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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

2008 participants

Primary outcome timeframe

1 year

Results posted on

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

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

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

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 year

Population: 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

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 year

Population: 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

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 year

Population: 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

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 year

Population: 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

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

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

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 years

Population: 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

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 years

Population: 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

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 years

Population: 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

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 years

Population: 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

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 years

Population: 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

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 years

Population: 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

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 years

Population: 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

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 years

Population: 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

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 years

Population: 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

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 years

Population: 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

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 years

Population: 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

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 Day

Population: 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

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 Days

Population: 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

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 Days

Population: 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

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 Days

Population: 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

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 Days

Population: 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

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 Days

Population: 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

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 day

Population: 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

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 day

Population: 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

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 procedure

Population: 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

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 procedure

Population: 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

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 procedure

Population: 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

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 procedure

Population: 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

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 procedure

Population: 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

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 Years

Population: 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

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 Years

Population: 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

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 Years

Population: 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

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 Years

Population: 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

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 Years

Population: 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

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 Years

Population: 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

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: Baseline

Population: 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

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 month

Population: 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

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 months

Population: 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

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: Baseline

Population: 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

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 month

Population: 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

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 months

Population: 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

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: Baseline

Population: 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

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 month

Population: 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

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 months

Population: 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

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: Baseline

Population: 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

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 month

Population: 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

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 months

Population: 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

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 years

Population: 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

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 years

Population: 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

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 years

Population: 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

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 years

Population: 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

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

Serious events: 801 serious events
Other events: 1174 other events
Deaths: 85 deaths

XIENCE

Serious events: 398 serious events
Other events: 601 other events
Deaths: 44 deaths

Serious adverse events

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

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

Latania Chura / Project Manager

Abbott Vascular

Phone: 503.935.3002

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: LTE60