SPYRAL HTN-ON MED Study of Renal Denervation With the Sym... | NCT02439775

NCT02439775

Status Module

Oversight Module

Description 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
Change in Systolic Blood Pressure as Measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)	Baseline adjusted change (using Analysis of Covariance) in systolic blood pressure (SBP) from baseline (Screening Visit 2) to 6 months post-procedure as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM).	From baseline to 6 months post-procedure
Acute and Chronic Safety by Evaluating Incidence of Major Adverse Events	The Primary safety endpoint of the study is the incidence of Major Adverse Events (MAE), defined as composite of the following 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%, confirmed by angiography and as determined by the angiographic core laboratory, through one-month post-randomization (6-months for new renal artery stenosis)	From Baseline to 1 month post-procedure (6 months for new renal artery stenosis)

Secondary Outcomes

Measure	Description	Time Frame
Change in Office Systolic Blood Pressure to 6-months	Change in office systolic blood pressure from baseline (Screening Visit 2) to 6 months post-procedure	From baseline to 6 months post-procedure
Antihypertensive Medication Usage and Changes to 6-months

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. Minimum Value 0; No Maximum value (See Secondary Outcome Measure #5 for comparison)

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
Stanford Hospital and Clinics

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
42294771	Derived	Kandzari DE, Mahfoud F, Townsend RR, Kario K, Weber MA, Schmieder RE, Tsioufis K, Pocock S, Yang G, Brar S, Bohm M. Three-Year Durability of Radiofrequency Renal Denervation: SPYRAL HTN-ON MED. J Am Heart Assoc. 2026 Jun 15:e049081. doi: 10.1161/JAHA.126.049081. Online ahead of print.
40391448	Derived	Kandzari DE, Mahfoud F, Townsend RR, Kario K, Weber MA, Schmieder RE, Tsioufis K, Pocock S, Liu M, DeBruin V, Brar S, Bohm M. Long-Term Safety and Efficacy of Renal Denervation: 24-Month Results From the SPYRAL HTN-ON MED Trial. Circ Cardiovasc Interv. 2025 Jul;18(7):e015194. doi: 10.1161/CIRCINTERVENTIONS.125.015194. Epub 2025 May 20.

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	Sep 10, 2020	Aug 17, 2023

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, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	OG000-6.5± 10.7 OG001-4.5± 10.3

Secondary

Change in Office Systolic Blood Pressure to 6-months

Change in office systolic blood pressure from baseline (Screening Visit 2) to 6 months post-procedure

Valid readings at time of data collection

Posted

Mean

Standard Deviation

mmHg

From baseline to 6 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

Antihypertensive Medication Usage and Changes to 6-months

Number of medications from baseline (Screening Visit 2) through 6 Months post-procedure

Prescribed daily medication reported

Posted

Mean

Standard Deviation

Number of Daily Medications

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

Antihypertensive Medication Burden to 6-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.

Minimum value 0; No Maximum value

Prescribed medications reported

Posted

Mean

Standard Deviation

Medication Index 2 Score

From baseline to 6 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

Medication Changes

Patients who had medication changes based on Medication Index 2 drug testing data. Medication Index 2 score 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.

Confirmed via Drug Testing Data at both Baseline (Screening Visit 2) and 6-months post-procedure

Posted

Count of Participants

Participants

Baseline to 6-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

Incidence of Achieving Target Office Systolic Blood Pressure

Incidence of achieving target office systolic blood pressure (SBP<140 mmHg) at 6 months post- procedure.

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

Count of Participants

Participants

From baseline to 6 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 Systolic Blood Pressure as Measured by 24-hour ABPM 12 Months

Change in systolic blood pressure from baseline (screening visit 2) to 12 months as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM)

Posted

Mean

Standard Deviation

mmHg

From Baseline to 12 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 Systolic Blood Pressure as Measured by 24-hour ABPM 24-months

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

Posted

Mean

Standard Deviation

mmHg

From baseline to 24 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 Systolic Blood Pressure as Measured by 24-hour ABPM 36-months

Change in systolic blood pressure from baseline (screening visit 2) to 36 months as measured by 24-hour Ambulatory Blood Pressure Monitoring (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

Secondary

Change in Office Systolic Blood Pressure to 12-months

Change in office systolic blood pressure from baseline (screening visit 2) to 12 months.

Posted

Mean

Standard Deviation

mmHg

From Baseline to 12 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 to 24-months

Change in office systolic blood pressure from baseline (screening visit 2) to 24 months.

Posted

Mean

Standard Deviation

mmHg

From baseline to 24 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 to 36-months

Change in office systolic 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 Diastolic Blood Pressure as Measured by 24-hour ABPM 12-months

Change in diastolic blood pressure from baseline (screening visit 2) to 12 months as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM).

Posted

Mean

Standard Deviation

mmHg

From Baseline to 12 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 Diastolic Blood Pressure as Measured by 24-hour ABPM 24-months

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

Posted

Mean

Standard Deviation

mmHg

From baseline to 24 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 Diastolic Blood Pressure as Measured by 24-hour ABPM 36-months

Change in diastolic blood pressure from baseline (screening visit 2) to 36 months as measured by 24-hour Ambulatory Blood Pressure Monitoring (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

Secondary

Change in Office Diastolic Blood Pressure 12 Months

Change in office diastolic blood pressure from baseline (screening visit 2) to 12 months.

Posted

Mean

Standard Deviation

mmHg

From baseline to 12 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 24 Months

Change in office diastolic blood pressure from baseline (screening visit 2) to 24 months.

Posted

Mean

Standard Deviation

mmHg

From baseline to 24 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 36 Months

Change in office diastolic 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

Number of Participants Achieving Target Office Systolic Blood Pressure 12 Months

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

Posted

Count of Participants

Participants

From baseline to 12 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 Achieving Target Office Systolic Blood Pressure 24 Months

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

Posted

Count of Participants

Participants

From baseline to 24 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 Achieving Target Office Systolic Blood Pressure. 36 Months

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

Secondary

Number of Participants With All Cause Mortality

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 End-Stage Renal Disease (ESRD)

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-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

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 Renal Artery Perforation Requiring Intervention

Renal artery perforation requiring intervention

Posted

Count of Participants

Participants

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

Number of Participants With Renal Artery Dissection Requiring Intervention

Number of Participants with Renal artery dissection requiring intervention

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

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 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.

Secondary

Number of Participants With Hospitalization for Hypertensive Crisis Not Related to Confirmed Non-adherence With Medications and/or the Protocol.

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 Procdure	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 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-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 Procdure	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

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 Increase in Serum Creatinine >50% From Screening Visit 2 (Baseline)

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 New Myocardial Infarct

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 New Stroke

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 Renal Artery Re-intervention

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 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 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.

Other Pre-specified

Antihypertensive Medication Burden to 36-months

There are no clinically established thresholds. Minimum Value 0; No Maximum value (See Secondary Outcome Measure #5 for comparison)

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.

Primary

Acute and Chronic Safety by Evaluating Incidence of Major Adverse Events

The Primary safety endpoint of the study is the incidence of Major Adverse Events (MAE), defined as composite of the following 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%, confirmed by angiography and as determined by the angiographic core laboratory, through one-month post-randomization (6-months for new renal artery stenosis)

All randomized subjects are analyzed according to their randomized treatment.

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.

Other Pre-specified

Antihypertensive Medication Burden to 24-months

There are no clinically established thresholds. Minimum Value 0; No Maximum value (See Secondary Outcome Measure #5 for comparison)

Posted

Mean

Standard Deviation

Medication Index 2 Score

From baseline to 24 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.

Other Pre-specified

Antihypertensive Medication Burden to 12-Months

There are no clinically established thresholds. Minimum Value 0; No Maximum value (See Secondary Outcome Measure #5 for comparison)

Posted

Mean

Standard Deviation

Medication Index 2 Score

From Baseline to 12 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

Change in Diastolic Blood Pressure as Measured by 24-hour (ABPM) 6-months

Change in diastolic blood pressure from baseline (screening visit 2) to 6 months as measured by 24-hour Ambulatory Blood Pressure Monitoring (ABPM).

Posted

Mean

Standard Deviation

mmHg

From baseline to 6 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 to 6-months

Change in office diastolic blood pressure from baseline (screening visit 2) to 6 months post-procedure

Posted

Mean

Standard Deviation

mmHg

From baseline to 6 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

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.	2	206	51	206	148	206
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.	1	131	26	131	96	131

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Atrial Fibrillation	Cardiac disorders	MedDRA (26.0)	Systematic Assessment		EG0005 affected206 at risk EG0010 affected131 at risk
Atrial Flutter	Cardiac disorders	MedDRA (26.0)	Systematic Assessment		EG0002 affected206 at risk EG0010 affected131 at risk
Bradycardia	Cardiac disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0011 affected131 at risk
Cardiac Failure Congestive	Cardiac disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0011 affected131 at risk
Adrenal Mass	Endocrine disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Colitis Ulcerative	Gastrointestinal disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Asthenia	General disorders	MedDRA (26.0)	Systematic Assessment	General Disorders And Administration Site Conditions	EG0000 affected206 at risk EG0011 affected131 at risk
Chest Discomfort	General disorders	MedDRA (26.0)	Systematic Assessment	General Disorders And Administration Site Conditions	EG0000 affected206 at risk EG0011 affected131 at risk
Non-Cardiac Chest Pain	General disorders	MedDRA (26.0)	Systematic Assessment	General Disorders And Administration Site Conditions	EG0003 affected206 at risk EG0012 affected131 at risk
Oedema Peripheral	General disorders	MedDRA (26.0)	Systematic Assessment	General Disorders And Administration Site Conditions	EG0000 affected206 at risk EG0011 affected131 at risk
Bile Duct Stone	Hepatobiliary disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Cholecystitis Acute	Hepatobiliary disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Pneumonia	Infections and infestations	MedDRA (26.0)	Systematic Assessment		EG0002 affected206 at risk EG0011 affected131 at risk
Vestibular Neuronitis	Infections and infestations	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Meniscus Injury	Injury, poisoning and procedural complications	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Upper Limb Fracture	Injury, poisoning and procedural complications	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Vascular Access Site Haematoma	Injury, poisoning and procedural complications	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Vascular Access Site Pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA (26.0)	Systematic Assessment		EG0002 affected206 at risk EG0011 affected131 at risk
Diabetes Mellitus	Metabolism and nutrition disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0011 affected131 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0011 affected131 at risk
Cervical Spinal Stenosis	Musculoskeletal and connective tissue disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Intervertebral Disc Protrusion	Musculoskeletal and connective tissue disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (26.0)	Systematic Assessment		EG0003 affected206 at risk EG0013 affected131 at risk
Anogenital Warts	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Lung Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Metastases To Lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Prostate Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.0)	Systematic Assessment		EG0002 affected206 at risk EG0011 affected131 at risk
Renal Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Cerebrovascular Accident	Nervous system disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Headache	Nervous system disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0012 affected131 at risk
Bladder Neck Obstruction	Renal and urinary disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Removal Of Foreign Body	Surgical and medical procedures	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Raynaud's Phenomenon	Vascular disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Angina Unstable	Cardiac disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Retinal Detachment	Eye disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0010 affected131 at risk
Gastrooesophageal Reflux Disease	Gastrointestinal disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0010 affected131 at risk
Chest Pain	General disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0010 affected131 at risk
Diverticulitis	Infections and infestations	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0010 affected131 at risk
Bladder Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0010 affected131 at risk
Simple Partial Seizures	Nervous system disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0010 affected131 at risk
Subarachnoid Haemorrhage	Nervous system disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0010 affected131 at risk
Syncope	Nervous system disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0010 affected131 at risk
Nervousness	Psychiatric disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0010 affected131 at risk
Renal Artery Stenosis	Renal and urinary disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0010 affected131 at risk
Dyspnoea Exertional	Respiratory, thoracic and mediastinal disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0010 affected131 at risk
Hypertensive Crisis	Vascular disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0010 affected131 at risk
Varicose Vein	Vascular disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Peripheral Venous Disease	Vascular disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Hypertension	Vascular disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0011 affected131 at risk
Prostatectomy	Surgical and medical procedures	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Sleep Apnoea Syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Benign Prostatic Hyperplasia	Reproductive system and breast disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Ureteric Stenosis	Renal and urinary disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Renal Impairment	Renal and urinary disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Renal Artery Fibromuscular Dysplasia	Renal and urinary disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0010 affected131 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Acute Kidney Injury	Renal and urinary disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Putamen Haemorrhage	Nervous system disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Presyncope	Nervous system disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Diplegia	Nervous system disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Papillary Renal Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Lung Adenocarcinoma Stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Invasive Ductal Breast Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Gastrointestinal Stromal Tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Gastric Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Colon Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Clear Cell Renal Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Basal Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Rotator Cuff Syndrome	Musculoskeletal and connective tissue disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Neck Pain	Musculoskeletal and connective tissue disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Obesity	Metabolism and nutrition disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Csf Volume Increased	Investigations	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Blood Pressure Increased	Investigations	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Tibia Fracture	Injury, poisoning and procedural complications	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Stoma Prolapse	Injury, poisoning and procedural complications	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Clavicle Fracture	Injury, poisoning and procedural complications	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Ankle Fracture	Injury, poisoning and procedural complications	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Urinary Tract Infection	Infections and infestations	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0011 affected131 at risk
Sinusitis	Infections and infestations	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Sepsis	Infections and infestations	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Post Procedural Pneumonia	Infections and infestations	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Orchitis	Infections and infestations	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Influenza	Infections and infestations	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Epididymitis	Infections and infestations	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Cystitis	Infections and infestations	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Cellulitis	Infections and infestations	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Vascular Stent Thrombosis	General disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Vascular Stent Stenosis	General disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Sudden Cardiac Death	General disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0011 affected131 at risk
Umbilical Hernia	Gastrointestinal disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Rectal Haemorrhage	Gastrointestinal disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Inguinal Hernia	Gastrointestinal disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Abdominal Hernia	Gastrointestinal disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Ventricular Tachycardia	Cardiac disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Ventricular Extrasystoles	Cardiac disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Right Ventricular Failure	Cardiac disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Palpitations	Cardiac disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Mitral Valve Incompetence	Cardiac disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Coronary Artery Disease	Cardiac disorders	MedDRA (26.0)	Systematic Assessment		EG0003 affected206 at risk EG0010 affected131 at risk
Cardiac Arrest	Cardiac disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Angina Pectoris	Cardiac disorders	MedDRA (26.0)	Systematic Assessment		EG0002 affected206 at risk EG0010 affected131 at risk
Acute Right Ventricular Failure	Cardiac disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Acute Myocardial Infarction	Cardiac disorders	MedDRA (26.0)	Systematic Assessment		EG0003 affected206 at risk EG0010 affected131 at risk
Sars-Cov-2 Sepsis	Infections and infestations	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Covid-19	Infections and infestations	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Anemia	Blood and lymphatic system disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0011 affected131 at risk
Iron Deficiency Anaemia	Blood and lymphatic system disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Angina Pectoris	Cardiac disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0012 affected131 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA (26.0)	Systematic Assessment		EG0002 affected206 at risk EG0012 affected131 at risk
Atrial Flutter	Cardiac disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Atrioventricular Block Second Degree	Cardiac disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Bradycardia	Cardiac disorders	MedDRA (26.0)	Systematic Assessment		EG0003 affected206 at risk EG0011 affected131 at risk
Cardiac Failure Congestive	Cardiac disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Left Ventricular Failure	Cardiac disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Palpitations	Cardiac disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0012 affected131 at risk
Sinus Tachycardia	Cardiac disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Tachycardia	Cardiac disorders	MedDRA (26.0)	Systematic Assessment		EG0002 affected206 at risk EG0012 affected131 at risk
Ear Pain	Ear and labyrinth disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Adrenal Mass	Endocrine disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Graves' Disease	Endocrine disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Hypothyroidism	Endocrine disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0012 affected131 at risk
Primary Hyperaldosteronism	Endocrine disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Conjunctivitis Allergic	Eye disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Swelling Of Eyelid	Eye disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Vision Blurred	Eye disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Visual Impairment	Eye disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Abdominal Discomfort	Gastrointestinal disorders	MedDRA (26.0)	Systematic Assessment		EG0003 affected206 at risk EG0011 affected131 at risk
Colitis	Gastrointestinal disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Colitis Ulcerative	Gastrointestinal disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0011 affected131 at risk
Constipation	Gastrointestinal disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0011 affected131 at risk
Diarrhea	Gastrointestinal disorders	MedDRA (26.0)	Systematic Assessment		EG0002 affected206 at risk EG0012 affected131 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Food Poisoning	Gastrointestinal disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Gastritis	Gastrointestinal disorders	MedDRA (26.0)	Systematic Assessment		EG0002 affected206 at risk EG0010 affected131 at risk
Gastrooesophageal Reflux Disease	Gastrointestinal disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0011 affected131 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0011 affected131 at risk
Inguinal Hernia	Gastrointestinal disorders	MedDRA (26.0)	Systematic Assessment		EG0002 affected206 at risk EG0010 affected131 at risk
Lip Swelling	Gastrointestinal disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Nausea	Gastrointestinal disorders	MedDRA (26.0)	Systematic Assessment		EG0004 affected206 at risk EG0010 affected131 at risk
Toothache	Gastrointestinal disorders	MedDRA (26.0)	Systematic Assessment		EG0002 affected206 at risk EG0012 affected131 at risk
Adverse Drug Reaction	General disorders	MedDRA (26.0)	Systematic Assessment	General Disorders And Administration Site Conditions	EG0003 affected206 at risk EG0012 affected131 at risk
Asthenia	General disorders	MedDRA (26.0)	Systematic Assessment	General Disorders And Administration Site Conditions	EG0001 affected206 at risk EG0011 affected131 at risk
Chest Discomfort	General disorders	MedDRA (26.0)	Systematic Assessment	General Disorders And Administration Site Conditions	EG0003 affected206 at risk EG0011 affected131 at risk
Chest Pain	General disorders	MedDRA (26.0)	Systematic Assessment	General Disorders And Administration Site Conditions	EG0001 affected206 at risk EG0014 affected131 at risk
Cyst	General disorders	MedDRA (26.0)	Systematic Assessment	General Disorders And Administration Site Conditions	EG0000 affected206 at risk EG0011 affected131 at risk
Drug Intolerance	General disorders	MedDRA (26.0)	Systematic Assessment	General Disorders And Administration Site Conditions	EG0002 affected206 at risk EG0010 affected131 at risk
Fatigue	General disorders	MedDRA (26.0)	Systematic Assessment	General Disorders And Administration Site Conditions	EG0002 affected206 at risk EG0012 affected131 at risk
Influenza Like Illness	General disorders	MedDRA (26.0)	Systematic Assessment	General Disorders And Administration Site Conditions	EG0000 affected206 at risk EG0011 affected131 at risk
Non-Cardiac Chest Pain	General disorders	MedDRA (26.0)	Systematic Assessment	General Disorders And Administration Site Conditions	EG0004 affected206 at risk EG0014 affected131 at risk
Oedema Peripheral	General disorders	MedDRA (26.0)	Systematic Assessment	General Disorders And Administration Site Conditions	EG0009 affected206 at risk EG00114 affected131 at risk
Peripheral Swelling	General disorders	MedDRA (26.0)	Systematic Assessment	General Disorders And Administration Site Conditions	EG0002 affected206 at risk EG0012 affected131 at risk
Puncture Site Haematoma	General disorders	MedDRA (26.0)	Systematic Assessment	General Disorders And Administration Site Conditions	EG0001 affected206 at risk EG0010 affected131 at risk
Pyrexia	General disorders	MedDRA (26.0)	Systematic Assessment	General Disorders And Administration Site Conditions	EG0001 affected206 at risk EG0010 affected131 at risk
Swelling	General disorders	MedDRA (26.0)	Systematic Assessment	General Disorders And Administration Site Conditions	EG0000 affected206 at risk EG0011 affected131 at risk
Vessel Puncture Site Haematoma	General disorders	MedDRA (26.0)	Systematic Assessment	General Disorders And Administration Site Conditions	EG0001 affected206 at risk EG0010 affected131 at risk
Vascular Access Site Induration	Injury, poisoning and procedural complications	MedDRA (26.0)	Systematic Assessment	General Disorders And Administration Site Conditions	EG0001 affected206 at risk EG0010 affected131 at risk
Bile Duct Stone	Hepatobiliary disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Cholecystitis Acute	Hepatobiliary disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Hepatic Lesion	Hepatobiliary disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Hepatic Steatosis	Hepatobiliary disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Contrast Media Reaction	Immune system disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Hypersensitivity	Immune system disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Bacterial Vaginosis	Infections and infestations	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Bronchitis	Infections and infestations	MedDRA (26.0)	Systematic Assessment		EG0004 affected206 at risk EG0011 affected131 at risk
Bursitis Infective	Infections and infestations	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Cellulitis	Infections and infestations	MedDRA (26.0)	Systematic Assessment		EG0002 affected206 at risk EG0011 affected131 at risk
Conjunctivitis	Infections and infestations	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Conjunctivitis Viral	Infections and infestations	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Covid-19	Infections and infestations	MedDRA (26.0)	Systematic Assessment		EG0009 affected206 at risk EG0015 affected131 at risk
Cystitis	Infections and infestations	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0012 affected131 at risk
Eye Infection	Infections and infestations	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Folliculitis	Infections and infestations	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Fungal Foot Infection	Infections and infestations	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Gastroenteritis	Infections and infestations	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Gastrointestinal Viral Infection	Infections and infestations	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Groin Abscess	Infections and infestations	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Infectious Mononucleosis	Infections and infestations	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Influenza	Infections and infestations	MedDRA (26.0)	Systematic Assessment		EG0003 affected206 at risk EG0017 affected131 at risk
Localised Infection	Infections and infestations	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Lower Respiratory Tract Infection	Infections and infestations	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Ludwig Angina	Infections and infestations	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Nasopharyngitis	Infections and infestations	MedDRA (26.0)	Systematic Assessment		EG0004 affected206 at risk EG0012 affected131 at risk
Onychomycosis	Infections and infestations	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Oral Herpes	Infections and infestations	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Paronychia	Infections and infestations	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Pneumonia	Infections and infestations	MedDRA (26.0)	Systematic Assessment		EG0003 affected206 at risk EG0012 affected131 at risk
Pulpitis Dental	Infections and infestations	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Respiratory Tract Infection	Infections and infestations	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0011 affected131 at risk
Rhinitis	Infections and infestations	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Scrotal Abscess	Infections and infestations	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Sinusitis	Infections and infestations	MedDRA (26.0)	Systematic Assessment		EG0002 affected206 at risk EG0011 affected131 at risk
Tinea Cruris	Infections and infestations	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Tinea Pedis	Infections and infestations	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Tonsillitis	Infections and infestations	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0011 affected131 at risk
Tooth Abscess	Infections and infestations	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Tooth Infection	Infections and infestations	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Upper Respiratory Tract Infection	Infections and infestations	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0014 affected131 at risk
Urethritis	Infections and infestations	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0011 affected131 at risk
Urinary Tract Infection	Infections and infestations	MedDRA (26.0)	Systematic Assessment		EG0002 affected206 at risk EG0013 affected131 at risk
Vestibular Neuronitis	Infections and infestations	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Viral Upper Respiratory Tract Infection	Infections and infestations	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0012 affected131 at risk
Wound Infection Staphylococcal	Infections and infestations	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Arthropod Bite	Injury, poisoning and procedural complications	MedDRA (26.0)	Systematic Assessment		EG0002 affected206 at risk EG0010 affected131 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0013 affected131 at risk
Exposure To Extreme Temperature	Injury, poisoning and procedural complications	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Foot Fracture	Injury, poisoning and procedural complications	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0012 affected131 at risk
Head Injury	Injury, poisoning and procedural complications	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Incision Site Complication	Injury, poisoning and procedural complications	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Incision Site Pain	Injury, poisoning and procedural complications	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Ligament Sprain	Injury, poisoning and procedural complications	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Lower Limb Fracture	Injury, poisoning and procedural complications	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Meniscus Injury	Injury, poisoning and procedural complications	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Muscle Strain	Injury, poisoning and procedural complications	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0011 affected131 at risk
Post Procedural Discomfort	Injury, poisoning and procedural complications	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Procedural Pain	Injury, poisoning and procedural complications	MedDRA (26.0)	Systematic Assessment		EG0002 affected206 at risk EG0011 affected131 at risk
Skin Abrasion	Injury, poisoning and procedural complications	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Skin Laceration	Injury, poisoning and procedural complications	MedDRA (26.0)	Systematic Assessment		EG0002 affected206 at risk EG0010 affected131 at risk
Soft Tissue Injury	Injury, poisoning and procedural complications	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0011 affected131 at risk
Stoma Prolapse	Injury, poisoning and procedural complications	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Thermal Burn	Injury, poisoning and procedural complications	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Tooth Fracture	Injury, poisoning and procedural complications	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Upper Limb Fracture	Injury, poisoning and procedural complications	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Immunisation Reaction	Injury, poisoning and procedural complications	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Vascular Access Site Bruising	Injury, poisoning and procedural complications	MedDRA (26.0)	Systematic Assessment		EG0002 affected206 at risk EG0010 affected131 at risk
Vascular Access Site Haematoma	Injury, poisoning and procedural complications	MedDRA (26.0)	Systematic Assessment		EG00010 affected206 at risk EG00110 affected131 at risk
Vascular Access Site Haemorrhage	Injury, poisoning and procedural complications	MedDRA (26.0)	Systematic Assessment		EG0003 affected206 at risk EG0011 affected131 at risk
Vascular Access Site Pain	Injury, poisoning and procedural complications	MedDRA (26.0)	Systematic Assessment		EG0005 affected206 at risk EG0010 affected131 at risk
Vascular Access Site Pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA (26.0)	Systematic Assessment		EG0002 affected206 at risk EG0011 affected131 at risk
Vascular Access Site Thrombosis	Injury, poisoning and procedural complications	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Wound Secretion	Injury, poisoning and procedural complications	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Blood Cholesterol Increased	Investigations	MedDRA (26.0)	Systematic Assessment		EG0003 affected206 at risk EG0011 affected131 at risk
Blood Creatinine Increased	Investigations	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0014 affected131 at risk
Blood Glucose Increased	Investigations	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Blood Potassium Decreased	Investigations	MedDRA (26.0)	Systematic Assessment		EG0002 affected206 at risk EG0010 affected131 at risk
Blood Potassium Increased	Investigations	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Blood Pressure Abnormal	Investigations	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Blood Pressure Increased	Investigations	MedDRA (26.0)	Systematic Assessment		EG0007 affected206 at risk EG0015 affected131 at risk
Blood Pressure Orthostatic Decreased	Investigations	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Blood Uric Acid Increased	Investigations	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0012 affected131 at risk
C-Reactive Protein Increased	Investigations	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Gamma-Glutamyltransferase Increased	Investigations	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Glycosylated Haemoglobin Increased	Investigations	MedDRA (26.0)	Systematic Assessment		EG0002 affected206 at risk EG0011 affected131 at risk
Heart Rate Increased	Investigations	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Hepatic Enzyme Increased	Investigations	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Lipids Increased	Investigations	MedDRA (26.0)	Systematic Assessment		EG0002 affected206 at risk EG0010 affected131 at risk
Liver Function Test Increased	Investigations	MedDRA (26.0)	Systematic Assessment		EG0002 affected206 at risk EG0011 affected131 at risk
Oxygen Saturation Decreased	Investigations	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Pancreatic Enzymes Increased	Investigations	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Renal Function Test Abnormal	Investigations	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0011 affected131 at risk
Troponin T Increased	Investigations	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Weight Increased	Investigations	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Decreased Appetite	Metabolism and nutrition disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Diabetes Mellitus	Metabolism and nutrition disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0011 affected131 at risk
Dyslipidaemia	Metabolism and nutrition disorders	MedDRA (26.0)	Systematic Assessment		EG0002 affected206 at risk EG0011 affected131 at risk
Gout	Metabolism and nutrition disorders	MedDRA (26.0)	Systematic Assessment		EG0003 affected206 at risk EG0010 affected131 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA (26.0)	Systematic Assessment		EG0004 affected206 at risk EG0012 affected131 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0011 affected131 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (26.0)	Systematic Assessment		EG0002 affected206 at risk EG0011 affected131 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA (26.0)	Systematic Assessment		EG0003 affected206 at risk EG0011 affected131 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (26.0)	Systematic Assessment		EG00013 affected206 at risk EG0018 affected131 at risk
Hypolipidaemia	Metabolism and nutrition disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (26.0)	Systematic Assessment		EG0002 affected206 at risk EG0010 affected131 at risk
Type 2 Diabetes Mellitus	Metabolism and nutrition disorders	MedDRA (26.0)	Systematic Assessment		EG0004 affected206 at risk EG0010 affected131 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (26.0)	Systematic Assessment		EG0005 affected206 at risk EG0016 affected131 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA (26.0)	Systematic Assessment		EG00011 affected206 at risk EG0015 affected131 at risk
Bone Pain	Musculoskeletal and connective tissue disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Cervical Spinal Stenosis	Musculoskeletal and connective tissue disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Facet Joint Syndrome	Musculoskeletal and connective tissue disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Flank Pain	Musculoskeletal and connective tissue disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Groin Pain	Musculoskeletal and connective tissue disorders	MedDRA (26.0)	Systematic Assessment		EG0002 affected206 at risk EG0010 affected131 at risk
Inguinal Mass	Musculoskeletal and connective tissue disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Intervertebral Disc Protrusion	Musculoskeletal and connective tissue disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0011 affected131 at risk
Joint Effusion	Musculoskeletal and connective tissue disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Joint Swelling	Musculoskeletal and connective tissue disorders	MedDRA (26.0)	Systematic Assessment		EG0002 affected206 at risk EG0011 affected131 at risk
Muscle Spasms	Musculoskeletal and connective tissue disorders	MedDRA (26.0)	Systematic Assessment		EG0002 affected206 at risk EG0012 affected131 at risk
Musculoskeletal Chest Pain	Musculoskeletal and connective tissue disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Musculoskeletal Discomfort	Musculoskeletal and connective tissue disorders	MedDRA (26.0)	Systematic Assessment		EG0004 affected206 at risk EG0012 affected131 at risk
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0012 affected131 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (26.0)	Systematic Assessment		EG0003 affected206 at risk EG0011 affected131 at risk
Pain In Extremity	Musculoskeletal and connective tissue disorders	MedDRA (26.0)	Systematic Assessment		EG0005 affected206 at risk EG0015 affected131 at risk
Plantar Fasciitis	Musculoskeletal and connective tissue disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0012 affected131 at risk
Rotator Cuff Syndrome	Musculoskeletal and connective tissue disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Tenosynovitis	Musculoskeletal and connective tissue disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0011 affected131 at risk
Lung Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Metastases To Lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Prostate Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0012 affected131 at risk
Renal Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Carpal Tunnel Syndrome	Nervous system disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Cerebrovascular Accident	Nervous system disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Dizziness	Nervous system disorders	MedDRA (26.0)	Systematic Assessment		EG0006 affected206 at risk EG0017 affected131 at risk
Dizziness Postural	Nervous system disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Headache	Nervous system disorders	MedDRA (26.0)	Systematic Assessment		EG0008 affected206 at risk EG00110 affected131 at risk
Hypoaesthesia	Nervous system disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0012 affected131 at risk
Ischaemic Stroke	Nervous system disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Lethargy	Nervous system disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Leukoencephalopathy	Nervous system disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Migraine	Nervous system disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0012 affected131 at risk
Nerve Compression	Nervous system disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Neuropathy Peripheral	Nervous system disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Paraesthesia	Nervous system disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0011 affected131 at risk
Presyncope	Nervous system disorders	MedDRA (26.0)	Systematic Assessment		EG0003 affected206 at risk EG0011 affected131 at risk
Radiculopathy	Nervous system disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Sciatic Nerve Neuropathy	Nervous system disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Syncope	Nervous system disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0012 affected131 at risk
Anxiety	Psychiatric disorders	MedDRA (26.0)	Systematic Assessment		EG0004 affected206 at risk EG0011 affected131 at risk
Depression	Psychiatric disorders	MedDRA (26.0)	Systematic Assessment		EG0002 affected206 at risk EG0010 affected131 at risk
Mental Disorder	Psychiatric disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Mental Status Changes	Psychiatric disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Neuropsychiatric Symptoms	Psychiatric disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Poor Quality Sleep	Psychiatric disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Acute Kidney Injury	Renal and urinary disorders	MedDRA (26.0)	Systematic Assessment		EG0002 affected206 at risk EG0010 affected131 at risk
Bladder Neck Obstruction	Renal and urinary disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Hypertonic Bladder	Renal and urinary disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Micturition Urgency	Renal and urinary disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Renal Artery Dissection	Renal and urinary disorders	MedDRA (26.0)	Systematic Assessment		EG0002 affected206 at risk EG0010 affected131 at risk
Renal Cyst	Renal and urinary disorders	MedDRA (26.0)	Systematic Assessment		EG0007 affected206 at risk EG0010 affected131 at risk
Urinary Incontinence	Renal and urinary disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Urinary Retention	Renal and urinary disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Benign Prostatic Hyperplasia	Reproductive system and breast disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0011 affected131 at risk
Breast Mass	Reproductive system and breast disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Dysmenorrhoea	Reproductive system and breast disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Erectile Dysfunction	Reproductive system and breast disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0011 affected131 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Scrotal Cyst	Reproductive system and breast disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Testicular Pain	Reproductive system and breast disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0011 affected131 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (26.0)	Systematic Assessment		EG0005 affected206 at risk EG0011 affected131 at risk
Cough Variant Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Dyspnoea Exertional	Respiratory, thoracic and mediastinal disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (26.0)	Systematic Assessment		EG0002 affected206 at risk EG0011 affected131 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Oropharyngeal Pain	Respiratory, thoracic and mediastinal disorders	MedDRA (26.0)	Systematic Assessment		EG0003 affected206 at risk EG0010 affected131 at risk
Respiratory Depression	Respiratory, thoracic and mediastinal disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Sleep Apnoea Syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Upper-Airway Cough Syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Actinic Keratosis	Skin and subcutaneous tissue disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0011 affected131 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Blister	Skin and subcutaneous tissue disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0011 affected131 at risk
Rash Maculo-Papular	Skin and subcutaneous tissue disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Rash Pruritic	Skin and subcutaneous tissue disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Skin Lesion	Skin and subcutaneous tissue disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Skin Swelling	Skin and subcutaneous tissue disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Transient Acantholytic Dermatosis	Skin and subcutaneous tissue disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Removal Of Foreign Body	Surgical and medical procedures	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Wisdom Teeth Removal	Surgical and medical procedures	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Arterial Spasm	Vascular disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Haematoma	Vascular disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Hypertension	Vascular disorders	MedDRA (26.0)	Systematic Assessment		EG0007 affected206 at risk EG0016 affected131 at risk
Hypertensive Crisis	Vascular disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0011 affected131 at risk
Hypertensive Urgency	Vascular disorders	MedDRA (26.0)	Systematic Assessment		EG0003 affected206 at risk EG0011 affected131 at risk
Hypotension	Vascular disorders	MedDRA (26.0)	Systematic Assessment		EG0002 affected206 at risk EG0011 affected131 at risk
Iliac Artery Dissection	Vascular disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Orthostatic Hypotension	Vascular disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0011 affected131 at risk
Raynaud's Phenomenon	Vascular disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Vasospasm	Vascular disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Anogenital Warts	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Angina Unstable	Cardiac disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0010 affected131 at risk
Cardiac Hypertrophy	Cardiac disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0010 affected131 at risk
Liddle's Syndrome	Congenital, familial and genetic disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0010 affected131 at risk
Retinal Detachment	Eye disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0010 affected131 at risk
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0010 affected131 at risk
Diverticulum	Gastrointestinal disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0010 affected131 at risk
Stomach Mass	Gastrointestinal disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0010 affected131 at risk
Vomiting	Gastrointestinal disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0010 affected131 at risk
Pain	General disorders	MedDRA (26.0)	Systematic Assessment	General Disorders And Administration Site Conditions	EG0000 affected206 at risk EG0010 affected131 at risk
Acute Sinusitis	Infections and infestations	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0010 affected131 at risk
Diverticulitis	Infections and infestations	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0010 affected131 at risk
Ear Infection	Infections and infestations	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0010 affected131 at risk
Gastrointestinal Infection	Infections and infestations	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0010 affected131 at risk
Pyelonephritis	Infections and infestations	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0010 affected131 at risk
Bone Contusion	Injury, poisoning and procedural complications	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0010 affected131 at risk
Scratch	Injury, poisoning and procedural complications	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0010 affected131 at risk
Subcutaneous Haematoma	Injury, poisoning and procedural complications	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0010 affected131 at risk
Aortic Bruit	Investigations	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0010 affected131 at risk
Liver Function Test Abnormal	Investigations	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0010 affected131 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0010 affected131 at risk
Diabetes Mellitus Inadequate Control	Metabolism and nutrition disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0010 affected131 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Pain In Jaw	Musculoskeletal and connective tissue disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0010 affected131 at risk
Bladder Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0010 affected131 at risk
Bell's Palsy	Nervous system disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Cognitive Disorder	Nervous system disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0010 affected131 at risk
Exertional Headache	Nervous system disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0010 affected131 at risk
Sciatica	Nervous system disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0010 affected131 at risk
Simple Partial Seizures	Nervous system disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0010 affected131 at risk
Subarachnoid Haemorrhage	Nervous system disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0010 affected131 at risk
Nervousness	Psychiatric disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0010 affected131 at risk
Cystitis Noninfective	Renal and urinary disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0010 affected131 at risk
Renal Artery Stenosis	Renal and urinary disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0010 affected131 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0010 affected131 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0010 affected131 at risk
Arteriosclerosis	Vascular disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0010 affected131 at risk
Deep Vein Thrombosis	Vascular disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Varicose Vein	Vascular disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Peripheral Venous Disease	Vascular disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Peripheral Arterial Occlusive Disease	Vascular disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Hypotensive Crisis	Vascular disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Flushing	Vascular disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Blood Pressure Inadequately Controlled	Vascular disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Photosensitivity Reaction	Skin and subcutaneous tissue disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Pemphigus	Skin and subcutaneous tissue disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Vulvovaginal Discomfort	Reproductive system and breast disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Testicular Retraction	Reproductive system and breast disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Renal Mass	Renal and urinary disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Renal Haemorrhage	Renal and urinary disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Renal Disorder	Renal and urinary disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Renal Artery Fibromuscular Dysplasia	Renal and urinary disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0010 affected131 at risk
Renal Aneurysm	Renal and urinary disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Pyelocaliectasis	Renal and urinary disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Pollakiuria	Renal and urinary disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0011 affected131 at risk
Chronic Kidney Disease	Renal and urinary disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Burnout Syndrome	Psychiatric disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Tension Headache	Nervous system disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Neurological Symptom	Nervous system disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Uterine Leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Squamous Cell Carcinoma of Skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Papillary Renal Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Malignant Melanoma In Situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Lung Adenocarcinoma Stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Clear Cell Renal Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Basal Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Adrenal Adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Posture Abnormal	Musculoskeletal and connective tissue disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Polymyalgia Rheumatica	Musculoskeletal and connective tissue disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Neck Pain	Musculoskeletal and connective tissue disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0011 affected131 at risk
Prostatic Specific Antigen Increased	Investigations	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Heart Rate Irregular	Investigations	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Glomerular Filtration Rate Decreased	Investigations	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Electrocardiogram Change	Investigations	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Blood Creatine Phosphokinase Increased	Investigations	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Vascular Access Site Necrosis	Injury, poisoning and procedural complications	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Spinal Compression Fracture	Injury, poisoning and procedural complications	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Ankle Fracture	Injury, poisoning and procedural complications	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Respiratory Tract Infection Viral	Infections and infestations	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Pharyngitis Streptococcal	Infections and infestations	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Genital Infection	Infections and infestations	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Covid-19 Pneumonia	Infections and infestations	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Seasonal Allergy	Immune system disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Non-Alcoholic Fatty Liver	Hepatobiliary disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Rectal Haemorrhage	Gastrointestinal disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Peptic Ulcer	Gastrointestinal disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Pancreatic Cyst	Gastrointestinal disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Large Intestine Polyp	Gastrointestinal disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Intestinal Mass	Gastrointestinal disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Dental Caries	Gastrointestinal disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Coeliac Artery Aneurysm	Gastrointestinal disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Photopsia	Eye disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0011 affected131 at risk
Hyperthyroidism	Endocrine disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0010 affected131 at risk
Type V Hyperlipidaemia	Congenital, familial and genetic disorders	MedDRA (26.0)	Systematic Assessment		EG0000 affected206 at risk EG0010 affected131 at risk
Nodal Rhythm	Cardiac disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Coronary Artery Disease	Cardiac disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Cardiac Failure Chronic	Cardiac disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Acute Myocardial Infarction	Cardiac disorders	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk
Sars-Cov-2 Sepsis	Infections and infestations	MedDRA (26.0)	Systematic Assessment		EG0001 affected206 at risk EG0010 affected131 at risk

ID	Term
D006973	Hypertension
D014652	Vascular Diseases
D002318	Cardiovascular Diseases