SPYRAL PIVOTAL - SPYRAL HTN-OFF MED Study | NCT02439749

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
Renal Denervation	Experimental	Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system)	Device: Symplicity Spyral™ multi-electrode renal denervation system
Sham Procedure	Sham Comparator	Renal angiography	Procedure: Sham Procedure

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Symplicity Spyral™ multi-electrode renal denervation system	Device	After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Major Adverse Events (MAE) Defined as a Composite of Events.	All-cause mortality End-stage Renal Disease (ESRD) Significant embolic event resulting in end-organ damage Renal artery perforation requiring intervention Renal artery dissection requiring intervention Vascular complications Hospitalization for hypertensive crisis not related to confirmed non-adherence with medications or the protocol New renal artery stenosis >70% (6 months for new renal artery stenosis)	From baseline to 1 month post-procedure (6 months for new renal artery stenosis)
Baseline Adjusted Change (Using Analysis of Covariance) in Systolic Blood Pressure as Measured by 24-hour Ambulatory Blood Pressure Monitoring	The outcome measure is the change in ambulatory systolic blood pressure from baseline to 3-month. The unadjusted treatment difference between renal denervation and sham control groups is -3.9 mmHg. The baseline adjusted treatment difference is -3.9 mmHg.	From baseline to 3 months post-procedure

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With Significant Embolic Event Resulting in End-organ Damage	Significant embolic event resulting in end-organ damage (e.g. kidney/bowel infarct, lower extremity ulceration or gangrene, or doubling of serum creatinine documented by at least two measurements at least 21 days apart)	From baseline to 1 month post-procedure

Other Outcomes

Measure	Description	Time Frame
Antihypertensive Medication Burden to 36-months	Based on the prescribed medications reported, medication burden was calculated using Medication Index 2 score which is a composite index based on the doses of antihypertensive medications multiplied by the number of medications prescribed; all classes (ACE/ARB, calcium channel blockers, etc.) were considered equivalent in potency. Higher score indicates higher dosages being prescribed over the standard dose. There are no clinically established thresholds.

Eligibility Module

Contacts/Locations Module

Overall Officials

Name	Affiliation	Role
Raymond Townsend, MD	University of Pennsylvania	Principal Investigator
David Kandzari, MD	Piedmont Hospital	Principal Investigator
Michael Böhm, MD	Universitätskliniken des Saarlandes	Principal Investigator
Kazuomi Kario, MD	Jichi Medical University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Heart Center Research, LLC		Huntsville	Alabama	35801	United States
Honor Health Research Institute

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35852582	Derived	Weber MA, Schmieder RE, Kandzari DE, Townsend RR, Mahfoud F, Tsioufis K, Kario K, Pocock S, Tatakis F, Ewen S, Choi JW, East C, Lee DP, Ma A, Cohen DL, Wilensky R, Devireddy CM, Lea JP, Schmid A, Fahy M, Bohm M. Hypertension urgencies in the SPYRAL HTN-OFF MED Pivotal trial. Clin Res Cardiol. 2022 Nov;111(11):1269-1275. doi: 10.1007/s00392-022-02064-5. Epub 2022 Jul 19.
34474735

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Renal Denervation	Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 22, 2020	Apr 28, 2021

Arm/Group Information

ID	Title	Description
BG000	Renal Denervation	Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
BG001	Sham Procedure	Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
BG002	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, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020
Between 18 and 65 years

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00052.5± 10.8 BG00152.7± 10.1 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00065 BG00156 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

Greece

Title	Measurements
	BG00028 BG00130 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

Number of Participants With Major Adverse Events (MAE) Defined as a Composite of Events.

All-cause mortality End-stage Renal Disease (ESRD) Significant embolic event resulting in end-organ damage Renal artery perforation requiring intervention Renal artery dissection requiring intervention Vascular complications Hospitalization for hypertensive crisis not related to confirmed non-adherence with medications or the protocol New renal artery stenosis >70% (6 months for new renal artery stenosis)

Posted

Count of Participants

Participants

From baseline to 1 month post-procedure (6 months for new renal artery stenosis)

ID	Title	Description
OG000	Renal Denervation	Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
OG001	Sham Procedure	Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.

Units	Counts
Participants	OG000182 OG001184

Title

Denominators

Categories

Title	Measurements
	OG0000 OG0010

Primary

Baseline Adjusted Change (Using Analysis of Covariance) in Systolic Blood Pressure as Measured by 24-hour Ambulatory Blood Pressure Monitoring

The outcome measure is the change in ambulatory systolic blood pressure from baseline to 3-month. The unadjusted treatment difference between renal denervation and sham control groups is -3.9 mmHg. The baseline adjusted treatment difference is -3.9 mmHg.

The number of participants analyzed reflects the number of subjects within each treatment arm who have data available for outcome measure analysis. This number can be variable from the number of subjects in each treatment arm at study start.

Posted

Mean

Standard Deviation

mmHg

From baseline to 3 months post-procedure

ID	Title	Description
OG000	Renal Denervation	Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
OG001	Sham Procedure	Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.

Secondary

Number of Participants With Significant Embolic Event Resulting in End-organ Damage

Significant embolic event resulting in end-organ damage (e.g. kidney/bowel infarct, lower extremity ulceration or gangrene, or doubling of serum creatinine documented by at least two measurements at least 21 days apart)

Posted

Count of Participants

Participants

From baseline to 1 month post-procedure

ID	Title	Description
OG000	Renal Denervation	Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
OG001	Sham Procedure	Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.

Units	Counts
Participants

Secondary

Number of Participants With Renal Artery Perforation Requiring Intervention

Renal artery perforation requiring intervention

Posted

Count of Participants

Participants

From baseline to 1 month post-procedure

ID	Title	Description
OG000	Renal Denervation	Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
OG001	Sham Procedure	Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.

Units	Counts
Participants	OG000

Secondary

Renal Artery Dissection

Number of Participants with Renal artery dissection requiring intervention

Posted

Count of Participants

Participants

From baseline to 1 month post-procedure

ID	Title	Description
OG000	Renal Denervation	Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
OG001	Sham Procedure	Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Vascular Complications

Vascular complications (e.g., clinically significant groin hematoma, arteriovenous fistula, pseudoaneurysm, excessive bleeding) requiring surgical repair, interventional procedure, thrombin injection, or blood transfusion (requiring more than 2 units of packed red blood cells within any 24 hour period during the first 7 days post renal denervation procedure).

Posted

Count of Participants

Participants

From baseline to 1 month post-procedure

ID	Title	Description
OG000	Renal Denervation	Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
OG001	Sham Procedure	Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.

Units	Counts
Participants

Secondary

Number of Participants With End-stage Renal Disease

defined as two or more eGFR measurements < 15 mL/min/1.73m2 at least 21 days apart and requiring dialysis for one of more of the following:

Volume management refractory to diuretics
Hyperkalemia unmanageable by diet and diuretics
Acidosis bicarbonate <18 unmanageable with HCO3 supplements
Symptoms of uremia, nausea, vomiting

Posted

Count of Participants

Participants

From baseline to 1 month post-procedure

ID	Title	Description
OG000	Renal Denervation	Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
OG001	Sham Procedure	Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.

Units	Counts
Participants

Secondary

Number of Participants With Decline in eGFR

≥40% decline in eGFR

Posted

Count of Participants

Participants

From baseline to 1 month post-procedure

ID	Title	Description
OG000	Renal Denervation	Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
OG001	Sham Procedure	Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.

Units	Counts
Participants

Secondary

Myocardial Infarction

Number of Participants with New myocardial infarction

Posted

Count of Participants

Participants

From baseline to 1 month post-procedure

ID	Title	Description
OG000	Renal Denervation	Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
OG001	Sham Procedure	Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.

Units	Counts
Participants	OG000

Secondary

New Stroke

Number of Participants with New stroke

Posted

Count of Participants

Participants

From baseline to 1 month post-procedure

ID	Title	Description
OG000	Renal Denervation	Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
OG001	Sham Procedure	Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Renal Artery Re-intervention

Renal artery re-intervention

Posted

Count of Participants

Participants

From baseline to 1 month post-procedure

ID	Title	Description
OG000	Renal Denervation	Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
OG001	Sham Procedure	Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Major Bleeding According to TIMI Definition

Major bleeding according to TIMI definition (i.e. intracranial hemorrhage, ≥5g/dl decrease in hemoglobin concentration, a ≥15% absolute decrease in hematocrit, or death due to bleeding within 7 days of the procedure).

Posted

Count of Participants

Participants

From baseline to 1 month post-procedure

ID	Title	Description
OG000	Renal Denervation	Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
OG001	Sham Procedure	Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.

Units	Counts
Participants

Secondary

Number of Participants With Increase in Serum Creatinine

Increase in serum creatinine > 50% from screening visit 2.

Posted

Count of Participants

Participants

From baseline to 1 month post-procedure

ID	Title	Description
OG000	Renal Denervation	Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
OG001	Sham Procedure	Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.

Units	Counts
Participants

Secondary

Number of Participants With Hospitalization for Hypertensive Crisis With Medications or the Protocol

Hospitalization for hypertensive crisis not related to confirmed non-adherence with medications or the protocol.

Posted

Count of Participants

Participants

From baseline to 1 month post-procedure

ID	Title	Description
OG000	Renal Denervation	Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
OG001	Sham Procedure	Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.

Units	Counts
Participants	OG000

Secondary

Change in Office Systolic Blood Pressure

Change in office systolic blood pressure from baseline (Screening Visit 2) to 1-month

Posted

Mean

Standard Deviation

mmHg

From baseline to 1 month post procedure

ID	Title	Description
OG000	Renal Denervation	Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
OG001	Sham Procedure	Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.

Units	Counts
Participants

Secondary

Change in Office Diastolic Blood Pressure

Change in office diastolic blood pressure from baseline (Screening Visit 2)

Posted

Mean

Standard Deviation

mmHg

From baseline to 1 month post procedure

ID	Title	Description
OG000	Renal Denervation	Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
OG001	Sham Procedure	Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.

Units	Counts
Participants

Secondary

Number of Participants Achieving Target Office Systolic Blood Pressure

Incidence of achieving target office systolic blood pressure (SBP <140 mmHg)

Posted

Count of Participants

Participants

From baseline to 1 month post procedure

ID	Title	Description
OG000	Renal Denervation	Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
OG001	Sham Procedure	Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.

Units	Counts

Secondary

Baseline Adjusted Change (Using Analysis of Covariance) in Office Systolic Blood Pressure

The outcome measure is the change in office systolic blood pressure from baseline to 3-month. The unadjusted treatment difference between renal denervation and sham control groups is -7.0 mmHg. The baseline adjusted treatment difference is -6.9 mmHg.

Posted

Mean

Standard Deviation

mmHg

From baseline to 3 months post-procedure

ID	Title	Description
OG000	Renal Denervation	Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
OG001	Sham Procedure	Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.

Secondary

Number of Participants With All-cause Mortality

All-cause mortality

Posted

Count of Participants

Participants

From baseline to 3 months post-procedure

ID	Title	Description
OG000	Renal Denervation	Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
OG001	Sham Procedure	Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.

Units	Counts
Participants

Secondary

Number of Participants With ≥40% Decline in eGFR

≥40% Decline in eGFR

Posted

Count of Participants

Participants

From baseline to 3 months post randomization

ID	Title	Description
OG000	Renal Denervation	Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
OG001	Sham Procedure	Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.

Units	Counts
Participants

Secondary

Number of Participants With End-Stage Renal Disease (ESRD)

Defined as two or more eGFR measurements < 15 mL/min/1.73m2 at least 21 days apart and requiring dialysis for one of more of the following:

Volume management refractory to diuretics
Hyperkalemia unmanageable by diet and diuretics
Acidosis bicarbonate <18 unmanageable with HCO3 supplements
Symptoms of uremia, nausea, vomiting

Posted

Count of Participants

Participants

From baseline to 3 months post randomization

ID	Title	Description
OG000	Renal Denervation	Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
OG001	Sham Procedure	Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.

Secondary

Number of Participants With New Myocardial Infarction

New Myocardial Infarction

Posted

Count of Participants

Participants

From baseline to 3 months post randomization

ID	Title	Description
OG000	Renal Denervation	Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
OG001	Sham Procedure	Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.

Units	Counts
Participants

Secondary

New Stroke

Number of Participants with New Stroke

Posted

Count of Participants

Participants

From baseline to 3 months post randomization

ID	Title	Description
OG000	Renal Denervation	Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
OG001	Sham Procedure	Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.

Units	Counts
Participants

Secondary

Number of Participants With Renal Artery Re-intervention

Renal Artery Re-intervention

Posted

Count of Participants

Participants

From baseline to 3 months post randomization

ID	Title	Description
OG000	Renal Denervation	Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
OG001	Sham Procedure	Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.

Units	Counts
Participants

Secondary

Number of Participants With Major Bleeding According to TIMI Definition

Posted

Count of Participants

Participants

From baseline to 3 months post randomization

ID	Title	Description
OG000	Renal Denervation	Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
OG001	Sham Procedure	Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.

Secondary

Increase in Serum Creatinine

Number of Participants with Increase in Serum Creatinine > 50% from screening visit 2.

Posted

Count of Participants

Participants

From baseline to 3 months post randomization

ID	Title	Description
OG000	Renal Denervation	Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
OG001	Sham Procedure	Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.

Units	Counts
Participants

Secondary

Number of Participants With Hospitalization for Hypertensive Crisis

Hospitalization for Hypertensive Crisis Not Related to Confirmed Nonadherence With Medications or the Protocol

Posted

Count of Participants

Participants

From baseline to 3 months post randomization

ID	Title	Description
OG000	Renal Denervation	Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
OG001	Sham Procedure	Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.

Units	Counts

Secondary

Change in Diastolic Blood Pressure as Measured by 24-hour ABPM

Change in diastolic blood pressure from baseline (screening visit 2) to 3-month as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM).

Posted

Mean

Standard Deviation

mmHg

From baseline to 3 months post procedure

ID	Title	Description
OG000	Renal Denervation	Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
OG001	Sham Procedure	Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.

Units	Counts

Secondary

Change in Office Diastolic Blood Pressure

Change in Office Diastolic Blood Pressure From Baseline (Screening Visit 2) to 3-months

Posted

Mean

Standard Deviation

mmHg

From baseline to 3 months post procedure

ID	Title	Description
OG000	Renal Denervation	Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
OG001	Sham Procedure	Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.

Units	Counts
Participants

Secondary

Number of Participants Achieving Target Office Systolic Blood Pressure

Incidence of Achieving Target Office Systolic Blood Pressure (SBP <140 mmHg)

Posted

Count of Participants

Participants

From baseline to 3 months post procedure

ID	Title	Description
OG000	Renal Denervation	Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
OG001	Sham Procedure	Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.

Units	Counts

Secondary

Number of Participants With New Renal Artery Stenosis > 70%

Confirmed by angiography and as determined by the angiographic core laboratory.

Posted

Count of Participants

Participants

From baseline to 6 month post-procedure

ID	Title	Description
OG000	Renal Denervation	Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
OG001	Sham Procedure	Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.

Units	Counts
Participants

Secondary

Change in Systolic Blood Pressure as Measured by 24-hour ABPM

Posted

Mean

Standard Deviation

mmHg

From baseline to 36 month post-procedure

ID	Title	Description
OG000	Renal Denervation	Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
OG001	Sham Procedure	Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.

Units	Counts
Participants

Secondary

Change in Diastolic Blood Pressure as Measured by 24-hour ABPM

Change in diastolic blood pressure as measured by 24-hour ABPM

Posted

Mean

Standard Deviation

mmHg

From baseline to 36 months post-procedure

ID	Title	Description
OG000	Renal Denervation	Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
OG001	Sham Procedure	Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.

Units	Counts
Participants

Secondary

Change in Office Systolic Blood Pressure

Change in Office Systiloc Blood Pressure From Baseline (Screening Visit 2) to 36 months.

Posted

Mean

Standard Deviation

mmHg

From baseline to 36 months post procedure

ID	Title	Description
OG000	Renal Denervation	Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
OG001	Sham Procedure	Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.

Units	Counts
Participants

Secondary

Change in Office Diastolic Blood Pressure

Change in office diastolic blood pressure

Posted

Mean

Standard Deviation

mmHg

From baseline to 36 months post-procedure

ID	Title	Description
OG000	Renal Denervation	Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
OG001	Sham Procedure	Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.

Units	Counts
Participants

Secondary

Number of Participants With Incidence of Achieving Target Office Systolic Blood Pressure (SBP <140) mmHg)

Posted

Count of Participants

Participants

From baseline to 36 months post-procedure

ID	Title	Description
OG000	Renal Denervation	Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
OG001	Sham Procedure	Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.

Units	Counts
Participants

Secondary

Number of Participants With All-cause Mortality

Posted

Count of Participants

Participants

From baseline to 36 months post-randomization

ID	Title	Description
OG000	Renal Denervation	Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
OG001	Sham Procedure	Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.

Units	Counts
Participants

Secondary

Number of Participants With End-Stage Renal Disease (ESRD)

Defined as two or more eGFR measurements < 15 mL/min/1.73m2 at least 21 days apart and requiring dialysis for one of more of the following:

Volume management refractory to diuretics
Hyperkalemia unmanageable by diet and diuretics
Acidosis bicarbonate <18 unmanageable with HCO3 supplements
Symptoms of uremia, nausea, vomiting

Posted

Count of Participants

Participants

From baseline to 36 months post randomization

ID	Title	Description
OG000	Renal Denervation	Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
OG001	Sham Procedure	Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.

Secondary

Number of Participants With ≥40% Decline in eGFR

≥40% Decline in eGFR

Posted

Count of Participants

Participants

From baseline to 36 months post randomization

ID	Title	Description
OG000	Renal Denervation	Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
OG001	Sham Procedure	Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.

Units	Counts
Participants

Secondary

Number of Participants With New Myocardial Infarction

New Myocardial Infarction

Posted

Count of Participants

Participants

From baseline to 36 months post randomization

ID	Title	Description
OG000	Renal Denervation	Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
OG001	Sham Procedure	Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.

Units	Counts
Participants

Secondary

Number of Participants With New Stroke

New Stroke

Posted

Count of Participants

Participants

From baseline to 36 months post randomization

ID	Title	Description
OG000	Renal Denervation	Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
OG001	Sham Procedure	Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.

Units	Counts
Participants

Secondary

Number of Participants With Renal Artery Re-intervention

Renal Artery Re-intervention

Posted

Count of Participants

Participants

From baseline to 36 months post randomization

ID	Title	Description
OG000	Renal Denervation	Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
OG001	Sham Procedure	Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.

Units	Counts
Participants

Secondary

Number of Participants With Major Bleeding According to TIMI Definition

Posted

Count of Participants

Participants

From baseline to 36 months post randomization

ID	Title	Description
OG000	Renal Denervation	Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
OG001	Sham Procedure	Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.

Secondary

Number of Participants With an Increase in Serum Creatinine

Number of Participants with Increase in Serum Creatinine > 50% from screening visit 2.

Posted

Count of Participants

Participants

From baseline to 36 months post randomization

ID	Title	Description
OG000	Renal Denervation	Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
OG001	Sham Procedure	Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.

Units	Counts

Secondary

Number of Participants With New Renal Artery Stenosis > 70%

Confirmed by angiography and as determined by the angiographic core laboratory.

Posted

Count of Participants

Participants

From baseline to 36 months post randomization

ID	Title	Description
OG000	Renal Denervation	Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
OG001	Sham Procedure	Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.

Units	Counts

Secondary

Number of Participants With Hospitalization for Hypertensive Crisis

Hospitalization for hypertensive crisis not related to confirmed non-adherence with medications orthe protocol

Posted

Count of Participants

Participants

From baseline to 36 months post randomization

ID	Title	Description
OG000	Renal Denervation	Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
OG001	Sham Procedure	Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.

Units	Counts

Other Pre-specified

Antihypertensive Medication Burden to 36-months

Based on the prescribed medications reported, medication burden was calculated using Medication Index 2 score which is a composite index based on the doses of antihypertensive medications multiplied by the number of medications prescribed; all classes (ACE/ARB, calcium channel blockers, etc.) were considered equivalent in potency. Higher score indicates higher dosages being prescribed over the standard dose.

There are no clinically established thresholds.

The number of participants analyzed reflects the number of subjects with prescribed medications reported.

Posted

Mean

Standard Deviation

Medication Index 2 Score

From baseline to 36 months post-procedure

ID	Title	Description
OG000	Renal Denervation	Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
OG001	Sham Procedure	Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Renal Denervation	Renal angiography and Renal Denervation (Symplicity Spyral™ multi-electrode renal denervation system) Symplicity Spyral™ multi-electrode renal denervation system: After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.	1	182	38	182	149	182
EG001	Sham Procedure	Renal angiography Sham Procedure: After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.	2	184	36	184	155	184

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Angina Pectoris	Cardiac disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Cardiac Arrest	Cardiac disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Cardiac Failure	Cardiac disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Gastritis	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Abscess	Infections and infestations	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Appendicitis	Infections and infestations	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Covid-19	Infections and infestations	MedDRA 26.0	Systematic Assessment		EG0002 events2 affected182 at risk EG0011 events1 affected184 at risk
Ankle Fracture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Ligament Rupture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0011 events1 affected184 at risk
Ankylosing Spondylitis	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0015 events5 affected184 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Bladder Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Aphasia	Nervous system disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Basal Ganglia Hemorrage	Nervous system disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Carpal Tunnel Syndrome	Nervous system disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Cerebrovascular Accident	Nervous system disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0011 events1 affected184 at risk
Dizziness	Nervous system disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Encephalopathy	Nervous system disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Abnormal Uterine Bleeding	Reproductive system and breast disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Deep Vein Thrombosis	Vascular disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0010 events0 affected184 at risk
Mast Cell Activation Syndrome	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Thrombotic Microangiopathy	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Coronary Artery Disease	Cardiac disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Superventricular Tachycardia	Cardiac disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Ventricular Tachycardia	Cardiac disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Faecaloma	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Gastric Mucosal Lesion	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Anaphylactic Shock	Immune system disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Covid-19 Pneumonia	Infections and infestations	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Endocarditis Bacterial	Infections and infestations	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Infection	Infections and infestations	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Influenza	Infections and infestations	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Localized Infection	Infections and infestations	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Otitis Externa	Infections and infestations	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Pyelonephritis	Infections and infestations	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Pyelonephritis Acute	Infections and infestations	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Sepsis	Infections and infestations	MedDRA 26.0	Systematic Assessment		EG0002 events2 affected182 at risk EG0012 events2 affected184 at risk
Non-Cardiac Chest Pain	General disorders	MedDRA 26.0	Systematic Assessment	General Disorders And Administration Site Conditions	EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Colitis	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0010 events0 affected184 at risk
Pain	General disorders	MedDRA 26.0	Systematic Assessment	General Disorders And Administration Site Conditions	EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Pyrexia	General disorders	MedDRA 26.0	Systematic Assessment	General Disorders And Administration Site Conditions	EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Subcutaneous Abscess	Infections and infestations	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Systemic Candida	Infections and infestations	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Urinary Tract Infection	Infections and infestations	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Urosepsis	Infections and infestations	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Limb Injury	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Meniscus Injury	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Shoulder Fracture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Tendon Rupture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Traumatic Arthrosis	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Vascular Access Site Hematoma	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0012 events2 affected184 at risk
Wrist Fracture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0011 events1 affected184 at risk
Cardiac Stress Test Abnormal	Investigations	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Hyperkalemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Type 2 Diabetes Mellitus	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Intervertebral Disc Protrusion	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Knee Deformity	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Musculoskeletal Chest Pain	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment		EG0002 events2 affected182 at risk EG0011 events1 affected184 at risk
Rotator Cuff Syndrome	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment		EG0002 events2 affected182 at risk EG0010 events0 affected184 at risk
Vertebral Foraminal Stenosis	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Colon Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Gastric Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Invasive Ductal Breast Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Malignant Melanoma Stage Iii	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Prostate Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Salivary Gland Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Tongue Neoplasm Malignant Stage Unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Focal Dyscognitive Seizures	Nervous system disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Hemorrhagic Stroke	Nervous system disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Intracranial Pressure Increased	Nervous system disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Migraine	Nervous system disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Primary Headache Associated With Sexual Activity	Nervous system disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Thalamic Infarction	Nervous system disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Transient Ischaemic Attack	Nervous system disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0011 events1 affected184 at risk
Ruptured Ectopic Pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Anxiety	Psychiatric disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Depression	Psychiatric disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Major Depression	Psychiatric disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Suicidal Ideation	Psychiatric disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Acute Kidney Injury	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0011 events1 affected184 at risk
Renal Mass	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Urinary Retention	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Benign Prostatic Hyperplasia	Reproductive system and breast disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Heavy Menstrual Bleeding	Reproductive system and breast disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Ovarian Cyst	Reproductive system and breast disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Pelvic Organ Prolapse	Reproductive system and breast disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Rectocele	Reproductive system and breast disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Obstructive Sleep Apnea Syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0010 events0 affected184 at risk
Cataract Operation	Surgical and medical procedures	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Knee Operation	Surgical and medical procedures	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Percutaneous Coronary Intervention	Surgical and medical procedures	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Hypertension	Vascular disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0011 events1 affected184 at risk
Hypertensive Crisis	Vascular disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Hypertensive Emergency	Vascular disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0010 events0 affected184 at risk
Varicose Vein	Vascular disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Animal Bite	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0010 events0 affected184 at risk
Aphasia	Nervous system disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Anemia	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Mast Cell Activation Syndrome	Blood and lymphatic system disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Angina Pectoris	Cardiac disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Aortic Valve Incompetence	Cardiac disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA 26.0	Systematic Assessment		EG0002 events2 affected182 at risk EG0013 events3 affected184 at risk
Atrial Flutter	Cardiac disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Atrioventricular Block	Cardiac disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Bradycardia	Cardiac disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Bundle Branch Block Left	Cardiac disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Cardiac Arrest	Cardiac disorders	MedDRA 26.0	Systematic Assessment		EG0002 events2 affected182 at risk EG0010 events0 affected184 at risk
Cardiac Failure	Cardiac disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Coronary Artery Disease	Cardiac disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Extrasystoles	Cardiac disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Left Ventricular Hypertrophy	Cardiac disorders	MedDRA 26.0	Systematic Assessment		EG0002 events2 affected182 at risk EG0010 events0 affected184 at risk
Palpitations	Cardiac disorders	MedDRA 26.0	Systematic Assessment		EG0002 events2 affected182 at risk EG0012 events2 affected184 at risk
Sinus Arrest	Cardiac disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Sinus Bradycardia	Cardiac disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0011 events1 affected184 at risk
Sinus Tachycardia	Cardiac disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0011 events1 affected184 at risk
Supraventricular Extrasystoles	Cardiac disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0012 events2 affected184 at risk
Supraventricular Tachycardia	Cardiac disorders	MedDRA 26.0	Systematic Assessment		EG0004 events4 affected182 at risk EG0010 events0 affected184 at risk
Tachycardia	Cardiac disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Ventricular Tachycardia	Cardiac disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Ear Pain	Ear and labyrinth disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 26.0	Systematic Assessment		EG0002 events2 affected182 at risk EG0013 events3 affected184 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Goiter	Endocrine disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Hyperparathyroidism	Endocrine disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Hypothyroidism	Endocrine disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0010 events0 affected184 at risk
Conjunctival Hemorrhage	Eye disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Floppy Eyelid Syndrome	Eye disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Iridocyclitis	Eye disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Ocular Hyperemia	Eye disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Optic Nerve Disorder	Eye disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Vision Blurred	Eye disorders	MedDRA 26.0	Systematic Assessment		EG0002 events2 affected182 at risk EG0012 events2 affected184 at risk
Visual Impairment	Eye disorders	MedDRA 26.0	Systematic Assessment		EG0002 events2 affected182 at risk EG0014 events4 affected184 at risk
Abdominal Discomfort	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0012 events2 affected184 at risk
Abdominal Mass	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0010 events0 affected184 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0012 events2 affected184 at risk
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0012 events2 affected184 at risk
Angular Cheilitis	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0010 events0 affected184 at risk
Colitis	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0010 events0 affected184 at risk
Colitis Ulcerative	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Constipation	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment		EG0003 events3 affected182 at risk EG0012 events2 affected184 at risk
Dental Caries	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Diarrhea	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment		EG0006 events6 affected182 at risk EG0012 events2 affected184 at risk
Diverticulum	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Flatulence	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0011 events1 affected184 at risk
Gastritis	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment		EG0002 events2 affected182 at risk EG0011 events1 affected184 at risk
Gastroesophageal Reflux Disease	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0011 events1 affected184 at risk
Hematochezia	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Hemorrhoids	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment		EG0003 events3 affected182 at risk EG0010 events0 affected184 at risk
Hiatus Hernia	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Large Intestine Polyp	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Nausea	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment		EG0006 events6 affected182 at risk EG0011 events1 affected184 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Toothache	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0012 events2 affected184 at risk
Vomiting	Gastrointestinal disorders	MedDRA 26.0	Systematic Assessment		EG0003 events3 affected182 at risk EG0014 events4 affected184 at risk
Adverse Drug Reaction	General disorders	MedDRA 26.0	Systematic Assessment	General Disorders and Administration Site Conditions	EG0002 events2 affected182 at risk EG0010 events0 affected184 at risk
Asthenia	General disorders	MedDRA 26.0	Systematic Assessment	General Disorders and Administration Site Conditions	EG0001 events1 affected182 at risk EG0011 events1 affected184 at risk
Axillary Pain	General disorders	MedDRA 26.0	Systematic Assessment	General Disorders and Administration Site Conditions	EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Chest Discomfort	General disorders	MedDRA 26.0	Systematic Assessment	General Disorders and Administration Site Conditions	EG0003 events3 affected182 at risk EG0012 events2 affected184 at risk
Chest Pain	General disorders	MedDRA 26.0	Systematic Assessment	General Disorders and Administration Site Conditions	EG0004 events4 affected182 at risk EG0015 events5 affected184 at risk
Drug Intolerance	General disorders	MedDRA 26.0	Systematic Assessment	General Disorders and Administration Site Conditions	EG0001 events1 affected182 at risk EG0011 events1 affected184 at risk
Fatigue	General disorders	MedDRA 26.0	Systematic Assessment	General Disorders and Administration Site Conditions	EG0006 events6 affected182 at risk EG0019 events9 affected184 at risk
Feeling Hot	General disorders	MedDRA 26.0	Systematic Assessment	General Disorders and Administration Site Conditions	EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Gait Disturbance	General disorders	MedDRA 26.0	Systematic Assessment	General Disorders and Administration Site Conditions	EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Impaired Healing	General disorders	MedDRA 26.0	Systematic Assessment	General Disorders and Administration Site Conditions	EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Influenza Like Illness	General disorders	MedDRA 26.0	Systematic Assessment	General Disorders and Administration Site Conditions	EG0001 events1 affected182 at risk EG0013 events3 affected184 at risk
Malaise	General disorders	MedDRA 26.0	Systematic Assessment	General Disorders and Administration Site Conditions	EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Medical Device Site Irritation	General disorders	MedDRA 26.0	Systematic Assessment	General Disorders and Administration Site Conditions	EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Medical Device Site Pain	General disorders	MedDRA 26.0	Systematic Assessment	General Disorders and Administration Site Conditions	EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Medical Device Site Pruritus	General disorders	MedDRA 26.0	Systematic Assessment	General Disorders and Administration Site Conditions	EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Medical Device Site Reaction	General disorders	MedDRA 26.0	Systematic Assessment	General Disorders and Administration Site Conditions	EG0000 events0 affected182 at risk EG0010 events0 affected184 at risk
Non-Cardiac Chest Pain	General disorders	MedDRA 26.0	Systematic Assessment	General Disorders and Administration Site Conditions	EG0002 events2 affected182 at risk EG0016 events6 affected184 at risk
Oedema	General disorders	MedDRA 26.0	Systematic Assessment	General Disorders and Administration Site Conditions	EG0000 events0 affected182 at risk EG0010 events0 affected184 at risk
Oedema Peripheral	General disorders	MedDRA 26.0	Systematic Assessment	General Disorders and Administration Site Conditions	EG00012 events12 affected182 at risk EG00115 events15 affected184 at risk
Pain	General disorders	MedDRA 26.0	Systematic Assessment	General Disorders and Administration Site Conditions	EG0001 events1 affected182 at risk EG0012 events2 affected184 at risk
Peripheral Swelling	General disorders	MedDRA 26.0	Systematic Assessment	General Disorders and Administration Site Conditions	EG0002 events2 affected182 at risk EG0015 events5 affected184 at risk
Puncture Site Reaction	General disorders	MedDRA 26.0	Systematic Assessment	General Disorders and Administration Site Conditions	EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Pyrexia	General disorders	MedDRA 26.0	Systematic Assessment	General Disorders and Administration Site Conditions	EG0001 events1 affected182 at risk EG0013 events3 affected184 at risk
Swelling	General disorders	MedDRA 26.0	Systematic Assessment	General Disorders and Administration Site Conditions	EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Swelling Face	General disorders	MedDRA 26.0	Systematic Assessment	General Disorders and Administration Site Conditions	EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Vessel Puncture Site Pain	General disorders	MedDRA 26.0	Systematic Assessment	General Disorders and Administration Site Conditions	EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Hepatic Mass	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Hepatic Steatosis	Hepatobiliary disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0012 events2 affected184 at risk
Contrast Media Reaction	Immune system disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Drug Hypersensitivity	Immune system disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0011 events1 affected184 at risk
Hypersensitivity	Immune system disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Seasonal Allergy	Immune system disorders	MedDRA 26.0	Systematic Assessment		EG0003 events3 affected182 at risk EG0011 events1 affected184 at risk
Abscess	Infections and infestations	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Acute Sinusitis	Infections and infestations	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Bacterial Vulvovaginitis	Infections and infestations	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Borrelia Infection	Infections and infestations	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Bronchitis	Infections and infestations	MedDRA 26.0	Systematic Assessment		EG0004 events4 affected182 at risk EG0014 events4 affected184 at risk
Cellulitis	Infections and infestations	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0011 events1 affected184 at risk
Conjunctivitis	Infections and infestations	MedDRA 26.0	Systematic Assessment		EG0003 events3 affected182 at risk EG0011 events1 affected184 at risk
Covid-19	Infections and infestations	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0011 events1 affected184 at risk
Cystitis	Infections and infestations	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0011 events1 affected184 at risk
Diarrhea Infectious	Infections and infestations	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Ear Infection	Infections and infestations	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Fungal Foot Infection	Infections and infestations	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0010 events0 affected184 at risk
Fungal Skin Infection	Infections and infestations	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Gastroenteritis	Infections and infestations	MedDRA 26.0	Systematic Assessment		EG0002 events2 affected182 at risk EG0013 events3 affected184 at risk
Gastrointestinal Viral Infection	Infections and infestations	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0012 events2 affected184 at risk
H1n1 Influenza	Infections and infestations	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Helicobacter Gastritis	Infections and infestations	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Herpes Simplex	Infections and infestations	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Herpes Zoster	Infections and infestations	MedDRA 26.0	Systematic Assessment		EG0002 events2 affected182 at risk EG0010 events0 affected184 at risk
Hordeolum	Infections and infestations	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Infection	Infections and infestations	MedDRA 26.0	Systematic Assessment		EG0002 events2 affected182 at risk EG0010 events0 affected184 at risk
Influenza	Infections and infestations	MedDRA 26.0	Systematic Assessment		EG0008 events8 affected182 at risk EG0016 events6 affected184 at risk
Labyrinthitis	Infections and infestations	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Localized Infection	Infections and infestations	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0011 events1 affected184 at risk
Lower Respiratory Tract Infection	Infections and infestations	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0011 events1 affected184 at risk
Lyme Disease	Infections and infestations	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Nasopharyngitis	Infections and infestations	MedDRA 26.0	Systematic Assessment		EG00011 events11 affected182 at risk EG00114 events14 affected184 at risk
Oral Herpes	Infections and infestations	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Otitis Externa	Infections and infestations	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Paronychia	Infections and infestations	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0010 events0 affected184 at risk
Pneumonia	Infections and infestations	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0011 events1 affected184 at risk
Postoperative Wound Infection	Infections and infestations	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Pyelonephritis Acute	Infections and infestations	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Respiratory Tract Infection	Infections and infestations	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0011 events1 affected184 at risk
Rhinitis	Infections and infestations	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0011 events1 affected184 at risk
Sepsis	Infections and infestations	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0012 events2 affected184 at risk
Sinusitis	Infections and infestations	MedDRA 26.0	Systematic Assessment		EG0003 events3 affected182 at risk EG0014 events4 affected184 at risk
Skin Infection	Infections and infestations	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Tonsillitis	Infections and infestations	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Tooth Abscess	Infections and infestations	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Trichomoniasis	Infections and infestations	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA 26.0	Systematic Assessment		EG0007 events7 affected182 at risk EG0016 events6 affected184 at risk
Urinary Tract Infection	Infections and infestations	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0015 events5 affected184 at risk
Vaginal Infection	Infections and infestations	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Varicella	Infections and infestations	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Vestibular Neuronitis	Infections and infestations	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Viral Infection	Infections and infestations	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Viral Upper Respiratory Tract Infection	Infections and infestations	MedDRA 26.0	Systematic Assessment		EG0003 events3 affected182 at risk EG0010 events0 affected184 at risk
Vulvovaginal Mycotic Infection	Infections and infestations	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Ankle Fracture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0013 events3 affected184 at risk
Arthropod Bite	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Burns Second Degree	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0010 events0 affected184 at risk
Chemical Burn Of Skin	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0011 events1 affected184 at risk
Corneal Abrasion	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Dislocation Of Vertebra	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0010 events0 affected184 at risk
Foot Fracture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0011 events1 affected184 at risk
Head Injury	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Humerus Fracture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Incision Site Complication	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0011 events1 affected184 at risk
Incision Site Hematoma	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0012 events2 affected184 at risk
Incision Site Pain	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment		EG0002 events2 affected182 at risk EG0010 events0 affected184 at risk
Injury	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Joint Injury	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0011 events1 affected184 at risk
Ligament Rupture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment		EG0003 events3 affected182 at risk EG0010 events0 affected184 at risk
Ligament Sprain	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment		EG0002 events2 affected182 at risk EG0013 events3 affected184 at risk
Limb Injury	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0015 events5 affected184 at risk
Muscle Rupture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Muscle Strain	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment		EG0003 events3 affected182 at risk EG0010 events0 affected184 at risk
Post Procedural Hematoma	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment		EG0003 events3 affected182 at risk EG0014 events4 affected184 at risk
Post Procedural Hemorrhage	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Procedural Hypotension	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Procedural Site Reaction	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Scratch	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Skin Laceration	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0011 events1 affected184 at risk
Spinal Column Injury	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Sternal Fracture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Tendon Injury	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Tendon Rupture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Thermal Burn	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Tooth Fracture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Traumatic Arthrosis	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Vascular Access Site Bruising	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment		EG0004 events4 affected182 at risk EG0012 events2 affected184 at risk
Vascular Access Site Haematoma	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment		EG00016 events16 affected182 at risk EG00122 events22 affected184 at risk
Vascular Access Site Hemorrhage	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment		EG0002 events2 affected182 at risk EG0013 events3 affected184 at risk
Vascular Access Site Pain	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment		EG0003 events3 affected182 at risk EG0013 events3 affected184 at risk
Vascular Pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Vascular Pseudoaneurysm Thrombosis	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Wrist Fracture	Injury, poisoning and procedural complications	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0011 events1 affected184 at risk
Blood Cholesterol Increased	Investigations	MedDRA 26.0	Systematic Assessment		EG0002 events2 affected182 at risk EG0012 events2 affected184 at risk
Blood Creatinine Increased	Investigations	MedDRA 26.0	Systematic Assessment		EG0004 events4 affected182 at risk EG0013 events3 affected184 at risk
Blood Glucose Increased	Investigations	MedDRA 26.0	Systematic Assessment		EG0002 events2 affected182 at risk EG0011 events1 affected184 at risk
Blood Magnesium Decreased	Investigations	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Blood Potassium Decreased	Investigations	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Blood Pressure Abnormal	Investigations	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Blood Pressure Increased	Investigations	MedDRA 26.0	Systematic Assessment		EG0005 events5 affected182 at risk EG0014 events4 affected184 at risk
Blood Pressure Orthostatic Decreased	Investigations	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Blood Pressure Systolic Increased	Investigations	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0014 events4 affected184 at risk
Blood Uric Acid Increased	Investigations	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0014 events4 affected184 at risk
C-Reactive Protein Increased	Investigations	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Cardiac Murmur	Investigations	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Cardiac Stress Test Abnormal	Investigations	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Glomerular Filtration Rate Decreased	Investigations	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0012 events2 affected184 at risk
Hemoglobin Abnormal	Investigations	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Hepatic Enzyme Increased	Investigations	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Lipids Increased	Investigations	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0010 events0 affected184 at risk
Occult Blood	Investigations	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Oxygen Saturation Decreased	Investigations	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Renin Decreased	Investigations	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Respiratory Rate Decreased	Investigations	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Troponin Increased	Investigations	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Urine Analysis Abnormal	Investigations	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
White Blood Cell Count Decreased	Investigations	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Decreased Appetite	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Diabetes Mellitus	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0011 events1 affected184 at risk
Gout	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0013 events3 affected184 at risk
Hypercholesterolemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment		EG0004 events4 affected182 at risk EG0014 events4 affected184 at risk
Hyperglycemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Hyperkalemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0011 events1 affected184 at risk
Hyperlipidemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment		EG0002 events2 affected182 at risk EG0012 events2 affected184 at risk
Hypokalemia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment		EG0005 events5 affected182 at risk EG0012 events2 affected184 at risk
Hypophagia	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Insulin Resistance	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Iron Deficiency	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Obesity	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Type 2 Diabetes Mellitus	Metabolism and nutrition disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0013 events3 affected184 at risk
Ankylosing Spondylitis	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment		EG00012 events12 affected182 at risk EG00113 events13 affected184 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0011 events1 affected184 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment		EG00012 events12 affected182 at risk EG0018 events8 affected184 at risk
Flank Pain	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Foot Deformity	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Groin Pain	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Intervertebral Disc Protrusion	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0012 events2 affected184 at risk
Joint Effusion	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Joint Stiffness	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Joint Swelling	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0015 events5 affected184 at risk
Knee Deformity	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Limb Discomfort	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0011 events1 affected184 at risk
Muscle Spasms	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment		EG0002 events2 affected182 at risk EG0013 events3 affected184 at risk
Musculoskeletal Chest Pain	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Musculoskeletal Discomfort	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment		EG0003 events3 affected182 at risk EG0012 events2 affected184 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Neck Pain	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment		EG0003 events3 affected182 at risk EG0012 events2 affected184 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment		EG0002 events2 affected182 at risk EG0012 events2 affected184 at risk
Pain In Extremity	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment		EG0005 events5 affected182 at risk EG0018 events8 affected184 at risk
Plantar Fasciitis	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Rotator Cuff Syndrome	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Spinal Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Synovitis	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0010 events0 affected184 at risk
Temporomandibular Joint Syndrome	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0010 events0 affected184 at risk
Tendon Discomfort	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Vertebral Foraminal Stenosis	Musculoskeletal and connective tissue disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Gastric Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Hypergammaglobulinemia Benign Monoclonal	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Invasive Ductal Breast Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Malignant Melanoma Stage Iii	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Pancreatic Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Paraganglion Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Parathyroid Tumor Benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Prostate Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment		EG0002 events2 affected182 at risk EG0010 events0 affected184 at risk
Renal Hamartoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Skin Papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Uterine Leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0011 events1 affected184 at risk
Carpal Tunnel Syndrome	Nervous system disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Cerebrovascular Accident	Nervous system disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Cervicobrachial Syndrome	Nervous system disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Cranial Nerve Disorder	Nervous system disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Dizziness	Nervous system disorders	MedDRA 26.0	Systematic Assessment		EG00015 events15 affected182 at risk EG00112 events12 affected184 at risk
Dizziness Postural	Nervous system disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0014 events4 affected184 at risk
Drug Withdrawal Headache	Nervous system disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0010 events0 affected184 at risk
Electric Shock Sensation	Nervous system disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Encephalopathy	Nervous system disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Essential Tremor	Nervous system disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0010 events0 affected184 at risk
Focal Dyscognitive Seizures	Nervous system disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Headache	Nervous system disorders	MedDRA 26.0	Systematic Assessment		EG00032 events32 affected182 at risk EG00131 events31 affected184 at risk
Hemorrhagic Stroke	Nervous system disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Hypoesthesia	Nervous system disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Lethargy	Nervous system disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0013 events3 affected184 at risk
Loss Of Consciousness	Nervous system disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Memory Impairment	Nervous system disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Migraine	Nervous system disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0018 events8 affected184 at risk
Nerve Compression	Nervous system disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Orthostatic Intolerance	Nervous system disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Paresthesia	Nervous system disorders	MedDRA 26.0	Systematic Assessment		EG0002 events2 affected182 at risk EG0012 events2 affected184 at risk
Presyncope	Nervous system disorders	MedDRA 26.0	Systematic Assessment		EG0002 events2 affected182 at risk EG0011 events1 affected184 at risk
Primary Headache Associated With Sexual Activity	Nervous system disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Sciatica	Nervous system disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0011 events1 affected184 at risk
Somnolence	Nervous system disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Syncope	Nervous system disorders	MedDRA 26.0	Systematic Assessment		EG0003 events3 affected182 at risk EG0013 events3 affected184 at risk
Tension Headache	Nervous system disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Thalamic Infarction	Nervous system disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Transient Ischemic Attack	Nervous system disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0011 events1 affected184 at risk
Trigeminal Nerve Paresis	Nervous system disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Trigeminal Neuralgia	Nervous system disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Device Physical Property Issue	Product Issues	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Alcohol Use Disorder	Psychiatric disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Anxiety	Psychiatric disorders	MedDRA 26.0	Systematic Assessment		EG0004 events4 affected182 at risk EG0012 events2 affected184 at risk
Depressed Mood	Psychiatric disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Insomnia	Psychiatric disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0012 events2 affected184 at risk
Intrusive Thoughts	Psychiatric disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Post-Traumatic Stress Disorder	Psychiatric disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Psychotic Disorder	Psychiatric disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Restlessness	Psychiatric disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0010 events0 affected184 at risk
Sleep Disorder	Psychiatric disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Stress	Psychiatric disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Vomiting Psychogenic	Psychiatric disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Dysuria	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Hematuria	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Microalbuminuria	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0012 events2 affected184 at risk
Nocturia	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Pollakiuria	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment		EG0003 events3 affected182 at risk EG0012 events2 affected184 at risk
Renal Artery Occlusion	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Renal Colic	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Renal Cyst	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Renal Mass	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment		EG0002 events2 affected182 at risk EG0011 events1 affected184 at risk
Urinary Retention	Renal and urinary disorders	MedDRA 26.0	Systematic Assessment		EG0002 events2 affected182 at risk EG0010 events0 affected184 at risk
Benign Prostatic Hyperplasia	Reproductive system and breast disorders	MedDRA 26.0	Systematic Assessment		EG0002 events2 affected182 at risk EG0010 events0 affected184 at risk
Breast Inflammation	Reproductive system and breast disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Breast Pain	Reproductive system and breast disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Dyspareunia	Reproductive system and breast disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Endometrial Hyperplasia	Reproductive system and breast disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0010 events0 affected184 at risk
Erectile Dysfunction	Reproductive system and breast disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0013 events3 affected184 at risk
Heavy Menstrual Bleeding	Reproductive system and breast disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Pelvic Organ Prolapse	Reproductive system and breast disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Prostatomegaly	Reproductive system and breast disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0011 events1 affected184 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment		EG0004 events4 affected182 at risk EG0013 events3 affected184 at risk
Dyspnea	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment		EG0004 events4 affected182 at risk EG0014 events4 affected184 at risk
Dyspnea At Rest	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Dyspnea Exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment		EG0002 events2 affected182 at risk EG0016 events6 affected184 at risk
Dyspnea Paroxysmal Nocturnal	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0010 events0 affected184 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment		EG0003 events3 affected182 at risk EG0011 events1 affected184 at risk
Nasal Congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment		EG0002 events2 affected182 at risk EG0012 events2 affected184 at risk
Obstructive Sleep Apnea Syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0011 events1 affected184 at risk
Oropharyngeal Pain	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment		EG0002 events2 affected182 at risk EG0011 events1 affected184 at risk
Paranasal Sinus Discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Productive Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0010 events0 affected184 at risk
Rales	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0010 events0 affected184 at risk
Respiratory Tract Congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Rhinitis Allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Rhinorrhea	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Sinus Congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment		EG0003 events3 affected182 at risk EG0010 events0 affected184 at risk
Sinus Pain	Respiratory, thoracic and mediastinal disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Blister	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0010 events0 affected184 at risk
Cold Sweat	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Dermal Cyst	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0010 events0 affected184 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment		EG0002 events2 affected182 at risk EG0010 events0 affected184 at risk
Dermatitis Allergic	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Dermatitis Contact	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Drug Eruption	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Dry Skin	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Petechiae	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0012 events2 affected184 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment		EG0002 events2 affected182 at risk EG0011 events1 affected184 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment		EG0003 events3 affected182 at risk EG0010 events0 affected184 at risk
Skin Discoloration	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Skin Fissures	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Skin Irritation	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment		EG0002 events2 affected182 at risk EG0011 events1 affected184 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0010 events0 affected184 at risk
Stress At Work	Social circumstances	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Facet Joint Block	Surgical and medical procedures	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Knee Arthroplasty	Surgical and medical procedures	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Knee Operation	Surgical and medical procedures	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Wisdom Teeth Removal	Surgical and medical procedures	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0010 events0 affected184 at risk
Aortic Aneurysm	Vascular disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0011 events1 affected184 at risk
Arterial Spasm	Vascular disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Circulatory Collapse	Vascular disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Deep Vein Thrombosis	Vascular disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0010 events0 affected184 at risk
Embolism	Vascular disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Flushing	Vascular disorders	MedDRA 26.0	Systematic Assessment		EG0002 events2 affected182 at risk EG0010 events0 affected184 at risk
Giant Cell Arteritis	Vascular disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Hot Flush	Vascular disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0012 events2 affected184 at risk
Hypertension	Vascular disorders	MedDRA 26.0	Systematic Assessment		EG00010 events10 affected182 at risk EG00111 events11 affected184 at risk
Hypertensive Crisis	Vascular disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0013 events3 affected184 at risk
Hypertensive Emergency	Vascular disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0010 events0 affected184 at risk
Hypertensive Urgency	Vascular disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk
Hypotension	Vascular disorders	MedDRA 26.0	Systematic Assessment		EG0006 events6 affected182 at risk EG0014 events4 affected184 at risk
Jugular Vein Distension	Vascular disorders	MedDRA 26.0	Systematic Assessment		EG0002 events2 affected182 at risk EG0010 events0 affected184 at risk
Orthostatic Hypotension	Vascular disorders	MedDRA 26.0	Systematic Assessment		EG0002 events2 affected182 at risk EG0011 events1 affected184 at risk
Peripheral Coldness	Vascular disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Peripheral Venous Disease	Vascular disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Phlebitis	Vascular disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0011 events1 affected184 at risk
Systolic Hypertension	Vascular disorders	MedDRA 26.0	Systematic Assessment		EG0000 events0 affected182 at risk EG0010 events0 affected184 at risk
Thrombophlebitis	Vascular disorders	MedDRA 26.0	Systematic Assessment		EG0001 events1 affected182 at risk EG0010 events0 affected184 at risk

ID	Term
D006973	Hypertension
D014652	Vascular Diseases
D002318	Cardiovascular Diseases