A Comparison of Prasugrel at PCI or Time of Diagnosis of... | NCT01015287

ID	Type	Description	Link
H7T-MC-TADF	Other Identifier	Eli Lilly and Company

Status Module

Name	Class
Daiichi Sankyo Co., Ltd.	INDUSTRY

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
Non pre-treatment	Experimental	A placebo oral loading dose is given at the time of diagnosis and a 60 milligrams (mg) oral loading dose of prasugrel is given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.	Drug: Placebo Drug: Prasugrel
Split Loading Dose	Experimental	A 30 mg oral loading dose of prasugrel is given at diagnosis and a 30 mg oral dose of prasugrel is given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days	Drug: Prasugrel

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	Administered once orally	Non pre-treatment
Prasugrel

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The Percentage of Participants With Occurrence of Cardiovascular (CV) Death, Myocardial Infarction (MI), Stroke, Urgent Revascularization (UR), or Glycoprotein (GP) IIb/IIIa Inhibitor Bailout	The percentage of participants is the total number of participants experiencing a CV death, MI, stroke, UR or GPIIb/IIIa Inhibitor bailout divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.	First loading dose (LD) through 7 days after first LD

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With All-Cause Death, Myocardial Infarction (MI), Stroke, or All Coronary Artery Bypass Graft (CABG) and Non-CABG Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding	The percentage of participants is the total number of participants experiencing an all-cause death, MI, stroke or CABG and non-CABG TIMI major bleeding divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.

Other Outcomes

Measure	Description	Time Frame
Summary of All-Cause Death	All deaths, regardless of possible relatedness, were adjudicated by the Clinical Endpoint Committee (CEC) and are reported in this table.	Randomization through 30 days

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST)	Eli Lilly and Company	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.		Braunau am Inn		5280

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30819358	Derived	Silvain J, Rakowski T, Lattuca B, Liu Z, Bolognese L, Goldstein P, Hamm C, Tanguay JF, Ten Berg J, Widimsky P, Miller D, Portal JJ, Collet JP, Vicaut E, Montalescot G, Dudek D; ACCOAST Investigators. Interval From Initiation of Prasugrel to Coronary Angiography in Patients With Non-ST-Segment Elevation Myocardial Infarction. J Am Coll Cardiol. 2019 Mar 5;73(8):906-914. doi: 10.1016/j.jacc.2018.11.055.
27151605

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Non Pre-treatment	A placebo oral loading dose (LD) was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Non Pre-treatment	A placebo oral loading dose (LD) was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
BG001	Pre-treatment	A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
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
	OG0009.77 OG0019.97

Secondary

Percentage of Participants With All-Cause Death, Myocardial Infarction (MI), Stroke, or All Coronary Artery Bypass Graft (CABG) and Non-CABG Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding

The percentage of participants is the total number of participants experiencing an all-cause death, MI, stroke or CABG and non-CABG TIMI major bleeding divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.

All randomized participants who received at least 1 dose of study drug.

Posted

Number

percentage of participants

First loading dose (LD) through 7 days after first LD

ID	Title	Description
OG000	Non Pre-treatment	A placebo LD was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
OG001	Pre-treatment	A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.

Units	Counts

Secondary

Percentage of Participants With Incidence of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Stroke Through 30 Days From First Loading Dose (LD)

The percentage of participants is the total number of participants experiencing a CV death, MI, or stroke divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.

All randomized participants who received at least 1 dose of study drug.

Posted

Number

percentage of participants

First LD through 30 days after first LD

ID	Title	Description
OG000	Non Pre-treatment	A placebo oral LD was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
OG001	Pre-treatment	A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.

Units	Counts
Participants

Secondary

Percentage of Participants With Incidence of Cardiovascular (CV) Death or Myocardial Infarction (MI) Through 30 Days From First Loading Dose (LD)

The percentage of participants is the total number of participants experiencing a CV death or MI divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.

All randomized participants who received at least 1 dose of study drug.

Posted

Number

percentage of participants

First LD through 30 days after first LD

ID	Title	Description
OG000	Non Pre-treatment	A placebo oral LD was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
OG001	Pre-treatment	A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.

Units	Counts
Participants

Secondary

Percentage of Participants With Incidence of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Urgent Revascularization (UR) Through 30 Days From First Loading Dose (LD)

The percentage of participants is the total number of participants experiencing a CV death, MI, or UR divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.

All randomized participants who received at least 1 dose of study drug.

Posted

Number

percentage of participants

First LD through 30 days after first LD

ID	Title	Description
OG000	Non Pre-treatment	A placebo oral LD was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
OG001	Pre-treatment	A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.

Units	Counts
Participants

Secondary

Percentage of Participants With Incidence of Cardiovascular (CV) Death Through 30 Days From First Loading Dose (LD)

The percentage of participants is the total number of participants experiencing a CV death divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.

All randomized participants who received at least 1 dose of study drug.

Posted

Number

percentage of participants

First LD through 30 days after first LD

ID	Title	Description
OG000	Non Pre-treatment	A placebo oral LD was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
OG001	Pre-treatment	A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.

Units	Counts
Participants

Secondary

Percentage of Participants With Incidence of Definite or Probable Stent Thrombosis (ST) According to the Academic Research Consortium (ARC) Criteria Through 30 Days From First Loading Dose (LD)

ARC criteria were used to define ST. Definite ST is angiographic or pathologic confirmation of partial or total thrombotic occlusion within the peri-stent region, and at least one of the following additional criteria: acute ischemic symptoms; ischemic electrocardiogram changes; elevated cardiac biomarkers. Probable ST is any unexplained death within 30 days of stent implantation; any MI, which is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of ST and in the absence of any other obvious cause. The percentage of participants is the total number of participants experiencing a definite or probable stent thrombosis divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.

