ABSORB III Randomized Controlled Trial (RCT) | NCT01751906

Label	Type	Description	Intervention Names
Absorb BVS	Experimental	Subjects receiving Absorb BVS	Device: Absorb BVS
XIENCE	Active Comparator	Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition	Device: XIENCE

Name	Type	Description	Arm Group Labels	Other Names
Absorb BVS	Device	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.

Measure	Description	Time Frame
Number of Cardiac Death/TV-MI/ID-TLR (TLF)	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).	1 year

Measure	Description	Time Frame
Number of Participants With Powered Secondary Endpoint: Angina	Angina is defined as the first adverse event resulting in the site diagnosis of angina.	1 year
Number of Participants With Powered Secondary Endpoint: All Revascularization

Measure	Description	Time Frame
Patient Reported Outcomes (PRO): Overall Health Status	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

Name	Affiliation	Role
Stephen G Ellis, MD	Cleveland Clinic, Cleveland OH	Principal Investigator
Dean J Kereiakes, MD	The Christ Hospital, Cincinnati, OH	Principal Investigator
Gregg W Stone, MD	Columbia University Medical Center, New York, NY	Study Chair
Jennifer McMeans Jones	Abbott Medical Devices	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Baptist Medical Center Princeton		Birmingham	Alabama	35211	United States
University of Alabama Hospital

PubMed Identifier	Type	Citation	Retractions
33893022	Derived	Nishi T, Okada K, Kitahara H, Kameda R, Ikutomi M, Imura S, Hollak MB, Yock PG, Popma JJ, Kusano H, Cheong WF, Sudhir K, Fitzgerald PJ, Ellis SG, Kereiakes DJ, Stone GW, Honda Y, Kimura T; ABSORB III and ABSORB Japan Investigators. Intravascular ultrasound predictors of long-term outcomes following ABSORB bioresorbable scaffold implantation: A pooled analysis of the ABSORB III and ABSORB Japan trials. J Cardiol. 2021 Sep;78(3):224-229. doi: 10.1016/j.jjcc.2021.03.005. Epub 2021 Apr 21.
31561250

ID	Title	Description
FG000	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.

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Cardiac Death/TV-MI/ID-TLR (TLF)

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).

Intent-To-Treat Population set (ITT). The number of participants analyzed includes subjects who had available follow up data at that time frame.

Posted

Count of Participants

Participants

1 year

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG0001313 OG001677

Title

Denominators

Categories

Title	Measurements
	OG000102 OG00141

Secondary

Number of Participants With Powered Secondary Endpoint: Angina

Angina is defined as the first adverse event resulting in the site diagnosis of angina.

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.

Posted

Count of Participants

Participants

1 year

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Number of Participants With Powered Secondary Endpoint: All Revascularization

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.

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).

Posted

Count of Participants

Participants

1 year

ID	Title	Description
OG000	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.
OG001	XIENCE

Secondary

Number of Participants With Powered Secondary Endpoint: Ischemia Driven Target Vessel Revascularization (ID-TVR)

This powered secondary endpoint is intended to assess all ID-TVR at 1 year and test for superiority of Absorb BVS to XIENCE.

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

Posted

Count of Participants

Participants

1 year

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Acute Success- Device Success (Lesion Level Analysis)

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.

Intent-To-Treat Population set (ITT). The number of participants analyzed includes subjects who had available follow up data at that time frame.

Posted

Number

Percentage of lesions

On day 0 (the day of procedure)

Target Lesions

ID	Title	Description
OG000	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.

Secondary

Acute Success: Procedural Success (Subject Level Analysis)

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).

Intent-To-Treat Population set (ITT). The number of participants analyzed includes subjects who had available follow up data at that time frame.

Posted

Count of Participants

Participants

On day 0 (the day of procedure)

ID	Title	Description
OG000	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.
OG001

Secondary

Number of Death (Cardiac, Vascular, Non-cardiovascular)

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.

ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Posted

Count of Participants

Participants

0 to 5 years

ID	Title	Description
OG000	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.

Secondary

Number of Participants With All Myocardial Infarction (MI)

Attributable to target vessel (TV-MI)
Not attributable to target vessel (NTV-MI)

ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Posted

Count of Participants

Participants

0 to 5 years

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Number of Participants With All Target Lesion Revascularization (TLR)

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.

ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Posted

Count of Participants

Participants

0 to 5 years

ID	Title	Description
OG000	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.
OG001

Secondary

Number of Participants With All Target Vessel Revascularization (TVR) Excluding Target Lesion Revascularization (TLR)

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.

ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Posted

Count of Participants

Participants

0 to 5 years

ID	Title	Description
OG000	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.
OG001	XIENCE

Secondary

Number of Participants With All Revascularization

All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.

ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Posted

Count of Participants

Participants

0 to 5 years

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Number of Death/All MI

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

ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Posted

Count of Participants

Participants

0 to 5 years

ID	Title	Description
OG000	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.

Secondary

Number of Cardiac Death/All MI

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

ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Posted

Count of Participants

Participants

0 to 5 years

ID	Title	Description
OG000	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.

Secondary

Number of Cardiac Death/TV-MI/ID-TLR (TLF)

Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).

ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Posted

Count of Participants

Participants

0 to 5 years

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Number of Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)

Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).

ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Posted

Count of Participants

Participants

0 to 5 years

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Number of Participants With Target Vessel Failure (TVF)

Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).

ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Posted

Count of Participants

Participants

0 to 5 years

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Number of Death/All MI/All Revascularization (DMR)

DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.

ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Posted

Count of Participants

Participants

0 to 5 years

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Number of Participants With Acute Stent/Scaffold Thrombosis (Per ARC Definition)

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.

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.

Posted

Count of Participants

Participants

≤ 1 Day

ID	Title	Description
OG000	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.

Secondary

Number of Participants With Acute/Subacute Stent/Scaffold Thrombosis (Per ARC Definition)

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.

Posted

Count of Participants

Participants

0 to 30 Days

ID	Title	Description
OG000	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.

Secondary

Number of Participants With Subacute Stent/Scaffold Thrombosis

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.

Posted

Count of Participants

Participants

>1 to 30 Days

ID	Title	Description
OG000	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.

Secondary

Number of Participants With Late Stent/Scaffold Thrombosis (Per ARC Definition)

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.

Posted

Count of Participants

Participants

31 to 365 Days

ID	Title	Description
OG000	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.

Secondary

Number of Participants With Very Late Stent /Scaffold Thrombosis (Per ARC Definition)

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.

Posted

Count of Participants

Participants

366 to 393 Days

ID	Title	Description
OG000	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.

Secondary

Number of Participants With Cumulative Stent/Scaffold Thrombosis

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.

Posted

Count of Participants

Participants

0 to 1853 Days

ID	Title	Description
OG000	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.

Secondary

Pre-Procedure Minimum Lumen Diameter (MLD)

Angiographic endpoint Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen.

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.

Posted

Mean

Standard Deviation

Millimeter

< or = 1 day

Target Lesions

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Pre-Procedure Percent Diameter Stenosis (%DS)

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).

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.

Posted

Mean

Standard Deviation

Percent Diameter stenosis

< or = 1 day

Target Lesions

ID	Title	Description
OG000	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.
OG001	XIENCE

Secondary

Post-Procedure In-Segment Minimum Lumen Diameter (MLD)

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.

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.

Posted

Mean

Standard Deviation

Millimeter

≤ 7 days post index procedure

Target Lesions

ID	Title	Description
OG000	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.
OG001	XIENCE

Secondary

Post-Procedure In-Segment Percent Diameter Stenosis (%DS)

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.

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.

Posted

Mean

Standard Deviation

Percent Diameter stenosis

≤ 7 days post index procedure

Target Lesions

ID	Title	Description
OG000	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.

Secondary

Post-Procedure In-Device Minimum Lumen Diameter (MLD)

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

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.

Posted

Mean

Standard Deviation

Millimeter

≤ 7 days post index procedure

Target Lesions

ID	Title	Description
OG000	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.
OG001	XIENCE

Secondary

Post-Procedure In-Device Percent Diameter Stenosis (%DS)

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.

Posted

Mean

Standard Deviation

Percent Diameter stenosis

≤ 7 days post index procedure

Target Lesions

ID	Title	Description
OG000	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.
OG001	XIENCE

Secondary

Post-Procedure In-Device Acute Gain

The acute gain was defined as the difference between post- and pre procedural minimal lumen diameter (MLD).

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.

Posted

Mean

Standard Deviation

≤ 7 days post index procedure

Target Lesions

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Powered Imaging Cohort Secondary Endpoint: The Instent/Scaffold Mean Lumen Area Change, From Post Procedure to 3 Years by Intravascular Ultrasound (IVUS)

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.

The full analysis set (FAS) population is defined as the patients wherein the target lesion was treated with the assigned device.

Posted

Mean

Standard Deviation

mm^2

From Post procedure to 3 Years

Lesions

ID	Title	Description
OG000	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.
OG001	XIENCE

Secondary

Optical Coherence Tomography (OCT) Endpoint: Mean Neointimal Area (NIA)

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

The full analysis set (FAS) population is defined as the patients wherein the target lesion was treated with the assigned device

Posted

Mean

Standard Deviation

mm^2

3 Years

Leisions

ID	Title	Description
OG000	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.

Secondary

Optical Coherence Tomography (OCT) Endpoint: Mean Device Area, Adluminal

The full analysis set (FAS) population is defined as the patients wherein the target lesion was treated with the assigned device.

Posted

Mean

Standard Deviation

mm^2

3 Years

Leisions

ID	Title	Description
OG000	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.

Secondary

Optical Coherence Tomography (OCT) Endpoint: Mean Lumen Area

The full analysis set (FAS) population is defined as the patients wherein the target lesion was treated with the assigned device.

Posted

Mean

Standard Deviation

mm^2

3 Years

Leisions

ID	Title	Description
OG000	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.

Secondary

Optical Coherence Tomography (OCT) Endpoint: Minimal Lumen Area

The full analysis set (FAS) population is defined as the patients wherein the target lesion was treated with the assigned device.

Posted

Mean

Standard Deviation

mm^2

3 Years

Leisions

ID	Title	Description
OG000	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.

Secondary

Optical Coherence Tomography (OCT) Endpoint: Percentage of Malapposition Struts

The full analysis set (FAS) population is defined as the patients wherein the target lesion was treated with the assigned device.

Posted

Mean

Standard Deviation

Percentage of Malapposition Struts

3 Years

Leisions

ID	Title	Description
OG000	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.

Other Pre-specified

Patient Reported Outcomes (PRO): Overall Health Status

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

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.

Posted

Mean

Standard Deviation

score on a scale

Baseline

ID	Title	Description
OG000	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.

Other Pre-specified

Patient Reported Outcomes (PRO): Overall Health Status

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.

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.

Posted

Mean

Standard Deviation

score on a scale

1 month

ID	Title	Description
OG000	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.

Other Pre-specified

Patient Reported Outcomes (PRO): Overall Health Status

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.

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.

Posted

Mean

Standard Deviation

score on a scale

12 months

ID	Title	Description
OG000	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.

Other Pre-specified

Patient Reported Outcomes (PRO): Anxiety

Anxiety assessed using the Generalized Anxiety Disorder scale (GAD-7).

GAD-7:

Scale range: 0 to 21
Lower values represent better outcomes
No subscales

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.

Posted

Mean

Standard Deviation

score on a scale

Baseline

ID	Title	Description
OG000	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.
OG001	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.

Other Pre-specified

Patient Reported Outcomes (PRO): Anxiety

Anxiety assessed using the Generalized Anxiety Disorder scale (GAD-7).

GAD-7:

Scale range: 0 to 21
Lower values represent better outcomes
No subscales

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.

Posted

Mean

Standard Deviation

score on a scale

1 month

ID	Title	Description
OG000	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.
OG001	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.

Other Pre-specified

Patient Reported Outcomes (PRO): Anxiety

Anxiety assessed using the Generalized Anxiety Disorder scale (GAD-7).

GAD-7:

Scale range: 0 to 21
Lower values represent better outcomes
No subscales

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.

Posted

Mean

Standard Deviation

score on a scale

12 months

ID	Title	Description
OG000	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.
OG001	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.

Other Pre-specified

Patient Reported Outcomes (PRO): Disease-Specific Quality of Life

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).

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.

Posted

Mean

Standard Deviation

score on a scale

Baseline

ID	Title	Description
OG000	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.
OG001	XIENCE

Other Pre-specified

Patient Reported Outcomes (PRO): Disease-Specific Quality of Life

Disease-Specific quality of life in hospital baseline and at 1 year assessed using the Seattle Angina Questionnaire (SAQ).

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.

Posted

Mean

Standard Deviation

score on a scale

1 month

ID	Title	Description
OG000	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.
OG001	XIENCE

Other Pre-specified

Patient Reported Outcomes (PRO): Disease-Specific Quality of Life

Disease-Specific quality of life in hospital baseline and at 1 year assessed using the Seattle Angina Questionnaire (SAQ).

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.

Posted

Mean

Standard Deviation

score on a scale

12 months

ID	Title	Description
OG000	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.
OG001	XIENCE

Other Pre-specified

Patient Reported Outcomes (PRO): Dyspnea Severity

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

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.

Posted

Mean

Standard Deviation

score on a scale

Baseline

ID	Title	Description
OG000	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.
OG001	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.

Other Pre-specified

Patient Reported Outcomes (PRO): Dyspnea Severity

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

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.

Posted

Mean

Standard Deviation

score on a scale

1 month

ID	Title	Description
OG000	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.
OG001	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.

Other Pre-specified

Patient Reported Outcomes (PRO): Dyspnea Severity

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

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.

Posted

Mean

Standard Deviation

score on a scale

12 months

ID	Title	Description
OG000	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.
OG001	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.

Other Pre-specified

Landmark Analysis on TLF and Components

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).

ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Posted

Count of Participants

Participants

3-4 years

ID	Title	Description
OG000	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.
OG001	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.

Other Pre-specified

Landmark Analysis on TLF and Components

ITT set. The number of participants analyzed includes subjects who had available follow up data at that time frame.

Posted

Count of Participants

Participants

3-5 years

ID	Title	Description
OG000	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.
OG001	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.

Other Pre-specified

Landmark Analysis on Cumulative Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable)

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.

Posted

Count of Participants

Participants

3-4 years

ID	Title	Description
OG000	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.

Other Pre-specified

Landmark Analysis on Cumulative Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable)

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.

