIT
|
0.53%
7/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Investigations
CATHETERISATION CARDIAC
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Investigations
CLOSTRIDIUM TEST POSITIVE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Investigations
COMPUTERISED TOMOGRAM ABNORMAL
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Investigations
COMPUTERISED TOMOGRAM THORAX ABNORMAL
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Investigations
ECHOCARDIOGRAM ABNORMAL
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Investigations
EJECTION FRACTION ABNORMAL
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Investigations
EJECTION FRACTION DECREASED
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Investigations
ELECTROCARDIOGRAM ABNORMAL
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Investigations
ELECTROCARDIOGRAM CHANGE
|
0.30%
4/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Investigations
ELECTROCARDIOGRAM QT PROLONGED
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Investigations
ELECTROCARDIOGRAM ST SEGMENT ABNORMAL
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Investigations
ELECTROCARDIOGRAM ST SEGMENT ELEVATION
|
0.61%
8/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Investigations
ELECTROCARDIOGRAM ST-T CHANGE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Investigations
FEMORAL BRUIT
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Investigations
GLOMERULAR FILTRATION RATE DECREASED
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Investigations
GLYCOSYLATED HAEMOGLOBIN INCREASED
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Investigations
HAEMOGLOBIN DECREASED
|
0.23%
3/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Investigations
HEART RATE DECREASED
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Investigations
HEART RATE INCREASED
|
0.30%
4/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Investigations
HEART RATE IRREGULAR
|
0.08%
1/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Investigations
HELICOBACTER TEST POSITIVE
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Investigations
HEPATIC ENZYME INCREASED
|
0.30%
4/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Investigations
LIPIDS ABNORMAL
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Investigations
LIVER FUNCTION TEST ABNORMAL
|
0.15%
2/1322 • 5 years
|
0.58%
4/686 • 5 years
|
|
Investigations
METABOLIC FUNCTION TEST ABNORMAL
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Investigations
OCCULT BLOOD POSITIVE
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Investigations
OXYGEN CONSUMPTION INCREASED
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Investigations
PROSTATIC SPECIFIC ANTIGEN INCREASED
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Investigations
RED BLOOD CELL COUNT DECREASED
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Investigations
RED BLOOD CELL SEDIMENTATION RATE INCREASED
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Investigations
RENAL FUNCTION TEST ABNORMAL
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Investigations
THYROID FUNCTION TEST ABNORMAL
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Investigations
TROPONIN I INCREASED
|
1.8%
24/1322 • 5 years
|
1.5%
10/686 • 5 years
|
|
Investigations
TROPONIN INCREASED
|
3.8%
50/1322 • 5 years
|
2.9%
20/686 • 5 years
|
|
Investigations
TROPONIN T INCREASED
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Investigations
URINE LEUKOCYTE ESTERASE POSITIVE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Investigations
VITAMIN B12 DECREASED
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Investigations
VITAMIN D DECREASED
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Investigations
WEIGHT DECREASED
|
0.23%
3/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Investigations
WEIGHT INCREASED
|
0.30%
4/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Investigations
WHITE BLOOD CELL COUNT INCREASED
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.83%
11/1322 • 5 years
|
1.6%
11/686 • 5 years
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
0.68%
9/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS INADEQUATE CONTROL
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Metabolism and nutrition disorders
DIABETIC KETOACIDOSIS
|
0.38%
5/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Metabolism and nutrition disorders
FAILURE TO THRIVE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Metabolism and nutrition disorders
FLUID OVERLOAD
|
0.15%
2/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Metabolism and nutrition disorders
FLUID RETENTION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Metabolism and nutrition disorders
GOUT
|
0.38%
5/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
1.1%
14/1322 • 5 years
|
1.0%
7/686 • 5 years
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
0.30%
4/1322 • 5 years
|
0.73%
5/686 • 5 years
|
|
Metabolism and nutrition disorders
HYPERLIPIDAEMIA
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Metabolism and nutrition disorders
HYPERURICAEMIA
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Metabolism and nutrition disorders
HYPOALBUMINAEMIA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Metabolism and nutrition disorders
HYPOCALCAEMIA
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
0.76%
10/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
1.1%
15/1322 • 5 years
|
1.6%
11/686 • 5 years
|
|
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
|
0.38%
5/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.61%
8/1322 • 5 years
|
0.73%
5/686 • 5 years
|
|
Metabolism and nutrition disorders
HYPOVOLAEMIA
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Metabolism and nutrition disorders
IMPAIRED FASTING GLUCOSE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Metabolism and nutrition disorders
LACTIC ACIDOSIS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Metabolism and nutrition disorders
METABOLIC ACIDOSIS
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Metabolism and nutrition disorders
OBESITY
|
0.45%
6/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Metabolism and nutrition disorders
TYPE 2 DIABETES MELLITUS
|
0.38%
5/1322 • 5 years
|
0.58%
4/686 • 5 years
|
|
Metabolism and nutrition disorders
VITAMIN B COMPLEX DEFICIENCY
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Metabolism and nutrition disorders
VITAMIN D DEFICIENCY
|
0.00%
0/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
2.0%
27/1322 • 5 years
|
2.3%
16/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
0.61%
8/1322 • 5 years
|
0.73%
5/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
ARTHROFIBROSIS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
4.2%
55/1322 • 5 years
|
4.1%
28/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
BONE LESION
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
BURSITIS
|
0.30%
4/1322 • 5 years
|
0.58%
4/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
CERVICAL SPINAL STENOSIS
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
CHONDROCALCINOSIS PYROPHOSPHATE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
COSTOCHONDRITIS
|
0.45%
6/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
DUPUYTREN'S CONTRACTURE
|
0.15%
2/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
EXOSTOSIS
|
0.00%
0/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
FLANK PAIN
|
0.08%
1/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
FOOT DEFORMITY
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
FRACTURE NONUNION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC DEGENERATION
|
0.15%
2/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
0.68%
9/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
JOINT EFFUSION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
JOINT STIFFNESS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
JOINT SWELLING
|
0.30%
4/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
LIMB DISCOMFORT
|
0.23%
3/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
LUMBAR SPINAL STENOSIS
|
0.53%
7/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
MOBILITY DECREASED
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
0.76%
10/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
0.45%
6/1322 • 5 years
|
0.58%
4/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
1.6%
21/1322 • 5 years
|
1.0%
7/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL DISCOMFORT
|
0.38%
5/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL DISORDER
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
1.4%
18/1322 • 5 years
|
2.3%
16/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.91%
12/1322 • 5 years
|
1.2%
8/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
MYOSITIS
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
0.53%
7/1322 • 5 years
|
0.73%
5/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
2.3%
30/1322 • 5 years
|
2.6%
18/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
OSTEOPENIA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
OSTEOPOROSIS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
3.0%
40/1322 • 5 years
|
2.2%
15/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
PAIN IN JAW
|
0.53%
7/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
PERIARTHRITIS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
PLANTAR FASCIITIS
|
0.15%
2/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
POLYMYALGIA RHEUMATICA
|
0.00%
0/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
RHABDOMYOLYSIS
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
RHEUMATOID ARTHRITIS
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
ROTATOR CUFF SYNDROME
|
0.61%
8/1322 • 5 years
|
0.58%
4/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
SACROILIITIS
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
SPINAL OSTEOARTHRITIS
|
0.45%
6/1322 • 5 years
|
0.58%
4/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
SPONDYLITIS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
SPONDYLOLISTHESIS
|
0.23%
3/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
SYNOVIAL CYST
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
SYSTEMIC LUPUS ERYTHEMATOSUS
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
TENDINOUS CONTRACTURE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
TENDONITIS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
TENOSYNOVITIS STENOSANS
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
TRIGGER FINGER
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Musculoskeletal and connective tissue disorders
VERTEBRAL FORAMINAL STENOSIS
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ACOUSTIC NEUROMA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ACUTE MYELOID LEUKAEMIA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ACUTE MYELOID LEUKAEMIA RECURRENT
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ADENOCARCINOMA
|
0.15%
2/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ADENOCARCINOMA PANCREAS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-CELL LYMPHOMA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-CELL LYMPHOMA STAGE IV
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA
|
0.45%
6/1322 • 5 years
|
1.0%
7/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BENIGN BREAST NEOPLASM
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BENIGN OVARIAN TUMOUR
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BILE DUCT CANCER
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BLADDER CANCER
|
0.23%
3/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BLADDER CANCER RECURRENT
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BLADDER CANCER STAGE IV
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BLADDER NEOPLASM
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BRAIN NEOPLASM
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
0.38%
5/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER STAGE III
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CERVIX CARCINOMA
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CHRONIC LYMPHOCYTIC LEUKAEMIA
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
COLON ADENOMA
|
0.23%
3/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
COLON CANCER
|
0.23%
3/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
DIFFUSE LARGE B-CELL LYMPHOMA
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
GASTRIC CANCER
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
GLIOBLASTOMA
|
0.00%
0/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HAEMANGIOMA OF SPLEEN
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HEAD AND NECK CANCER
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HEAD AND NECK CANCER METASTATIC
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HEPATIC CANCER METASTATIC
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HEPATIC NEOPLASM MALIGNANT
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HYPOPHARYNGEAL CANCER
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LARYNGEAL CANCER
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LEUKAEMIA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LEUKAEMIA RECURRENT
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LIP AND/OR ORAL CAVITY CANCER
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LIPOMA
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG ADENOCARCINOMA
|
0.23%
3/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG CANCER METASTATIC
|
0.08%
1/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG NEOPLASM
|
0.38%
5/1322 • 5 years
|
0.87%
6/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG NEOPLASM MALIGNANT
|
0.53%
7/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG SQUAMOUS CELL CARCINOMA STAGE III
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG SQUAMOUS CELL CARCINOMA STAGE UNSPECIFIED
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LYMPHOMA
|
0.30%
4/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT MELANOMA
|
0.15%
2/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MELANOCYTIC NAEVUS
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
OESOPHAGEAL CARCINOMA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ORAL NEOPLASM
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
OROPHARYNGEAL CANCER STAGE UNSPECIFIED
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
OVARIAN CANCER METASTATIC
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
OVARIAN EPITHELIAL CANCER
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PANCREATIC CARCINOMA
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PERICARDIAL EFFUSION MALIGNANT
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER
|
0.83%
11/1322 • 5 years
|
0.58%
4/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROSTATE CANCER RECURRENT
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RECTAL CANCER
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RENAL CANCER
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RENAL CELL CARCINOMA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RENAL HAEMANGIOMA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RENAL NEOPLASM
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SEBORRHOEIC KERATOSIS
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SINONASAL PAPILLOMA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SKIN CANCER
|
0.23%
3/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SKIN PAPILLOMA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SMALL CELL LUNG CANCER LIMITED STAGE
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SMALL CELL LUNG CANCER STAGE UNSPECIFIED
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA
|
0.38%
5/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA OF SKIN
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
THYROID NEOPLASM
|
0.08%
1/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TRANSITIONAL CELL CARCINOMA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
URETERIC CANCER
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
UTERINE CANCER
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
UTERINE LEIOMYOMA
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
VULVAL CANCER STAGE 0
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Nervous system disorders
ALTERED STATE OF CONSCIOUSNESS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Nervous system disorders
AMNESIA
|
0.30%
4/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Nervous system disorders
APHASIA
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Nervous system disorders
ARACHNOIDITIS
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Nervous system disorders
ATAXIA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Nervous system disorders
AUTONOMIC NERVOUS SYSTEM IMBALANCE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Nervous system disorders
BALANCE DISORDER
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Nervous system disorders
BURNING SENSATION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Nervous system disorders
CAROTID ARTERY DISEASE
|
0.15%