All randomized participants who received at least 1 dose of study drug.

Posted

Number

percentage of participants

First LD through 30 days after first LD

ID	Title	Description
OG000	Non Pre-treatment	A placebo oral LD was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
OG001	Pre-treatment

Secondary

Percentage of Participants With All-cause Death, Myocardial Infarction (MI), Stroke, or All Coronary Artery Bypass Graft (CABG) and Non-CABG Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding Through 30 Days From First Loading Dose (LD)

All randomized participants who received at least 1 dose of study drug.

Posted

Number

percentage of participants

First LD through 30 days after first LD

ID	Title	Description
OG000	Non Pre-treatment	A placebo oral LD was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
OG001	Pre-treatment	A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.

Secondary

Change in Standardized Troponin From Baseline to Percutaneous Coronary Intervention (PCI)

Standardized troponin is defined as the ratio of the assayed troponin value divided by the upper limit of normal (ULN). Least Squares (LS) means were obtained from an Analysis of Covariance (ANCOVA) model with treatment as a fixed effect and baseline standardized troponin as a covariate.

All randomized participants who received at least 1 dose of study drug, had standardized troponin measured at baseline and before PCI (not greater than 48 hours after randomization).

Posted

Least Squares Mean

Standard Error

ratio of assayed troponin/ULN

Baseline, before PCI (not greater than 48 hours after randomization)

ID	Title	Description
OG000	Non Pre-treatment	A placebo oral loading dose (LD) was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
OG001	Pre-treatment	A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.

Secondary

Percentage of Participants With Incidence of All Coronary Artery Bypass Graft (CABG) or Non-CABG Thrombolysis In Myocardial Infarction (TIMI) Major Bleeding

The percentage of participants is the total number of participants experiencing a CABG or non-CABG TIMI major bleeding divided by number of participants in the treatment arm multiplied by 100. Endpoint events were adjudicated by the Clinical Endpoint Committee.

All randomized participants who received at least 1 dose of study drug.

Posted

Number

percentage of participants

First loading dose (LD) through 7 days after first LD

ID	Title	Description
OG000	Non Pre-treatment	A placebo oral LD was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
OG001	Pre-treatment	A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.

Units	Counts
Participants

Other Pre-specified

Summary of All-Cause Death

All deaths, regardless of possible relatedness, were adjudicated by the Clinical Endpoint Committee (CEC) and are reported in this table.

All randomized participants who received at least 1 dose of study drug.

Posted

Number

participants

Randomization through 30 days

ID	Title	Description
OG000	Non Pre-treatment	A placebo oral loading dose (LD) was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
OG001	Pre-treatment	A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.

Units	Counts
Participants	OG000

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	Non Pre-treatment	A placebo oral loading dose (LD) was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.			167	1,996	860	1,996
EG001	Pre-treatment	A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.			206	2,037	876	2,037