Posted

Count of Participants

Participants

3-5 years

ID	Title	Description
OG000	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.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0007 affected1,322 at risk EG0017 affected686 at risk
ANAEMIA OF CHRONIC DISEASE	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
COAGULOPATHY	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0012 affected686 at risk
FEBRILE NEUTROPENIA	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
HAEMORRHAGIC ANAEMIA	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0013 affected686 at risk
HEPARIN-INDUCED THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
IRON DEFICIENCY ANEMIA	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
LEUKOCYTOSIS	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0011 affected686 at risk
LYMPHADENOPATHY	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
MICROCYTIC ANAEMIA	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
NORMOCHROMIC NORMOCYTIC ANAEMIA	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
ACUTE CORONARY SYNDROME	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0006 affected1,322 at risk EG0015 affected686 at risk
ACUTE LEFT VENTRICULAR FAILURE	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
ACUTE MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG00049 affected1,322 at risk EG00121 affected686 at risk
ANGINA PECTORIS	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG000161 affected1,322 at risk EG00187 affected686 at risk
ANGINA UNSTABLE	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG00068 affected1,322 at risk EG00128 affected686 at risk
AORTIC VALVE DISEASE	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
AORTIC VALVE STENOSIS	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0006 affected1,322 at risk EG0012 affected686 at risk
ARRHYTHMIA	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0012 affected686 at risk
ARTERIOSCLEROSIS CORONARY ARTERY	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
ARTERIOSPASM CORONARY	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
ATRIAL FIBRILLATION	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG00052 affected1,322 at risk EG00121 affected686 at risk
ATRIAL FLUTTER	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0006 affected1,322 at risk EG0012 affected686 at risk
ATRIAL TACHYCARDIA	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
ATRIOVENTRICULAR BLOCK	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0010 affected686 at risk
ATRIOVENTRICULAR BLOCK COMPLETE	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
ATRIOVENTRICULAR BLOCK SECOND DEGREE	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0004 affected1,322 at risk EG0010 affected686 at risk
BRADYCARDIA	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0009 affected1,322 at risk EG0012 affected686 at risk
BUNDLE BRANCH BLOCK	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
CARDIAC ARREST	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG00010 affected1,322 at risk EG0016 affected686 at risk
CARDIAC FAILURE	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0008 affected1,322 at risk EG0014 affected686 at risk
CARDIAC FAILURE ACUTE	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0005 affected1,322 at risk EG0011 affected686 at risk
CARDIAC FAILURE CHRONIC	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0013 affected686 at risk
CARDIAC FAILURE CONGESTIVE	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG00032 affected1,322 at risk EG00125 affected686 at risk
CARDIAC TAMPONADE	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
CARDIAC VALVE DISEASE	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
CARDIO-RESPIRATORY ARREST	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected1,322 at risk EG0011 affected686 at risk
CARDIOGENIC SHOCK	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0013 affected686 at risk
CARDIOMYOPATHY	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
CARDIORENAL SYNDROME	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
CHRONIC LEFT VENTRICULAR FAILURE	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
CONDUCTION DISORDER	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
CONGESTIVE CARDIOMYOPATHY	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
CORONARY ARTERY DISEASE	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG00038 affected1,322 at risk EG00124 affected686 at risk
CORONARY ARTERY DISSECTION	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG00022 affected1,322 at risk EG00112 affected686 at risk
CORONARY ARTERY EMBOLISM	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0012 affected686 at risk
CORONARY ARTERY OCCLUSION	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0004 affected1,322 at risk EG0012 affected686 at risk
CORONARY ARTERY PERFORATION	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0005 affected1,322 at risk EG0013 affected686 at risk
CORONARY ARTERY STENOSIS	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG00020 affected1,322 at risk EG00113 affected686 at risk
CORONARY OSTIAL STENOSIS	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
DRESSLER'S SYNDROME	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected1,322 at risk EG0012 affected686 at risk
IN-STENT CORONARY ARTERY RESTENOSIS	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0004 affected1,322 at risk EG0015 affected686 at risk
INTRACARDIAC THROMBUS	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
ISCHAEMIC CARDIOMYOPATHY	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0011 affected686 at risk
LEFT VENTRICULAR DYSFUNCTION	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
MITRAL VALVE INCOMPETENCE	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0005 affected1,322 at risk EG0011 affected686 at risk
MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG00052 affected1,322 at risk EG00123 affected686 at risk
MYOCARDIAL ISCHAEMIA	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0010 affected686 at risk
PALPITATIONS	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
PERICARDIAL EFFUSION	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0005 affected1,322 at risk EG0011 affected686 at risk
PERICARDITIS	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
PRINZMETAL ANGINA	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
SICK SINUS SYNDROME	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0006 affected1,322 at risk EG0013 affected686 at risk
SINUS ARRHYTHMIA	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
SINUS BRADYCARDIA	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
SUPRAVENTRICULAR TACHYCARDIA	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0005 affected1,322 at risk EG0012 affected686 at risk
TACHYCARDIA	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
TORSADE DE POINTES	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
VENTRICULAR ARRHYTHMIA	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
VENTRICULAR EXTRASYSTOLES	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0010 affected686 at risk
VENTRICULAR FIBRILLATION	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0005 affected1,322 at risk EG0010 affected686 at risk
VENTRICULAR TACHYCARDIA	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0008 affected1,322 at risk EG0013 affected686 at risk
CYSTIC LYMPHANGIOMA	Congenital, familial and genetic disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
PULMONARY ARTERIOVENOUS FISTULA	Congenital, familial and genetic disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
VERTIGO	Ear and labyrinth disorders	MedDRA 11.0	Systematic Assessment	EG0005 affected1,322 at risk EG0011 affected686 at risk
AMAUROSIS FUGAX	Eye disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
CATARACT	Eye disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0013 affected686 at risk
CATARACT NUCLEAR	Eye disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
DIPLOPIA	Eye disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
GLAUCOMA	Eye disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
MACULAR OEDEMA	Eye disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
PAPILLOEDEMA	Eye disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
POSTERIOR CAPSULE OPACIFICATION	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
RETINAL DETACHMENT	Eye disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
RETINAL HAEMORRHAGE	Eye disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
VISION BLURRED	Eye disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
ABDOMINAL HERNIA	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0013 affected686 at risk
ABDOMINAL HERNIA OBSTRUCTIVE	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0013 affected686 at risk
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0013 affected686 at risk
ABDOMINAL WALL HAEMATOMA	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
ALCOHOLIC PANCREATITIS	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
COELIAC ARTERY STENOSIS	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
COLITIS	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0011 affected686 at risk
COLITIS ISCHAEMIC	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
CONSTIPATION	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
CROHN'S DISEASE	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
DENTAL CARIES	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
DIABETIC GASTROPARESIS	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0012 affected686 at risk
DIVERTICULUM	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
DIVERTICULUM INTESTINAL HAEMORRHAGIC	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0011 affected686 at risk
DUODENAL ULCER	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
DUODENAL ULCER HAEMORRHAGE	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
DYSPHAGIA	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0005 affected1,322 at risk EG0011 affected686 at risk
ENTEROVESICAL FISTULA	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
FAECALOMA	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
GASTRIC HAEMORRHAGE	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
GASTRIC ULCER	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0012 affected686 at risk
GASTRIC ULCER HAEMORRHAGE	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
GASTRITIS	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
GASTROINTESTINAL ANGIODYSPLASIA	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG00013 affected1,322 at risk EG00113 affected686 at risk
GASTROINTESTINAL ULCER HAEMORRHAGE	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
GASTROOESOPHAGEAL REFLUX DISEASE	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0005 affected1,322 at risk EG0010 affected686 at risk
HAEMATEMESIS	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
HAEMATOCHEZIA	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
HAEMORRHOIDAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
HIATUS HERNIA	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
ILEUS	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0012 affected686 at risk
IMPAIRED GASTRIC EMPTYING	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0011 affected686 at risk
INGUINAL HERNIA	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0013 affected686 at risk
INTESTINAL MASS	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0011 affected686 at risk
INTESTINAL OBSTRUCTION	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0012 affected686 at risk
IRRITABLE BOWEL SYNDROME	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
LARGE INTESTINE PERFORATION	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
LOWER GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0012 affected686 at risk
MALLORY-WEISS SYNDROME	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
MELAENA	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
MOUTH HAEMORRHAGE	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
OESOPHAGEAL ACHALASIA	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
OESOPHAGITIS	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
PANCREATIC CYST	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
PANCREATITIS	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0012 affected686 at risk
PANCREATITIS ACUTE	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected1,322 at risk EG0011 affected686 at risk
RECTAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0012 affected686 at risk
RETROPERITONEAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0010 affected686 at risk
SMALL INTESTINAL OBSTRUCTION	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0016 affected686 at risk
SMALL INTESTINAL PERFORATION	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
UMBILICAL HERNIA	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
UMBILICAL HERNIA, OBSTRUCTIVE	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
UPPER GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0014 affected686 at risk
ABASIA	General disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
ADVERSE DRUG REACTION	General disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0011 affected686 at risk
ASTHENIA	General disorders	MedDRA 11.0	Systematic Assessment	EG0005 affected1,322 at risk EG0010 affected686 at risk
CARDIAC DEATH	General disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
CATHETER SITE HAEMATOMA	General disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
CATHETER SITE HAEMORRHAGE	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected1,322 at risk EG0012 affected686 at risk
CATHETER SITE PAIN	General disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected1,322 at risk EG0012 affected686 at risk
CHEST DISCOMFORT	General disorders	MedDRA 11.0	Systematic Assessment	EG00010 affected1,322 at risk EG0018 affected686 at risk
CHEST PAIN	General disorders	MedDRA 11.0	Systematic Assessment	EG00040 affected1,322 at risk EG00118 affected686 at risk
DEATH	General disorders	MedDRA 11.0	Systematic Assessment	EG00010 affected1,322 at risk EG0016 affected686 at risk
DEVICE ELECTRICAL FINDING	General disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
DEVICE FAILURE	General disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
DEVICE MALFUNCTION	General disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
DEVICE OCCLUSION	General disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
DROWNING	General disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
DRUG INTOLERANCE	General disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
DRUG WITHDRAWAL SYNDROME	General disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
HERNIA	General disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
HERNIA OBSTRUCTIVE	General disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
IMPAIRED HEALING	General disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
MEDICAL DEVICE SITE REACTION	General disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
MULTI-ORGAN FAILURE	General disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0012 affected686 at risk
NON-CARDIAC CHEST PAIN	General disorders	MedDRA 11.0	Systematic Assessment	EG00084 affected1,322 at risk EG00151 affected686 at risk
OEDEMA PERIPHERAL	General disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
PAIN	General disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
PELVIC MASS	General disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0012 affected686 at risk
PYREXIA	General disorders	MedDRA 11.0	Systematic Assessment	EG0006 affected1,322 at risk EG0013 affected686 at risk
SUDDEN CARDIAC DEATH	General disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
SURGICAL FAILURE	General disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
SYSTEMIC INFLAMMATORY RESPONSE SYNDROME	General disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0011 affected686 at risk
THROMBOSIS IN DEVICE	General disorders	MedDRA 11.0	Systematic Assessment	EG0009 affected1,322 at risk EG0016 affected686 at risk
BILE DUCT STONE	Hepatobiliary disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
CHOLANGITIS	Hepatobiliary disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
CHOLECYSTITIS	Hepatobiliary disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0012 affected686 at risk
CHOLECYSTITIS ACUTE	Hepatobiliary disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0014 affected686 at risk
CHOLECYSTITIS CHRONIC	Hepatobiliary disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
CHOLELITHIASIS	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0007 affected1,322 at risk EG0013 affected686 at risk
GALLBLADDER DISORDER	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
HEPATIC LESION	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected1,322 at risk EG0011 affected686 at risk
PORTAL VEIN THROMBOSIS	Hepatobiliary disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
ALLERGY TO ARTHROPOD STING	Immune system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
ABDOMINAL ABSCESS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
ABSCESS NECK	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
APPENDICITIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0004 affected1,322 at risk EG0012 affected686 at risk
APPENDICITIS PERFORATED	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
ARTHRITIS BACTERIAL	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
ARTHRITIS INFECTIVE	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
BACTERAEMIA	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0004 affected1,322 at risk EG0010 affected686 at risk
BACTERIAL INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
BACTERIAL SEPSIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0012 affected686 at risk
BREAST CELLULITIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
BRONCHITIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG00010 affected1,322 at risk EG0016 affected686 at risk
BRONCHITIS VIRAL	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
CATHETER SITE ABSCESS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
CATHETER SITE CELLULITIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
CATHETER SITE INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
CELLULITIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG00011 affected1,322 at risk EG00111 affected686 at risk
CHOLECYSTITIS INFECTIVE	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0012 affected686 at risk
CLOSTRIDIAL INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
CLOSTRIDIUM DIFFICILE COLITIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0012 affected686 at risk
CYSTITIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
DIABETIC FOOT INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
DIVERTICULITIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0005 affected1,322 at risk EG0013 affected686 at risk
ENDOCARDITIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
ENTEROCOCCAL SEPSIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
ESCHERICHIA BACTERAEMIA	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
FUNGAL INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
GANGRENE	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
GASTROENTERITIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0006 affected1,322 at risk EG0013 affected686 at risk
GASTROENTERITIS VIRAL	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0012 affected686 at risk
GENITAL INFECTION FEMALE	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
HERPES ZOSTER	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
HIV INFECTION	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
IMPLANT SITE INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
INFECTED DERMAL CYST	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
INFECTED SKIN ULCER	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
INFLUENZA	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0013 affected686 at risk
KIDNEY INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0010 affected686 at risk
LOBAR PNEUMONIA	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
LOCALISED INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0013 affected686 at risk
LUNG ABSCESS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
MENINGITIS ASEPTIC	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
METAPNEUMOVIRUS INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
MYCOBACTERIUM ABSCESSUS INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
ORAL FUNGAL INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
ORCHITIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
OSTEOMYELITIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0014 affected686 at risk
PERITONITIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
PERITONSILLAR ABSCESS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
PNEUMONIA	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG00025 affected1,322 at risk EG00119 affected686 at risk
PNEUMONIA ADENOVIRAL	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
PNEUMONIA BACTERIAL	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
PNEUMONIA NECROTISING	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
PNEUMONIA PRIMARY ATYPICAL	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
PNEUMONIA STAPHYLOCOCCAL	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
POST PROCEDURAL CELLULITIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
POST PROCEDURAL INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
POST PROCEDURAL PNEUMONIA	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
POSTOPERATIVE WOUND INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
RESPIRATORY SYNCYTIAL VIRUS INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
SEPSIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG00014 affected1,322 at risk EG00110 affected686 at risk
SEPSIS SYNDROME	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
SEPTIC ENCEPHALOPATHY	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
SEPTIC SHOCK	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0011 affected686 at risk
SPINAL CORD INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
STAPHYLOCOCCAL BACTERAEMIA	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0012 affected686 at risk
STAPHYLOCOCCAL INFECTION	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
URINARY TRACT INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0009 affected1,322 at risk EG0017 affected686 at risk
URINARY TRACT INFECTION BACTERIAL	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
UROSEPSIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0014 affected686 at risk
VIRAL INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
VIRAL LABYRINTHITIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
WOUND INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0012 affected686 at risk
WOUND INFECTION BACTERIAL	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
WOUND INFECTION STAPHYLOCOCCAL	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
ACETABULUM FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
ALCOHOL POISONING	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0012 affected686 at risk
ANAEMIA POSTOPERATIVE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0012 affected686 at risk
ANKLE FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0013 affected686 at risk
BURNS THIRD DEGREE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
CARDIAC PROCEDURE COMPLICATION	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
CEREBRAL HAEMORRHAGE TRAUMATIC	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
CLAVICLE FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
COLON INJURY	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
CONCUSSION	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
CONTRAST MEDIA ALLERGY	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
CONTUSION	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
CORONARY ARTERY RESTENOSIS	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG00051 affected1,322 at risk EG00115 affected686 at risk
CRANIOCEREBRAL INJURY	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0010 affected686 at risk
CYSTITIS RADIATION	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
DEEP VEIN THROMBOSIS POSTOPERATIVE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
EXPOSURE TO TOXIC AGENT	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
FALL	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0009 affected1,322 at risk EG0017 affected686 at risk
FEMORAL NECK FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0012 affected686 at risk
FEMUR FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0010 affected686 at risk
FOOT FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
GASTROINTESTINAL ANASTOMOTIC LEAK	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
HAND FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
HEAD INJURY	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
HIP FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0004 affected1,322 at risk EG0012 affected686 at risk
HUMERUS FRACTURE	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 affected1,322 at risk EG0012 affected686 at risk
ILIOTIBIAL BAND SYNDROME	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
IN-STENT ARTERIAL RESTENOSIS	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
IN-STENT CORONARY ARTERY RESTENOSIS	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0007 affected1,322 at risk EG0015 affected686 at risk
INCISIONAL HERNIA	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0010 affected686 at risk
INJURY	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
JOINT DISLOCATION	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
LACERATION	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
LIGAMENT RUPTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
LIMB INJURY	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
LIMB TRAUMATIC AMPUTATION	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
MENISCUS LESION	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0004 affected1,322 at risk EG0011 affected686 at risk
MULTIPLE FRACTURES	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
MULTIPLE INJURIES	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
MUSCLE RUPTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
PELVIC FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
PLAQUE SHIFT	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0013 affected686 at risk
POST CONCUSSION SYNDROME	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
POST PROCEDURAL HAEMATOMA	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0012 affected686 at risk
POST PROCEDURAL HAEMORRHAGE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0012 affected686 at risk
POST PROCEDURAL MYOCARDIAL INFARCTION	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0007 affected1,322 at risk EG0015 affected686 at risk
POST PROCEDURAL STROKE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
POST-TRAUMATIC PAIN	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
POSTOPERATIVE ADHESION	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
PROCEDURAL COMPLICATION	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
PROCEDURAL DIZZINESS	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
PROCEDURAL HEADACHE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
PROCEDURAL HYPOTENSION	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
PROCEDURAL VOMITING	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
RADIUS FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
RESPIRATORY FUME INHALATION DISORDER	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
RIB FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0012 affected686 at risk
ROAD TRAFFIC ACCIDENT	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0004 affected1,322 at risk EG0010 affected686 at risk
SEROMA	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
SKULL FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
SNAKE BITE	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
SPINAL COMPRESSION FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0004 affected1,322 at risk EG0012 affected686 at risk
SPINAL FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
SPLENIC RUPTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
STERNAL FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
SUBDURAL HAEMATOMA	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0006 affected1,322 at risk EG0013 affected686 at risk
TENDON INJURY	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
TENDON RUPTURE	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
THERMAL BURN	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
THORACIC VERTEBRAL FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
TIBIA FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0012 affected686 at risk
TRAUMATIC HAEMATOMA	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
TRAUMATIC HAEMORRHAGE	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
ULNA FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
UPPER LIMB FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
URINARY RETENTION POSTOPERATIVE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0010 affected686 at risk
VASCULAR GRAFT OCCLUSION	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0011 affected686 at risk
VASCULAR PSEUDOANEURYSM	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0007 affected1,322 at risk EG0013 affected686 at risk
WOUND	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
WOUND EVISCERATION	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
WOUND HAEMORRHAGE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
WRIST FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0011 affected686 at risk
BIOPSY LUNG	Investigations	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
BLOOD CREATINE INCREASED	Investigations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
BLOOD CREATINE PHOSPHOKINASE MB INCREASED	Investigations	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
BLOOD CREATININE INCREASED	Investigations	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0010 affected686 at risk
BLOOD PRESSURE INCREASED	Investigations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
BLOOD PRESSURE SYSTOLIC INCREASED	Investigations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
CARDIAC ENZYMES INCREASED	Investigations	MedDRA 11.0	Systematic Assessment	EG0004 affected1,322 at risk EG0011 affected686 at risk
CARDIAC STRESS TEST ABNORMAL	Investigations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0012 affected686 at risk
COMPUTERISED TOMOGRAM ABNORMAL	Investigations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
COMPUTERISED TOMOGRAM THORAX ABNORMAL	Investigations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
EJECTION FRACTION DECREASED	Investigations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
ELECTROCARDIOGRAM ST SEGMENT ELEVATION	Investigations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
HAEMOGLOBIN DECREASED	Investigations	MedDRA 10.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
HEART RATE INCREASED	Investigations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
OXYGEN CONSUMPTION INCREASED	Investigations	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
TROPONIN INCREASED	Investigations	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
WHITE BLOOD CELL COUNT INCREASED	Investigations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
DEHYDRATION	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0007 affected1,322 at risk EG0015 affected686 at risk
DIABETES MELLITUS	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
DIABETIC KETOACIDOSIS	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0005 affected1,322 at risk EG0011 affected686 at risk
FAILURE TO THRIVE	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
FLUID OVERLOAD	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
HYPERGLYCAEMIA	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0006 affected1,322 at risk EG0012 affected686 at risk
HYPERKALAEMIA	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0012 affected686 at risk
HYPOGLYCAEMIA	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0004 affected1,322 at risk EG0010 affected686 at risk
HYPOKALAEMIA	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0011 affected686 at risk
HYPOMAGNESAEMIA	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
HYPONATRAEMIA	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0012 affected686 at risk
HYPOVOLAEMIA	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
LACTIC ACIDOSIS	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
METABOLIC ACIDOSIS	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
OBESITY	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0006 affected1,322 at risk EG0013 affected686 at risk
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0005 affected1,322 at risk EG0013 affected686 at risk
ARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0004 affected1,322 at risk EG0012 affected686 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0014 affected686 at risk
BURSITIS	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
CHONDROCALCINOSIS PYROPHOSPHATE	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
COSTOCHONDRITIS	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
DUPUYTREN'S CONTRACTURE	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
EXOSTOSIS	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
FLANK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
FRACTURE NONUNION	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
INTERVERTEBRAL DISC PROTRUSION	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0009 affected1,322 at risk EG0012 affected686 at risk
JOINT EFFUSION	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
LUMBAR SPINAL STENOSIS	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0007 affected1,322 at risk EG0012 affected686 at risk
MUSCULAR WEAKNESS	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0011 affected686 at risk
MUSCULOSKELETAL CHEST PAIN	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0004 affected1,322 at risk EG0010 affected686 at risk
MUSCULOSKELETAL DISORDER	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
MUSCULOSKELETAL PAIN	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0013 affected686 at risk
NECK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
OSTEOARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG00026 affected1,322 at risk EG00114 affected686 at risk
OSTEOPENIA	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
OSTEOPOROSIS	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0004 affected1,322 at risk EG0012 affected686 at risk
PAIN IN JAW	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
RHABDOMYOLYSIS	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
RHEUMATOID ARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
ROTATOR CUFF SYNDROME	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
SACROILIITIS	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
SPINAL OSTEOARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0012 affected686 at risk
SPONDYLITIS	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
SPONDYLOLISTHESIS	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0012 affected686 at risk
TENDINOUS CONTRACTURE	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
VERTEBRAL FORAMINAL STENOSIS	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
ACUTE MYELOID LEUKAEMIA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
ACUTE MYELOID LEUKAEMIA RECURRENT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
ADENOCARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0011 affected686 at risk
ADENOCARCINOMA PANCREAS	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
B-CELL LYMPHOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
B-CELL LYMPHOMA STAGE IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
BASAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0012 affected686 at risk
BENIGN OVARIAN TUMOUR	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
BILE DUCT CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
BLADDER CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0011 affected686 at risk
BLADDER CANCER RECURRENT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
BLADDER CANCER STAGE IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
BLADDER NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
BRAIN NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
BREAST CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0005 affected1,322 at risk EG0010 affected686 at risk
BREAST CANCER STAGE III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
CERVIX CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
CHRONIC LYMPHOCYTIC LEUKAEMIA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
COLON ADENOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0012 affected686 at risk
COLON CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0012 affected686 at risk
DIFFUSE LARGE B-CELL LYMPHOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
GASTRIC CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
GLIOBLASTOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0012 affected686 at risk
HEAD AND NECK CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
HEAD AND NECK CANCER METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
HEPATIC CANCER METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
HEPATIC NEOPLASM MALIGNANT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
HYPOPHARYNGEAL CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
LEUKAEMIA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
LEUKAEMIA RECURRENT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
LIP AND/OR ORAL CAVITY CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
LUNG ADENOCARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0010 affected686 at risk
LUNG CANCER METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
LUNG NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
LUNG NEOPLASM MALIGNANT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0006 affected1,322 at risk EG0010 affected686 at risk
LUNG SQUAMOUS CELL CARCINOMA STAGE III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
LUNG SQUAMOUS CELL CARCINOMA STAGE UNSPECIFIED	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
LYMPHOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0004 affected1,322 at risk EG0010 affected686 at risk
MALIGNANT MELANOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
MENINGIOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
METASTASES TO LIVER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
METASTASES TO LUNG	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
METASTASES TO LYMPH NODES	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
METASTASES TO SPINE	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
METASTATIC MALIGNANT MELANOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0010 affected686 at risk
METASTATIC NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
MULTIPLE MYELOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
NEOPLASM MALIGNANT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
NON-HODGKIN'S LYMPHOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
NON-SMALL CELL LUNG CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
OESOPHAGEAL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
ORAL NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
OROPHARYNGEAL CANCER STAGE UNSPECIFIED	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
OVARIAN CANCER METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
OVARIAN EPITHELIAL CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
PANCREATIC CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
PERICARDIAL EFFUSION MALIGNANT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
PROSTATE CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG00011 affected1,322 at risk EG0013 affected686 at risk
RECTAL CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
RENAL CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
RENAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
RENAL NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
SINONASAL PAPILLOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
SKIN CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
SMALL CELL LUNG CANCER LIMITED STAGE	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
SMALL CELL LUNG CANCER STAGE UNSPECIFIED	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
SQUAMOUS CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0012 affected686 at risk
SQUAMOUS CELL CARCINOMA OF SKIN	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
TRANSITIONAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
URETERIC CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
UTERINE CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
VULVAL CANCER STAGE 0	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
ALTERED STATE OF CONSCIOUSNESS	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
APHASIA	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
ARACHNOIDITIS	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
AUTONOMIC NERVOUS SYSTEM IMBALANCE	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
CAROTID ARTERY DISEASE	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
CAROTID ARTERY STENOSIS	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG00011 affected1,322 at risk EG0017 affected686 at risk
CARPAL TUNNEL SYNDROME	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
CENTRAL NERVOUS SYSTEM LESION	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
CEREBELLAR INFARCTION	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
CEREBRAL HAEMORRHAGE	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
CEREBRAL INFARCTION	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
CEREBROVASCULAR ACCIDENT	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG00019 affected1,322 at risk EG00115 affected686 at risk
CEREBROVASCULAR DISORDER	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
CERVICOBRACHIAL SYNDROME	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
COMPLICATED MIGRAINE	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
CONVULSION	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0011 affected686 at risk
DIABETIC NEUROPATHY	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
DIZZINESS	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0006 affected1,322 at risk EG0011 affected686 at risk
DYSARTHRIA	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
EMBOLIC STROKE	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
ENCEPHALOPATHY	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0012 affected686 at risk
GUILLAIN-BARRE SYNDROME	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
HAEMORRHAGE INTRACRANIAL	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
HAEMORRHAGIC STROKE	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
HEADACHE	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0013 affected686 at risk
HEMIPARESIS	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
HEMIPLEGIC MIGRAINE	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
HEPATIC ENCEPHALOPATHY	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
HYPOAESTHESIA	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0013 affected686 at risk
HYPOXIC-ISCHAEMIC ENCEPHALOPATHY	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
ISCHAEMIC STROKE	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0005 affected1,322 at risk EG0013 affected686 at risk
LATERAL MEDULLARY SYNDROME	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
LOSS OF CONSCIOUSNESS	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
LUMBAR RADICULOPATHY	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0011 affected686 at risk
METABOLIC ENCEPHALOPATHY	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
MIGRAINE	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0011 affected686 at risk
MYELOMALACIA	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
NEUROLOGICAL SYMPTOM	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
NYSTAGMUS	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
PARAESTHESIA	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0004 affected1,322 at risk EG0011 affected686 at risk
POLYNEUROPATHY ALCOHOLIC	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
POST-TRAUMATIC HEADACHE	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
PRESYNCOPE	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0005 affected1,322 at risk EG0011 affected686 at risk
RADICULITIS	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
RADICULITIS CERVICAL	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
SPONDYLITIC MYELOPATHY	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
SUBARACHNOID HAEMORRHAGE	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
SUBDURAL HYGROMA	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
SYNCOPE	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG00024 affected1,322 at risk EG00113 affected686 at risk
THALAMIC INFARCTION	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0010 affected686 at risk
THROMBOTIC STROKE	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
TRANSIENT ISCHAEMIC ATTACK	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG00011 affected1,322 at risk EG0016 affected686 at risk
UNRESPONSIVE TO STIMULI	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
URAEMIC ENCEPHALOPATHY	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
VERTEBRAL ARTERY OCCLUSION	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
VITH NERVE PARALYSIS	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0011 affected686 at risk
ACUTE STRESS DISORDER	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
ADJUSTMENT DISORDER WITH MIXED DISTURBANCE OF EMOTION AND CONDUCT	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
ALCOHOL ABUSE	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
ALCOHOL WITHDRAWAL SYNDROME	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
ANXIETY	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0011 affected686 at risk
BIPOLAR DISORDER	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
COMPLETED SUICIDE	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
CONFUSIONAL STATE	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
DELIRIUM	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
DELIRIUM TREMENS	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
DEPRESSION SUICIDAL	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
HALLUCINATION, VISUAL	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
INTENTIONAL SELF-INJURY	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
MAJOR DEPRESSION	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0011 affected686 at risk
MENTAL STATUS CHANGES	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0005 affected1,322 at risk EG0012 affected686 at risk
PANIC ATTACK	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
SUICIDAL IDEATION	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0012 affected686 at risk
CALCULUS URETERIC	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0013 affected686 at risk
HAEMATURIA	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0012 affected686 at risk
HYDRONEPHROSIS	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
NEPHROLITHIASIS	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0007 affected1,322 at risk EG0017 affected686 at risk
RENAL ARTERY STENOSIS	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0012 affected686 at risk
RENAL DISORDER	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
RENAL FAILURE	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0005 affected1,322 at risk EG0014 affected686 at risk
RENAL FAILURE ACUTE	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG00012 affected1,322 at risk EG00112 affected686 at risk
RENAL FAILURE CHRONIC	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0013 affected686 at risk
RENAL IMPAIRMENT	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
RENAL TUBULAR NECROSIS	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
STRESS URINARY INCONTINENCE	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
URINARY RETENTION	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0004 affected1,322 at risk EG0011 affected686 at risk
BENIGN PROSTATIC HYPERPLASIA	Reproductive system and breast disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0013 affected686 at risk
FALLOPIAN TUBE CYST	Reproductive system and breast disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
PELVIC HAEMATOMA	Reproductive system and breast disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
UTERINE POLYP	Reproductive system and breast disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
VAGINAL HAEMORRHAGE	Reproductive system and breast disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
VULVA CYST	Reproductive system and breast disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
ACUTE PULMONARY OEDEMA	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0014 affected686 at risk
ACUTE RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG00016 affected1,322 at risk EG0017 affected686 at risk
ASPIRATION	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
ASTHMA	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
CHRONIC OBSTRUCTIVE PULMONARY DISEASE	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG00028 affected1,322 at risk EG00110 affected686 at risk
DYSPHONIA	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG00033 affected1,322 at risk EG00113 affected686 at risk
DYSPNOEA EXERTIONAL	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0005 affected1,322 at risk EG0013 affected686 at risk
EPISTAXIS	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
HAEMOPTYSIS	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0012 affected686 at risk
HYPERVENTILATION	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
HYPOXIA	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0012 affected686 at risk
INTERSTITIAL LUNG DISEASE	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
MEDIASTINAL MASS	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
NASAL POLYPS	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
NON-CARDIOGENIC PULMONARY OEDEMA	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
ORGANISING PNEUMONIA	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
PLEURAL EFFUSION	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0004 affected1,322 at risk EG0013 affected686 at risk
PLEURITIC PAIN	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
PNEUMONIA ASPIRATION	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0014 affected686 at risk
PNEUMONITIS	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
PNEUMOTHORAX	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0015 affected686 at risk
PULMONARY EMBOLISM	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0009 affected1,322 at risk EG0017 affected686 at risk
PULMONARY OEDEMA	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0011 affected686 at risk
RESPIRATORY ARREST	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG00013 affected1,322 at risk EG0018 affected686 at risk
TRACHEAL STENOSIS	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
DIABETIC FOOT	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
RASH	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
SKIN ULCER	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0004 affected1,322 at risk EG0011 affected686 at risk
AORTIC ANEURYSM REPAIR	Surgical and medical procedures	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
CHOLECYSTECTOMY	Surgical and medical procedures	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
COLOSTOMY	Surgical and medical procedures	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
CORONARY ARTERY BYPASS	Surgical and medical procedures	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
HIP ARTHROPLASTY	Surgical and medical procedures	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0010 affected686 at risk
INGUINAL HERNIA REPAIR	Surgical and medical procedures	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
KNEE ARTHROPLASTY	Surgical and medical procedures	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
LEG AMPUTATION	Surgical and medical procedures	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
MEDICAL DEVICE REMOVAL	Surgical and medical procedures	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
NEPHRECTOMY	Surgical and medical procedures	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
SPINAL FUSION SURGERY	Surgical and medical procedures	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
TENDON OPERATION	Surgical and medical procedures	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
TRANSURETHRAL PROSTATECTOMY	Surgical and medical procedures	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
ACCELERATED HYPERTENSION	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0011 affected686 at risk
AORTIC ANEURYSM	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0006 affected1,322 at risk EG0012 affected686 at risk
AORTIC DISSECTION	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
AORTIC INTRAMURAL HAEMATOMA	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
AORTIC STENOSIS	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0004 affected1,322 at risk EG0015 affected686 at risk
ARTERIAL SPASM	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
ARTERIOSCLEROSIS	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
BLOOD PRESSURE INADEQUATELY CONTROLLED	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
CIRCULATORY COLLAPSE	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
DEEP VEIN THROMBOSIS	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG00011 affected1,322 at risk EG0014 affected686 at risk
FEMORAL ARTERIAL STENOSIS	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
HAEMATOMA	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
HYPERTENSION	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0008 affected1,322 at risk EG0012 affected686 at risk
HYPERTENSIVE CRISIS	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0015 affected686 at risk
HYPOTENSION	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0005 affected1,322 at risk EG0014 affected686 at risk
ILIAC ARTERY STENOSIS	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
INTERMITTENT CLAUDICATION	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0008 affected1,322 at risk EG0017 affected686 at risk
MALIGNANT HYPERTENSION	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
ORTHOSTATIC HYPOTENSION	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0011 affected686 at risk
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0018 affected686 at risk
PERIPHERAL ISCHAEMIA	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
PERIPHERAL VASCULAR DISORDER	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0007 affected1,322 at risk EG0016 affected686 at risk
SUBCLAVIAN ARTERY OCCLUSION	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
SUBCLAVIAN ARTERY STENOSIS	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
SUBCLAVIAN STEAL SYNDROME	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
THROMBOSIS	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
VASOSPAM	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
VENOUS INSUFFICIENCY	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG00021 affected1,322 at risk EG00116 affected686 at risk
ANAEMIA OF CHRONIC DISEASE	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
COAGULOPATHY	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0012 affected686 at risk
FEBRILE NEUTROPENIA	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
HAEMORRHAGIC ANAEMIA	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0014 affected686 at risk
HAEMORRHAGIC DIATHESIS	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0011 affected686 at risk
HEPARIN-INDUCED THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
IRON DEFICIENCY ANAEMIA	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0011 affected686 at risk
LEUKOCYTOSIS	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG0005 affected1,322 at risk EG0012 affected686 at risk
LYMPHADENITIS	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
LYMPHADENOPATHY	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
MICROCYTIC ANAEMIA	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
NORMOCHROMIC NORMOCYTIC ANAEMIA	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
SPLENIC INFARCTION	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0012 affected686 at risk
ACUTE CORONARY SYNDROME	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0006 affected1,322 at risk EG0015 affected686 at risk
ACUTE LEFT VENTRICULAR FAILURE	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
ACUTE MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG00049 affected1,322 at risk EG00122 affected686 at risk
ANGINA PECTORIS	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG000381 affected1,322 at risk EG001202 affected686 at risk
ANGINA UNSTABLE	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG00077 affected1,322 at risk EG00129 affected686 at risk
AORTIC VALVE DISEASE	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
AORTIC VALVE INCOMPETENCE	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
AORTIC VALVE STENOSIS	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0008 affected1,322 at risk EG0012 affected686 at risk
ARRHYTHMIA	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0013 affected686 at risk
ARTERIOSCLEROSIS CORONARY ARTERY	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0004 affected1,322 at risk EG0010 affected686 at risk
ARTERIOSPASM CORONARY	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0004 affected1,322 at risk EG0014 affected686 at risk
ATRIAL FIBRILLATION	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG00095 affected1,322 at risk EG00142 affected686 at risk
ATRIAL FLUTTER	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG00011 affected1,322 at risk EG0013 affected686 at risk
ATRIAL HYPERTROPHY	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
ATRIAL TACHYCARDIA	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
ATRIAL THROMBOSIS	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
ATRIOVENTRICULAR BLOCK	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0006 affected1,322 at risk EG0010 affected686 at risk
ATRIOVENTRICULAR BLOCK COMPLETE	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
ATRIOVENTRICULAR BLOCK SECOND DEGREE	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0005 affected1,322 at risk EG0011 affected686 at risk
BRADYCARDIA	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG00031 affected1,322 at risk EG00113 affected686 at risk
BUNDLE BRANCH BLOCK	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
BUNDLE BRANCH BLOCK LEFT	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
BUNDLE BRANCH BLOCK RIGHT	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
CARDIAC ARREST	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG00010 affected1,322 at risk EG0016 affected686 at risk
CARDIAC FAILURE	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0008 affected1,322 at risk EG0014 affected686 at risk
CARDIAC FAILURE ACUTE	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0005 affected1,322 at risk EG0011 affected686 at risk
CARDIAC FAILURE CHRONIC	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0013 affected686 at risk
CARDIAC FAILURE CONGESTIVE	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG00039 affected1,322 at risk EG00130 affected686 at risk
CARDIAC FLUTTER	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0011 affected686 at risk
CARDIAC TAMPONADE	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
CARDIAC VALVE DISEASE	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
CARDIO-RESPIRATORY ARREST	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0011 affected686 at risk
CARDIOGENIC SHOCK	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0013 affected686 at risk
CARDIOMEGALY	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
CARDIOMYOPATHY	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0012 affected686 at risk
CARDIORENAL SYNDROME	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
CHRONIC LEFT VENTRICULAR FAILURE	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
CONDUCTION DISORDER	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
CONGESTIVE CARDIOMYOPATHY	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
CORONARY ARTERY DISEASE	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG00044 affected1,322 at risk EG00128 affected686 at risk
CORONARY ARTERY DISSECTION	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG00085 affected1,322 at risk EG00156 affected686 at risk
CORONARY ARTERY EMBOLISM	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0014 affected686 at risk
CORONARY ARTERY OCCLUSION	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0005 affected1,322 at risk EG0012 affected686 at risk
CORONARY ARTERY PERFORATION	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0007 affected1,322 at risk EG0013 affected686 at risk
CORONARY ARTERY STENOSIS	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG00023 affected1,322 at risk EG00114 affected686 at risk
CORONARY NO-REFLOW PHENOMENON	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
CORONARY OSTIAL STENOSIS	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
CYANOSIS	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
DIASTOLIC DYSFUNCTION	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
DRESSLER'S SYNDROME	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0013 affected686 at risk
EXTRASYSTOLES	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
HEART VALVE INCOMPETENCE	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
HYPERTROPHIC CARDIOMYOPATHY	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
IN-STENT CORONARY ARTERY RESTENOSIS	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0004 affected1,322 at risk EG0015 affected686 at risk
INTRACARDIAC THROMBUS	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
ISCHAEMIC CARDIOMYOPATHY	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0004 affected1,322 at risk EG0012 affected686 at risk
LEFT VENTRICULAR DYSFUNCTION	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
LEFT VENTRICULAR HYPERTROPHY	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
MITRAL VALVE INCOMPETENCE	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0008 affected1,322 at risk EG0011 affected686 at risk
MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG00054 affected1,322 at risk EG00124 affected686 at risk
MYOCARDIAL ISCHAEMIA	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0006 affected1,322 at risk EG0011 affected686 at risk
NODAL ARRHYTHMIA	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
NODAL RHYTHM	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
PALPITATIONS	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG00032 affected1,322 at risk EG00117 affected686 at risk
PERICARDIAL EFFUSION	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0006 affected1,322 at risk EG0013 affected686 at risk
PERICARDITIS	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
PRINZMETAL ANGINA	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
SICK SINUS SYNDROME	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0006 affected1,322 at risk EG0014 affected686 at risk
SINUS ARREST	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
SINUS ARRHYTHMIA	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
SINUS BRADYCARDIA	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0013 affected686 at risk
SINUS TACHYCARDIA	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
SUPRAVENTRICULAR EXTRASYSTOLES	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
SUPRAVENTRICULAR TACHYCARDIA	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG00012 affected1,322 at risk EG0015 affected686 at risk
TACHYCARDIA	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG00012 affected1,322 at risk EG0016 affected686 at risk
TORSADE DE POINTES	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
TRICUSPID VALVE INCOMPETENCE	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
VENTRICULAR ARRHYTHMIA	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
VENTRICULAR EXTRASYSTOLES	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0006 affected1,322 at risk EG0010 affected686 at risk
VENTRICULAR FIBRILLATION	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG0006 affected1,322 at risk EG0010 affected686 at risk
VENTRICULAR TACHYCARDIA	Cardiac disorders	MedDRA 11.0	Systematic Assessment	EG00014 affected1,322 at risk EG0016 affected686 at risk
ARTERIOVENOUS MALFORMATION	Congenital, familial and genetic disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
CYSTIC LYMPHANGIOMA	Congenital, familial and genetic disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
MYOTONIC DYSTROPHY	Congenital, familial and genetic disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
PULMONARY ARTERIOVENOUS FISTULA	Congenital, familial and genetic disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
DEAFNESS	Ear and labyrinth disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
EAR PAIN	Ear and labyrinth disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0012 affected686 at risk
EUSTACHIAN TUBE OBSTRUCTION	Ear and labyrinth disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
MIXED DEAFNESS	Ear and labyrinth disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
TINNITUS	Ear and labyrinth disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0012 affected686 at risk
TYMPANIC MEMBRANE PERFORATION	Ear and labyrinth disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
VERTIGO	Ear and labyrinth disorders	MedDRA 11.0	Systematic Assessment	EG00013 affected1,322 at risk EG0017 affected686 at risk
ADRENAL MASS	Endocrine disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
GOITRE	Endocrine disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
HYPERTHYROIDISM	Endocrine disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
HYPOGONADISM	Endocrine disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
HYPOTHYROIDISM	Endocrine disorders	MedDRA 11.0	Systematic Assessment	EG0006 affected1,322 at risk EG0011 affected686 at risk
THYROID CYST	Endocrine disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
AGE-RELATED MACULAR DEGENERATION	Eye disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
AMAUROSIS FUGAX	Eye disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
CATARACT	Eye disorders	MedDRA 11.0	Systematic Assessment	EG0007 affected1,322 at risk EG0018 affected686 at risk
CATARACT NUCLEAR	Eye disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
CONJUNCTIVAL HAEMORRHAGE	Eye disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
CONJUNCTIVITIS	Eye disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0012 affected686 at risk
DIABETIC RETINOPATHY	Eye disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
DIPLOPIA	Eye disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
EYE PRURITUS	Eye disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
EYE SWELLING	Eye disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
GAZE PALSY	Eye disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
GLAUCOMA	Eye disorders	MedDRA 11.0	Systematic Assessment	EG0004 affected1,322 at risk EG0010 affected686 at risk
MACULAR FIBROSIS	Eye disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
MACULAR OEDEMA	Eye disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
PAPILLOEDEMA	Eye disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
POSTERIOR CAPSULE OPACIFICATION	Eye disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
RETINAL DETACHMENT	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected1,322 at risk EG0011 affected686 at risk
RETINAL HAEMORRHAGE	Eye disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
SCLERAL DISCOLOURATION	Eye disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
SCLERAL HAEMORRHAGE	Eye disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
VISION BLURRED	Eye disorders	MedDRA 11.0	Systematic Assessment	EG0005 affected1,322 at risk EG0011 affected686 at risk
VISUAL IMPAIRMENT	Eye disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
ABDOMINAL DISCOMFORT	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0005 affected1,322 at risk EG0014 affected686 at risk
ABDOMINAL DISTENSION	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
ABDOMINAL HERNIA	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0013 affected686 at risk
ABDOMINAL HERNIA OBSTRUCTIVE	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
ABDOMINAL MASS	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG00013 affected1,322 at risk EG00113 affected686 at risk
ABDOMINAL PAIN LOWER	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0008 affected1,322 at risk EG0017 affected686 at risk
ABDOMINAL WALL HAEMATOMA	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
ALCOHOLIC PANCREATITIS	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
BARRETT'S OESOPHAGUS	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0010 affected686 at risk
COELIAC ARTERY STENOSIS	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
COELIAC DISEASE	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
COLITIS	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0004 affected1,322 at risk EG0013 affected686 at risk
COLITIS ISCHAEMIC	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
COLONIC POLYP	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0011 affected686 at risk
CONSTIPATION	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG00011 affected1,322 at risk EG0012 affected686 at risk
CROHN'S DISEASE	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0011 affected686 at risk
DENTAL CARIES	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
DIABETIC GASTROPARESIS	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG00018 affected1,322 at risk EG0017 affected686 at risk
DIVERTICULUM	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0011 affected686 at risk
DIVERTICULUM INTESTINAL	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
DIVERTICULUM INTESTINAL HAEMORRHAGIC	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0011 affected686 at risk
DRY MOUTH	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
DUODENAL ULCER	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
DUODENAL ULCER HAEMORRHAGE	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
DUODENITIS	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
DYSPEPSIA	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG00015 affected1,322 at risk EG0014 affected686 at risk
DYSPHAGIA	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG00010 affected1,322 at risk EG0012 affected686 at risk
ENTEROVESICAL FISTULA	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
EROSIVE OESOPHAGITIS	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
ERUCTATION	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
FAECAL INCONTINENCE	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
FAECALOMA	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
FAECES DISCOLOURED	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
FLATULENCE	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
FOOD POISONING	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
FUNCTIONAL GASTROINTESTINAL DISORDER	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
GASTRIC HAEMORRHAGE	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
GASTRIC ULCER	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected1,322 at risk EG0014 affected686 at risk
GASTRIC ULCER HAEMORRHAGE	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
GASTRITIS	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0006 affected1,322 at risk EG0013 affected686 at risk
GASTRITIS EROSIVE	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0010 affected686 at risk
GASTROINTESTINAL ANGIODYSPLASIA	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
GASTROINTESTINAL DISORDER	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG00016 affected1,322 at risk EG00115 affected686 at risk
GASTROINTESTINAL PAIN	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
GASTROINTESTINAL ULCER HAEMORRHAGE	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
GASTROOESOPHAGEAL REFLUX DISEASE	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG00023 affected1,322 at risk EG0018 affected686 at risk
HAEMATEMESIS	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0012 affected686 at risk
HAEMATOCHEZIA	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0004 affected1,322 at risk EG0010 affected686 at risk
HAEMORRHOIDAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0004 affected1,322 at risk EG0011 affected686 at risk
HAEMORRHOIDS	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
HIATUS HERNIA	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0009 affected1,322 at risk EG0014 affected686 at risk
HYPOAESTHESIA ORAL	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
ILEUS	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0012 affected686 at risk
IMPAIRED GASTRIC EMPTYING	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0011 affected686 at risk
INFREQUENT BOWEL MOVEMENTS	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
INGUINAL HERNIA	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0004 affected1,322 at risk EG0016 affected686 at risk
INTESTINAL MASS	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0011 affected686 at risk
INTESTINAL OBSTRUCTION	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0012 affected686 at risk
IRRITABLE BOWEL SYNDROME	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
LARGE INTESTINE PERFORATION	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
LOWER GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0012 affected686 at risk
MALLORY-WEISS SYNDROME	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
MELAENA	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0011 affected686 at risk
MOUTH HAEMORRHAGE	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
MOUTH ULCERATION	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
NAUSEA	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG00019 affected1,322 at risk EG00113 affected686 at risk
OESOPHAGEAL ACHALASIA	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
OESOPHAGEAL FOOD IMPACTION	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
OESOPHAGEAL PAIN	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
OESOPHAGEAL SPASM	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
OESOPHAGEAL ULCER	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
OESOPHAGITIS	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
PANCREATIC CYST	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0013 affected686 at risk
PANCREATITIS	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0013 affected686 at risk
PANCREATITIS ACUTE	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0011 affected686 at risk
PANCREATITIS CHRONIC	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
PEPTIC ULCER	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
PROCTALGIA	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
RECTAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0008 affected1,322 at risk EG0018 affected686 at risk
RECTAL PROLAPSE	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
RETROPERITONEAL HAEMATOMA	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
RETROPERITONEAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
SMALL INTESTINAL OBSTRUCTION	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0016 affected686 at risk
SMALL INTESTINAL PERFORATION	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
STOMATITIS	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
TONGUE CYST	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
TONGUE HAEMORRHAGE	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
TOOTH SOCKET HAEMORRHAGE	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
UMBILICAL HERNIA	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0004 affected1,322 at risk EG0012 affected686 at risk
UMBILICAL HERNIA, OBSTRUCTIVE	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
UPPER GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0014 affected686 at risk
VOMITING	Gastrointestinal disorders	MedDRA 11.0	Systematic Assessment	EG00013 affected1,322 at risk EG00110 affected686 at risk
ABASIA	General disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
ADVERSE DRUG REACTION	General disorders	MedDRA 11.0	Systematic Assessment	EG00074 affected1,322 at risk EG00142 affected686 at risk
ASTHENIA	General disorders	MedDRA 11.0	Systematic Assessment	EG00012 affected1,322 at risk EG0014 affected686 at risk
BREAST COMPLICATION ASSOCIATED WITH DEVICE	General disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
CARDIAC DEATH	General disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
CATHETER SITE HAEMATOMA	General disorders	MedDRA 11.0	Systematic Assessment	EG00030 affected1,322 at risk EG00114 affected686 at risk
CATHETER SITE HAEMORRHAGE	General disorders	MedDRA 10.0	Systematic Assessment	EG00022 affected1,322 at risk EG00114 affected686 at risk
CATHETER SITE PAIN	General disorders	MedDRA 11.0	Systematic Assessment	EG00029 affected1,322 at risk EG00115 affected686 at risk
CATHETER SITE RASH	General disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
CATHETER SITE RELATED REACTION	General disorders	MedDRA 11.0	Systematic Assessment	EG0009 affected1,322 at risk EG0014 affected686 at risk
CATHETER SITE SWELLING	General disorders	MedDRA 11.0	Systematic Assessment	EG0005 affected1,322 at risk EG0012 affected686 at risk
CHEST DISCOMFORT	General disorders	MedDRA 11.0	Systematic Assessment	EG00087 affected1,322 at risk EG00134 affected686 at risk
CHEST PAIN	General disorders	MedDRA 11.0	Systematic Assessment	EG00079 affected1,322 at risk EG00149 affected686 at risk
CHILLS	General disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
CYST	General disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
DEATH	General disorders	MedDRA 11.0	Systematic Assessment	EG00010 affected1,322 at risk EG0016 affected686 at risk
DEVICE ELECTRICAL FINDING	General disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
DEVICE FAILURE	General disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
DEVICE MALFUNCTION	General disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
DEVICE OCCLUSION	General disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
DISCOMFORT	General disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
DROWNING	General disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
DRUG INTOLERANCE	General disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
DRUG WITHDRAWAL SYNDROME	General disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
FACE OEDEMA	General disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
FATIGUE	General disorders	MedDRA 11.0	Systematic Assessment	EG00050 affected1,322 at risk EG00120 affected686 at risk
FEELING COLD	General disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
GAIT DISTURBANCE	General disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
GENERALISED OEDEMA	General disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
HERNIA	General disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
HERNIA OBSTRUCTIVE	General disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
HERNIA PAIN	General disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
IMPAIRED HEALING	General disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0012 affected686 at risk
IMPLANT SITE HAEMORRHAGE	General disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
IMPLANT SITE PAIN	General disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
INFLUENZA LIKE ILLNESS	General disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0011 affected686 at risk
LOCAL SWELLING	General disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
MALAISE	General disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0011 affected686 at risk
MASS	General disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
MEDICAL DEVICE SITE REACTION	General disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
MULTI-ORGAN FAILURE	General disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0012 affected686 at risk
NON-CARDIAC CHEST PAIN	General disorders	MedDRA 11.0	Systematic Assessment	EG000271 affected1,322 at risk EG001122 affected686 at risk
OEDEMA	General disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
OEDEMA PERIPHERAL	General disorders	MedDRA 11.0	Systematic Assessment	EG00025 affected1,322 at risk EG00110 affected686 at risk
PAIN	General disorders	MedDRA 11.0	Systematic Assessment	EG0009 affected1,322 at risk EG0016 affected686 at risk
PELVIC MASS	General disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0012 affected686 at risk
PYREXIA	General disorders	MedDRA 11.0	Systematic Assessment	EG0009 affected1,322 at risk EG0013 affected686 at risk
SPINAL PAIN	General disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
SUDDEN CARDIAC DEATH	General disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
SURGICAL FAILURE	General disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
SWELLING	General disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
SYSTEMIC INFLAMMATORY RESPONSE SYNDROME	General disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0011 affected686 at risk
THROMBOSIS IN DEVICE	General disorders	MedDRA 11.0	Systematic Assessment	EG00014 affected1,322 at risk EG0016 affected686 at risk
BILE DUCT STONE	Hepatobiliary disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
BILIARY COLIC	Hepatobiliary disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
CHOLANGITIS	Hepatobiliary disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
CHOLECYSTITIS	Hepatobiliary disorders	MedDRA 11.0	Systematic Assessment	EG0004 affected1,322 at risk EG0012 affected686 at risk
CHOLECYSTITIS ACUTE	Hepatobiliary disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0014 affected686 at risk
CHOLECYSTITIS CHRONIC	Hepatobiliary disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
CHOLELITHIASIS	Hepatobiliary disorders	MedDRA 11.0	Systematic Assessment	EG00012 affected1,322 at risk EG0016 affected686 at risk
GALLBLADDER DISORDER	Hepatobiliary disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
HEPATIC LESION	Hepatobiliary disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0011 affected686 at risk
HEPATIC STEATOSIS	Hepatobiliary disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
HEPATOMEGALY	Hepatobiliary disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
ISCHAEMIC HEPATITIS	Hepatobiliary disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
PORTAL VEIN THROMBOSIS	Hepatobiliary disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
ALLERGY TO ARTHROPOD STING	Immune system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
ANAPHYLACTIC REACTION	Immune system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
CONTRAST MEDIA ALLERGY	Immune system disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0012 affected686 at risk
DRUG HYPERSENSITIVITY	Immune system disorders	MedDRA 11.0	Systematic Assessment	EG0005 affected1,322 at risk EG0014 affected686 at risk
FOOD ALLERGY	Immune system disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
HYPERSENSITIVITY	Immune system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0012 affected686 at risk
SEASONAL ALLERGY	Immune system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
ABDOMINAL ABSCESS	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
ABDOMINAL INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
ABSCESS NECK	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
ACUTE SINUSITIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0011 affected686 at risk
ACUTE TONSILLITIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
APPENDICITIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0004 affected1,322 at risk EG0012 affected686 at risk
APPENDICITIS PERFORATED	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
ARTERIOVENOUS GRAFT SITE INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
ARTHRITIS BACTERIAL	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
ARTHRITIS INFECTIVE	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
BACTERAEMIA	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0004 affected1,322 at risk EG0010 affected686 at risk
BACTERIAL DISEASE CARRIER	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
BACTERIAL INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
BACTERIAL SEPSIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0012 affected686 at risk
BREAST ABSCESS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
BREAST CELLULITIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
BRONCHITIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG00034 affected1,322 at risk EG00121 affected686 at risk
BRONCHITIS VIRAL	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
BRONCHOPNEUMONIA	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
CARBUNCLE	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
CATHETER SITE ABSCESS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
CATHETER SITE CELLULITIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0010 affected686 at risk
CATHETER SITE INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
CELLULITIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG00015 affected1,322 at risk EG00114 affected686 at risk
CHOLECYSTITIS INFECTIVE	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0012 affected686 at risk
CLOSTRIDIAL INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0004 affected1,322 at risk EG0011 affected686 at risk
CLOSTRIDIUM DIFFICILE COLITIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0013 affected686 at risk
CYSTITIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0011 affected686 at risk
DIABETIC FOOT INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
DIVERTICULITIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0005 affected1,322 at risk EG0013 affected686 at risk
EAR INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0010 affected686 at risk
ENDOCARDITIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
ENTEROCOCCAL SEPSIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
ESCHERICHIA BACTERAEMIA	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
ESCHERICHIA URINARY TRACT INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
EYELID INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
FOLLICULITIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
FUNGAL INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
FURUNCLE	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
GANGRENE	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
GASTROENTERITIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG00010 affected1,322 at risk EG0013 affected686 at risk
GASTROENTERITIS VIRAL	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0004 affected1,322 at risk EG0013 affected686 at risk
GENITAL INFECTION FEMALE	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
GROIN ABSCESS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
HELICOBACTER INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
HEPATITIS C	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
HERPES ZOSTER	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0007 affected1,322 at risk EG0013 affected686 at risk
HERPES ZOSTER OPHTHALMIC	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
HIV INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
IMPLANT SITE INFECTION	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
INFECTED DERMAL CYST	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
INFECTED SKIN ULCER	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
INFLUENZA	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0008 affected1,322 at risk EG0018 affected686 at risk
KIDNEY INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0004 affected1,322 at risk EG0010 affected686 at risk
LARYNGITIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0011 affected686 at risk
LOBAR PNEUMONIA	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0011 affected686 at risk
LOCALISED INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0013 affected686 at risk
LUNG ABSCESS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
MENINGITIS ASEPTIC	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
METAPNEUMOVIRUS INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
MYCOBACTERIUM ABSCESSUS INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
NASOPHARYNGITIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0006 affected1,322 at risk EG0015 affected686 at risk
ONYCHOMYCOSIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
ORAL FUNGAL INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
ORCHITIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
OSTEOMYELITIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0014 affected686 at risk
OTITIS EXTERNA	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
OTITIS MEDIA	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
OTITIS MEDIA ACUTE	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
PARONYCHIA	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
PERITONITIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
PERITONSILLAR ABSCESS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
PHARYNGITIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
PHARYNGITIS STREPTOCOCCAL	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
PILONIDAL CYST	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
PNEUMONIA	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG00033 affected1,322 at risk EG00127 affected686 at risk
PNEUMONIA ADENOVIRAL	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
PNEUMONIA BACTERIAL	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
PNEUMONIA NECROTISING	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
PNEUMONIA PRIMARY ATYPICAL	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
PNEUMONIA STAPHYLOCOCCAL	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
POST PROCEDURAL CELLULITIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
POST PROCEDURAL INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0010 affected686 at risk
POST PROCEDURAL PNEUMONIA	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
POSTOPERATIVE WOUND INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
PROSTATE INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
PYELONEPHRITIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
RESPIRATORY SYNCYTIAL VIRUS INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
SEPSIS	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG00015 affected1,322 at risk EG00110 affected686 at risk
SEPSIS SYNDROME	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
SEPTIC ENCEPHALOPATHY	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
SEPTIC SHOCK	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0011 affected686 at risk
SINUSITIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG00011 affected1,322 at risk EG00110 affected686 at risk
SPINAL CORD INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
STAPHYLOCOCCAL BACTERAEMIA	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0012 affected686 at risk
STAPHYLOCOCCAL INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
SUBCUTANEOUS ABSCESS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
TINEA PEDIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
TOOTH ABSCESS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0012 affected686 at risk
UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG00025 affected1,322 at risk EG0016 affected686 at risk
URINARY TRACT INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG00032 affected1,322 at risk EG00123 affected686 at risk
URINARY TRACT INFECTION BACTERIAL	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
UROSEPSIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0014 affected686 at risk
VIRAL INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0004 affected1,322 at risk EG0013 affected686 at risk
VIRAL LABYRINTHITIS	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
VIRAL UPPER RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0012 affected686 at risk
WOUND INFECTION	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0013 affected686 at risk
WOUND INFECTION BACTERIAL	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
WOUND INFECTION STAPHYLOCOCCAL	Infections and infestations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0012 affected686 at risk
ACCIDENT	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
ACCIDENTAL OVERDOSE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
ACETABULUM FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
ALCOHOL POISONING	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0012 affected686 at risk
ANAEMIA POSTOPERATIVE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0005 affected1,322 at risk EG0013 affected686 at risk
ANIMAL BITE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0011 affected686 at risk
ANKLE FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0014 affected686 at risk
ANXIETY POSTOPERATIVE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
ARTHROPOD BITE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
ARTHROPOD STING	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
ASBESTOSIS	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
AVULSION FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
BURNS THIRD DEGREE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
CARDIAC FUNCTION DISTURBANCE POSTOPERATIVE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
CARDIAC PROCEDURE COMPLICATION	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0004 affected1,322 at risk EG0014 affected686 at risk
CATHETER SITE HAEMATOMA	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG00010 affected1,322 at risk EG0018 affected686 at risk
CEREBRAL HAEMORRHAGE TRAUMATIC	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
CLAVICLE FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
COLON INJURY	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
CONCUSSION	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
CONTRAST MEDIA ALLERGY	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
CONTUSION	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG00025 affected1,322 at risk EG0016 affected686 at risk
CORNEAL ABRASION	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
CORONARY ARTERY RESTENOSIS	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG00051 affected1,322 at risk EG00115 affected686 at risk
CRANIOCEREBRAL INJURY	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0011 affected686 at risk
CYSTITIS RADIATION	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
DEEP VEIN THROMBOSIS POSTOPERATIVE	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
DRUG ADMINISTRATION ERROR	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
EXCORIATION	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
EXPOSURE TO TOXIC AGENT	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
FACIAL BONES FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
FALL	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG00028 affected1,322 at risk EG00120 affected686 at risk
FEMORAL NECK FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0012 affected686 at risk
FEMUR FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0010 affected686 at risk
FOOT FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0004 affected1,322 at risk EG0011 affected686 at risk
FOREIGN BODY	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
GASTROINTESTINAL ANASTOMOTIC LEAK	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
HAEMATURIA TRAUMATIC	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
HAND FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
HEAD INJURY	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0012 affected686 at risk
HIP FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0004 affected1,322 at risk EG0012 affected686 at risk
HUMERUS FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0012 affected686 at risk
ILIOTIBIAL BAND SYNDROME	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
IN-STENT ARTERIAL RESTENOSIS	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
IN-STENT CORONARY ARTERY RESTENOSIS	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0008 affected1,322 at risk EG0016 affected686 at risk
INCISION SITE PRURITUS	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
INCISIONAL HERNIA	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0010 affected686 at risk
INJURY	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
JOINT DISLOCATION	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
JOINT INJURY	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
LACERATION	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0007 affected1,322 at risk EG0014 affected686 at risk
LIGAMENT RUPTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
LIGAMENT SPRAIN	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0016 affected686 at risk
LIMB INJURY	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0014 affected686 at risk
LIMB TRAUMATIC AMPUTATION	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
LOWER LIMB FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
MENISCUS LESION	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0008 affected1,322 at risk EG0014 affected686 at risk
MOUTH INJURY	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
MULTIPLE FRACTURES	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
MULTIPLE INJURIES	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
MUSCLE RUPTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
MUSCLE STRAIN	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0011 affected686 at risk
PELVIC FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
PERIORBITAL HAEMATOMA	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
PLAQUE SHIFT	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0004 affected1,322 at risk EG0016 affected686 at risk
POST CONCUSSION SYNDROME	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
POST PROCEDURAL CONSTIPATION	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
POST PROCEDURAL DISCOMFORT	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
POST PROCEDURAL HAEMATOMA	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0012 affected686 at risk
POST PROCEDURAL HAEMORRHAGE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0006 affected1,322 at risk EG0014 affected686 at risk
POST PROCEDURAL MYOCARDIAL INFARCTION	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG00012 affected1,322 at risk EG0017 affected686 at risk
POST PROCEDURAL STROKE	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
POST PROCEDURAL SWELLING	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
POST-TRAUMATIC NECK SYNDROME	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
POST-TRAUMATIC PAIN	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0004 affected1,322 at risk EG0011 affected686 at risk
POSTOPERATIVE ADHESION	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
POSTOPERATIVE FEVER	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
PROCEDURAL COMPLICATION	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
PROCEDURAL DIZZINESS	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0012 affected686 at risk
PROCEDURAL HEADACHE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0005 affected1,322 at risk EG0012 affected686 at risk
PROCEDURAL HYPERTENSION	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG00010 affected1,322 at risk EG0014 affected686 at risk
PROCEDURAL HYPOTENSION	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG00013 affected1,322 at risk EG0017 affected686 at risk
PROCEDURAL NAUSEA	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0008 affected1,322 at risk EG0014 affected686 at risk
PROCEDURAL PAIN	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0013 affected686 at risk
PROCEDURAL VOMITING	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0010 affected686 at risk
RADIUS FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
RESPIRATORY FUME INHALATION DISORDER	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
RIB FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0004 affected1,322 at risk EG0013 affected686 at risk
ROAD TRAFFIC ACCIDENT	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG00010 affected1,322 at risk EG0012 affected686 at risk
SCAPULA FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
SEROMA	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
SKULL FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
SNAKE BITE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
SOFT TISSUE INJURY	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
SPINAL COMPRESSION FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0006 affected1,322 at risk EG0012 affected686 at risk
SPINAL FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0011 affected686 at risk
SPLENIC RUPTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
STERNAL FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
SUBDURAL HAEMATOMA	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0006 affected1,322 at risk EG0014 affected686 at risk
SUTURE RELATED COMPLICATION	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
TENDON INJURY	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0012 affected686 at risk
TENDON RUPTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0012 affected686 at risk
THERMAL BURN	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
THORACIC VERTEBRAL FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
TIBIA FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0014 affected686 at risk
TOXICITY TO VARIOUS AGENTS	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
TRAUMATIC HAEMATOMA	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0005 affected1,322 at risk EG0012 affected686 at risk
TRAUMATIC HAEMORRHAGE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
ULNA FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
UPPER LIMB FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0004 affected1,322 at risk EG0010 affected686 at risk
URINARY RETENTION POSTOPERATIVE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0005 affected1,322 at risk EG0011 affected686 at risk
VASCULAR ACCESS COMPLICATION	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
VASCULAR GRAFT OCCLUSION	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0011 affected686 at risk
VASCULAR PSEUDOANEURYSM	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG00010 affected1,322 at risk EG0016 affected686 at risk
WOUND	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
WOUND EVISCERATION	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
WOUND HAEMORRHAGE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
WRIST FRACTURE	Injury, poisoning and procedural complications	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0011 affected686 at risk
ALANINE AMINOTRANSFERASE INCREASED	Investigations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
ANGIOGRAM	Investigations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
ARTERIOGRAM CORONARY ABNORMAL	Investigations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0012 affected686 at risk
BIOPSY LUNG	Investigations	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
BLOOD ALKALINE PHOSPHATASE INCREASED	Investigations	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0010 affected686 at risk
BLOOD CREATINE INCREASED	Investigations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
BLOOD CREATINE PHOSPHOKINASE INCREASED	Investigations	MedDRA 11.0	Systematic Assessment	EG00012 affected1,322 at risk EG0018 affected686 at risk
BLOOD CREATINE PHOSPHOKINASE MB INCREASED	Investigations	MedDRA 11.0	Systematic Assessment	EG000153 affected1,322 at risk EG00172 affected686 at risk
BLOOD CREATININE INCREASED	Investigations	MedDRA 11.0	Systematic Assessment	EG0005 affected1,322 at risk EG0012 affected686 at risk
BLOOD GLUCOSE DECREASED	Investigations	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
BLOOD GLUCOSE INCREASED	Investigations	MedDRA 11.0	Systematic Assessment	EG0004 affected1,322 at risk EG0011 affected686 at risk
BLOOD HOMOCYSTEINE INCREASED	Investigations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
BLOOD IRON DECREASED	Investigations	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
BLOOD MAGNESIUM DECREASED	Investigations	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
BLOOD POTASSIUM DECREASED	Investigations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
BLOOD PRESSURE DECREASED	Investigations	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
BLOOD PRESSURE INCREASED	Investigations	MedDRA 11.0	Systematic Assessment	EG00012 affected1,322 at risk EG0014 affected686 at risk
BLOOD PRESSURE ORTHOSTATIC ABNORMAL	Investigations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
BLOOD PRESSURE SYSTOLIC INCREASED	Investigations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
BLOOD TESTOSTERONE DECREASED	Investigations	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
BLOOD THYROID STIMULATING HORMONE DECREASED	Investigations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
BLOOD TRIGLYCERIDES INCREASED	Investigations	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0010 affected686 at risk
BLOOD URIC ACID INCREASED	Investigations	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
BLOOD URINE PRESENT	Investigations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
BONE DENSITY ABNORMAL	Investigations	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
BREATH SOUNDS ABNORMAL	Investigations	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
CARDIAC ENZYMES INCREASED	Investigations	MedDRA 11.0	Systematic Assessment	EG000104 affected1,322 at risk EG00145 affected686 at risk
CARDIAC MURMUR	Investigations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
CARDIAC STRESS TEST ABNORMAL	Investigations	MedDRA 11.0	Systematic Assessment	EG0009 affected1,322 at risk EG0013 affected686 at risk
CAROTID BRUIT	Investigations	MedDRA 11.0	Systematic Assessment	EG0007 affected1,322 at risk EG0013 affected686 at risk
CATHETERISATION CARDIAC	Investigations	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
CLOSTRIDIUM TEST POSITIVE	Investigations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
COMPUTERISED TOMOGRAM ABNORMAL	Investigations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
COMPUTERISED TOMOGRAM THORAX ABNORMAL	Investigations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
ECHOCARDIOGRAM ABNORMAL	Investigations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
EJECTION FRACTION ABNORMAL	Investigations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
EJECTION FRACTION DECREASED	Investigations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
ELECTROCARDIOGRAM ABNORMAL	Investigations	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
ELECTROCARDIOGRAM CHANGE	Investigations	MedDRA 10.0	Systematic Assessment	EG0004 affected1,322 at risk EG0011 affected686 at risk
ELECTROCARDIOGRAM QT PROLONGED	Investigations	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
ELECTROCARDIOGRAM ST SEGMENT ABNORMAL	Investigations	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
ELECTROCARDIOGRAM ST SEGMENT ELEVATION	Investigations	MedDRA 11.0	Systematic Assessment	EG0008 affected1,322 at risk EG0010 affected686 at risk
ELECTROCARDIOGRAM ST-T CHANGE	Investigations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
FEMORAL BRUIT	Investigations	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
GLOMERULAR FILTRATION RATE DECREASED	Investigations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
GLYCOSYLATED HAEMOGLOBIN INCREASED	Investigations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
HAEMOGLOBIN DECREASED	Investigations	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0010 affected686 at risk
HEART RATE DECREASED	Investigations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
HEART RATE INCREASED	Investigations	MedDRA 11.0	Systematic Assessment	EG0004 affected1,322 at risk EG0010 affected686 at risk
HEART RATE IRREGULAR	Investigations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0012 affected686 at risk
HELICOBACTER TEST POSITIVE	Investigations	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
HEPATIC ENZYME INCREASED	Investigations	MedDRA 11.0	Systematic Assessment	EG0004 affected1,322 at risk EG0011 affected686 at risk
LIPIDS ABNORMAL	Investigations	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
LIVER FUNCTION TEST ABNORMAL	Investigations	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0014 affected686 at risk
METABOLIC FUNCTION TEST ABNORMAL	Investigations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
OCCULT BLOOD POSITIVE	Investigations	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
OXYGEN CONSUMPTION INCREASED	Investigations	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
PROSTATIC SPECIFIC ANTIGEN INCREASED	Investigations	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
RED BLOOD CELL COUNT DECREASED	Investigations	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
RED BLOOD CELL SEDIMENTATION RATE INCREASED	Investigations	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
RENAL FUNCTION TEST ABNORMAL	Investigations	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
THYROID FUNCTION TEST ABNORMAL	Investigations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
TROPONIN I INCREASED	Investigations	MedDRA 11.0	Systematic Assessment	EG00024 affected1,322 at risk EG00110 affected686 at risk
TROPONIN INCREASED	Investigations	MedDRA 11.0	Systematic Assessment	EG00050 affected1,322 at risk EG00120 affected686 at risk
TROPONIN T INCREASED	Investigations	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
URINE LEUKOCYTE ESTERASE POSITIVE	Investigations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
VITAMIN B12 DECREASED	Investigations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
VITAMIN D DECREASED	Investigations	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
WEIGHT DECREASED	Investigations	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0011 affected686 at risk
WEIGHT INCREASED	Investigations	MedDRA 11.0	Systematic Assessment	EG0004 affected1,322 at risk EG0010 affected686 at risk
WHITE BLOOD CELL COUNT INCREASED	Investigations	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
DECREASED APPETITE	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
DEHYDRATION	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG00011 affected1,322 at risk EG00111 affected686 at risk
DIABETES MELLITUS	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0009 affected1,322 at risk EG0013 affected686 at risk
DIABETES MELLITUS INADEQUATE CONTROL	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
DIABETIC KETOACIDOSIS	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0005 affected1,322 at risk EG0011 affected686 at risk
FAILURE TO THRIVE	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
FLUID OVERLOAD	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0012 affected686 at risk
FLUID RETENTION	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
GOUT	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0005 affected1,322 at risk EG0012 affected686 at risk
HYPERGLYCAEMIA	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG00014 affected1,322 at risk EG0017 affected686 at risk
HYPERKALAEMIA	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0004 affected1,322 at risk EG0015 affected686 at risk
HYPERLIPIDAEMIA	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
HYPERURICAEMIA	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
HYPOALBUMINAEMIA	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
HYPOCALCAEMIA	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
HYPOGLYCAEMIA	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG00010 affected1,322 at risk EG0013 affected686 at risk
HYPOKALAEMIA	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG00015 affected1,322 at risk EG00111 affected686 at risk
HYPOMAGNESAEMIA	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0005 affected1,322 at risk EG0013 affected686 at risk
HYPONATRAEMIA	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0008 affected1,322 at risk EG0015 affected686 at risk
HYPOVOLAEMIA	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
IMPAIRED FASTING GLUCOSE	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
LACTIC ACIDOSIS	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
METABOLIC ACIDOSIS	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
OBESITY	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0006 affected1,322 at risk EG0013 affected686 at risk
TYPE 2 DIABETES MELLITUS	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0005 affected1,322 at risk EG0014 affected686 at risk
VITAMIN B COMPLEX DEFICIENCY	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
VITAMIN D DEFICIENCY	Metabolism and nutrition disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0012 affected686 at risk
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG00027 affected1,322 at risk EG00116 affected686 at risk
ARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0008 affected1,322 at risk EG0015 affected686 at risk
ARTHROFIBROSIS	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG00055 affected1,322 at risk EG00128 affected686 at risk
BONE LESION	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
BONE PAIN	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
BURSITIS	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0004 affected1,322 at risk EG0014 affected686 at risk
CERVICAL SPINAL STENOSIS	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
CHONDROCALCINOSIS PYROPHOSPHATE	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
COSTOCHONDRITIS	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0006 affected1,322 at risk EG0011 affected686 at risk
DUPUYTREN'S CONTRACTURE	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0011 affected686 at risk
EXOSTOSIS	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0012 affected686 at risk
FLANK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0013 affected686 at risk
FOOT DEFORMITY	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
FRACTURE NONUNION	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
INTERVERTEBRAL DISC DEGENERATION	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0011 affected686 at risk
INTERVERTEBRAL DISC PROTRUSION	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0009 affected1,322 at risk EG0012 affected686 at risk
JOINT EFFUSION	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
JOINT STIFFNESS	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
JOINT SWELLING	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0004 affected1,322 at risk EG0011 affected686 at risk
LIMB DISCOMFORT	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0012 affected686 at risk
LUMBAR SPINAL STENOSIS	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0007 affected1,322 at risk EG0012 affected686 at risk
MOBILITY DECREASED	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
MUSCLE SPASMS	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG00010 affected1,322 at risk EG0011 affected686 at risk
MUSCULAR WEAKNESS	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0006 affected1,322 at risk EG0014 affected686 at risk
MUSCULOSKELETAL CHEST PAIN	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG00021 affected1,322 at risk EG0017 affected686 at risk
MUSCULOSKELETAL DISCOMFORT	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0005 affected1,322 at risk EG0012 affected686 at risk
MUSCULOSKELETAL DISORDER	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
MUSCULOSKELETAL PAIN	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG00018 affected1,322 at risk EG00116 affected686 at risk
MYALGIA	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG00012 affected1,322 at risk EG0018 affected686 at risk
MYOSITIS	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
NECK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0007 affected1,322 at risk EG0015 affected686 at risk
OSTEOARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG00030 affected1,322 at risk EG00118 affected686 at risk
OSTEOPENIA	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
OSTEOPOROSIS	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG00040 affected1,322 at risk EG00115 affected686 at risk
PAIN IN JAW	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0007 affected1,322 at risk EG0011 affected686 at risk
PERIARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
PLANTAR FASCIITIS	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0011 affected686 at risk
POLYMYALGIA RHEUMATICA	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0012 affected686 at risk
RHABDOMYOLYSIS	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
RHEUMATOID ARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
ROTATOR CUFF SYNDROME	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0008 affected1,322 at risk EG0014 affected686 at risk
SACROILIITIS	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
SPINAL OSTEOARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0006 affected1,322 at risk EG0014 affected686 at risk
SPONDYLITIS	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
SPONDYLOLISTHESIS	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0012 affected686 at risk
SYNOVIAL CYST	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
SYSTEMIC LUPUS ERYTHEMATOSUS	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
TENDINOUS CONTRACTURE	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
TENDONITIS	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
TENOSYNOVITIS STENOSANS	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
TRIGGER FINGER	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
VERTEBRAL FORAMINAL STENOSIS	Musculoskeletal and connective tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
ACOUSTIC NEUROMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
ACUTE MYELOID LEUKAEMIA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
ACUTE MYELOID LEUKAEMIA RECURRENT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
ADENOCARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0011 affected686 at risk
ADENOCARCINOMA PANCREAS	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
B-CELL LYMPHOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
B-CELL LYMPHOMA STAGE IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
BASAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0006 affected1,322 at risk EG0017 affected686 at risk
BENIGN BREAST NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
BENIGN OVARIAN TUMOUR	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
BILE DUCT CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
BLADDER CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0011 affected686 at risk
BLADDER CANCER RECURRENT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
BLADDER CANCER STAGE IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
BLADDER NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
BRAIN NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
BREAST CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0005 affected1,322 at risk EG0010 affected686 at risk
BREAST CANCER STAGE III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
CERVIX CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
CHRONIC LYMPHOCYTIC LEUKAEMIA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
COLON ADENOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0012 affected686 at risk
COLON CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0012 affected686 at risk
DIFFUSE LARGE B-CELL LYMPHOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
GASTRIC CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
GLIOBLASTOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0000 affected1,322 at risk EG0012 affected686 at risk
HAEMANGIOMA OF SPLEEN	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
HEAD AND NECK CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
HEAD AND NECK CANCER METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
HEPATIC CANCER METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
HEPATIC NEOPLASM MALIGNANT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
HYPOPHARYNGEAL CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
LARYNGEAL CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
LEUKAEMIA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
LEUKAEMIA RECURRENT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
LIP AND/OR ORAL CAVITY CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
LIPOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
LUNG ADENOCARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0010 affected686 at risk
LUNG CANCER METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0012 affected686 at risk
LUNG NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0005 affected1,322 at risk EG0016 affected686 at risk
LUNG NEOPLASM MALIGNANT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0007 affected1,322 at risk EG0010 affected686 at risk
LUNG SQUAMOUS CELL CARCINOMA STAGE III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
LUNG SQUAMOUS CELL CARCINOMA STAGE UNSPECIFIED	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
LYMPHOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0004 affected1,322 at risk EG0010 affected686 at risk
MALIGNANT MELANOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0011 affected686 at risk
MELANOCYTIC NAEVUS	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
MENINGIOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
METASTASES TO LIVER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
METASTASES TO LUNG	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
METASTASES TO LYMPH NODES	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
METASTASES TO SPINE	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
METASTATIC MALIGNANT MELANOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0010 affected686 at risk
METASTATIC NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
MULTIPLE MYELOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
NEOPLASM MALIGNANT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
NEURILEMMOMA MALIGNANT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
NON-HODGKIN'S LYMPHOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
NON-SMALL CELL LUNG CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
OESOPHAGEAL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
ORAL NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
OROPHARYNGEAL CANCER STAGE UNSPECIFIED	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
OVARIAN CANCER METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
OVARIAN EPITHELIAL CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
PANCREATIC CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
PERICARDIAL EFFUSION MALIGNANT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
PROSTATE CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG00011 affected1,322 at risk EG0014 affected686 at risk
PROSTATE CANCER RECURRENT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
RECTAL CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
RENAL CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
RENAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
RENAL HAEMANGIOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
RENAL NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
SEBORRHOEIC KERATOSIS	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
SINONASAL PAPILLOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
SKIN CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0010 affected686 at risk
SKIN PAPILLOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
SMALL CELL LUNG CANCER LIMITED STAGE	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
SMALL CELL LUNG CANCER STAGE UNSPECIFIED	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
SQUAMOUS CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0005 affected1,322 at risk EG0013 affected686 at risk
SQUAMOUS CELL CARCINOMA OF SKIN	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
THYROID NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0012 affected686 at risk
TONGUE NEOPLASM MALIGNANT STAGE UNSPECIFIED	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
TRANSITIONAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
URETERIC CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
UTERINE CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
UTERINE LEIOMYOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
VULVAL CANCER STAGE 0	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
ALTERED STATE OF CONSCIOUSNESS	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
AMNESIA	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0004 affected1,322 at risk EG0012 affected686 at risk
APHASIA	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
ARACHNOIDITIS	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
ATAXIA	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
AUTONOMIC NERVOUS SYSTEM IMBALANCE	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
BALANCE DISORDER	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
BURNING SENSATION	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
CAROTID ARTERY DISEASE	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0011 affected686 at risk
CAROTID ARTERY STENOSIS	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG00015 affected1,322 at risk EG0019 affected686 at risk
CARPAL TUNNEL SYNDROME	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0004 affected1,322 at risk EG0012 affected686 at risk
CAUDA EQUINA SYNDROME	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
CENTRAL NERVOUS SYSTEM LESION	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
CEREBELLAR INFARCTION	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
CEREBRAL HAEMORRHAGE	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
CEREBRAL INFARCTION	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
CEREBROVASCULAR ACCIDENT	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG00020 affected1,322 at risk EG00115 affected686 at risk
CEREBROVASCULAR DISORDER	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
CERVICOBRACHIAL SYNDROME	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
COMPLICATED MIGRAINE	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
CONVULSION	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0004 affected1,322 at risk EG0012 affected686 at risk
CUBITAL TUNNEL SYNDROME	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
DEMENTIA	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
DIABETIC NEUROPATHY	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
DIZZINESS	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG00058 affected1,322 at risk EG00127 affected686 at risk
DIZZINESS EXERTIONAL	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
DIZZINESS POSTURAL	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0007 affected1,322 at risk EG0010 affected686 at risk
DYSAESTHESIA	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
DYSARTHRIA	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0004 affected1,322 at risk EG0010 affected686 at risk
DYSGEUSIA	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
EMBOLIC STROKE	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
ENCEPHALOPATHY	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
ESSENTIAL TREMOR	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
GUILLAIN-BARRE SYNDROME	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
HAEMORRHAGE INTRACRANIAL	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
HAEMORRHAGIC STROKE	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
HEAD DISCOMFORT	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
HEAD TITUBATION	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
HEADACHE	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG00028 affected1,322 at risk EG00119 affected686 at risk
HEMIPARESIS	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
HEMIPLEGIC MIGRAINE	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
HEPATIC ENCEPHALOPATHY	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
HYPOAESTHESIA	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG00013 affected1,322 at risk EG0018 affected686 at risk
HYPOXIC-ISCHAEMIC ENCEPHALOPATHYv	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
IIIRD NERVE PARALYSIS	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
INTENTION TREMOR	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
ISCHAEMIC STROKE	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0006 affected1,322 at risk EG0013 affected686 at risk
LACUNAR INFARCTION	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
LATERAL MEDULLARY SYNDROME	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
LETHARGY	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
LOSS OF CONSCIOUSNESS	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
LUMBAR RADICULOPATHY	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0012 affected686 at risk
MEMORY IMPAIRMENT	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0006 affected1,322 at risk EG0010 affected686 at risk
MENTAL IMPAIRMENT	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
METABOLIC ENCEPHALOPATHY	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0011 affected686 at risk
MIGRAINE	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected1,322 at risk EG0011 affected686 at risk
MYELOMALACIA	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
NERVE COMPRESSION	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0012 affected686 at risk
NEURALGIA	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
NEUROLOGICAL SYMPTOM	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0012 affected686 at risk
NEUROPATHY PERIPHERAL	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
NYSTAGMUS	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
PARAESTHESIA	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0008 affected1,322 at risk EG0014 affected686 at risk
POLYNEUROPATHY ALCOHOLIC	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
POST-TRAUMATIC HEADACHE	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0012 affected686 at risk
PRESYNCOPE	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG00026 affected1,322 at risk EG0018 affected686 at risk
RADICULITIS	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
RADICULITIS CERVICAL	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
SCIATICA	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0004 affected1,322 at risk EG0012 affected686 at risk
SENSORY DISTURBANCE	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
SOMNOLENCE	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0010 affected686 at risk
SPEECH DISORDER	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
SPONDYLITIC MYELOPATHY	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
SUBARACHNOID HAEMORRHAGE	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
SUBDURAL HYGROMA	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
SYNCOPE	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG00040 affected1,322 at risk EG00122 affected686 at risk
THALAMIC INFARCTION	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0010 affected686 at risk
THROMBOTIC STROKE	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
TRANSIENT GLOBAL AMNESIA	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
TRANSIENT ISCHAEMIC ATTACK	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG00017 affected1,322 at risk EG0018 affected686 at risk
TREMOR	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0004 affected1,322 at risk EG0012 affected686 at risk
UNRESPONSIVE TO STIMULI	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
URAEMIC ENCEPHALOPATHY	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
VERTEBRAL ARTERY OCCLUSION	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
VITH NERVE PARALYSIS	Nervous system disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0011 affected686 at risk
ACUTE STRESS DISORDER	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
ADJUSTMENT DISORDER WITH MIXED DISTURBANCE OF EMOTION AND CONDUCT	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
AFFECTIVE DISORDER	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
ALCOHOL ABUSE	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
ALCOHOL PROBLEM	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
ALCOHOL WITHDRAWAL SYNDROME	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
ANXIETY	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG00020 affected1,322 at risk EG0017 affected686 at risk
ANXIETY DISORDER	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
BIPOLAR DISORDER	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
BIPOLAR I DISORDER	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
COMPLETED SUICIDE	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
CONFUSIONAL STATE	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0004 affected1,322 at risk EG0012 affected686 at risk
DELIRIUM	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
DELIRIUM TREMENS	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
DEPRESSED MOOD	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
DEPRESSION	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG00017 affected1,322 at risk EG0013 affected686 at risk
DEPRESSION SUICIDAL	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
HALLUCINATION	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
HALLUCINATION, VISUAL	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
INSOMNIA	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0004 affected1,322 at risk EG0013 affected686 at risk
INTENTIONAL SELF-INJURY	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
MAJOR DEPRESSION	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0011 affected686 at risk
MENTAL STATUS CHANGES	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0006 affected1,322 at risk EG0012 affected686 at risk
OBSESSIVE-COMPULSIVE DISORDER	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
PANIC ATTACK	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0011 affected686 at risk
STRESS	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
SUICIDAL IDEATION	Psychiatric disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0012 affected686 at risk
BLADDER DISORDER	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
CALCULUS URETERIC	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0013 affected686 at risk
CYSTITIS HAEMORRHAGIC	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
CYSTITIS INTERSTITIAL	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
DYSURIA	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0004 affected1,322 at risk EG0010 affected686 at risk
HAEMATURIA	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG00013 affected1,322 at risk EG00111 affected686 at risk
HYDRONEPHROSIS	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0011 affected686 at risk
HYPERTONIC BLADDER	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
MICROALBUMINURIA	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
NEPHROLITHIASIS	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG00018 affected1,322 at risk EG00110 affected686 at risk
NOCTURIA	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
POLLAKIURIA	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
RENAL ARTERY STENOSIS	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0013 affected686 at risk
RENAL CYST	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0004 affected1,322 at risk EG0012 affected686 at risk
RENAL DISORDER	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
RENAL FAILURE	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0008 affected1,322 at risk EG0015 affected686 at risk
RENAL FAILURE ACUTE	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG00017 affected1,322 at risk EG00114 affected686 at risk
RENAL FAILURE CHRONIC	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0015 affected686 at risk
RENAL IMPAIRMENT	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0012 affected686 at risk
RENAL TUBULAR NECROSIS	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
STRESS URINARY INCONTINENCE	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
URETHRAL STENOSIS	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
URINARY HESITATION	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
URINARY INCONTINENCE	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
URINARY RETENTION	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG00012 affected1,322 at risk EG0013 affected686 at risk
URINE FLOW DECREASED	Renal and urinary disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
BENIGN PROSTATIC HYPERPLASIA	Reproductive system and breast disorders	MedDRA 11.0	Systematic Assessment	EG0007 affected1,322 at risk EG0015 affected686 at risk
BREAST CALCIFICATIONS	Reproductive system and breast disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
BREAST MASS	Reproductive system and breast disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
BREAST PAIN	Reproductive system and breast disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
DYSFUNCTIONAL UTERINE BLEEDING	Reproductive system and breast disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
EPIDIDYMAL CYST	Reproductive system and breast disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
FALLOPIAN TUBE CYST	Reproductive system and breast disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
FEMALE GENITAL TRACT FISTULA	Reproductive system and breast disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
HAEMATOSPERMIA	Reproductive system and breast disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0010 affected686 at risk
MENORRHAGIA	Reproductive system and breast disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0012 affected686 at risk
PELVIC HAEMATOMA	Reproductive system and breast disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
PENILE HAEMORRHAGE	Reproductive system and breast disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
POLYCYSTIC OVARIES	Reproductive system and breast disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
PROSTATITIS	Reproductive system and breast disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
PROSTATOMEGALY	Reproductive system and breast disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
SEXUAL DYSFUNCTION	Reproductive system and breast disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
SPERMATOCELE	Reproductive system and breast disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
TESTICULAR PAIN	Reproductive system and breast disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
UTERINE POLYP	Reproductive system and breast disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
VAGINAL HAEMORRHAGE	Reproductive system and breast disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0011 affected686 at risk
VULVA CYST	Reproductive system and breast disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
ACUTE PULMONARY OEDEMA	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0014 affected686 at risk
ACUTE RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG00018 affected1,322 at risk EG0017 affected686 at risk
ALLERGIC GRANULOMATOUS ANGIITIS	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
ASPIRATION	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
ASTHMA	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0006 affected1,322 at risk EG0014 affected686 at risk
ATELECTASIS	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0011 affected686 at risk
BRONCHIAL HYPERREACTIVITY	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
BRONCHITIS CHRONIC	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
CHOKING	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
CHRONIC OBSTRUCTIVE PULMONARY DISEASE	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG00035 affected1,322 at risk EG00115 affected686 at risk
COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG00021 affected1,322 at risk EG00112 affected686 at risk
DYSPHONIA	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG000126 affected1,322 at risk EG00155 affected686 at risk
DYSPNOEA EXERTIONAL	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG00051 affected1,322 at risk EG00133 affected686 at risk
DYSPNOEA PAROXYSMAL NOCTURNAL	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
EMPHYSEMA	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
EPISTAXIS	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG00026 affected1,322 at risk EG00115 affected686 at risk
HAEMOPTYSIS	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0015 affected686 at risk
HYPERVENTILATION	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
HYPOXIA	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0012 affected686 at risk
INTERSTITIAL LUNG DISEASE	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
MEDIASTINAL MASS	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
NASAL POLYPS	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
NASAL SEPTUM ULCERATION	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
NON-CARDIOGENIC PULMONARY OEDEMA	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
OBSTRUCTIVE AIRWAYS DISORDER	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
ORGANISING PNEUMONIA	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
OROPHARYNGEAL PAIN	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0004 affected1,322 at risk EG0013 affected686 at risk
ORTHOPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0010 affected686 at risk
PHARYNGEAL OEDEMA	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
PLEURAL EFFUSION	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0009 affected1,322 at risk EG0016 affected686 at risk
PLEURITIC PAIN	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0004 affected1,322 at risk EG0012 affected686 at risk
PNEUMONIA ASPIRATION	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0014 affected686 at risk
PNEUMONITIS	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
PNEUMOTHORAX	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0016 affected686 at risk
PRODUCTIVE COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
PULMONARY CONGESTION	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
PULMONARY EMBOLISM	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0009 affected1,322 at risk EG0017 affected686 at risk
PULMONARY FIBROSIS	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0012 affected686 at risk
PULMONARY HYPERTENSION	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
PULMONARY OEDEMA	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0012 affected686 at risk
RESPIRATORY ALKALOSIS	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
RESPIRATORY ARREST	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
RESPIRATORY DISORDER	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG00014 affected1,322 at risk EG0018 affected686 at risk
RHINITIS ALLERGIC	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0010 affected686 at risk
RHINORRHOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
SINUS CONGESTION	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0011 affected686 at risk
SLEEP APNOEA SYNDROME	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0008 affected1,322 at risk EG0016 affected686 at risk
THROAT TIGHTNESS	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
TRACHEAL STENOSIS	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
UPPER RESPIRATORY TRACT CONGESTION	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
UPPER-AIRWAY COUGH SYNDROME	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
WHEEZING	Respiratory, thoracic and mediastinal disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
ACTINIC KERATOSIS	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0011 affected686 at risk
ANGIOEDEMA	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0011 affected686 at risk
DECUBITUS ULCER	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0011 affected686 at risk
DERMATITIS	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
DERMATITIS ATOPIC	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
DERMATITIS CONTACT	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
DIABETIC FOOT	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0010 affected686 at risk
DRUG ERUPTION	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0012 affected686 at risk
ECCHYMOSIS	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0010 affected686 at risk
ECZEMA	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
ERYTHEMA	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
HYPERHIDROSIS	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0005 affected1,322 at risk EG0011 affected686 at risk
HYPERKERATOSIS	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0012 affected686 at risk
INCREASED TENDENCY TO BRUISE	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0009 affected1,322 at risk EG0015 affected686 at risk
INGROWING NAIL	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
LICHENOID KERATOSIS	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
LIVEDO RETICULARIS	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
NIGHT SWEATS	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
PRECANCEROUS SKIN LESION	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
PRURITUS	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0004 affected1,322 at risk EG0012 affected686 at risk
PRURITUS ALLERGIC	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
PSORIASIS	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
RASH	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG00015 affected1,322 at risk EG0018 affected686 at risk
RASH GENERALISED	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0011 affected686 at risk
RASH PRURITIC	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0011 affected686 at risk
SEBORRHOEIC DERMATITIS	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
SKIN LESION	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
SKIN ULCER	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0005 affected1,322 at risk EG0013 affected686 at risk
SWELLING FACE	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
URTICARIA	Skin and subcutaneous tissue disorders	MedDRA 11.0	Systematic Assessment	EG0004 affected1,322 at risk EG0010 affected686 at risk
AORTIC ANEURYSM REPAIR	Surgical and medical procedures	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
CARDIAC ABLATION	Surgical and medical procedures	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
CARDIAC PACEMAKER BATTERY REPLACEMENT	Surgical and medical procedures	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
CARDIAC PACEMAKER REPLACEMENT	Surgical and medical procedures	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
CHOLECYSTECTOMY	Surgical and medical procedures	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
COLOSTOMY	Surgical and medical procedures	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
CORONARY ARTERY BYPASS	Surgical and medical procedures	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
DENTAL IMPLANTATION	Surgical and medical procedures	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
HERNIA HIATUS REPAIR	Surgical and medical procedures	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
HIP ARTHROPLASTY	Surgical and medical procedures	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0010 affected686 at risk
INGUINAL HERNIA REPAIR	Surgical and medical procedures	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
KNEE ARTHROPLASTY	Surgical and medical procedures	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
LEG AMPUTATION	Surgical and medical procedures	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
MEDICAL DEVICE REMOVAL	Surgical and medical procedures	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
NEPHRECTOMY	Surgical and medical procedures	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
SINUS OPERATION	Surgical and medical procedures	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
SPINAL FUSION SURGERY	Surgical and medical procedures	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
TENDON OPERATION	Surgical and medical procedures	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
THERAPY CESSATION	Surgical and medical procedures	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
TONSILLECTOMY	Surgical and medical procedures	MedDRA 10.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
TOOTH EXTRACTION	Surgical and medical procedures	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
TRANSURETHRAL PROSTATECTOMY	Surgical and medical procedures	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
ACCELERATED HYPERTENSION	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0004 affected1,322 at risk EG0011 affected686 at risk
AORTIC ANEURYSM	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0008 affected1,322 at risk EG0013 affected686 at risk
AORTIC DISSECTION	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
AORTIC INTRAMURAL HAEMATOMA	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
AORTIC STENOSIS	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0004 affected1,322 at risk EG0015 affected686 at risk
ARTERIAL SPASM	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
ARTERIOSCLEROSIS	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
ARTERIOVENOUS FISTULA	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
BLEEDING VARICOSE VEIN	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
BLOOD PRESSURE FLUCTUATION	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
BLOOD PRESSURE INADEQUATELY CONTROLLED	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
CIRCULATORY COLLAPSE	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
DEEP VEIN THROMBOSIS	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG00012 affected1,322 at risk EG0018 affected686 at risk
ESSENTIAL HYPERTENSION	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
FEMORAL ARTERIAL STENOSIS	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0011 affected686 at risk
FEMORAL ARTERY OCCLUSION	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
FLUSHING	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0000 affected1,322 at risk EG0011 affected686 at risk
HAEMATOMA	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0008 affected1,322 at risk EG0011 affected686 at risk
HAEMORRHAGE	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0011 affected686 at risk
HOT FLUSH	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
HYPERTENSION	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG00060 affected1,322 at risk EG00124 affected686 at risk
HYPERTENSIVE CRISIS	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0007 affected1,322 at risk EG0017 affected686 at risk
HYPOTENSION	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG00038 affected1,322 at risk EG00113 affected686 at risk
ILIAC ARTERY OCCLUSION	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
ILIAC ARTERY STENOSIS	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
INTERMITTENT CLAUDICATION	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG00014 affected1,322 at risk EG00110 affected686 at risk
LABILE HYPERTENSION	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
MALIGNANT HYPERTENSION	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
ORTHOSTATIC HYPERTENSION	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
ORTHOSTATIC HYPOTENSION	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0008 affected1,322 at risk EG0013 affected686 at risk
PALLOR	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0005 affected1,322 at risk EG00110 affected686 at risk
PERIPHERAL COLDNESS	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0002 affected1,322 at risk EG0010 affected686 at risk
PERIPHERAL ISCHAEMIA	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
PERIPHERAL VASCULAR DISORDER	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0008 affected1,322 at risk EG0016 affected686 at risk
POOR PERIPHERAL CIRCULATION	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
RAYNAUD'S PHENOMENON	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
REPERFUSION INJURY	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0005 affected1,322 at risk EG0012 affected686 at risk
SUBCLAVIAN ARTERY OCCLUSION	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
SUBCLAVIAN ARTERY STENOSIS	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
SUBCLAVIAN STEAL SYNDROME	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
THROMBOPHLEBITIS SUPERFICIAL	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0011 affected686 at risk
THROMBOSIS	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0003 affected1,322 at risk EG0010 affected686 at risk
VARICOSE VEIN	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
VASOSPASM	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
VENOUS INSUFFICIENCY	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk
WEGENER'S GRANULOMATOSIS	Vascular disorders	MedDRA 11.0	Systematic Assessment	EG0001 affected1,322 at risk EG0010 affected686 at risk

ID	Term
D003324	Coronary Artery Disease
D023921	Coronary Stenosis
D003327	Coronary Disease
D023903	Coronary Restenosis
D017202	Myocardial Ischemia

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases

ID	Title	Description
BG000	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.
BG001	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.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.	85	1,322	801	1,322	1,174	1,322
EG001	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.	44	686	398	686	601	686