2/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Nervous system disorders
CAROTID ARTERY STENOSIS
|
1.1%
15/1322 • 5 years
|
1.3%
9/686 • 5 years
|
|
Nervous system disorders
CARPAL TUNNEL SYNDROME
|
0.30%
4/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Nervous system disorders
CAUDA EQUINA SYNDROME
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Nervous system disorders
CENTRAL NERVOUS SYSTEM LESION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Nervous system disorders
CEREBELLAR INFARCTION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Nervous system disorders
CEREBRAL HAEMORRHAGE
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Nervous system disorders
CEREBRAL INFARCTION
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
1.5%
20/1322 • 5 years
|
2.2%
15/686 • 5 years
|
|
Nervous system disorders
CEREBROVASCULAR DISORDER
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Nervous system disorders
CERVICOBRACHIAL SYNDROME
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Nervous system disorders
COMPLICATED MIGRAINE
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Nervous system disorders
CONVULSION
|
0.30%
4/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Nervous system disorders
CUBITAL TUNNEL SYNDROME
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Nervous system disorders
DEMENTIA
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Nervous system disorders
DIABETIC NEUROPATHY
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Nervous system disorders
DIZZINESS
|
4.4%
58/1322 • 5 years
|
3.9%
27/686 • 5 years
|
|
Nervous system disorders
DIZZINESS EXERTIONAL
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Nervous system disorders
DIZZINESS POSTURAL
|
0.53%
7/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Nervous system disorders
DYSAESTHESIA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Nervous system disorders
DYSARTHRIA
|
0.30%
4/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Nervous system disorders
DYSGEUSIA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Nervous system disorders
EMBOLIC STROKE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Nervous system disorders
ENCEPHALOPATHY
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Nervous system disorders
ESSENTIAL TREMOR
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Nervous system disorders
GUILLAIN-BARRE SYNDROME
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Nervous system disorders
HAEMORRHAGE INTRACRANIAL
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Nervous system disorders
HAEMORRHAGIC STROKE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Nervous system disorders
HEAD DISCOMFORT
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Nervous system disorders
HEAD TITUBATION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Nervous system disorders
HEADACHE
|
2.1%
28/1322 • 5 years
|
2.8%
19/686 • 5 years
|
|
Nervous system disorders
HEMIPARESIS
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Nervous system disorders
HEMIPLEGIC MIGRAINE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Nervous system disorders
HEPATIC ENCEPHALOPATHY
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Nervous system disorders
HYPOAESTHESIA
|
0.98%
13/1322 • 5 years
|
1.2%
8/686 • 5 years
|
|
Nervous system disorders
HYPOXIC-ISCHAEMIC ENCEPHALOPATHYv
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Nervous system disorders
IIIRD NERVE PARALYSIS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Nervous system disorders
INTENTION TREMOR
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Nervous system disorders
ISCHAEMIC STROKE
|
0.45%
6/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Nervous system disorders
LACUNAR INFARCTION
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Nervous system disorders
LATERAL MEDULLARY SYNDROME
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Nervous system disorders
LETHARGY
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Nervous system disorders
LOSS OF CONSCIOUSNESS
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Nervous system disorders
LUMBAR RADICULOPATHY
|
0.15%
2/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Nervous system disorders
MEMORY IMPAIRMENT
|
0.45%
6/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Nervous system disorders
MENTAL IMPAIRMENT
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Nervous system disorders
METABOLIC ENCEPHALOPATHY
|
0.15%
2/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Nervous system disorders
MIGRAINE
|
0.23%
3/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Nervous system disorders
MYELOMALACIA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Nervous system disorders
NERVE COMPRESSION
|
0.08%
1/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Nervous system disorders
NEURALGIA
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Nervous system disorders
NEUROLOGICAL SYMPTOM
|
0.08%
1/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Nervous system disorders
NYSTAGMUS
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Nervous system disorders
PARAESTHESIA
|
0.61%
8/1322 • 5 years
|
0.58%
4/686 • 5 years
|
|
Nervous system disorders
POLYNEUROPATHY ALCOHOLIC
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Nervous system disorders
POST-TRAUMATIC HEADACHE
|
0.00%
0/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Nervous system disorders
PRESYNCOPE
|
2.0%
26/1322 • 5 years
|
1.2%
8/686 • 5 years
|
|
Nervous system disorders
RADICULITIS
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Nervous system disorders
RADICULITIS CERVICAL
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Nervous system disorders
SCIATICA
|
0.30%
4/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Nervous system disorders
SENSORY DISTURBANCE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Nervous system disorders
SOMNOLENCE
|
0.23%
3/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Nervous system disorders
SPEECH DISORDER
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Nervous system disorders
SPONDYLITIC MYELOPATHY
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Nervous system disorders
SUBARACHNOID HAEMORRHAGE
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Nervous system disorders
SUBDURAL HYGROMA
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Nervous system disorders
SYNCOPE
|
3.0%
40/1322 • 5 years
|
3.2%
22/686 • 5 years
|
|
Nervous system disorders
THALAMIC INFARCTION
|
0.23%
3/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Nervous system disorders
THROMBOTIC STROKE
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Nervous system disorders
TRANSIENT GLOBAL AMNESIA
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
1.3%
17/1322 • 5 years
|
1.2%
8/686 • 5 years
|
|
Nervous system disorders
TREMOR
|
0.30%
4/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Nervous system disorders
UNRESPONSIVE TO STIMULI
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Nervous system disorders
URAEMIC ENCEPHALOPATHY
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Nervous system disorders
VERTEBRAL ARTERY OCCLUSION
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Nervous system disorders
VITH NERVE PARALYSIS
|
0.15%
2/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Psychiatric disorders
ACUTE STRESS DISORDER
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Psychiatric disorders
ADJUSTMENT DISORDER WITH MIXED DISTURBANCE OF EMOTION AND CONDUCT
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Psychiatric disorders
AFFECTIVE DISORDER
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Psychiatric disorders
ALCOHOL ABUSE
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Psychiatric disorders
ALCOHOL PROBLEM
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Psychiatric disorders
ALCOHOL WITHDRAWAL SYNDROME
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Psychiatric disorders
ANXIETY
|
1.5%
20/1322 • 5 years
|
1.0%
7/686 • 5 years
|
|
Psychiatric disorders
ANXIETY DISORDER
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Psychiatric disorders
BIPOLAR DISORDER
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Psychiatric disorders
BIPOLAR I DISORDER
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Psychiatric disorders
COMPLETED SUICIDE
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
0.30%
4/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Psychiatric disorders
DELIRIUM
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Psychiatric disorders
DELIRIUM TREMENS
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Psychiatric disorders
DEPRESSED MOOD
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Psychiatric disorders
DEPRESSION
|
1.3%
17/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Psychiatric disorders
DEPRESSION SUICIDAL
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Psychiatric disorders
HALLUCINATION
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Psychiatric disorders
HALLUCINATION, VISUAL
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Psychiatric disorders
INSOMNIA
|
0.30%
4/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Psychiatric disorders
INTENTIONAL SELF-INJURY
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Psychiatric disorders
MAJOR DEPRESSION
|
0.15%
2/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Psychiatric disorders
MENTAL STATUS CHANGES
|
0.45%
6/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Psychiatric disorders
OBSESSIVE-COMPULSIVE DISORDER
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Psychiatric disorders
PANIC ATTACK
|
0.15%
2/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Psychiatric disorders
STRESS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Psychiatric disorders
SUICIDAL IDEATION
|
0.00%
0/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Renal and urinary disorders
BLADDER DISORDER
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Renal and urinary disorders
CALCULUS URETERIC
|
0.08%
1/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Renal and urinary disorders
CYSTITIS HAEMORRHAGIC
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Renal and urinary disorders
CYSTITIS INTERSTITIAL
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Renal and urinary disorders
DYSURIA
|
0.30%
4/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Renal and urinary disorders
HAEMATURIA
|
0.98%
13/1322 • 5 years
|
1.6%
11/686 • 5 years
|
|
Renal and urinary disorders
HYDRONEPHROSIS
|
0.15%
2/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Renal and urinary disorders
HYPERTONIC BLADDER
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Renal and urinary disorders
MICROALBUMINURIA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
1.4%
18/1322 • 5 years
|
1.5%
10/686 • 5 years
|
|
Renal and urinary disorders
NOCTURIA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Renal and urinary disorders
POLLAKIURIA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Renal and urinary disorders
RENAL ARTERY STENOSIS
|
0.08%
1/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Renal and urinary disorders
RENAL CYST
|
0.30%
4/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Renal and urinary disorders
RENAL DISORDER
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.61%
8/1322 • 5 years
|
0.73%
5/686 • 5 years
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
1.3%
17/1322 • 5 years
|
2.0%
14/686 • 5 years
|
|
Renal and urinary disorders
RENAL FAILURE CHRONIC
|
0.23%
3/1322 • 5 years
|
0.73%
5/686 • 5 years
|
|
Renal and urinary disorders
RENAL IMPAIRMENT
|
0.08%
1/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Renal and urinary disorders
RENAL TUBULAR NECROSIS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Renal and urinary disorders
STRESS URINARY INCONTINENCE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Renal and urinary disorders
URETHRAL STENOSIS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Renal and urinary disorders
URINARY HESITATION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Renal and urinary disorders
URINARY INCONTINENCE
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Renal and urinary disorders
URINARY RETENTION
|
0.91%
12/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Renal and urinary disorders
URINE FLOW DECREASED
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Reproductive system and breast disorders
BENIGN PROSTATIC HYPERPLASIA
|
0.53%
7/1322 • 5 years
|
0.73%
5/686 • 5 years
|
|
Reproductive system and breast disorders
BREAST CALCIFICATIONS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Reproductive system and breast disorders
BREAST MASS
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Reproductive system and breast disorders
BREAST PAIN
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Reproductive system and breast disorders
DYSFUNCTIONAL UTERINE BLEEDING
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Reproductive system and breast disorders
EPIDIDYMAL CYST
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Reproductive system and breast disorders
FALLOPIAN TUBE CYST
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Reproductive system and breast disorders
FEMALE GENITAL TRACT FISTULA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Reproductive system and breast disorders
HAEMATOSPERMIA
|
0.23%
3/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Reproductive system and breast disorders
MENORRHAGIA
|
0.00%
0/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Reproductive system and breast disorders
PELVIC HAEMATOMA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Reproductive system and breast disorders
PENILE HAEMORRHAGE
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Reproductive system and breast disorders
POLYCYSTIC OVARIES
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Reproductive system and breast disorders
PROSTATITIS
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Reproductive system and breast disorders
PROSTATOMEGALY
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Reproductive system and breast disorders
SEXUAL DYSFUNCTION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Reproductive system and breast disorders
SPERMATOCELE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Reproductive system and breast disorders
TESTICULAR PAIN
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Reproductive system and breast disorders
UTERINE POLYP
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Reproductive system and breast disorders
VAGINAL HAEMORRHAGE
|
0.15%
2/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Reproductive system and breast disorders
VULVA CYST
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE PULMONARY OEDEMA
|
0.00%
0/1322 • 5 years
|
0.58%
4/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE
|
1.4%
18/1322 • 5 years
|
1.0%
7/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
ALLERGIC GRANULOMATOUS ANGIITIS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
ASPIRATION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.45%
6/1322 • 5 years
|
0.58%
4/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
ATELECTASIS
|
0.15%
2/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHIAL HYPERREACTIVITY
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHITIS CHRONIC
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
CHOKING
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE PULMONARY DISEASE
|
2.6%
35/1322 • 5 years
|
2.2%
15/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
1.6%
21/1322 • 5 years
|
1.7%
12/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
9.5%
126/1322 • 5 years
|
8.0%
55/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
3.9%
51/1322 • 5 years
|
4.8%
33/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA PAROXYSMAL NOCTURNAL
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
EMPHYSEMA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
2.0%
26/1322 • 5 years
|
2.2%
15/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
0.15%
2/1322 • 5 years
|
0.73%
5/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
HYPERVENTILATION
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
0.23%
3/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
INTERSTITIAL LUNG DISEASE
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
MEDIASTINAL MASS
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
NASAL POLYPS
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
NASAL SEPTUM ULCERATION
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
NON-CARDIOGENIC PULMONARY OEDEMA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
OBSTRUCTIVE AIRWAYS DISORDER
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
ORGANISING PNEUMONIA
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
0.30%
4/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
ORTHOPNOEA
|
0.23%
3/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
PHARYNGEAL OEDEMA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.68%
9/1322 • 5 years
|
0.87%
6/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
PLEURITIC PAIN
|
0.30%
4/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA ASPIRATION
|
0.00%
0/1322 • 5 years
|
0.58%
4/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
0.15%
2/1322 • 5 years
|
0.87%
6/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY CONGESTION
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.68%
9/1322 • 5 years
|
1.0%
7/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY FIBROSIS
|
0.00%
0/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY HYPERTENSION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY OEDEMA
|
0.23%
3/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY ALKALOSIS
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY ARREST
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY DISORDER
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
1.1%
14/1322 • 5 years
|
1.2%
8/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
RHINITIS ALLERGIC
|
0.23%
3/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
SINUS CONGESTION
|
0.15%
2/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
SLEEP APNOEA SYNDROME
|
0.61%
8/1322 • 5 years
|
0.87%
6/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
THROAT TIGHTNESS
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
TRACHEAL STENOSIS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
UPPER RESPIRATORY TRACT CONGESTION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
UPPER-AIRWAY COUGH SYNDROME
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
WHEEZING
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Skin and subcutaneous tissue disorders
ACTINIC KERATOSIS
|
0.15%
2/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Skin and subcutaneous tissue disorders
ANGIOEDEMA
|
0.15%
2/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Skin and subcutaneous tissue disorders
DECUBITUS ULCER
|
0.23%
3/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Skin and subcutaneous tissue disorders
DERMATITIS
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Skin and subcutaneous tissue disorders
DERMATITIS ATOPIC
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Skin and subcutaneous tissue disorders
DERMATITIS CONTACT
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Skin and subcutaneous tissue disorders
DIABETIC FOOT
|
0.23%
3/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Skin and subcutaneous tissue disorders
DRUG ERUPTION
|
0.00%
0/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Skin and subcutaneous tissue disorders
ECCHYMOSIS
|
0.23%
3/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Skin and subcutaneous tissue disorders
ECZEMA
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
0.38%
5/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Skin and subcutaneous tissue disorders
HYPERKERATOSIS
|
0.00%
0/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Skin and subcutaneous tissue disorders
INCREASED TENDENCY TO BRUISE
|
0.68%
9/1322 • 5 years
|
0.73%
5/686 • 5 years
|
|
Skin and subcutaneous tissue disorders
INGROWING NAIL
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Skin and subcutaneous tissue disorders
LICHENOID KERATOSIS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Skin and subcutaneous tissue disorders
LIVEDO RETICULARIS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Skin and subcutaneous tissue disorders
NIGHT SWEATS
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Skin and subcutaneous tissue disorders
PRECANCEROUS SKIN LESION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
0.30%
4/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Skin and subcutaneous tissue disorders
PRURITUS ALLERGIC
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Skin and subcutaneous tissue disorders
PSORIASIS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Skin and subcutaneous tissue disorders
RASH
|
1.1%
15/1322 • 5 years
|
1.2%
8/686 • 5 years
|
|
Skin and subcutaneous tissue disorders
RASH GENERALISED
|
0.15%
2/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Skin and subcutaneous tissue disorders
RASH PRURITIC
|
0.15%
2/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Skin and subcutaneous tissue disorders
SEBORRHOEIC DERMATITIS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Skin and subcutaneous tissue disorders
SKIN LESION
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Skin and subcutaneous tissue disorders
SKIN ULCER
|
0.38%
5/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Skin and subcutaneous tissue disorders
SWELLING FACE
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
0.30%
4/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Surgical and medical procedures
AORTIC ANEURYSM REPAIR
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Surgical and medical procedures
CARDIAC ABLATION
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Surgical and medical procedures
CARDIAC PACEMAKER BATTERY REPLACEMENT
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Surgical and medical procedures
CARDIAC PACEMAKER REPLACEMENT
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Surgical and medical procedures
CHOLECYSTECTOMY
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Surgical and medical procedures
COLOSTOMY
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Surgical and medical procedures
CORONARY ARTERY BYPASS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Surgical and medical procedures
DENTAL IMPLANTATION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Surgical and medical procedures
HERNIA HIATUS REPAIR
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Surgical and medical procedures
HIP ARTHROPLASTY
|
0.23%
3/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Surgical and medical procedures
INGUINAL HERNIA REPAIR
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Surgical and medical procedures
KNEE ARTHROPLASTY
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Surgical and medical procedures
LEG AMPUTATION
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Surgical and medical procedures
MEDICAL DEVICE REMOVAL
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Surgical and medical procedures
NEPHRECTOMY
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Surgical and medical procedures
SINUS OPERATION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Surgical and medical procedures
SPINAL FUSION SURGERY
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Surgical and medical procedures
TENDON OPERATION
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Surgical and medical procedures
THERAPY CESSATION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Surgical and medical procedures
TONSILLECTOMY
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Surgical and medical procedures
TOOTH EXTRACTION
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Surgical and medical procedures
TRANSURETHRAL PROSTATECTOMY
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Vascular disorders
ACCELERATED HYPERTENSION
|
0.30%
4/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Vascular disorders
AORTIC ANEURYSM
|
0.61%
8/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Vascular disorders
AORTIC DISSECTION
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Vascular disorders
AORTIC INTRAMURAL HAEMATOMA
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Vascular disorders
AORTIC STENOSIS
|
0.30%
4/1322 • 5 years
|
0.73%
5/686 • 5 years
|
|
Vascular disorders
ARTERIAL SPASM
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Vascular disorders
ARTERIOSCLEROSIS
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Vascular disorders
ARTERIOVENOUS FISTULA
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Vascular disorders
BLEEDING VARICOSE VEIN
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Vascular disorders
BLOOD PRESSURE FLUCTUATION
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Vascular disorders
BLOOD PRESSURE INADEQUATELY CONTROLLED
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Vascular disorders
CIRCULATORY COLLAPSE
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.91%
12/1322 • 5 years
|
1.2%
8/686 • 5 years
|
|
Vascular disorders
ESSENTIAL HYPERTENSION
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Vascular disorders
FEMORAL ARTERIAL STENOSIS
|
0.15%
2/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Vascular disorders
FEMORAL ARTERY OCCLUSION
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Vascular disorders
FLUSHING
|
0.00%
0/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Vascular disorders
HAEMATOMA
|
0.61%
8/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Vascular disorders
HAEMORRHAGE
|
0.15%
2/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Vascular disorders
HOT FLUSH
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Vascular disorders
HYPERTENSION
|
4.5%
60/1322 • 5 years
|
3.5%
24/686 • 5 years
|
|
Vascular disorders
HYPERTENSIVE CRISIS
|
0.53%
7/1322 • 5 years
|
1.0%
7/686 • 5 years
|
|
Vascular disorders
HYPOTENSION
|
2.9%
38/1322 • 5 years
|
1.9%
13/686 • 5 years
|
|
Vascular disorders
ILIAC ARTERY OCCLUSION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Vascular disorders
ILIAC ARTERY STENOSIS
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Vascular disorders
INTERMITTENT CLAUDICATION
|
1.1%
14/1322 • 5 years
|
1.5%
10/686 • 5 years
|
|
Vascular disorders
LABILE HYPERTENSION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Vascular disorders
MALIGNANT HYPERTENSION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Vascular disorders
ORTHOSTATIC HYPERTENSION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Vascular disorders
ORTHOSTATIC HYPOTENSION
|
0.61%
8/1322 • 5 years
|
0.44%
3/686 • 5 years
|
|
Vascular disorders
PALLOR
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Vascular disorders
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE
|
0.38%
5/1322 • 5 years
|
1.5%
10/686 • 5 years
|
|
Vascular disorders
PERIPHERAL COLDNESS
|
0.15%
2/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Vascular disorders
PERIPHERAL ISCHAEMIA
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Vascular disorders
PERIPHERAL VASCULAR DISORDER
|
0.61%
8/1322 • 5 years
|
0.87%
6/686 • 5 years
|
|
Vascular disorders
POOR PERIPHERAL CIRCULATION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Vascular disorders
RAYNAUD'S PHENOMENON
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Vascular disorders
REPERFUSION INJURY
|
0.38%
5/1322 • 5 years
|
0.29%
2/686 • 5 years
|
|
Vascular disorders
SUBCLAVIAN ARTERY OCCLUSION
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Vascular disorders
SUBCLAVIAN ARTERY STENOSIS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Vascular disorders
SUBCLAVIAN STEAL SYNDROME
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Vascular disorders
THROMBOPHLEBITIS SUPERFICIAL
|
0.08%
1/1322 • 5 years
|
0.15%
1/686 • 5 years
|
|
Vascular disorders
THROMBOSIS
|
0.23%
3/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Vascular disorders
VARICOSE VEIN
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Vascular disorders
VASOSPASM
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Vascular disorders
VENOUS INSUFFICIENCY
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
|
Vascular disorders
WEGENER'S GRANULOMATOSIS
|
0.08%
1/1322 • 5 years
|
0.00%
0/686 • 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60