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0011 events1 affected2,037 at risk
Anaemia vitamin B12 deficiency	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Hyperchromic anaemia	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Splenic infarction	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Thrombocytosis	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0011 events1 affected2,037 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected1,996 at risk EG0016 events6 affected2,037 at risk
Angina pectoris	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0016 events5 affected2,037 at risk
Angina unstable	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0016 events6 affected2,037 at risk
Aortic valve incompetence	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Arrhythmia	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Arteriospasm coronary	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0010 events0 affected2,037 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0005 events4 affected1,996 at risk EG0013 events3 affected2,037 at risk
Atrioventricular block	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0011 events1 affected2,037 at risk
Atrioventricular block first degree	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Atrioventricular block second degree	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Bifascicular block	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Bradycardia	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0012 events2 affected2,037 at risk
Cardiac arrest	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected1,996 at risk EG0015 events5 affected2,037 at risk
Cardiac failure	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected1,996 at risk EG0014 events3 affected2,037 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0012 events2 affected2,037 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0010 events0 affected2,037 at risk
Cardiac tamponade	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0013 events3 affected2,037 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Cardiogenic shock	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0005 events5 affected1,996 at risk EG0017 events7 affected2,037 at risk
Coronary artery disease	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Coronary artery dissection	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0013 events3 affected2,037 at risk
Coronary artery embolism	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0012 events2 affected2,037 at risk
Coronary artery thrombosis	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected1,996 at risk EG0015 events5 affected2,037 at risk
Coronary no-reflow phenomenon	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Coronary ostial stenosis	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Haemorrhage coronary artery	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Intracardiac thrombus	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Left ventricular failure	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0010 events0 affected2,037 at risk
Myocardial infarction	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG00010 events10 affected1,996 at risk EG00115 events15 affected2,037 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Myocardial rupture	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Pericardial effusion	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected1,996 at risk EG0010 events0 affected2,037 at risk
Pericardial haemorrhage	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0013 events3 affected2,037 at risk
Pericarditis	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0011 events1 affected2,037 at risk
Pericarditis constrictive	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Pleuropericarditis	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Postinfarction angina	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Sinus arrest	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Sinus bradycardia	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0005 events5 affected1,996 at risk EG0017 events7 affected2,037 at risk
Ventricular flutter	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected1,996 at risk EG0014 events4 affected2,037 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Hypothyroidism	Endocrine disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Faeces discoloured	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Flatulence	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0012 events2 affected2,037 at risk
Gastritis	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0012 events2 affected2,037 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected1,996 at risk EG0015 events5 affected2,037 at risk
Gingival bleeding	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Mesenteric artery thrombosis	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Peritoneal haematoma	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0012 events2 affected2,037 at risk
Retroperitoneal haematoma	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0012 events2 affected2,037 at risk
Retroperitoneal haemorrhage	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0013 events3 affected2,037 at risk
Asthenia	General disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Chest pain	General disorders	MedDRA 15.1	Systematic Assessment	EG0008 events8 affected1,996 at risk EG0019 events9 affected2,037 at risk
Device dislocation	General disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Non-cardiac chest pain	General disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected1,996 at risk EG0011 events1 affected2,037 at risk
Puncture site haemorrhage	General disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0011 events1 affected2,037 at risk
Pyrexia	General disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Spinal pain	General disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Sudden cardiac death	General disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Sudden death	General disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Thrombosis in device	General disorders	MedDRA 15.1	Systematic Assessment	EG0005 events4 affected1,996 at risk EG0011 events1 affected2,037 at risk
Vessel puncture site haematoma	General disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0011 events1 affected2,037 at risk
Vessel puncture site haemorrhage	General disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0012 events2 affected2,037 at risk
Biliary tract disorder	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Hepatic necrosis	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Hypersensitivity	Immune system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Bronchitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Cystitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Gastroenteritis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0012 events2 affected2,037 at risk
Groin abscess	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Labyrinthitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Nasopharyngitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Pneumonia	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0014 events4 affected2,037 at risk
Puncture site infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Sepsis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0012 events2 affected2,037 at risk
Sinusitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Urinary tract infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0012 events2 affected2,037 at risk
Accidental overdose	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Cardiac procedure complication	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Graft thrombosis	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0014 events4 affected2,037 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0016 events6 affected2,037 at risk
Post procedural myocardial infarction	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Postoperative thrombosis	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0012 events2 affected2,037 at risk
Procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected1,996 at risk EG0016 events6 affected2,037 at risk
Subcutaneous haematoma	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0016 events6 affected2,037 at risk
Vena cava injury	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Cardiac output decreased	Investigations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Ejection fraction decreased	Investigations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Haemoglobin decreased	Investigations	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0012 events2 affected2,037 at risk
Inflammatory marker increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Troponin increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0012 events2 affected2,037 at risk
Troponin t increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0011 events1 affected2,037 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Spondylitis	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Central nervous system lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Renal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0012 events2 affected2,037 at risk
Convulsion	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Dizziness	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0010 events0 affected2,037 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Haemorrhagic stroke	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Hypotonia	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Intracranial aneurysm	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0012 events2 affected2,037 at risk
Monoplegia	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Syncope	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0013 events3 affected2,037 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0012 events2 affected2,037 at risk
Disorientation	Psychiatric disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Haematuria	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0012 events2 affected2,037 at risk
Nephropathy toxic	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Renal failure	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0013 events3 affected2,037 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0011 events1 affected2,037 at risk
Renal failure chronic	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0011 events1 affected2,037 at risk
Renal impairment	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Renal tubular necrosis	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0012 events1 affected2,037 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0010 events0 affected2,037 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0010 events0 affected2,037 at risk
Hyperventilation	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Laryngeal oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0004 events3 affected1,996 at risk EG0010 events0 affected2,037 at risk
Pulmonary alveolar haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0005 events5 affected1,996 at risk EG0014 events4 affected2,037 at risk
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected1,996 at risk EG0014 events3 affected2,037 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0011 events1 affected2,037 at risk
Respiratory tract haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Acute generalised exanthematous pustulosis	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Photosensitivity reaction	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Coronary artery bypass	Surgical and medical procedures	MedDRA 15.1	Systematic Assessment	EG0005 events5 affected1,996 at risk EG0016 events6 affected2,037 at risk
Coronary revascularisation	Surgical and medical procedures	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Percutaneous coronary intervention	Surgical and medical procedures	MedDRA 15.1	Systematic Assessment	EG00010 events10 affected1,996 at risk EG00117 events16 affected2,037 at risk
Thrombolysis	Surgical and medical procedures	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Aneurysm	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Arterial haemorrhage	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Arterial rupture	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Embolism	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Femoral artery occlusion	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Haematoma	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected1,996 at risk EG0016 events6 affected2,037 at risk
Haemodynamic instability	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Haemorrhage	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0013 events3 affected2,037 at risk
Hypertension	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0010 events0 affected2,037 at risk
Hypertensive crisis	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Hypotension	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0012 events2 affected2,037 at risk
Ischaemia	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0011 events1 affected2,037 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Peripheral artery thrombosis	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0010 events0 affected2,037 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Shock	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Thrombosis	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Venous thrombosis limb	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0012 events2 affected2,037 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG00010 events10 affected1,996 at risk EG00117 events17 affected2,037 at risk
Anaemia macrocytic	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Coagulopathy	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0012 events2 affected2,037 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected1,996 at risk EG0014 events4 affected2,037 at risk
Macrocytosis	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Normochromic normocytic anaemia	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Polycythaemia	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0011 events1 affected2,037 at risk
Spontaneous haematoma	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0012 events2 affected2,037 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected1,996 at risk EG0015 events5 affected2,037 at risk
Accelerated idioventricular rhythm	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected1,996 at risk EG0010 events0 affected2,037 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0013 events3 affected2,037 at risk
Angina pectoris	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG00019 events18 affected1,996 at risk EG00115 events14 affected2,037 at risk
Angina unstable	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0006 events6 affected1,996 at risk EG0014 events4 affected2,037 at risk
Aortic valve incompetence	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0005 events5 affected1,996 at risk EG0015 events5 affected2,037 at risk
Aortic valve sclerosis	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0012 events2 affected2,037 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected1,996 at risk EG0013 events3 affected2,037 at risk
Arrhythmia	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0013 events3 affected2,037 at risk
Arrhythmia supraventricular	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected1,996 at risk EG0010 events0 affected2,037 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0011 events1 affected2,037 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG00028 events28 affected1,996 at risk EG00138 events36 affected2,037 at risk
Atrial flutter	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0005 events5 affected1,996 at risk EG0013 events3 affected2,037 at risk
Atrial tachycardia	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Atrioventricular block	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0010 events0 affected2,037 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0011 events1 affected2,037 at risk
Atrioventricular block first degree	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0012 events2 affected2,037 at risk
Atrioventricular block second degree	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0016 events6 affected2,037 at risk
Bradycardia	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG00021 events21 affected1,996 at risk EG00125 events25 affected2,037 at risk
Bundle branch block right	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Cardiac aneurysm	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Cardiac arrest	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Cardiac disorder	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Cardiac failure	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG00021 events21 affected1,996 at risk EG00115 events15 affected2,037 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0011 events1 affected2,037 at risk
Cardiac valve disease	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Cardiomegaly	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0011 events1 affected2,037 at risk
Cardiovascular disorder	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Cardiovascular insufficiency	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Congestive cardiomyopathy	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Coronary artery disease	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0014 events4 affected2,037 at risk
Coronary artery dissection	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected1,996 at risk EG0011 events1 affected2,037 at risk
Coronary artery embolism	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0016 events6 affected2,037 at risk
Coronary artery perforation	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0012 events2 affected2,037 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0012 events2 affected2,037 at risk
Coronary artery thrombosis	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected1,996 at risk EG0017 events7 affected2,037 at risk
Coronary no-reflow phenomenon	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Diastolic dysfunction	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0012 events2 affected2,037 at risk
Dressler's syndrome	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Hypertensive cardiomyopathy	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Hypertrophic cardiomyopathy	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Intracardiac thrombus	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Left ventricular dysfunction	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0016 events6 affected2,037 at risk
Left ventricular failure	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Left ventricular hypertrophy	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG00017 events17 affected1,996 at risk EG00119 events19 affected2,037 at risk
Myocardial haemorrhage	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Myocardial infarction	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG00050 events49 affected1,996 at risk EG00141 events41 affected2,037 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0012 events2 affected2,037 at risk
Myocarditis	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected1,996 at risk EG0012 events2 affected2,037 at risk
Palpitations	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0007 events7 affected1,996 at risk EG0012 events2 affected2,037 at risk
Pericardial effusion	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0011 events1 affected2,037 at risk
Pericarditis	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected1,996 at risk EG0010 events0 affected2,037 at risk
Pericarditis constrictive	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Pulmonary valve incompetence	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Sick sinus syndrome	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0010 events0 affected2,037 at risk
Sinoatrial block	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Sinus arrest	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Sinus bradycardia	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0013 events3 affected2,037 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected1,996 at risk EG0010 events0 affected2,037 at risk
Stress cardiomyopathy	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0010 events0 affected2,037 at risk
Supraventricular extrasystoles	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected1,996 at risk EG0013 events3 affected2,037 at risk
Tachyarrhythmia	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0011 events1 affected2,037 at risk
Tachycardia	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected1,996 at risk EG0017 events7 affected2,037 at risk
Tachycardia paroxysmal	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Tricuspid valve incompetence	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG00010 events10 affected1,996 at risk EG0016 events6 affected2,037 at risk
Ventricular arrhythmia	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected1,996 at risk EG0015 events5 affected2,037 at risk
Ventricular failure	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Ventricular hypokinesia	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0012 events2 affected2,037 at risk
Ventricular tachyarrhythmia	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG00012 events10 affected1,996 at risk EG00116 events16 affected2,037 at risk
Gene mutation	Congenital, familial and genetic disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Right aortic arch	Congenital, familial and genetic disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Type v hyperlipidaemia	Congenital, familial and genetic disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0013 events3 affected2,037 at risk
Ear discomfort	Ear and labyrinth disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Ear haemorrhage	Ear and labyrinth disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Hypoacusis	Ear and labyrinth disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Tympanic membrane perforation	Ear and labyrinth disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 15.1	Systematic Assessment	EG0005 events5 affected1,996 at risk EG00111 events11 affected2,037 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Autoimmune thyroiditis	Endocrine disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Goitre	Endocrine disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0010 events0 affected2,037 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected1,996 at risk EG0014 events4 affected2,037 at risk
Hypothyroidism	Endocrine disorders	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected1,996 at risk EG0012 events2 affected2,037 at risk
Conjunctival haemorrhage	Eye disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Diplopia	Eye disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0010 events0 affected2,037 at risk
Eye haemorrhage	Eye disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0012 events2 affected2,037 at risk
Eye oedema	Eye disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Panophthalmitis	Eye disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Refraction disorder	Eye disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Ulcerative keratitis	Eye disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Visual impairment	Eye disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected1,996 at risk EG0010 events0 affected2,037 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0011 events1 affected2,037 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG00011 events10 affected1,996 at risk EG0018 events8 affected2,037 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected1,996 at risk EG00112 events12 affected2,037 at risk
Anal fissure	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0011 events1 affected2,037 at risk
Ascites	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Constipation	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG00011 events11 affected1,996 at risk EG0018 events8 affected2,037 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG00019 events19 affected1,996 at risk EG00119 events19 affected2,037 at risk
Diverticulum	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Duodenitis	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0011 events1 affected2,037 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0005 events5 affected1,996 at risk EG0012 events2 affected2,037 at risk
Enteritis	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Epigastric discomfort	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0011 events1 affected2,037 at risk
Faeces discoloured	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Flatulence	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Gastric disorder	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Gastritis	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected1,996 at risk EG0016 events6 affected2,037 at risk
Gastroduodenitis	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0012 events2 affected2,037 at risk
Gastrointestinal inflammation	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0014 events4 affected2,037 at risk
Gingival bleeding	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0009 events9 affected1,996 at risk EG0012 events2 affected2,037 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0005 events5 affected1,996 at risk EG0012 events2 affected2,037 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0012 events2 affected2,037 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0010 events0 affected2,037 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0011 events1 affected2,037 at risk
Intestinal haemorrhage	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Lip oedema	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Mechanical ileus	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Melaena	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0013 events3 affected2,037 at risk
Mesenteric haematoma	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Mouth haemorrhage	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Nausea	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG00022 events22 affected1,996 at risk EG00125 events25 affected2,037 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Oral disorder	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Oral pain	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Pancreatic cyst	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Peptic ulcer	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0011 events1 affected2,037 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Rectal polyp	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Retroperitoneal haematoma	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Toothache	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected1,996 at risk EG0012 events2 affected2,037 at risk
Vomiting	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG00010 events10 affected1,996 at risk EG0019 events9 affected2,037 at risk
Asthenia	General disorders	MedDRA 15.1	Systematic Assessment	EG00017 events17 affected1,996 at risk EG00115 events15 affected2,037 at risk
Catheter site discharge	General disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Catheter site erythema	General disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0010 events0 affected2,037 at risk
Catheter site haematoma	General disorders	MedDRA 15.1	Systematic Assessment	EG0006 events6 affected1,996 at risk EG0015 events5 affected2,037 at risk
Catheter site haemorrhage	General disorders	MedDRA 15.1	Systematic Assessment	EG0005 events5 affected1,996 at risk EG0018 events7 affected2,037 at risk
Catheter site inflammation	General disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Catheter site pain	General disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0010 events0 affected2,037 at risk
Catheter site phlebitis	General disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Chest discomfort	General disorders	MedDRA 15.1	Systematic Assessment	EG0006 events6 affected1,996 at risk EG0016 events6 affected2,037 at risk
Chest pain	General disorders	MedDRA 15.1	Systematic Assessment	EG00056 events55 affected1,996 at risk EG00150 events47 affected2,037 at risk
Chills	General disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Cyst	General disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Device dislocation	General disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Discomfort	General disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0011 events1 affected2,037 at risk
Drug intolerance	General disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0012 events2 affected2,037 at risk
Fatigue	General disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected1,996 at risk EG0019 events9 affected2,037 at risk
Feeling abnormal	General disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Feeling cold	General disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Feeling hot	General disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Gait disturbance	General disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Hyperthermia	General disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Hypertrophy	General disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Inflammation	General disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0012 events2 affected2,037 at risk
Injection site haemorrhage	General disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0011 events1 affected2,037 at risk
Injection site induration	General disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0011 events1 affected2,037 at risk
Malaise	General disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0010 events0 affected2,037 at risk
Non-cardiac chest pain	General disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0011 events1 affected2,037 at risk
Oedema	General disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0011 events1 affected2,037 at risk
Oedema peripheral	General disorders	MedDRA 15.1	Systematic Assessment	EG0009 events9 affected1,996 at risk EG00115 events14 affected2,037 at risk
Pain	General disorders	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected1,996 at risk EG0012 events2 affected2,037 at risk
Polyp	General disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Puncture site discharge	General disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Puncture site haemorrhage	General disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0017 events7 affected2,037 at risk
Puncture site pain	General disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0010 events0 affected2,037 at risk
Pyrexia	General disorders	MedDRA 15.1	Systematic Assessment	EG00024 events24 affected1,996 at risk EG00133 events33 affected2,037 at risk
Spinal pain	General disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0013 events3 affected2,037 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Thrombosis in device	General disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected1,996 at risk EG0010 events0 affected2,037 at risk
Vessel puncture site haematoma	General disorders	MedDRA 15.1	Systematic Assessment	EG0009 events9 affected1,996 at risk EG00112 events12 affected2,037 at risk
Vessel puncture site haemorrhage	General disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0016 events4 affected2,037 at risk
Vessel puncture site pain	General disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Biliary colic	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Cholecystitis chronic	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0011 events1 affected2,037 at risk
Gallbladder disorder	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Hepatic cyst	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Hepatic steatosis	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected1,996 at risk EG0013 events3 affected2,037 at risk
Jaundice	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Liver disorder	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Allergy to chemicals	Immune system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Contrast media allergy	Immune system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0011 events1 affected2,037 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0012 events2 affected2,037 at risk
Hypersensitivity	Immune system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0011 events1 affected2,037 at risk
Iodine allergy	Immune system disorders	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected1,996 at risk EG0012 events2 affected2,037 at risk
Asymptomatic bacteriuria	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Bronchitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected1,996 at risk EG0013 events3 affected2,037 at risk
Bronchopneumonia	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Candidiasis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Cellulitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Cystitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected1,996 at risk EG0011 events1 affected2,037 at risk
Diverticulitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Erysipelas	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Eye abscess	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Fungal skin infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Gastroenteritis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Genital infection fungal	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Gingivitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Groin infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Hepatitis a	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Hepatitis e	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Herpes zoster	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Infected skin ulcer	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0012 events2 affected2,037 at risk
Influenza	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0011 events1 affected2,037 at risk
Labyrinthitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Leprosy	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Lobar pneumonia	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Lung infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0013 events3 affected2,037 at risk
Lymphangitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Nasopharyngitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected1,996 at risk EG0011 events1 affected2,037 at risk
Nosocomial infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Oral fungal infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Pharyngitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0011 events1 affected2,037 at risk
Pneumonia	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0005 events5 affected1,996 at risk EG0016 events6 affected2,037 at risk
Post procedural infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Respiratory tract infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected1,996 at risk EG0010 events0 affected2,037 at risk
Septic shock	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Staphylococcal infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0014 events4 affected2,037 at risk
Urinary tract infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG00010 events10 affected1,996 at risk EG00110 events10 affected2,037 at risk
Viral diarrhoea	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Vulvovaginal mycotic infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected552 at risk
Anaemia postoperative	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0012 events2 affected2,037 at risk
Arterial restenosis	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Arteriovenous graft aneurysm	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Cardiac function disturbance postoperative	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Cardiac procedure complication	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0013 events3 affected2,037 at risk
Contrast media reaction	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG00014 events14 affected1,996 at risk EG00116 events15 affected2,037 at risk
Coronary artery restenosis	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Dislocation of sternum	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Excoriation	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0012 events2 affected2,037 at risk
Face injury	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0012 events2 affected2,037 at risk
Haematuria traumatic	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Incision site haematoma	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0010 events0 affected2,037 at risk
Incision site haemorrhage	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0012 events2 affected2,037 at risk
Periorbital haematoma	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Post procedural fistula	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected1,996 at risk EG0010 events0 affected2,037 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected1,996 at risk EG0019 events9 affected2,037 at risk
Post procedural myocardial infarction	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0005 events5 affected1,996 at risk EG0017 events7 affected2,037 at risk
Post procedural oedema	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Postoperative thoracic procedure complication	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Postoperative thrombosis	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected1,996 at risk EG0015 events5 affected2,037 at risk
Procedural hypotension	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected1,996 at risk EG0010 events0 affected2,037 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected1,996 at risk EG0012 events2 affected2,037 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Skin wound	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Subcutaneous haematoma	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Traumatic haemorrhage	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Vascular graft occlusion	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Vascular graft thrombosis	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected1,996 at risk EG0013 events3 affected2,037 at risk
Wound haemorrhage	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0012 events2 affected2,037 at risk
Wound secretion	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Alanine aminotransferase increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Amylase increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Antibiotic resistant staphylococcus test positive	Investigations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Aortic bruit	Investigations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0011 events1 affected2,037 at risk
Arteriogram coronary	Investigations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Blood bilirubin decreased	Investigations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0007 events7 affected1,996 at risk EG0016 events6 affected2,037 at risk
Blood creatine phosphokinase mb increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected1,996 at risk EG0012 events2 affected2,037 at risk
Blood creatinine increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0011 events1 affected2,037 at risk
Blood glucose increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0011 events1 affected2,037 at risk
Blood magnesium decreased	Investigations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Blood potassium decreased	Investigations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0011 events1 affected2,037 at risk
Blood pressure increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0014 events4 affected2,037 at risk
Blood triglycerides increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Blood urine	Investigations	MedDRA 15.1	Systematic Assessment	EG0002 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Blood urine present	Investigations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Body temperature increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0012 events2 affected2,037 at risk
C-reactive protein increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0013 events3 affected2,037 at risk
Carbohydrate tolerance decreased	Investigations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Cardiac enzymes increased	Investigations	MedDRA 15.1	Systematic Assessment	EG00016 events16 affected1,996 at risk EG00119 events19 affected2,037 at risk
Cardiac murmur	Investigations	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0013 events3 affected2,037 at risk
Central venous pressure increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Ejection fraction decreased	Investigations	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0011 events1 affected2,037 at risk
Electrocardiogram qt prolonged	Investigations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Electrocardiogram st segment depression	Investigations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Electrocardiogram st segment elevation	Investigations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Electrophoresis protein abnormal	Investigations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Haemoglobin decreased	Investigations	MedDRA 15.1	Systematic Assessment	EG00020 events20 affected1,996 at risk EG00128 events28 affected2,037 at risk
Heart rate increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Hepatic enzyme increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0015 events5 affected2,037 at risk
Hepatitis c virus test positive	Investigations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Inflammatory marker increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0011 events1 affected2,037 at risk
Low density lipoprotein increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0010 events0 affected2,037 at risk
Oxygen saturation decreased	Investigations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Peripheral pulse decreased	Investigations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Platelet count decreased	Investigations	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0012 events2 affected2,037 at risk
Prostatic specific antigen increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected1,485 at risk
Transaminases increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0012 events2 affected2,037 at risk
Troponin i increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected1,996 at risk EG0014 events4 affected2,037 at risk
Troponin increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected1,996 at risk EG0014 events4 affected2,037 at risk
Urine output decreased	Investigations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Weight increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
White blood cell count increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0010 events0 affected2,037 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0011 events1 affected2,037 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG00024 events24 affected1,996 at risk EG00127 events27 affected2,037 at risk
Dyslipidaemia	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG00027 events27 affected1,996 at risk EG00122 events22 affected2,037 at risk
Fluid retention	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Glucose tolerance impaired	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected1,996 at risk EG0015 events5 affected2,037 at risk
Gout	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected1,996 at risk EG0013 events3 affected2,037 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG00087 events87 affected1,996 at risk EG00172 events72 affected2,037 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected1,996 at risk EG0016 events6 affected2,037 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0011 events1 affected2,037 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG00042 events42 affected1,996 at risk EG00126 events26 affected2,037 at risk
Hypernatraemia	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0012 events2 affected2,037 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected1,996 at risk EG0015 events5 affected2,037 at risk
Hypo hdl cholesterolaemia	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0012 events2 affected2,037 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0012 events2 affected2,037 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG00018 events18 affected1,996 at risk EG00114 events14 affected2,037 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Impaired fasting glucose	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0011 events1 affected2,037 at risk
Lipid metabolism disorder	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Obesity	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0005 events5 affected1,996 at risk EG0012 events2 affected2,037 at risk
Overweight	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0011 events1 affected2,037 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0006 events6 affected1,996 at risk EG0017 events7 affected2,037 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected1,996 at risk EG0017 events7 affected2,037 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0012 events2 affected2,037 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG00015 events15 affected1,996 at risk EG00120 events20 affected2,037 at risk
Bone lesion	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Bone swelling	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Gouty arthritis	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0015 events5 affected2,037 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0011 events1 affected2,037 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0012 events2 affected2,037 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0010 events0 affected2,037 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0015 events5 affected2,037 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0014 events4 affected2,037 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0013 events3 affected2,037 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0007 events7 affected1,996 at risk EG0016 events6 affected2,037 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0007 events7 affected1,996 at risk EG0019 events9 affected2,037 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0011 events1 affected2,037 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0011 events1 affected2,037 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG00014 events14 affected1,996 at risk EG00117 events17 affected2,037 at risk
Rheumatic disorder	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0012 events2 affected2,037 at risk
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Adrenal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Hypergammaglobulinaemia benign monoclonal	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Small cell lung cancer stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Akinesia	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0002 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Burning sensation	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Carotid arteriosclerosis	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected1,996 at risk EG0011 events1 affected2,037 at risk
Carotid artery disease	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0013 events3 affected2,037 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected1,996 at risk EG0014 events4 affected2,037 at risk
Cerebellar syndrome	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected1,996 at risk EG0012 events2 affected2,037 at risk
Dizziness	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG00011 events11 affected1,996 at risk EG00114 events14 affected2,037 at risk
Drop attacks	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0002 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Dysarthria	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0011 events1 affected2,037 at risk
Headache	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG00048 events48 affected1,996 at risk EG00145 events44 affected2,037 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0011 events1 affected2,037 at risk
Hypotonia	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0012 events2 affected2,037 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Motor dysfunction	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Neuralgia	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0012 events2 affected2,037 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Paraesthesia	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0012 events2 affected2,037 at risk
Presyncope	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0008 events8 affected1,996 at risk EG00110 events10 affected2,037 at risk
Psychomotor hyperactivity	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0012 events2 affected2,037 at risk
Sciatica	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0012 events2 affected2,037 at risk
Sensory disturbance	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Somnolence	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Syncope	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0005 events5 affected1,996 at risk EG0013 events3 affected2,037 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Tremor	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Vertebral artery stenosis	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Agitation	Psychiatric disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0013 events3 affected2,037 at risk
Alcoholism	Psychiatric disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Anxiety	Psychiatric disorders	MedDRA 15.1	Systematic Assessment	EG00010 events10 affected1,996 at risk EG00113 events13 affected2,037 at risk
Confusional state	Psychiatric disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0016 events6 affected2,037 at risk
Delirium	Psychiatric disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0012 events2 affected2,037 at risk
Depression	Psychiatric disorders	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected1,996 at risk EG0013 events3 affected2,037 at risk
Disorientation	Psychiatric disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0014 events3 affected2,037 at risk
Hallucination	Psychiatric disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Histrionic personality disorder	Psychiatric disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Insomnia	Psychiatric disorders	MedDRA 15.1	Systematic Assessment	EG0006 events6 affected1,996 at risk EG0013 events3 affected2,037 at risk
Libido disorder	Psychiatric disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Mental disorder	Psychiatric disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Panic disorder	Psychiatric disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Sleep disorder	Psychiatric disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0011 events1 affected2,037 at risk
Transient psychosis	Psychiatric disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0011 events1 affected2,037 at risk
Cystitis haemorrhagic	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Dysuria	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0014 events4 affected2,037 at risk
Haematuria	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0006 events6 affected1,996 at risk EG0019 events9 affected2,037 at risk
Haemoglobinuria	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected1,996 at risk EG0010 events0 affected2,037 at risk
Nephropathy	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Nephropathy toxic	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Nephrotic syndrome	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Polyuria	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Renal colic	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Renal cyst	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0012 events2 affected2,037 at risk
Renal failure	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0009 events9 affected1,996 at risk EG0018 events8 affected2,037 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0012 events2 affected2,037 at risk
Renal failure chronic	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0006 events6 affected1,996 at risk EG0015 events5 affected2,037 at risk
Strangury	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Urethral haemorrhage	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Urinary retention	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0005 events4 affected1,996 at risk EG0012 events2 affected2,037 at risk
Balanoposthitis	Reproductive system and breast disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,438 at risk EG0010 events0 affected1,485 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,438 at risk EG0012 events2 affected1,485 at risk
Breast haematoma	Reproductive system and breast disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0011 events1 affected2,037 at risk
Epididymal cyst	Reproductive system and breast disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,438 at risk EG0010 events0 affected1,485 at risk
Epididymitis	Reproductive system and breast disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,438 at risk EG0010 events0 affected1,485 at risk
Erectile dysfunction	Reproductive system and breast disorders	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected1,438 at risk EG0011 events1 affected1,485 at risk
Gynaecomastia	Reproductive system and breast disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,438 at risk EG0011 events1 affected1,485 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected558 at risk EG0012 events2 affected552 at risk
Penis disorder	Reproductive system and breast disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,438 at risk EG0011 events1 affected1,485 at risk
Prostatic calcification	Reproductive system and breast disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,438 at risk EG0010 events0 affected1,485 at risk
Testicular oedema	Reproductive system and breast disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,438 at risk EG0011 events1 affected1,485 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected558 at risk EG0012 events2 affected552 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0010 events0 affected2,037 at risk
Bronchostenosis	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0007 events7 affected1,996 at risk EG0012 events2 affected2,037 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG00015 events15 affected1,996 at risk EG00122 events22 affected2,037 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0011 events1 affected2,037 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG00019 events18 affected1,996 at risk EG00121 events21 affected2,037 at risk
Dyspnoea at rest	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0015 events5 affected2,037 at risk
Emphysema	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0011 events1 affected2,037 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG00030 events28 affected1,996 at risk EG00148 events38 affected2,037 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0011 events1 affected2,037 at risk
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Hydrothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Lung consolidation	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0012 events2 affected2,037 at risk
Pharyngeal haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0012 events1 affected2,037 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0005 events5 affected1,996 at risk EG0013 events3 affected2,037 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0012 events1 affected2,037 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0015 events5 affected2,037 at risk
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0011 events1 affected2,037 at risk
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0003 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected1,996 at risk EG0011 events1 affected2,037 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0005 events4 affected1,996 at risk EG0014 events4 affected2,037 at risk
Rales	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0010 events0 affected2,037 at risk
Respiratory tract haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Rhonchi	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected1,996 at risk EG0010 events0 affected2,037 at risk
Sneezing	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Sputum discoloured	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Blister	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0011 events1 affected2,037 at risk
Cold sweat	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0012 events2 affected2,037 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected1,996 at risk EG0014 events4 affected2,037 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG00012 events12 affected1,996 at risk EG00112 events10 affected2,037 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected1,996 at risk EG0010 events0 affected2,037 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG00011 events11 affected1,996 at risk EG0016 events6 affected2,037 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0014 events4 affected2,037 at risk
Increased tendency to bruise	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0011 events1 affected2,037 at risk
Macule	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Palmar erythema	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Petechiae	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0012 events2 affected2,037 at risk
Prurigo	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected1,996 at risk EG0013 events3 affected2,037 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG00013 events13 affected1,996 at risk EG0014 events4 affected2,037 at risk
Scar pain	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Skin irritation	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Subcutaneous emphysema	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected1,996 at risk EG0012 events2 affected2,037 at risk
Xanthoma	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Bladder catheter removal	Surgical and medical procedures	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Blood product transfusion	Surgical and medical procedures	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Cardiac pacemaker insertion	Surgical and medical procedures	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0013 events3 affected2,037 at risk
Carotid angioplasty	Surgical and medical procedures	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Coronary angioplasty	Surgical and medical procedures	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Coronary artery bypass	Surgical and medical procedures	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0015 events5 affected2,037 at risk
Coronary revascularisation	Surgical and medical procedures	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Dialysis	Surgical and medical procedures	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Heart valve operation	Surgical and medical procedures	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Implantable defibrillator insertion	Surgical and medical procedures	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0011 events1 affected2,037 at risk
Packed red blood cell transfusion	Surgical and medical procedures	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Percutaneous coronary intervention	Surgical and medical procedures	MedDRA 15.1	Systematic Assessment	EG00014 events14 affected1,996 at risk EG0018 events8 affected2,037 at risk
Platelet transfusion	Surgical and medical procedures	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Thromboembolectomy	Surgical and medical procedures	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Aneurysm	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Angiopathy	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Aortic aneurysm	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Aortic arteriosclerosis	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Aortic calcification	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Aortic dilatation	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0013 events3 affected2,037 at risk
Aortic disorder	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Aortic stenosis	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0005 events5 affected1,996 at risk EG0013 events3 affected2,037 at risk
Aortic thrombosis	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Arterial haemorrhage	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Arterial stenosis	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Arteriosclerosis	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Artery dissection	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Blood pressure fluctuation	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0012 events2 affected2,037 at risk
Embolism	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0011 events1 affected2,037 at risk
Femoral artery dissection	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Flushing	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0011 events1 affected2,037 at risk
Haematoma	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG00062 events57 affected1,996 at risk EG00197 events96 affected2,037 at risk
Haemodynamic instability	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0010 events0 affected2,037 at risk
Haemorrhage	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG00010 events10 affected1,996 at risk EG00113 events13 affected2,037 at risk
Hypertension	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG00088 events88 affected1,996 at risk EG00190 events90 affected2,037 at risk
Hypertensive crisis	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0011 events1 affected2,037 at risk
Hypotension	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG00023 events23 affected1,996 at risk EG00129 events28 affected2,037 at risk
Ischaemia	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0011 events1 affected2,037 at risk
Macroangiopathy	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0011 events1 affected2,037 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected1,996 at risk EG0014 events4 affected2,037 at risk
Peripheral artery dissection	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0012 events2 affected2,037 at risk
Peripheral artery thrombosis	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Peripheral coldness	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0012 events2 affected2,037 at risk
Peripheral embolism	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk
Phlebitis	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0004 events4 affected1,996 at risk EG0013 events3 affected2,037 at risk
Raynaud's phenomenon	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0011 events1 affected2,037 at risk
Reperfusion injury	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0003 events3 affected1,996 at risk EG0013 events3 affected2,037 at risk
Thrombophlebitis	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Thrombophlebitis superficial	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Thrombosis	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0007 events6 affected1,996 at risk EG0014 events4 affected2,037 at risk
Varicose vein ruptured	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Vascular occlusion	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0002 events2 affected1,996 at risk EG0011 events1 affected2,037 at risk
Vasospasm	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0003 events2 affected1,996 at risk EG0012 events2 affected2,037 at risk
Venous thrombosis	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0000 events0 affected1,996 at risk EG0011 events1 affected2,037 at risk
Venous thrombosis limb	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0001 events1 affected1,996 at risk EG0010 events0 affected2,037 at risk

ID	Term
D054058	Acute Coronary Syndrome
D006331	Heart Diseases
D000072658	Non-ST Elevated Myocardial Infarction

ID	Term
D017202	Myocardial Ischemia
D002318	Cardiovascular Diseases
D014652	Vascular Diseases
D009203	Myocardial Infarction
D007238	Infarction
D007511	Ischemia
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009336	Necrosis

ID	Term
D013876	Thiophenes
D013457	Sulfur Compounds
D009930	Organic Chemicals
D010879	Piperazines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds