Attain Performa(TM) Quadripolar Lead Study | NCT01751022

NCT01751022

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Attain Performa LV Lead (Models 4298, 4398, 4598)	Experimental	N/A: single arm study, separate analysis for each lead model (total of 3).	Device: Device: Attain Performa Pacing Lead (along with a standard CRT-D system)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Device: Attain Performa Pacing Lead (along with a standard CRT-D system)	Device	Implant and follow-up of study lead, separate analysis for each lead model	Attain Performa LV Lead (Models 4298, 4398, 4598)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Lead Complication-free Rate at 6 Months	The three Attain Performa LV leads models are evaluated separately. The primary safety objective is listed as following: - Model 4298/4398: The Attain Performa Model 4298/4398 lead will be considered safe if the probability of subjects freed of Attain Performa lead-related complications at 6 months post-implant is greater than 87% (i.e., the one-sided 97.5% lower confidence bound must be greater than 87%). - Model 4598: The safety performance of the Attain Performa Model 4598 lead will be characterized by summarizing the probability of subjects who are free from Attain Performa LV lead related complications at 6 months. The lower boundaries of the 97.5% confidence intervals for the all lead models are greater than the pacing threshold of 87%, thus concluding that the crtiera was met for all lead models.	Implant to 6 months post-implant
LV Pacing Capture Thresholds Per Attain Performa Lead Model		6 months post-implant

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities	Percentage of patients with presence of PNS in all LV lead pacing polarities at 8.0 V at 0.5ms performed at 6-month visit.	6 months post-implant
Percentage of Subjects With Successful Implant Per Attain Performa Lead Model

Eligibility Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Model 4298	Patients with an implant attempt for the Attain Performa Lead Model 4298
FG001	Model 4398	Patients with an implant attempt for the Attain Performa Lead Model 4398

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Attain Performa LV Lead Model 4298	Subjects with an attempted Attain Performa LV Lead Model 4298 implant
BG001	Attain Performa LV Lead Model 4398	Subjects with an attempted Attain Performa LV Lead Model 4398 implant
BG002	Attain Performa LV Lead Model 4598	Subjects with an attempted Attain Performa LV Lead Model 4598 implant
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00068± 11 BG00166± 11 BG00267± 11 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000143 BG00193 BG002

Race/Ethnicity, Customized

Number

participants

Title

Denominators

Categories

Subject/physician chose not to provide information

Title	Measurements
	BG00014 BG0019 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG000360 BG001249 BG002

New York Heart Association Classification (NYHA)

NYHA Functional Classification is assessed as following. Class I: No limitation of physical activity. Class II:Slight limitation of physical activity. Class III: Marked limitation of physical activity. Class IV: Unable to carry on any physical activity without discomfort. For more details see American Heart Association website http://www.heart.org/HEARTORG/Conditions/HeartFailure/AboutHeartFailure/Classes-of-Heart-Failure\_UCM\_306328\_Article.jsp#.V\_5rPPkrJD8

Number

participants

Title

Denominators

Categories

Title	Measurements
	BG0008 BG001

Left Ventricular Ejection Fraction (LVEF)

Mean

Standard Deviation

Title

Denominators

Categories

Title	Measurements
	BG00025± 7 BG00126± 7 BG002

QRS (Electrocardiogram Complex)

Mean

Standard Deviation

Title

Denominators

Categories

Title	Measurements
	BG000155± 23 BG001156± 24 BG002

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

Lead Complication-free Rate at 6 Months

The three Attain Performa LV leads models are evaluated separately. The primary safety objective is listed as following:

- Model 4298/4398: The Attain Performa Model 4298/4398 lead will be considered safe if the probability of subjects freed of Attain Performa lead-related complications at 6 months post-implant is greater than 87% (i.e., the one-sided 97.5% lower confidence bound must be greater than 87%).

- Model 4598: The safety performance of the Attain Performa Model 4598 lead will be characterized by summarizing the probability of subjects who are free from Attain Performa LV lead related complications at 6 months.

The lower boundaries of the 97.5% confidence intervals for the all lead models are greater than the pacing threshold of 87%, thus concluding that the crtiera was met for all lead models.

Subjects with an attempted Attain Performa LV Lead Model. Results for lead model 4298 comes from its PMA-S Clinical Report Version 1, 27MAR2014; results for lead model 4398 comes from its PMA-S Clinical Report Version 3, 03SEP2014; results for lead model 4598 comes from its PMA-S Clinical Report Version 1, 29AUG2014.

Posted

Number

97.5% Confidence Interval

Survival Probability (%)

Implant to 6 months post-implant

ID	Title	Description
OG000	Attain Performa LV Lead Model 4298	Subjects with an attempted Attain Performa LV Lead Model 4298 implant.
OG001	Attain Performa LV Lead Model 4398	Subjects with an attempted Attain Performa LV Lead Model 4398 implant.
OG002	Attain Performa LV Lead Model 4598	Subjects with an attempted Attain Performa LV Lead Model 4598 implant.

Units	Counts
Participants	OG000499 OG001326 OG002300

Title

Denominators

Categories

Title	Measurements
	OG00096.04(94.30 to 100) OG00198.75(97.55 to 100) OG00296.21(94.04 to 100)

Primary

LV Pacing Capture Thresholds Per Attain Performa Lead Model

Subjects with Attain Performa LV Lead Model implanted and valid pacing thresholds measured at the 6 month follow-up visit. Results for model 4298 comes from its PMA-S Clinical Report Version 1, 27MAR2014; for model 4398 comes from its PMA-S Clinical Report Version 3, 03SEP2014; for model 4598 comes from its PMA-S Clinical Report V. 1, 29AUG2014.

Posted

Mean

97.5% Confidence Interval

percentage of participants

6 months post-implant

ID	Title	Description
OG000	Attain Performa LV Lead Model 4298	Subjects with Attain Performa LV Lead Model 4298 implanted and valid pacing thresholds measured at the 6 month follow-up visit.
OG001	Attain Performa LV Lead Model 4398	Subjects with Attain Performa LV Lead Model 4398 implanted and valid pacing thresholds measured at the 6 month follow-up visit.
OG002	Attain Performa LV Lead Model 4598	Subjects with Attain Performa LV Lead Model 4598 implanted and valid pacing thresholds measured at the 6 month follow-up visit.

Secondary

Percentage of Subjects With Presence of PNS in All LV Lead Pacing Polarities

Percentage of patients with presence of PNS in all LV lead pacing polarities at 8.0 V at 0.5ms performed at 6-month visit.

Subjects with Attain Performa LV Lead implanted and at least 1 valid pacing threshold at any LV lead pacing polarity measured at the 6 month visit. Results for model 4298 comes from its PMA-S Clinical Report V1, 27MAR14; for model 4398 comes from its PMA-S Clinical Report V3, 03SEP14; for model 4598 comes from its PMA-S Clinical Report V1, 29AUG14.

Posted

Number

percentage of participants

6 months post-implant

ID	Title	Description
OG000	Attain Performa LV Lead Model 4298	Subjects with Attain Performa LV Lead Model 4298 implanted and at least one valid pacing threshold at any LV lead pacing polarity measured at the 6 month follow-up visit.
OG001	Attain Performa LV Lead Model 4398	Subjects with Attain Performa LV Lead Model 4398 implanted and at least one valid pacing threshold at any LV lead pacing polarity measured at the 6 month follow-up visit.
OG002	Attain Performa LV Lead Model 4598	Subjects with Attain Performa LV Lead Model 4598 implanted and at least one valid pacing threshold at any LV lead pacing polarity measured at the 6 month.

Secondary

Percentage of Subjects With Successful Implant Per Attain Performa Lead Model

Posted

Number

95% Confidence Interval

percentage of participants

Implant up to 1-month post implant

ID	Title	Description
OG000	Model 4298	Patients with an implant attempt for the Attain Performa Lead Model 4298
OG001	Model 4398	Patients with an implant attempt for the Attain Performa Lead Model 4398
OG002	Model 4598	Patients with an implant attempt for the Attain Performa Lead Model 4598

Units	Counts
Participants

Secondary

Rate of Overall Acceptable Lead Handling Per Attain Performa Lead Model

Posted

Number

percentage of participants

Implant up to 1-month post implant

ID	Title	Description
OG000	Attain Performa LV Lead Model 4298	Subjects with an attempted Attain Performa LV Lead Model 4298 implant
OG001	Attain Performa LV Lead Model 4398	Subjects with an attempted Attain Performa LV Lead Model 4398 implant
OG002	Attain Performa LV Lead Model 4598	Subjects with an attempted Attain Performa LV Lead Model 4598 implant

Units	Counts
Participants

Secondary

Pacing Capture Thresholds at the Final Programmed Pacing Polarity

Posted

Mean

Standard Deviation

Volts

6 months post-implant

ID	Title	Description
OG000	Attain Performa LV Lead Model 4298	Subjects with Attain Performa LV Lead Model 4298 implanted and valid pacing thresholds measured at the 6 month follow-up visit.
OG001	Attain Performa LV Lead Model 4398	Subjects with Attain Performa LV Lead Model 4398 implanted and valid pacing thresholds measured at the 6 month follow-up.
OG002	Attain Performa LV Lead Model 4598	Subjects with Attain Performa LV Lead Model 4598 implanted and valid pacing thresholds measured at the 6 month follow-up visit.

Secondary

Implant Related Times Per Attain Performa Lead Model

Subjects with Attain Performa LV Lead Model successfully implanted. Results for model 4298 comes from its PMA-S Clinical Report Version 1, 27MAR2014; for model 4398 comes from its PMA-S Clinical Report Version 3, 03SEP2014; for model 4598 comes from its PMA-S Clinical Report Version 1, 29AUG2014.

Posted

Mean

Standard Deviation

minutes

Implant up to 1-month post implant

ID	Title	Description
OG000	Attain Performa LV Lead Model 4298	Subjects with Attain Performa LV Lead Model 4298 implanted successfully.
OG001	Attain Performa LV Lead Model 4398	Subjects with Attain Performa LV Lead Model 4398 implanted successfully.
OG002	Attain Performa LV Lead Model 4598	Subjects with Attain Performa LV Lead Model 4598 implanted successfully.

Units	Counts
Participants

Secondary

Pacing Impedance at the Final Programmed Pacing Polarity

Pacing impedance for each LV pacing polarity. Noticed that pacing impedance values are not recorded for reversed LV pacing polarities, since impedance from LV1 to LV2 is the same as from LV2 to LV1.

Impedance is a measurement of current/resistance between the pacing lead and the cardiac tissue (measured in Ohms).

Subjects with Attain Performa LV lead implanted and complete Medtronic Quad CRT-D system and valid measures of lead impedance at 6-month visit. Results for model 4298 comes from its PMA-S Clinical Report V1, 27MAR14; for model 4398 comes from its PMA-S Clinical Report V3, 03SEP14; for model 4598 comes from its PMA-S Clinical Report V1, 29AUG14.

Posted

Mean

Standard Deviation

Ohms

6 month post-implant

ID	Title	Description
OG000	Attain Performa LV Lead Model 4298	Subjects with Attain Performa LV Lead Model 4298 implanted and complete Medtronic Quad CRT-D system and valid measures of lead impedance at 6-month visit.
OG001	Attain Performa LV Lead Model 4398	Subjects with Attain Performa LV Lead Model 4398 implanted and complete Medtronic Quad CRT-D system and valid measures of lead impedance at 6-month visit.
OG002	Attain Performa LV Lead Model 4598

Secondary

Complication Rate for Individual Attain Performa Lead Related Events

Posted

Number

95% Confidence Interval

percentage of participants

6 month post-Implant

ID	Title	Description
OG000	Attain Performa LV Lead Model 4298	Subjects with Attain Performa LV Lead Model 4298 implanted successfully.
OG001	Attain Performa LV Lead Model 4398	Subjects with Attain Performa LV Lead Model 4398 implanted successfully.
OG002	Attain Performa LV Lead Model 4598	Subjects with Attain Performa LV Lead Model 4598 implanted successfully.

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Attain Performa LV Lead Model 4298	Subjects with an attempted Attain Performa LV Lead Model 4298 implant. Results as showed in the Model 4298 PMA-S Clinical Report Version 1, 27MAR2014.	218	499	155	499
EG001	Attain Performa LV Lead Model 4398	Subjects with an attempted Attain Performa LV Lead Model 4398 implant. Results as showed in the Model 4398 PMA-S Clinical Report Version 3, 03SEP2014.	134	326	84	326
EG002	Attain Performa LV Lead Model 4598	Subjects with an attempted Attain Performa LV Lead Model 4598 implant. Results as showed in the Model 4598 PMA-S Clinical Report Version 1, 29AUG2014.	117	300	84	300

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anemia	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment	EG0005 events5 affected499 at risk EG0011 events1 affected326 at risk EG0022 events2 affected300 at risk
AFib	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0012 events2 affected326 at risk EG0021 events1 affected300 at risk
Acute heart failure	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Alcoholic cardiomyopathy	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Angina pectoris	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0012 events2 affected326 at risk EG0020 events0 affected300 at risk
Aortic regurgitation	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Arrhythmia supraventricular	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0022 events1 affected300 at risk
Asystole	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Atrial arrhythmia	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG00018 events16 affected499 at risk EG00116 events12 affected326 at risk EG0023 events3 affected300 at risk
Atrial fibrillation paroxysmal	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Atrial fibrillation with rapid ventricular response	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0004 events4 affected499 at risk EG0011 events1 affected326 at risk EG0023 events3 affected300 at risk
Atrial flutter	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0005 events4 affected499 at risk EG0017 events5 affected326 at risk EG0022 events2 affected300 at risk
Atrial tachycardia	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Atypical angina	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected499 at risk EG0019 events2 affected326 at risk EG0021 events1 affected300 at risk
Cardiac arrest	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0014 events4 affected326 at risk EG0020 events0 affected300 at risk
Cardiac arrhythmia	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Cardiac perforation	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Cardiac tamponade	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0022 events2 affected300 at risk
Cardiogenic shock	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Cardiomyopathy	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0012 events2 affected326 at risk EG0020 events0 affected300 at risk
Cardiopulmonary arrest	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Cardiorenal syndrome	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Cardiovascular disease, unspecified	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Chronic heart failure	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Congestive heart failure	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0014 events4 affected326 at risk EG0022 events2 affected300 at risk
Coronary artery disease	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0003 events2 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Decompensated heart failure	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG00084 events57 affected499 at risk EG00151 events30 affected326 at risk EG00246 events33 affected300 at risk
Electromechanical dissociation	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Heart fluttering	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Intracardiac mass	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Left ventricular dysfunction	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Mitral valve disease	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Monomorphic ventricular tachycardia	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Myocardial infarction	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Non ST segment elevation myocardial infarction	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0013 events2 affected326 at risk EG0023 events3 affected300 at risk
Non-ischemic cardiomyopathy	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Non-sustained ventricular tachycardia	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Paroxysmal atrial fibrillation	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0012 events2 affected326 at risk EG0020 events0 affected300 at risk
Pericardial effusion	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected499 at risk EG0014 events3 affected326 at risk EG0020 events0 affected300 at risk
Pericarditis	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Permanent atrial fibrillation	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0022 events2 affected300 at risk
Persistent atrial fibrillation	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0003 events3 affected499 at risk EG0012 events2 affected326 at risk EG0024 events4 affected300 at risk
Premature ventricular contractions	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0003 events3 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Recurrent atrial fibrillation	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0022 events2 affected300 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0012 events2 affected326 at risk EG0021 events1 affected300 at risk
Sustained ventricular tachycardia	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Systolic dysfunction	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Tachyarrhythmia	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Tachycardia	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Torsades de pointes	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Tricuspid valve disease	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Unstable angina	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0003 events3 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Ventricular ectopic beats	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0003 events3 affected499 at risk EG0010 events0 affected326 at risk EG0023 events3 affected300 at risk
Ventricular flutter	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Ventricular tachyarrhythmia	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0004 events4 affected499 at risk EG0011 events1 affected326 at risk EG0028 events7 affected300 at risk
Patent ductus arteriosus	Congenital, familial and genetic disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Benign paroxysmal positional vertigo	Ear and labyrinth disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Right cataract	Eye disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Vitreous hemorrhage	Eye disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Abdominal catastrophe	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0003 events2 affected499 at risk EG0012 events2 affected326 at risk EG0021 events1 affected300 at risk
Acute duodenal ulcer	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Acute pancreatitis	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Antral ulcer	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Barrett s esophagus	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Diarrhea	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0002 events1 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Diverticular perforation	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
GI bleed	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0009 events7 affected499 at risk EG0012 events2 affected326 at risk EG0022 events2 affected300 at risk
GI upset	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Gastro intestinal bleed	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Gastrocutaneous fistula	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Gastrointestinal bleed	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Hernia hiatal	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Intestinal mass	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Irritable bowel syndrome	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Nausea	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Oesophageal reflux	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Parotid cyst	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Ruptured diverticulum	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Small bowel obstruction	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Vomiting	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Adverse drug reaction	General disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Chest Pain	General disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Chest discomfort	General disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Chest pain	General disorders	MedDRA 17.1	Systematic Assessment	EG00010 events10 affected499 at risk EG00124 events7 affected326 at risk EG0023 events3 affected300 at risk
Chest tightness	General disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Chronic chest pain	General disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Coronary restenosis	General disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Device capturing issue	General disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Device connection issue	General disorders	MedDRA 17.1	Systematic Assessment	EG0003 events3 affected499 at risk EG0012 events2 affected326 at risk EG0021 events1 affected300 at risk
Device malfunction	General disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Drug side effect	General disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0013 events3 affected326 at risk EG0020 events0 affected300 at risk
Elevated pacing threshold	General disorders	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Fever	General disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Hypothermia	General disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Implant site edema	General disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Implant site erythema	General disorders	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Implant site hematoma	General disorders	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected499 at risk EG0012 events2 affected326 at risk EG0021 events1 affected300 at risk
Implant site pain	General disorders	MedDRA 17.1	Systematic Assessment	EG0003 events3 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Inappropriate phrenic nerve stimulation	General disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0012 events1 affected326 at risk EG0020 events0 affected300 at risk
Inappropriate stimulation of diaphragm	General disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Injection site reaction	General disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Lead dislodgement	General disorders	MedDRA 17.1	Systematic Assessment	EG00017 events16 affected499 at risk EG0014 events3 affected326 at risk EG0028 events8 affected300 at risk
Loss of capture	General disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Multi organ failure	General disorders	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Non-cardiac chest pain	General disorders	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected499 at risk EG0014 events2 affected326 at risk EG0021 events1 affected300 at risk
Pain	General disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Phantom shocks	General disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Premature battery depletion	General disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Substernal chest pain	General disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Sudden death	General disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Undersensing	General disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Unknown cause of death	General disorders	MedDRA 17.1	Systematic Assessment	EG0004 events4 affected499 at risk EG0011 events1 affected326 at risk EG0024 events4 affected300 at risk
Weakness	General disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Acute cholecystitis	Hepatobiliary disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Chronic cholecystitis	Hepatobiliary disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Hepatitis	Hepatobiliary disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Abdominal sepsis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Abscess jaw	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Acute bronchitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0011 events1 affected326 at risk EG0021 events1 affected300 at risk
Acute gastroenteritis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Acute tracheobronchitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Appendicitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Bacteremia	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0004 events3 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Bronchitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Bronchitis acute	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Bronchitis viral	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Bronchopneumonia	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
C.difficile colitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Cellulitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Cellulitis of leg	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Cellulitis of toe	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Diverticulitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Endocarditis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Gastroenteritis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0021 events1 affected300 at risk
Implant site infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0005 events5 affected499 at risk EG0012 events2 affected326 at risk EG0022 events2 affected300 at risk
Infection of amputation stump	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Neutropenic sepsis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Osteomyelitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0022 events2 affected300 at risk
Peritonitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Pneumonia	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0008 events7 affected499 at risk EG0019 events8 affected326 at risk EG00212 events9 affected300 at risk
Prosthesis related infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Pulmonary sepsis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Renal abscess	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Sepsis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0005 events5 affected499 at risk EG0013 events2 affected326 at risk EG0021 events1 affected300 at risk
Sepsis MRSA	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Sepsis syndrome	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0023 events2 affected300 at risk
Septic joint	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Septic shock	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Sigmoid diverticulitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Staphylococcal infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Staphylococcus aureus septicemia	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Streptococcus viridans group infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Urinary tract infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0006 events5 affected499 at risk EG0010 events0 affected326 at risk EG0022 events2 affected300 at risk
Compression fracture	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Contusion of hip	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Digoxin toxicity	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
False aneurysm	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Foreign body in esophagus	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Fracture	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Fractured cervical spine	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Intraoperative bleeding	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Medication error	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Motor vehicle accident	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Patella fracture	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Postoperative bleeding	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Seroma	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Spurious aneurysm	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Stab wound	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Subdural hematoma	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Subdural hemorrhage	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Therapeutic procedural complication	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Trochanteric femoral fracture	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Twiddler s syndrome	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0022 events2 affected300 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0002 events1 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Abnormal coagulation profile	Investigations	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Elevated liver enzymes	Investigations	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Subtherapeutic INR	Investigations	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Gout	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Hyperkalemia	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Hypoglycemia	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Hypokalemia	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0004 events3 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Hyponatremia	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0005 events5 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Hypovolemia	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Volume depletion	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Volume overload	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Arthrosis	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0021 events1 affected300 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0021 events1 affected300 at risk
Cervical disc herniation	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Degenerative joint disease	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Muscle weakness	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Osteoarthritis knee	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Pain in hip	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Adenocarcinoma lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Bowel cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Multiple myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Multiple myeloma progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Pancreatic adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Pancreatic cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Pituitary tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Prostate adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Squamous cell carcinoma of lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Ataxia	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
CVA	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0011 events1 affected326 at risk EG0021 events1 affected300 at risk
Cerebral infarct	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Convulsive seizure	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Dizziness	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Dysarthria	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Encephalopathy	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Headache	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Hemorrhagic stroke	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Hepatic encephalopathy	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0002 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Hydrocephalus	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Intracerebral hemorrhage	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Intracranial hemorrhage	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Ischemic stroke	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Lethargy	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Lightheadedness	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Metabolic encephalopathy	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Myasthenia gravis	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Myasthenia gravis crisis	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Myelitis transverse	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Stroke	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Syncope	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0006 events6 affected499 at risk EG0012 events2 affected326 at risk EG0023 events3 affected300 at risk
Transient ischemic attacks	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0022 events2 affected300 at risk
Acute delirium	Psychiatric disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Delirium	Psychiatric disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Hallucinations	Psychiatric disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Mental status changes	Psychiatric disorders	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0013 events1 affected326 at risk EG0021 events1 affected300 at risk
Acute on chronic renal failure	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Acute renal failure	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0006 events5 affected499 at risk EG0012 events2 affected326 at risk EG0026 events3 affected300 at risk
Acute renal insufficiency	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0022 events2 affected300 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected499 at risk EG0013 events2 affected326 at risk EG0020 events0 affected300 at risk
Chronic renal insufficiency	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Dysuria	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Hematuria	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0012 events2 affected326 at risk EG0020 events0 affected300 at risk
Injury to kidney	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Kidney failure	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Kidney stone	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Renal failure	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0005 events5 affected499 at risk EG0011 events1 affected326 at risk EG0022 events2 affected300 at risk
Renal insufficiency	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0011 events1 affected326 at risk EG0022 events2 affected300 at risk
Renal mass	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Retention urinary	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Urinary retention	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0021 events1 affected300 at risk
Ovarian mass	Reproductive system and breast disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Acute on chronic respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Acute pulmonary edema	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0003 events3 affected499 at risk EG0012 events2 affected326 at risk EG0020 events0 affected300 at risk
Aspiration pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
COPD	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0012 events2 affected326 at risk EG0021 events1 affected300 at risk
COPD exacerbation	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0005 events1 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0011 events1 affected326 at risk EG0021 events1 affected300 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0012 events2 affected326 at risk EG0021 events1 affected300 at risk
Flash pulmonary edema	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Hemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Hypercapnic respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Interstitial pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Lung nodule	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0004 events3 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0006 events5 affected499 at risk EG0013 events3 affected326 at risk EG0024 events4 affected300 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Pulmonary toxicity	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0004 events4 affected499 at risk EG0012 events2 affected326 at risk EG0020 events0 affected300 at risk
Respiratory insufficiency	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Shortness of breath	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0021 events1 affected300 at risk
Sleep apnea	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Diabetic foot ulcer	Skin and subcutaneous tissue disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Dry gangrene	Skin and subcutaneous tissue disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Foot ulcer	Skin and subcutaneous tissue disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
AV fistula excision	Surgical and medical procedures	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Enterostomy closure	Surgical and medical procedures	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Inguinal hernia repair	Surgical and medical procedures	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Aneurysm	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Aortic aneurysm rupture	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Aortic stenosis	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Arterial bleeding	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Bleeding varicose vein	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Claudication	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0023 events1 affected300 at risk
DVT	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected499 at risk EG0013 events3 affected326 at risk EG0021 events1 affected300 at risk
Hemorrhage	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Hypertension	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Hypertension worsened	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Hypertensive episode	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Hypotension	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0006 events4 affected499 at risk EG0012 events2 affected326 at risk EG0025 events5 affected300 at risk
Ischemia	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Leg ischemia	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Obstructive arteriosclerosis of lower extremities	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0022 events2 affected300 at risk
Peripheral arterial disease	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Peripheral vascular disease	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0012 events2 affected326 at risk EG0021 events1 affected300 at risk
Subclavian vein thrombosis	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0022 events2 affected300 at risk
Uncontrolled hypertension	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Leukocytosis	Blood and lymphatic system disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
AFib	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Angina pectoris	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG00013 events12 affected499 at risk EG0013 events3 affected326 at risk EG00213 events12 affected300 at risk
Atrial fibrillation with rapid ventricular response	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Atrial flutter	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0003 events2 affected499 at risk EG0012 events2 affected326 at risk EG0020 events0 affected300 at risk
Atrial tachycardia	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0003 events3 affected499 at risk EG0012 events2 affected326 at risk EG0021 events1 affected300 at risk
Atypical angina	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Bradycardia	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Cardiac sarcoidosis	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Congestive heart failure	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Coronary artery disease	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Decompensated heart failure	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG00035 events31 affected499 at risk EG00118 events18 affected326 at risk EG00217 events14 affected300 at risk
Junctional rhythm	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
LV dyssynchrony	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Monomorphic ventricular tachycardia	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Non-sustained ventricular tachycardia	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0004 events4 affected499 at risk EG0012 events2 affected326 at risk EG0022 events1 affected300 at risk
Palpitations	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected499 at risk EG0010 events0 affected326 at risk EG0023 events3 affected300 at risk
Paroxysmal atrial fibrillation	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Paroxysmal atrial tachycardia	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Paroxysmal ventricular tachycardia	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Pericardial effusion	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Persistent atrial fibrillation	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Premature beat atrial	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Premature ventricular contractions	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0012 events2 affected326 at risk EG0020 events0 affected300 at risk
Recurrent ventricular tachycardia	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0012 events2 affected326 at risk EG0020 events0 affected300 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0004 events4 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Sustained ventricular tachycardia	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0022 events1 affected300 at risk
Tachycardia	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0021 events1 affected300 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0004 events2 affected499 at risk EG0011 events1 affected326 at risk EG0021 events1 affected300 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 17.1	Systematic Assessment	EG0009 events8 affected499 at risk EG0012 events2 affected326 at risk EG0023 events3 affected300 at risk
Vomiting	Gastrointestinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Adverse drug reaction	General disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Chest pain	General disorders	MedDRA 17.1	Systematic Assessment	EG00011 events8 affected499 at risk EG0013 events3 affected326 at risk EG0024 events4 affected300 at risk
Chest pressure	General disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Device alarm issue	General disorders	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Device connection issue	General disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Device damage	General disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Device electrical impedance issue	General disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Device migration	General disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Device stimulation issue	General disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Edema extremities	General disorders	MedDRA 17.1	Systematic Assessment	EG0003 events2 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Elevated pacing threshold	General disorders	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected499 at risk EG0012 events2 affected326 at risk EG0021 events1 affected300 at risk
Failure to capture	General disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Fatigue	General disorders	MedDRA 17.1	Systematic Assessment	EG0003 events3 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Impedance increased	General disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Implant site bleeding	General disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Implant site bruising	General disorders	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Implant site burning	General disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Implant site edema	General disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0021 events1 affected300 at risk
Implant site erythema	General disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Implant site hematoma	General disorders	MedDRA 17.1	Systematic Assessment	EG00012 events11 affected499 at risk EG0015 events5 affected326 at risk EG0020 events0 affected300 at risk
Implant site irritation	General disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Implant site numbness	General disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Implant site pain	General disorders	MedDRA 17.1	Systematic Assessment	EG00010 events7 affected499 at risk EG0016 events4 affected326 at risk EG0025 events5 affected300 at risk
Inappropriate device stimulation of tissue	General disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Inappropriate phrenic nerve stimulation	General disorders	MedDRA 17.1	Systematic Assessment	EG00020 events18 affected499 at risk EG00127 events23 affected326 at risk EG00219 events18 affected300 at risk
Inappropriate stimulation of diaphragm	General disorders	MedDRA 17.1	Systematic Assessment	EG00023 events21 affected499 at risk EG00114 events13 affected326 at risk EG0028 events8 affected300 at risk
Lead dislodgement	General disorders	MedDRA 17.1	Systematic Assessment	EG0004 events4 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Lead impedance abnormally low	General disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Lead microdislodgement	General disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Loss of capture	General disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Non-cardiac chest pain	General disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Oversensing	General disorders	MedDRA 17.1	Systematic Assessment	EG0004 events4 affected499 at risk EG0010 events0 affected326 at risk EG0022 events2 affected300 at risk
Pacing threshold increased	General disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0013 events3 affected326 at risk EG0020 events0 affected300 at risk
Phantom shocks	General disorders	MedDRA 17.1	Systematic Assessment	EG0003 events2 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Swelling arm	General disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Tissue erosion associated with device	General disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Undersensing	General disorders	MedDRA 17.1	Systematic Assessment	EG0003 events3 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Weakness worsened	General disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Wound healing delayed	General disorders	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Cellulitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Cystitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Implant site cellulitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Implant site infection	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0011 events1 affected326 at risk EG0023 events3 affected300 at risk
Osteomyelitis	Infections and infestations	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Anemia postoperative	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Cardiac vein dissection	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Contusion of chest wall	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Coronary sinus dissection	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0023 events3 affected300 at risk
Coronary sinus perforation	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Incision site pain	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Opiate toxicity	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Scalp laceration	Injury, poisoning and procedural complications	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Oxygen saturation low	Investigations	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Raised blood pressure	Investigations	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Troponin increased	Investigations	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Hyperkalemia	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Hyperlipidemia	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Hypervolemia	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Hypokalemia	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Volume overload	Metabolism and nutrition disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Chest wall pain	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Pain in arm	Musculoskeletal and connective tissue disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Carotid artery occlusion	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Dizziness	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0011 events1 affected326 at risk EG0021 events1 affected300 at risk
Lightheadedness	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Loss of consciousness	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Near syncope	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Paresthesia	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Pre-syncope	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Syncope	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0002 events1 affected499 at risk EG0011 events1 affected326 at risk EG0021 events1 affected300 at risk
Thrombotic stroke	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Vasovagal reaction	Nervous system disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Anxiety	Psychiatric disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Acute renal insufficiency	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0002 events2 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Nephrosclerosis	Renal and urinary disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Cheyne-Stokes respiration	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Exertional dyspnea	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Hydrothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Paroxysmal nocturnal dyspnea	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Shortness of breath	Respiratory, thoracic and mediastinal disorders	MedDRA 17.1	Systematic Assessment	EG0003 events3 affected499 at risk EG0011 events1 affected326 at risk EG0021 events1 affected300 at risk
Diaphoresis	Skin and subcutaneous tissue disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Erythema multiforme type skin reaction	Skin and subcutaneous tissue disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Itching	Skin and subcutaneous tissue disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Ulcus cruris	Skin and subcutaneous tissue disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Venous stasis ulcer	Skin and subcutaneous tissue disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Abdominal aortic aneurysm	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Aortic stenosis	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Arterial insufficiency peripheral	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Bleeding varicose vein	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Cardiovascular collapse	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0023 events3 affected300 at risk
Hematoma	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Hypertension	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0006 events6 affected499 at risk EG0010 events0 affected326 at risk EG0024 events4 affected300 at risk
Hypertension worsened	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Hypotension	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG00014 events11 affected499 at risk EG0012 events2 affected326 at risk EG0021 events1 affected300 at risk
Low BP	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0003 events3 affected499 at risk EG0011 events1 affected326 at risk EG0020 events0 affected300 at risk
Peripheral vascular disease	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0012 events2 affected326 at risk EG0020 events0 affected300 at risk
Superior vena cava stenosis	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0001 events1 affected499 at risk EG0010 events0 affected326 at risk EG0020 events0 affected300 at risk
Thrombosis	Vascular disorders	MedDRA 17.1	Systematic Assessment	EG0000 events0 affected499 at risk EG0010 events0 affected326 at risk EG0021 events1 affected300 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Glendale	California		United States

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases