Secondary Prevention of Cardiovascular Disease in the Eld... | NCT02596126

ID	Type	Description	Link
2015-002868-17	EudraCT Number

Status Module

Name	Class
Charite University, Berlin, Germany	OTHER
Centre Hospitalier Universitaire de Besancon	OTHER
Wroclaw Medical University	OTHER
Semmelweis University

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
Treatment Prevention for Secondary CV	Active Comparator	Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention according to the ESC guidelines. Drugs and doses will be left at the discretion of the treating physicians..	Drug: Treatment Prevention for Secondary CV
Cardiovascular Polypill	Experimental	Patients allocated to the experimental arm will receive a cardiovascular polypill containing aspirin 100 mg, atorvastatin (40 or 20 mg) and ramipril (2.5, 5 or 10 mg) taken orally once a day.	Drug: Cardiovascular Polypill

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cardiovascular Polypill	Drug	Cardiovascular Polypill contains Aspirin, Atorvastatin and Ramipril. Participants will receive one of the following cardiovascular polypill: (A) Aspirin 100 mg, Atorvastatin 40mg, and Ramipril (2.5 mg, or 5 mg, or 10mg). or (B) Aspirin 100 mg, Atorvastatin 20mg, and Ramipril (2.5 mg, or 5 mg, or 10mg).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Major Cardiovascular Adverse Events (MACE)	The incidence of the first occurrence of any component of the following composite endpoint, as adjudicated by the Clinical Events Committee: Cardiovascular death. Any nonfatal type 1 myocardial infarction. Any nonfatal ischemic stroke. Any urgent coronary revascularization not resulting in death.	Up to 5 years

Secondary Outcomes

Measure	Description	Time Frame
Efficacy Endpoints	Treatment adherence at 6 months measured using the Morisky-Medication Adherence Scale (8 item) Questionnaire (MMAS-8). Results: Low adherence (0-5); Medium adherence (6-7) and High adherence (8). The number and percentage of patients with low (0-5), medium (6-7) and high (8) adherence will be reported by treatment group.	6 months

Eligibility Module

Contacts/Locations Module

Overall Officials

Name	Affiliation	Role
Valentin Fuster, MD, PhD	Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III	Principal Investigator
Jose Maria Castellano Vazquez, MD, PhD	Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Všeobecná fakultní nemocnice v Praze		Prague	Prague	12808	Czechia
Fakultní nemocnice Královské Vinohrady

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36018037	Derived	Castellano JM, Pocock SJ, Bhatt DL, Quesada AJ, Owen R, Fernandez-Ortiz A, Sanchez PL, Marin Ortuno F, Vazquez Rodriguez JM, Domingo-Fernandez A, Lozano I, Roncaglioni MC, Baviera M, Foresta A, Ojeda-Fernandez L, Colivicchi F, Di Fusco SA, Doehner W, Meyer A, Schiele F, Ecarnot F, Linhart A, Lubanda JC, Barczi G, Merkely B, Ponikowski P, Kasprzak M, Fernandez Alvira JM, Andres V, Bueno H, Collier T, Van de Werf F, Perel P, Rodriguez-Manero M, Alonso Garcia A, Proietti M, Schoos MM, Simon T, Fernandez Ferro J, Lopez N, Beghi E, Bejot Y, Vivas D, Cordero A, Ibanez B, Fuster V; SECURE Investigators. Polypill Strategy in Secondary Cardiovascular Prevention. N Engl J Med. 2022 Sep 15;387(11):967-977. doi: 10.1056/NEJMoa2208275. Epub 2022 Aug 26.
34324628

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Treatment Prevention for Secondary CV	Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention according to the ESC guidelines. Drugs and doses will be left at the discretion of the treating physicians.. Treatment Prevention for Secondary CV: ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Sep 25, 2019	Oct 30, 2024

A total of 2499 participants (Treatment Prevention for Secondary CV - 1241; Cardiovascular Polypill - 1258) were included in the study. A total of 33 (Treatment Prevention for Secondary CV - 12; Cardiovascular Polypill - 21) participants were lost to follow-up as described in the "Results Participant Flow". The results were presented for a total of 1229 participants in the "Treatment Prevention for Secondary CV" and 1237 participants in the "Cardiovascular Polypill".

Arm/Group Information

ID	Title	Description
BG000	Treatment Prevention for Secondary CV	Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention according to the ESC guidelines. Drugs and doses will be left at the discretion of the treating physicians.. Treatment Prevention for Secondary CV: ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention.
BG001	Cardiovascular Polypill	Patients allocated to the experimental arm will receive a cardiovascular polypill containing aspirin 100 mg, atorvastatin (40 or 20 mg) and ramipril (2.5, 5 or 10 mg) taken orally once a day. Cardiovascular Polypill: Cardiovascular Polypill contains Aspirin, Atorvastatin and Ramipril. Participants will receive one of the following cardiovascular polypill: (A) Aspirin 100 mg, Atorvastatin 40mg, and Ramipril (2.5 mg, or 5 mg, or 10mg). or (B) Aspirin 100 mg, Atorvastatin 20mg, and Ramipril (2.5 mg, or 5 mg, or 10mg).
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

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

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000381 BG001384 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

Hungary

Title	Measurements
	BG00045 BG00145 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Major Cardiovascular Adverse Events (MACE)

The incidence of the first occurrence of any component of the following composite endpoint, as adjudicated by the Clinical Events Committee:

Cardiovascular death.
Any nonfatal type 1 myocardial infarction.
Any nonfatal ischemic stroke.
Any urgent coronary revascularization not resulting in death.

Posted

Number

number of adjudicated events

Up to 5 years

ID	Title	Description
OG000	Treatment Prevention for Secondary CV	Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention according to the ESC guidelines. Drugs and doses will be left at the discretion of the treating physicians.. Treatment Prevention for Secondary CV: ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention.
OG001	Cardiovascular Polypill	Patients allocated to the experimental arm will receive a cardiovascular polypill containing aspirin 100 mg, atorvastatin (40 or 20 mg) and ramipril (2.5, 5 or 10 mg) taken orally once a day. Cardiovascular Polypill: Cardiovascular Polypill contains Aspirin, Atorvastatin and Ramipril. Participants will receive one of the following cardiovascular polypill: (A) Aspirin 100 mg, Atorvastatin 40mg, and Ramipril (2.5 mg, or 5 mg, or 10mg). or (B) Aspirin 100 mg, Atorvastatin 20mg, and Ramipril (2.5 mg, or 5 mg, or 10mg).

Units	Counts
Participants	OG0001241 OG0011258

Title

Denominators

Categories

Title	Measurements
	OG000156 OG001118

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Regression, Cox		< 0.025		Hazard Ratio (HR)	0.76			2-Sided	95	0.6	0.96					Non-Inferiority	Non-inferiority hypothesis will be tested using a univariable Cox PH regression model including treatment group as the only covariate and stratified by country. One-sided non-inferiority test on the primary endpoint where the alpha level will be set to 2.5%. All statistical analyses will use 95% confidence intervals (CI). If the non-inferiority hypothesis is confirmed, it will be followed with a test of superiority using a log-rank test.

Secondary

Efficacy Endpoints

Treatment adherence at 6 months measured using the Morisky-Medication Adherence Scale (8 item) Questionnaire (MMAS-8). Results: Low adherence (0-5); Medium adherence (6-7) and High adherence (8). The number and percentage of patients with low (0-5), medium (6-7) and high (8) adherence will be reported by treatment group.

Posted

Number

percentage of participants

6 months

ID	Title	Description
OG000	Treatment Prevention for Secondary CV	Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention according to the ESC guidelines. Drugs and doses will be left at the discretion of the treating physicians.. Treatment Prevention for Secondary CV: ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention.
OG001	Cardiovascular Polypill	Patients allocated to the experimental arm will receive a cardiovascular polypill containing aspirin 100 mg, atorvastatin (40 or 20 mg) and ramipril (2.5, 5 or 10 mg) taken orally once a day. Cardiovascular Polypill: Cardiovascular Polypill contains Aspirin, Atorvastatin and Ramipril. Participants will receive one of the following cardiovascular polypill: (A) Aspirin 100 mg, Atorvastatin 40mg, and Ramipril (2.5 mg, or 5 mg, or 10mg). or (B) Aspirin 100 mg, Atorvastatin 20mg, and Ramipril (2.5 mg, or 5 mg, or 10mg).

Secondary

Safety Endpoints

All-cause mortality.

Posted

Number

number of events

Up to 5 Years

ID	Title	Description
OG000	Treatment Prevention for Secondary CV	Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention according to the ESC guidelines. Drugs and doses will be left at the discretion of the treating physicians.. Treatment Prevention for Secondary CV: ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention.
OG001	Cardiovascular Polypill	Patients allocated to the experimental arm will receive a cardiovascular polypill containing aspirin 100 mg, atorvastatin (40 or 20 mg) and ramipril (2.5, 5 or 10 mg) taken orally once a day. Cardiovascular Polypill: Cardiovascular Polypill contains Aspirin, Atorvastatin and Ramipril. Participants will receive one of the following cardiovascular polypill: (A) Aspirin 100 mg, Atorvastatin 40mg, and Ramipril (2.5 mg, or 5 mg, or 10mg). or (B) Aspirin 100 mg, Atorvastatin 20mg, and Ramipril (2.5 mg, or 5 mg, or 10mg).

Units	Counts
Participants

Secondary

Efficacy Endpoints

Treatment adherence at 24 months measured using the Morisky-Medication Adherence Scale (8 item) Questionnaire (MMAS-8). Results: Low adherence (0-5); Medium adherence (6-7) and High adherence (8). The number and percentage of patients with low (0-5), medium (6-7) and high (8) adherence will be reported by treatment group.

Posted

Number

percentage of participants

2 years

ID	Title	Description
OG000	Treatment Prevention for Secondary CV	Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention according to the ESC guidelines. Drugs and doses will be left at the discretion of the treating physicians.. Treatment Prevention for Secondary CV: ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention.
OG001	Cardiovascular Polypill	Patients allocated to the experimental arm will receive a cardiovascular polypill containing aspirin 100 mg, atorvastatin (40 or 20 mg) and ramipril (2.5, 5 or 10 mg) taken orally once a day. Cardiovascular Polypill: Cardiovascular Polypill contains Aspirin, Atorvastatin and Ramipril. Participants will receive one of the following cardiovascular polypill: (A) Aspirin 100 mg, Atorvastatin 40mg, and Ramipril (2.5 mg, or 5 mg, or 10mg). or (B) Aspirin 100 mg, Atorvastatin 20mg, and Ramipril (2.5 mg, or 5 mg, or 10mg).

Secondary

Efficacy Endpoints

The systolic Blood Pressure measured in millimeters of mercury (mmHg) at visit 1 (6 months). Mean and standard deviation will be reported by treatment group.

Posted

Mean

Standard Deviation

millimeters of mercury (mmHg)

6 months

ID	Title	Description
OG000	Treatment Prevention for Secondary CV	Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention according to the ESC guidelines. Drugs and doses will be left at the discretion of the treating physicians.. Treatment Prevention for Secondary CV: ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention.
OG001	Cardiovascular Polypill	Patients allocated to the experimental arm will receive a cardiovascular polypill containing aspirin 100 mg, atorvastatin (40 or 20 mg) and ramipril (2.5, 5 or 10 mg) taken orally once a day. Cardiovascular Polypill: Cardiovascular Polypill contains Aspirin, Atorvastatin and Ramipril. Participants will receive one of the following cardiovascular polypill: (A) Aspirin 100 mg, Atorvastatin 40mg, and Ramipril (2.5 mg, or 5 mg, or 10mg). or (B) Aspirin 100 mg, Atorvastatin 20mg, and Ramipril (2.5 mg, or 5 mg, or 10mg).

Secondary

Efficacy Endpoints

The systolic Blood Pressure measured in millimeters of mercury (mmHg) at visit 2 (12 months). Mean and standard deviation will be reported by treatment group.

Posted

Mean

Standard Deviation

millimeters of mercury (mmHg)

12 months

ID	Title	Description
OG000	Treatment Prevention for Secondary CV	Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention according to the ESC guidelines. Drugs and doses will be left at the discretion of the treating physicians.. Treatment Prevention for Secondary CV: ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention.
OG001	Cardiovascular Polypill	Patients allocated to the experimental arm will receive a cardiovascular polypill containing aspirin 100 mg, atorvastatin (40 or 20 mg) and ramipril (2.5, 5 or 10 mg) taken orally once a day. Cardiovascular Polypill: Cardiovascular Polypill contains Aspirin, Atorvastatin and Ramipril. Participants will receive one of the following cardiovascular polypill: (A) Aspirin 100 mg, Atorvastatin 40mg, and Ramipril (2.5 mg, or 5 mg, or 10mg). or (B) Aspirin 100 mg, Atorvastatin 20mg, and Ramipril (2.5 mg, or 5 mg, or 10mg).

Secondary

Efficacy Endpoints

The systolic Blood Pressure measured in millimeters of mercury (mmHg) at visit 3 (24 months). Mean and standard deviation will be reported by treatment group.

Posted

Mean

Standard Deviation

millimeters of mercury (mmHg)

2 years

ID	Title	Description
OG000	Treatment Prevention for Secondary CV	Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention according to the ESC guidelines. Drugs and doses will be left at the discretion of the treating physicians.. Treatment Prevention for Secondary CV: ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention.
OG001	Cardiovascular Polypill	Patients allocated to the experimental arm will receive a cardiovascular polypill containing aspirin 100 mg, atorvastatin (40 or 20 mg) and ramipril (2.5, 5 or 10 mg) taken orally once a day. Cardiovascular Polypill: Cardiovascular Polypill contains Aspirin, Atorvastatin and Ramipril. Participants will receive one of the following cardiovascular polypill: (A) Aspirin 100 mg, Atorvastatin 40mg, and Ramipril (2.5 mg, or 5 mg, or 10mg). or (B) Aspirin 100 mg, Atorvastatin 20mg, and Ramipril (2.5 mg, or 5 mg, or 10mg).

Secondary

Efficacy Endpoints

The Diastolic Blood Pressure measured in millimeters of mercury (mmHg) at visit 1 (6 months). Mean and standard deviation will be reported by treatment group. The frequency, mean and standard deviation at each visit will be reported by treatment group.

Posted

Mean

Standard Deviation

millimeters of mercury (mmHg)

6 months

ID	Title	Description
OG000	Treatment Prevention for Secondary CV	Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention according to the ESC guidelines. Drugs and doses will be left at the discretion of the treating physicians.. Treatment Prevention for Secondary CV: ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention.
OG001	Cardiovascular Polypill	Patients allocated to the experimental arm will receive a cardiovascular polypill containing aspirin 100 mg, atorvastatin (40 or 20 mg) and ramipril (2.5, 5 or 10 mg) taken orally once a day. Cardiovascular Polypill: Cardiovascular Polypill contains Aspirin, Atorvastatin and Ramipril. Participants will receive one of the following cardiovascular polypill: (A) Aspirin 100 mg, Atorvastatin 40mg, and Ramipril (2.5 mg, or 5 mg, or 10mg). or (B) Aspirin 100 mg, Atorvastatin 20mg, and Ramipril (2.5 mg, or 5 mg, or 10mg).

Secondary

Efficacy Endpoints

The Diastolic Blood Pressure measured in millimeters of mercury (mmHg) at visit 2 (12 months). Mean and standard deviation will be reported by treatment group. The frequency, mean and standard deviation at each visit will be reported by treatment group.

Posted

Mean

Standard Deviation

millimeters of mercury (mmHg)

12 months

ID	Title	Description
OG000	Treatment Prevention for Secondary CV	Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention according to the ESC guidelines. Drugs and doses will be left at the discretion of the treating physicians.. Treatment Prevention for Secondary CV: ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention.
OG001	Cardiovascular Polypill	Patients allocated to the experimental arm will receive a cardiovascular polypill containing aspirin 100 mg, atorvastatin (40 or 20 mg) and ramipril (2.5, 5 or 10 mg) taken orally once a day. Cardiovascular Polypill: Cardiovascular Polypill contains Aspirin, Atorvastatin and Ramipril. Participants will receive one of the following cardiovascular polypill: (A) Aspirin 100 mg, Atorvastatin 40mg, and Ramipril (2.5 mg, or 5 mg, or 10mg). or (B) Aspirin 100 mg, Atorvastatin 20mg, and Ramipril (2.5 mg, or 5 mg, or 10mg).

Secondary

Efficacy Endpoints

The Diastolic Blood Pressure measured in millimeters of mercury (mmHg) at visit 3 (24 months). Mean and standard deviation will be reported by treatment group. The frequency, mean and standard deviation at each visit will be reported by treatment group.

Posted

Mean

Standard Deviation

millimeters of mercury (mmHg)

2 years

ID	Title	Description
OG000	Treatment Prevention for Secondary CV	Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention according to the ESC guidelines. Drugs and doses will be left at the discretion of the treating physicians.. Treatment Prevention for Secondary CV: ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention.
OG001	Cardiovascular Polypill	Patients allocated to the experimental arm will receive a cardiovascular polypill containing aspirin 100 mg, atorvastatin (40 or 20 mg) and ramipril (2.5, 5 or 10 mg) taken orally once a day. Cardiovascular Polypill: Cardiovascular Polypill contains Aspirin, Atorvastatin and Ramipril. Participants will receive one of the following cardiovascular polypill: (A) Aspirin 100 mg, Atorvastatin 40mg, and Ramipril (2.5 mg, or 5 mg, or 10mg). or (B) Aspirin 100 mg, Atorvastatin 20mg, and Ramipril (2.5 mg, or 5 mg, or 10mg).

Secondary

Efficacy Endpoints

Low-density lipoprotein (LDL) cholesterol levels measured in mg/dL at visit 2 (12 months). Mean and standard deviation will be reported by treatment group. The frequency, mean and standard deviation at each visit will be reported by treatment group.

Posted

Mean

Standard Deviation

mg/dL

12 months

ID	Title	Description
OG000	Treatment Prevention for Secondary CV	Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention according to the ESC guidelines. Drugs and doses will be left at the discretion of the treating physicians.. Treatment Prevention for Secondary CV: ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention.
OG001	Cardiovascular Polypill	Patients allocated to the experimental arm will receive a cardiovascular polypill containing aspirin 100 mg, atorvastatin (40 or 20 mg) and ramipril (2.5, 5 or 10 mg) taken orally once a day. Cardiovascular Polypill: Cardiovascular Polypill contains Aspirin, Atorvastatin and Ramipril. Participants will receive one of the following cardiovascular polypill: (A) Aspirin 100 mg, Atorvastatin 40mg, and Ramipril (2.5 mg, or 5 mg, or 10mg). or (B) Aspirin 100 mg, Atorvastatin 20mg, and Ramipril (2.5 mg, or 5 mg, or 10mg).

Secondary

Efficacy Endpoints

Low-density lipoprotein (LDL) cholesterol levels measured in mg/dL at visit 3 (24 months). Mean and standard deviation will be reported by treatment group. The frequency, mean and standard deviation at each visit will be reported by treatment group.

Posted

Mean

Standard Deviation

mg/dL

2 years

ID	Title	Description
OG000	Treatment Prevention for Secondary CV	Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention according to the ESC guidelines. Drugs and doses will be left at the discretion of the treating physicians.. Treatment Prevention for Secondary CV: ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention.
OG001	Cardiovascular Polypill	Patients allocated to the experimental arm will receive a cardiovascular polypill containing aspirin 100 mg, atorvastatin (40 or 20 mg) and ramipril (2.5, 5 or 10 mg) taken orally once a day. Cardiovascular Polypill: Cardiovascular Polypill contains Aspirin, Atorvastatin and Ramipril. Participants will receive one of the following cardiovascular polypill: (A) Aspirin 100 mg, Atorvastatin 40mg, and Ramipril (2.5 mg, or 5 mg, or 10mg). or (B) Aspirin 100 mg, Atorvastatin 20mg, and Ramipril (2.5 mg, or 5 mg, or 10mg).

Secondary

Efficacy Endpoints

The incidence of the first occurrence of any component of the following composite endpoint, as adjudicated by the Clinical Events Committee: Cardiovascular death (CV death); Acute Myocardial Infarction (MI) type 1; stroke. Measured in number of cases.

Posted

Number

number of events

Up to 5 years

ID	Title	Description
OG000	Treatment Prevention for Secondary CV	Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention according to the ESC guidelines. Drugs and doses will be left at the discretion of the treating physicians.. Treatment Prevention for Secondary CV: ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention.
OG001	Cardiovascular Polypill	Patients allocated to the experimental arm will receive a cardiovascular polypill containing aspirin 100 mg, atorvastatin (40 or 20 mg) and ramipril (2.5, 5 or 10 mg) taken orally once a day. Cardiovascular Polypill: Cardiovascular Polypill contains Aspirin, Atorvastatin and Ramipril. Participants will receive one of the following cardiovascular polypill: (A) Aspirin 100 mg, Atorvastatin 40mg, and Ramipril (2.5 mg, or 5 mg, or 10mg). or (B) Aspirin 100 mg, Atorvastatin 20mg, and Ramipril (2.5 mg, or 5 mg, or 10mg).

Secondary

Efficacy Endpoints

The incidence of the first occurrence of the Cardiovascular (CV) death. Measured in number of cases.

Posted

Number

number of events

Up to 5 years

ID	Title	Description
OG000	Treatment Prevention for Secondary CV	Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention according to the ESC guidelines. Drugs and doses will be left at the discretion of the treating physicians.. Treatment Prevention for Secondary CV: ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention.
OG001	Cardiovascular Polypill	Patients allocated to the experimental arm will receive a cardiovascular polypill containing aspirin 100 mg, atorvastatin (40 or 20 mg) and ramipril (2.5, 5 or 10 mg) taken orally once a day. Cardiovascular Polypill: Cardiovascular Polypill contains Aspirin, Atorvastatin and Ramipril. Participants will receive one of the following cardiovascular polypill: (A) Aspirin 100 mg, Atorvastatin 40mg, and Ramipril (2.5 mg, or 5 mg, or 10mg). or (B) Aspirin 100 mg, Atorvastatin 20mg, and Ramipril (2.5 mg, or 5 mg, or 10mg).

Units	Counts

Secondary

Efficacy Endpoints

The incidence of the first occurrence of of the Nonfatal type 1 myocardial infarction. Measured in number of cases.

Posted

Number

number of events

Up to 5 years

ID	Title	Description
OG000	Treatment Prevention for Secondary CV	Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention according to the ESC guidelines. Drugs and doses will be left at the discretion of the treating physicians.. Treatment Prevention for Secondary CV: ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention.
OG001	Cardiovascular Polypill	Patients allocated to the experimental arm will receive a cardiovascular polypill containing aspirin 100 mg, atorvastatin (40 or 20 mg) and ramipril (2.5, 5 or 10 mg) taken orally once a day. Cardiovascular Polypill: Cardiovascular Polypill contains Aspirin, Atorvastatin and Ramipril. Participants will receive one of the following cardiovascular polypill: (A) Aspirin 100 mg, Atorvastatin 40mg, and Ramipril (2.5 mg, or 5 mg, or 10mg). or (B) Aspirin 100 mg, Atorvastatin 20mg, and Ramipril (2.5 mg, or 5 mg, or 10mg).

Units	Counts

Secondary

Efficacy Endpoints

The incidence of the first occurrence of the Nonfatal ischemic stroke. Measured in number of cases.

Posted

Number

number of events

Up to 5 years

ID	Title	Description
OG000	Treatment Prevention for Secondary CV	Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention according to the ESC guidelines. Drugs and doses will be left at the discretion of the treating physicians.. Treatment Prevention for Secondary CV: ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention.
OG001	Cardiovascular Polypill	Patients allocated to the experimental arm will receive a cardiovascular polypill containing aspirin 100 mg, atorvastatin (40 or 20 mg) and ramipril (2.5, 5 or 10 mg) taken orally once a day. Cardiovascular Polypill: Cardiovascular Polypill contains Aspirin, Atorvastatin and Ramipril. Participants will receive one of the following cardiovascular polypill: (A) Aspirin 100 mg, Atorvastatin 40mg, and Ramipril (2.5 mg, or 5 mg, or 10mg). or (B) Aspirin 100 mg, Atorvastatin 20mg, and Ramipril (2.5 mg, or 5 mg, or 10mg).

Units	Counts

Secondary

Efficacy Endpoints

The incidence of the first occurrence of the Urgent coronary revascularization. Measured in number of cases.

Posted

Number

number of events

Up to 5 years

ID	Title	Description
OG000	Treatment Prevention for Secondary CV	Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention according to the ESC guidelines. Drugs and doses will be left at the discretion of the treating physicians.. Treatment Prevention for Secondary CV: ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention.
OG001	Cardiovascular Polypill	Patients allocated to the experimental arm will receive a cardiovascular polypill containing aspirin 100 mg, atorvastatin (40 or 20 mg) and ramipril (2.5, 5 or 10 mg) taken orally once a day. Cardiovascular Polypill: Cardiovascular Polypill contains Aspirin, Atorvastatin and Ramipril. Participants will receive one of the following cardiovascular polypill: (A) Aspirin 100 mg, Atorvastatin 40mg, and Ramipril (2.5 mg, or 5 mg, or 10mg). or (B) Aspirin 100 mg, Atorvastatin 20mg, and Ramipril (2.5 mg, or 5 mg, or 10mg).

Units	Counts

Secondary

Efficacy Endpoints

Domain "effectiveness" of the Patient satisfaction measured at visit 1 (6 months) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument. The TSQM (version 1.4) has 14 questions divided into 4 domains: effectiveness (items 1 to 3), side effects (items 4 to 8), convenience (items 9 to 11), and global satisfaction (items 12 to 14). In this domain (effectiveness) the response was measured on a Likert-type scale of 5 or 7 points. The score is computed by summing the individual TSQM items and then transforming the composite score into a value ranging from 0 to 100, with 0 indicating complete dissatisfaction and 100 indicating complete satisfaction (higher scores reflect higher patient satisfaction with medication).

Posted

Mean

Standard Deviation

score on a scale

6 months

ID	Title	Description
OG000	Treatment Prevention for Secondary CV	Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention according to the ESC guidelines. Drugs and doses will be left at the discretion of the treating physicians.. Treatment Prevention for Secondary CV: ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention.
OG001	Cardiovascular Polypill	Patients allocated to the experimental arm will receive a cardiovascular polypill containing aspirin 100 mg, atorvastatin (40 or 20 mg) and ramipril (2.5, 5 or 10 mg) taken orally once a day. Cardiovascular Polypill: Cardiovascular Polypill contains Aspirin, Atorvastatin and Ramipril. Participants will receive one of the following cardiovascular polypill: (A) Aspirin 100 mg, Atorvastatin 40mg, and Ramipril (2.5 mg, or 5 mg, or 10mg). or (B) Aspirin 100 mg, Atorvastatin 20mg, and Ramipril (2.5 mg, or 5 mg, or 10mg).

Secondary

Efficacy Endpoints

Domain "Side effects score" of the Patient satisfaction measured at visit 1 (6 months) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument. The TSQM has 14 questions divided into 4 domains: effectiveness (items 1 to 3), side effects (items 4 to 8), convenience (items 9 to 11), and global satisfaction (items 12 to 14). In this domain the response was on a Likert-type scale of 5 or 7 points, except for question 4 which a yes/no question about the presence of side effects is asked. If the answer to this question is no (no side effects reported by the participant), other questions will not be asked (questions 5 to 8), and the total score is automatically computed as the maximum of 100. The score is computed by summing the individual TSQM items and then transforming the composite score into a value ranging from 0 to 100, with 0 indicating complete dissatisfaction and 100 indicating complete satisfaction.

Posted

Mean

Standard Deviation

score on a scale

6 months

ID	Title	Description
OG000	Treatment Prevention for Secondary CV	Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention according to the ESC guidelines. Drugs and doses will be left at the discretion of the treating physicians.. Treatment Prevention for Secondary CV: ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention.
OG001	Cardiovascular Polypill

Secondary

Efficacy Endpoints

Domain "Convenience score" of the Patient satisfaction measured at visit 1 (6 months) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument. The TSQM (version 1.4) has 14 questions divided into 4 domains: effectiveness (items 1 to 3), side effects (items 4 to 8), convenience (items 9 to 11), and global satisfaction (items 12 to 14). In this domain (Convenience score) the response was measured on a Likert-type scale of 5 or 7 points. The score is computed by summing the individual TSQM items and then transforming the composite score into a value ranging from 0 to 100, with 0 indicating complete dissatisfaction and 100 indicating complete satisfaction (higher scores reflect higher patient satisfaction with medication).

Posted

Mean

Standard Deviation

score on a scale

6 months

ID	Title	Description
OG000	Treatment Prevention for Secondary CV	Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention according to the ESC guidelines. Drugs and doses will be left at the discretion of the treating physicians.. Treatment Prevention for Secondary CV: ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention.
OG001	Cardiovascular Polypill	Patients allocated to the experimental arm will receive a cardiovascular polypill containing aspirin 100 mg, atorvastatin (40 or 20 mg) and ramipril (2.5, 5 or 10 mg) taken orally once a day. Cardiovascular Polypill: Cardiovascular Polypill contains Aspirin, Atorvastatin and Ramipril. Participants will receive one of the following cardiovascular polypill: (A) Aspirin 100 mg, Atorvastatin 40mg, and Ramipril (2.5 mg, or 5 mg, or 10mg). or (B) Aspirin 100 mg, Atorvastatin 20mg, and Ramipril (2.5 mg, or 5 mg, or 10mg).

Secondary

Efficacy Endpoints

Domain "Global satisfaction score" of the Patient satisfaction measured at visit 1 (6 months) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument. The TSQM (version 1.4) has 14 questions divided into 4 domains: effectiveness (items 1 to 3), side effects (items 4 to 8), convenience (items 9 to 11), and global satisfaction (items 12 to 14). In this domain (Global satisfaction score) the response was measured on a Likert-type scale of 5 or 7 points. The score is computed by summing the individual TSQM items and then transforming the composite score into a value ranging from 0 to 100, with 0 indicating complete dissatisfaction and 100 indicating complete satisfaction (higher scores reflect higher patient satisfaction with medication).

Posted

Mean

Standard Deviation

score on a scale

6 months

ID	Title	Description
OG000	Treatment Prevention for Secondary CV	Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention according to the ESC guidelines. Drugs and doses will be left at the discretion of the treating physicians.. Treatment Prevention for Secondary CV: ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention.
OG001	Cardiovascular Polypill	Patients allocated to the experimental arm will receive a cardiovascular polypill containing aspirin 100 mg, atorvastatin (40 or 20 mg) and ramipril (2.5, 5 or 10 mg) taken orally once a day. Cardiovascular Polypill: Cardiovascular Polypill contains Aspirin, Atorvastatin and Ramipril. Participants will receive one of the following cardiovascular polypill: (A) Aspirin 100 mg, Atorvastatin 40mg, and Ramipril (2.5 mg, or 5 mg, or 10mg). or (B) Aspirin 100 mg, Atorvastatin 20mg, and Ramipril (2.5 mg, or 5 mg, or 10mg).

Secondary

Efficacy Endpoints

Domain "effectiveness" of the Patient satisfaction measured at visit 3 (24 months) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument. The TSQM (version 1.4) has 14 questions divided into 4 domains: effectiveness (items 1 to 3), side effects (items 4 to 8), convenience (items 9 to 11), and global satisfaction (items 12 to 14). In this domain (effectiveness) the response was measured on a Likert-type scale of 5 or 7 points. The score is computed by summing the individual TSQM items and then transforming the composite score into a value ranging from 0 to 100, with 0 indicating complete dissatisfaction and 100 indicating complete satisfaction (higher scores reflect higher patient satisfaction with medication).

Posted

Mean

Standard Deviation

score on a scale

24 months

ID	Title	Description
OG000	Treatment Prevention for Secondary CV	Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention according to the ESC guidelines. Drugs and doses will be left at the discretion of the treating physicians.. Treatment Prevention for Secondary CV: ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention.
OG001	Cardiovascular Polypill	Patients allocated to the experimental arm will receive a cardiovascular polypill containing aspirin 100 mg, atorvastatin (40 or 20 mg) and ramipril (2.5, 5 or 10 mg) taken orally once a day. Cardiovascular Polypill: Cardiovascular Polypill contains Aspirin, Atorvastatin and Ramipril. Participants will receive one of the following cardiovascular polypill: (A) Aspirin 100 mg, Atorvastatin 40mg, and Ramipril (2.5 mg, or 5 mg, or 10mg). or (B) Aspirin 100 mg, Atorvastatin 20mg, and Ramipril (2.5 mg, or 5 mg, or 10mg).

Secondary

Efficacy Endpoints

Domain "Side effects score" of the Patient satisfaction measured at visit 3 (24 months) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument. The TSQM has 14 questions divided into 4 domains: effectiveness (items 1 to 3), side effects (items 4 to 8), convenience (items 9 to 11), and global satisfaction (items 12 to 14). In this domain (Side effects score) the response was on a Likert-type scale of 5 or 7 points, except for question 4 which a yes/no question about the presence of side effects is asked. If the answer to this question is no (no side effects reported by the participant), other questions will not be asked (questions 5 to 8), and the total score is automatically computed as the maximum of 100. The score is computed by summing the individual TSQM items and then transforming the composite score into a value ranging from 0 to 100, with 0 indicating complete dissatisfaction and 100 indicating complete satisfaction.

Posted

Mean

Standard Deviation

score on a scale

24 months

ID	Title	Description
OG000	Treatment Prevention for Secondary CV	Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention according to the ESC guidelines. Drugs and doses will be left at the discretion of the treating physicians.. Treatment Prevention for Secondary CV: ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention.
OG001	Cardiovascular Polypill

Secondary

Efficacy Endpoints

Domain "Convenience score" of the Patient satisfaction measured at visit 3 (24 months) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument. The TSQM (version 1.4) has 14 questions divided into 4 domains: effectiveness (items 1 to 3), side effects (items 4 to 8), convenience (items 9 to 11), and global satisfaction (items 12 to 14). In this domain (Convenience score) the response was measured on a Likert-type scale of 5 or 7 points. The score is computed by summing the individual TSQM items and then transforming the composite score into a value ranging from 0 to 100, with 0 indicating complete dissatisfaction and 100 indicating complete satisfaction (higher scores reflect higher patient satisfaction with medication).

Posted

Mean

Standard Deviation

score on a scale

24 months

ID	Title	Description
OG000	Treatment Prevention for Secondary CV	Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention according to the ESC guidelines. Drugs and doses will be left at the discretion of the treating physicians.. Treatment Prevention for Secondary CV: ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention.
OG001	Cardiovascular Polypill	Patients allocated to the experimental arm will receive a cardiovascular polypill containing aspirin 100 mg, atorvastatin (40 or 20 mg) and ramipril (2.5, 5 or 10 mg) taken orally once a day. Cardiovascular Polypill: Cardiovascular Polypill contains Aspirin, Atorvastatin and Ramipril. Participants will receive one of the following cardiovascular polypill: (A) Aspirin 100 mg, Atorvastatin 40mg, and Ramipril (2.5 mg, or 5 mg, or 10mg). or (B) Aspirin 100 mg, Atorvastatin 20mg, and Ramipril (2.5 mg, or 5 mg, or 10mg).

Secondary

Efficacy Endpoints

Domain "Global satisfaction score" of the Patient satisfaction measured at visit 3 (24 months) using the Treatment Satisfaction Questionnaire for Medication (TSQM) version 1.4 a 14-item psychometric instrument. The TSQM (version 1.4) has 14 questions divided into 4 domains: effectiveness (items 1 to 3), side effects (items 4 to 8), convenience (items 9 to 11), and global satisfaction (items 12 to 14). In this domain (Global satisfaction score) the response was measured on a Likert-type scale of 5 or 7 points. The score is computed by summing the individual TSQM items and then transforming the composite score into a value ranging from 0 to 100, with 0 indicating complete dissatisfaction and 100 indicating complete satisfaction (higher scores reflect higher patient satisfaction with medication).

Posted

Mean

Standard Deviation

score on a scale

24 months

ID	Title	Description
OG000	Treatment Prevention for Secondary CV	Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention according to the ESC guidelines. Drugs and doses will be left at the discretion of the treating physicians.. Treatment Prevention for Secondary CV: ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention.
OG001	Cardiovascular Polypill	Patients allocated to the experimental arm will receive a cardiovascular polypill containing aspirin 100 mg, atorvastatin (40 or 20 mg) and ramipril (2.5, 5 or 10 mg) taken orally once a day. Cardiovascular Polypill: Cardiovascular Polypill contains Aspirin, Atorvastatin and Ramipril. Participants will receive one of the following cardiovascular polypill: (A) Aspirin 100 mg, Atorvastatin 40mg, and Ramipril (2.5 mg, or 5 mg, or 10mg). or (B) Aspirin 100 mg, Atorvastatin 20mg, and Ramipril (2.5 mg, or 5 mg, or 10mg).

Secondary

Safety Endpoints

The incidence of the first occurrence of the Non-cardiovascular death. Measured in number of cases.

Posted

Number

number of events

Up to 5 Years

ID	Title	Description
OG000	Treatment Prevention for Secondary CV	Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention according to the ESC guidelines. Drugs and doses will be left at the discretion of the treating physicians.. Treatment Prevention for Secondary CV: ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention.
OG001	Cardiovascular Polypill	Patients allocated to the experimental arm will receive a cardiovascular polypill containing aspirin 100 mg, atorvastatin (40 or 20 mg) and ramipril (2.5, 5 or 10 mg) taken orally once a day. Cardiovascular Polypill: Cardiovascular Polypill contains Aspirin, Atorvastatin and Ramipril. Participants will receive one of the following cardiovascular polypill: (A) Aspirin 100 mg, Atorvastatin 40mg, and Ramipril (2.5 mg, or 5 mg, or 10mg). or (B) Aspirin 100 mg, Atorvastatin 20mg, and Ramipril (2.5 mg, or 5 mg, or 10mg).

Units	Counts

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Treatment Prevention for Secondary CV	Patients allocated to the usual care arm will receive standard of care therapies for secondary prevention according to the ESC guidelines. Drugs and doses will be left at the discretion of the treating physicians.. Treatment Prevention for Secondary CV: ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention.	117	1,229	220	1,229	388	1,229
EG001	Cardiovascular Polypill	Patients allocated to the experimental arm will receive a cardiovascular polypill containing aspirin 100 mg, atorvastatin (40 or 20 mg) and ramipril (2.5, 5 or 10 mg) taken orally once a day. Cardiovascular Polypill: Cardiovascular Polypill contains Aspirin, Atorvastatin and Ramipril. Participants will receive one of the following cardiovascular polypill: (A) Aspirin 100 mg, Atorvastatin 40mg, and Ramipril (2.5 mg, or 5 mg, or 10mg). or (B) Aspirin 100 mg, Atorvastatin 20mg, and Ramipril (2.5 mg, or 5 mg, or 10mg).	115	1,237	248	1,237	404	1,237

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
abdominal pain	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
abscess	Infections and infestations	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
abscess drainage	Surgical and medical procedures	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
accelerated hypertension	Vascular disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
acute cholecystitis	Hepatobiliary disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
acute coronary syndrome	Cardiac disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0012 events1 affected1,237 at risk
acute heart failure	Cardiac disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
acute kidney failure	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
acute kidney injury	Renal and urinary disorders	Systematic Assessment	EG0009 events9 affected1,229 at risk EG0019 events9 affected1,237 at risk
acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0011 events1 affected1,237 at risk
acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
acute respiratory failure	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 events2 affected1,229 at risk EG0010 events0 affected1,237 at risk
adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
adverse drug reaction	General disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
allergy to arthropod sting	Immune system disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
anaemia	Blood and lymphatic system disorders	Systematic Assessment	EG00010 events9 affected1,229 at risk EG00110 events10 affected1,237 at risk
angina pectoris	Cardiac disorders	Systematic Assessment	EG0003 events2 affected1,229 at risk EG0013 events3 affected1,237 at risk
angina unstable	Cardiac disorders	Systematic Assessment	EG0002 events2 affected1,229 at risk EG0011 events1 affected1,237 at risk
angioedema	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
arthralgia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
arthritis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
asthenia	General disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
atrial fibrillation	Cardiac disorders	Systematic Assessment	EG0002 events2 affected1,229 at risk EG0010 events0 affected1,237 at risk
atrioventricular block complete	Cardiac disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0012 events2 affected1,237 at risk
back pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0002 events2 affected1,229 at risk EG0013 events3 affected1,237 at risk
bacteraemia	Infections and infestations	Systematic Assessment	EG0003 events2 affected1,229 at risk EG0012 events2 affected1,237 at risk
benign gastric neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
benign neoplasm of testis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
benign prostatic hyperplasia	Reproductive system and breast disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
biliary obstruction	Hepatobiliary disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0011 events1 affected1,237 at risk
biliary sepsis	Infections and infestations	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0012 events2 affected1,237 at risk
bladder cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
blood creatine phosphokinase increased	Investigations	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
bone cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
bone pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
bradycardia	Cardiac disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
brain neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0013 events3 affected1,237 at risk
breast cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
bronchitis	Infections and infestations	Systematic Assessment	EG0004 events4 affected1,229 at risk EG0012 events2 affected1,237 at risk
bronchitis chronic	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
cachexia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
calculus bladder	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
campylobacter infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
carcinoid tumour pulmonary	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
cardiac arrest	Cardiac disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0012 events2 affected1,237 at risk
cardiac failure	Cardiac disorders	Systematic Assessment	EG0002 events1 affected1,229 at risk EG0019 events8 affected1,237 at risk
cardiac failure acute	Cardiac disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0011 events1 affected1,237 at risk
cardiac failure chronic	Cardiac disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
cardiac failure congestive	Cardiac disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
cardio-respiratory arrest	Cardiac disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
cardiorenal syndrome	Cardiac disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
cellulitis	Infections and infestations	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
cerebral circulatory failure	Nervous system disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
cerebral haemorrhage	Nervous system disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
cervix carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
chest pain	General disorders	Systematic Assessment	EG00016 events15 affected1,229 at risk EG00111 events10 affected1,237 at risk
cholangitis	Hepatobiliary disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0014 events3 affected1,237 at risk
cholangitis acute	Hepatobiliary disorders	Systematic Assessment	EG0002 events2 affected1,229 at risk EG0011 events1 affected1,237 at risk
cholecystitis	Hepatobiliary disorders	Systematic Assessment	EG0002 events2 affected1,229 at risk EG0010 events0 affected1,237 at risk
cholecystitis acute	Hepatobiliary disorders	Systematic Assessment	EG0004 events4 affected1,229 at risk EG0012 events2 affected1,237 at risk
cholelithiasis	Hepatobiliary disorders	Systematic Assessment	EG0003 events3 affected1,229 at risk EG0013 events2 affected1,237 at risk
cholestasis	Hepatobiliary disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
chronic kidney disease	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0012 events2 affected1,237 at risk
chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0017 events4 affected1,237 at risk
colectomy	Surgical and medical procedures	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
colitis	Gastrointestinal disorders	Systematic Assessment	EG0003 events3 affected1,229 at risk EG0012 events2 affected1,237 at risk
colitis ischaemic	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
colitis ulcerative	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0003 events3 affected1,229 at risk EG0010 events0 affected1,237 at risk
colorectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0003 events3 affected1,229 at risk EG0010 events0 affected1,237 at risk
complicated fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
confusional state	Nervous system disorders	Systematic Assessment	EG0002 events2 affected1,229 at risk EG0011 events1 affected1,237 at risk
cough	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0013 events3 affected1,237 at risk
covid-19	Infections and infestations	Systematic Assessment	EG0005 events5 affected1,229 at risk EG0019 events9 affected1,237 at risk
covid-19 pneumonia	Infections and infestations	Systematic Assessment	EG00011 events10 affected1,229 at risk EG00111 events11 affected1,237 at risk
craniocerebral injury	Injury, poisoning and procedural complications	Systematic Assessment	EG0002 events2 affected1,229 at risk EG0010 events0 affected1,237 at risk
deep vein thrombosis	Vascular disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
dementia of the alzheimer's type, with depressed mood	Nervous system disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
dermatitis atopic	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
dermo-hypodermitis	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
device dislocation	Product Issues	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
device related infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
diabetes mellitus inadequate control	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
diabetic complication(hlgt)	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0011 events1 affected1,237 at risk
diabetic foot	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
diarrhoea	Gastrointestinal disorders	Systematic Assessment	EG0004 events3 affected1,229 at risk EG0013 events3 affected1,237 at risk
dizziness	Nervous system disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
dressler's syndrome	Immune system disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
drug-induced liver injury	Hepatobiliary disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
dyspnoea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 events2 affected1,229 at risk EG0015 events5 affected1,237 at risk
dysuria	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
endocarditis	Infections and infestations	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0011 events1 affected1,237 at risk
endometrial adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
epistaxis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0003 events3 affected1,229 at risk EG0011 events1 affected1,237 at risk
erysipelas	Infections and infestations	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
escherichia sepsis	Infections and infestations	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0012 events2 affected1,237 at risk
extradural haematoma	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
faecalith	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
fall	Injury, poisoning and procedural complications	Systematic Assessment	EG0004 events4 affected1,229 at risk EG0011 events1 affected1,237 at risk
femur fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0003 events3 affected1,229 at risk EG0016 events6 affected1,237 at risk
gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0011 events1 affected1,237 at risk
gastric ulcer haemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0011 events1 affected1,237 at risk
gastroenteritis	Infections and infestations	Systematic Assessment	EG0002 events2 affected1,229 at risk EG0011 events1 affected1,237 at risk
gastroenteritis norovirus	Infections and infestations	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
gastrointestinal haemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0005 events4 affected1,229 at risk EG0018 events8 affected1,237 at risk
gastrointestinal necrosis	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
gastrointestinal vascular occlusion and infarction (hlt)	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
general physical health deterioration	General disorders	Systematic Assessment	EG0003 events3 affected1,229 at risk EG0011 events1 affected1,237 at risk
genitourinary tract neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
gouty arthritis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
haematemesis	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
haematochezia	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected1,229 at risk EG0011 events1 affected1,237 at risk
haematoma	Vascular disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0012 events2 affected1,237 at risk
haematoma infection	Infections and infestations	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
haematoma muscle	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
haematuria	Renal and urinary disorders	Systematic Assessment	EG0009 events7 affected1,229 at risk EG0014 events4 affected1,237 at risk
haemoptysis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 events2 affected1,229 at risk EG0011 events1 affected1,237 at risk
haemorrhage intracranial	Nervous system disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
haemorrhagic stroke	Nervous system disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
haemorrhoids	Vascular disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
hallucination, visual	Psychiatric disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
head injury	Injury, poisoning and procedural complications	Systematic Assessment	EG0002 events2 affected1,229 at risk EG0010 events0 affected1,237 at risk
heart failure	Cardiac disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
hepatic function abnormal	Hepatobiliary disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
hepatic mass	Hepatobiliary disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
hepatocellular carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0012 events2 affected1,237 at risk
hernial eventration	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
hip fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0005 events4 affected1,229 at risk EG0015 events5 affected1,237 at risk
hodgkin's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
hydrocephalus	Nervous system disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
hyperkalaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
hypertensive emergency	Vascular disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0011 events1 affected1,237 at risk
hypertransaminasaemia	Hepatobiliary disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
hypocalcaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
hypoglycaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
hypokalaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
hyponatraemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0012 events2 affected1,237 at risk
hypotension	Vascular disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
incarcerated parastomal hernia	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
infectious pleural effusion	Infections and infestations	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
influenza	Infections and infestations	Systematic Assessment	EG0002 events2 affected1,229 at risk EG0011 events1 affected1,237 at risk
injury	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
interventional procedure	Surgical and medical procedures	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
intestinal obstruction	Gastrointestinal disorders	Systematic Assessment	EG0006 events6 affected1,229 at risk EG0010 events0 affected1,237 at risk
iron deficiency anaemia	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0012 events2 affected1,237 at risk
ischaemic stroke	Nervous system disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0011 events1 affected1,237 at risk
jaundice cholestatic	Hepatobiliary disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
klebsiella sepsis	Infections and infestations	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
laryngeal oedema	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
leg amputation	Surgical and medical procedures	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
limb injury	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
lower gastrointestinal haemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0004 events3 affected1,229 at risk EG0013 events3 affected1,237 at risk
lung adenocarcinoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0012 events2 affected1,237 at risk
lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0012 events2 affected1,237 at risk
malaise	General disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
malignant urinary tract neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
melaena	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
mesenteric ischemia	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
metastasis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
metastatic gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
multiple fractures	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0012 events2 affected1,237 at risk
multiple injuries	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
musculoskeletal pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
myalgia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
myocardial infarction	Cardiac disorders	Systematic Assessment	EG0003 events3 affected1,229 at risk EG0016 events6 affected1,237 at risk
nausea	Gastrointestinal disorders	Systematic Assessment	EG0003 events3 affected1,229 at risk EG0011 events1 affected1,237 at risk
nephrectomy	Surgical and medical procedures	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
nephrolithiasis	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
neuroendocrine tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0002 events2 affected1,229 at risk EG0011 events1 affected1,237 at risk
non-hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
normocytic anaemia	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
obliterative bronchiolitis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
obstructive pancreatitis	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
odynophagia	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
oesophageal candidiasis	Infections and infestations	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
oesophageal varices haemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
open reduction of fracture	Surgical and medical procedures	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
osteoarthritis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0011 events1 affected1,237 at risk
osteomyelitis	Infections and infestations	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
ovarian cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
overdose	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
pain	General disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
palliative care	Surgical and medical procedures	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
palpitations	Cardiac disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0002 events2 affected1,229 at risk EG0013 events2 affected1,237 at risk
pancreatic carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
pancreatitis	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0013 events3 affected1,237 at risk
pancreatitis acute	Gastrointestinal disorders	Systematic Assessment	EG0003 events3 affected1,229 at risk EG0011 events1 affected1,237 at risk
papillary thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
paraesthesia	Nervous system disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
paralysis	Nervous system disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
partial seizures	Nervous system disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
pelvic fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0011 events1 affected1,237 at risk
pneumonia	Infections and infestations	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
peripheral ischaemia	Vascular disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
peritonsillar abscess	Infections and infestations	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
pleural effusion	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
pneumonia	Infections and infestations	Systematic Assessment	EG00017 events17 affected1,229 at risk EG00115 events14 affected1,237 at risk
pneumonia aspiration	Infections and infestations	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
pneumothorax	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
poisoning	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
post-traumatic pain	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
postoperative wound complication	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
postoperative wound infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
presyncope	Nervous system disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
prostate cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
prostatic operation	Surgical and medical procedures	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
prostatitis	Reproductive system and breast disorders	Systematic Assessment	EG0002 events2 affected1,229 at risk EG0010 events0 affected1,237 at risk
psychomotor disadaptation syndrome	Nervous system disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
pulmonary embolism	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0012 events2 affected1,237 at risk
pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
pulmonary oedema	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
pyelonephritis	Infections and infestations	Systematic Assessment	EG0002 events2 affected1,229 at risk EG0010 events0 affected1,237 at risk
pyrexia	General disorders	Systematic Assessment	EG0003 events2 affected1,229 at risk EG0011 events1 affected1,237 at risk
radical cystectomy	Surgical and medical procedures	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
rash	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
rectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0011 events1 affected1,237 at risk
rectal haemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0014 events4 affected1,237 at risk
renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0011 events1 affected1,237 at risk
renal colic	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
renal cyst	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
renal failure	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0014 events4 affected1,237 at risk
renal impairment	Renal and urinary disorders	Systematic Assessment	EG0002 events2 affected1,229 at risk EG0011 events1 affected1,237 at risk
respiratory failure	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0004 events3 affected1,229 at risk EG0010 events0 affected1,237 at risk
respiratory tract infection	Infections and infestations	Systematic Assessment	EG0005 events5 affected1,229 at risk EG0011 events1 affected1,237 at risk
rhabdomyolysis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0012 events2 affected1,237 at risk
road traffic accident	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0012 events2 affected1,237 at risk
salmonellosis	Infections and infestations	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
sciatica	Nervous system disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
seizure	Nervous system disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0012 events2 affected1,237 at risk
sepsis	Infections and infestations	Systematic Assessment	EG0002 events2 affected1,229 at risk EG0012 events2 affected1,237 at risk
septic shock	Infections and infestations	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0011 events1 affected1,237 at risk
serratia infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
shunt infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
sinus bradycardia	Cardiac disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
skin cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
skin ulcer	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0002 events2 affected1,229 at risk EG0010 events0 affected1,237 at risk
staphylococcal mediastinitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
strangulated hernia	General disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
streptococcal bacteraemia	Infections and infestations	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
subarachnoid haemorrhage	Nervous system disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0013 events3 affected1,237 at risk
subcapsular renal haematoma	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
subcutaneous haematoma	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
subdural haematoma	Injury, poisoning and procedural complications	Systematic Assessment	EG0002 events2 affected1,229 at risk EG0012 events2 affected1,237 at risk
subdural haemorrhage	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
sudden death	General disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
syncope	Nervous system disorders	Systematic Assessment	EG0009 events7 affected1,229 at risk EG0012 events2 affected1,237 at risk
systemic candida	Infections and infestations	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
temporal arteritis	Vascular disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
terminal state	General disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
testis cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
thrombocytopenia	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
toe amputation	Surgical and medical procedures	Systematic Assessment	EG0002 events2 affected1,229 at risk EG0010 events0 affected1,237 at risk
tongue neoplasm malignant stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
torsade de pointe	Cardiac disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
tracheobronchitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
transient ischaemic attack	Nervous system disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
transurethral bladder resection	Surgical and medical procedures	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
traumatic haematoma	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
ulcer haemorrhage	General disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
ulna fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
umbilical hernia	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
upper gastrointestinal bleeding	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
upper gastrointestinal haemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected1,229 at risk EG0011 events1 affected1,237 at risk
urethral calculus removal	Surgical and medical procedures	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
urinary retention	Renal and urinary disorders	Systematic Assessment	EG0002 events2 affected1,229 at risk EG0010 events0 affected1,237 at risk
urinary tract infection	Infections and infestations	Systematic Assessment	EG0009 events9 affected1,229 at risk EG0016 events6 affected1,237 at risk
urosepsis	Infections and infestations	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0011 events1 affected1,237 at risk
ventricular tachycardia	Cardiac disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
vertigo	Ear and labyrinth disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
viral infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
vomiting	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected1,229 at risk EG0010 events0 affected1,237 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	Systematic Assessment	EG00014 events13 affected1,229 at risk EG00113 events12 affected1,237 at risk
Anaemia macrocytic	Blood and lymphatic system disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Eosinophilia	Blood and lymphatic system disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0012 events2 affected1,237 at risk
Leukocytosis	Blood and lymphatic system disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Leukopenia	Blood and lymphatic system disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Splenic infarction	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Thrombocytosis	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Acute coronary syndrome	Cardiac disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0011 events1 affected1,237 at risk
Angina pectoris	Cardiac disorders	Systematic Assessment	EG00011 events9 affected1,229 at risk EG0018 events8 affected1,237 at risk
Angina unstable	Cardiac disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Atrial fibrillation	Cardiac disorders	Systematic Assessment	EG00020 events19 affected1,229 at risk EG00119 events16 affected1,237 at risk
Atrial flutter	Cardiac disorders	Systematic Assessment	EG0003 events3 affected1,229 at risk EG0012 events2 affected1,237 at risk
Atrial tachycardia	Cardiac disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Atrioventricular block	Cardiac disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Atrioventricular block first degree	Cardiac disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Atrioventricular block second degree	Cardiac disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Bradycardia	Cardiac disorders	Systematic Assessment	EG0003 events3 affected1,229 at risk EG0014 events4 affected1,237 at risk
Bundle branch block left	Cardiac disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Cardiac disorder	Cardiac disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Cardiac failure	Cardiac disorders	Systematic Assessment	EG0004 events4 affected1,229 at risk EG0018 events7 affected1,237 at risk
Cardiac failure acute	Cardiac disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0011 events1 affected1,237 at risk
Cardiac failure congestive	Cardiac disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0012 events1 affected1,237 at risk
Cardiac ventricular thrombosis	Cardiac disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Coronary artery aneurysm	Cardiac disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Coronary ostial stenosis	Cardiac disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Extrasystoles	Cardiac disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Mitral valve disease	Cardiac disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Myocardial infarction	Cardiac disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Myocardial ischaemia	Cardiac disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0011 events1 affected1,237 at risk
Palpitations	Cardiac disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0011 events1 affected1,237 at risk
Pericarditis	Cardiac disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Supraventricular tachyarrhythmia	Cardiac disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Supraventricular tachycardia	Cardiac disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Tachyarrhythmia	Cardiac disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Tachycardia	Cardiac disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Ventricular arrhythmia	Cardiac disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Ventricular extrasystoles	Cardiac disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Ventricular tachycardia	Cardiac disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0012 events2 affected1,237 at risk
Hydrocele	Congenital, familial and genetic disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0012 events2 affected1,237 at risk
Deafness	Ear and labyrinth disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Ear haemorrhage	Ear and labyrinth disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Tinnitus	Ear and labyrinth disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0011 events1 affected1,237 at risk
Tympanic membrane perforation	Ear and labyrinth disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Vertigo	Ear and labyrinth disorders	Systematic Assessment	EG0003 events3 affected1,229 at risk EG0015 events5 affected1,237 at risk
Vertigo positional	Ear and labyrinth disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Hypothyroidism	Endocrine disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0012 events2 affected1,237 at risk
Blindness transient	Eye disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Blindness unilateral	Eye disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Cataract	Eye disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Conjunctival haemorrhage	Eye disorders	Systematic Assessment	EG0002 events2 affected1,229 at risk EG0010 events0 affected1,237 at risk
Conjunctivitis allergic	Eye disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Diabetic retinopathy	Eye disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Diplopia	Eye disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Eye haemorrhage	Eye disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0011 events1 affected1,237 at risk
Eye inflammation	Eye disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Glaucoma	Eye disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Retinal haemorrhage	Eye disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Vision blurred	Eye disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Vitreous haemorrhage	Eye disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Abdominal pain	Gastrointestinal disorders	Systematic Assessment	EG0006 events6 affected1,229 at risk EG0013 events3 affected1,237 at risk
Abdominal pain lower	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Abdominal pain upper	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0017 events7 affected1,237 at risk
Anal fissure	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Anal fistula	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0011 events1 affected1,237 at risk
Colitis	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Constipation	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0011 events1 affected1,237 at risk
Diarrhoea	Gastrointestinal disorders	Systematic Assessment	EG0007 events6 affected1,229 at risk EG00112 events11 affected1,237 at risk
Dry mouth	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0012 events2 affected1,237 at risk
Dyspepsia	Gastrointestinal disorders	Systematic Assessment	EG0004 events4 affected1,229 at risk EG0011 events1 affected1,237 at risk
Erosive duodenitis	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Gastric haemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Gastritis	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Gastritis haemorrhagic	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected1,229 at risk EG0011 events1 affected1,237 at risk
Gastrointestinal ulcer haemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Gingival bleeding	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0012 events2 affected1,237 at risk
Haematemesis	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Haematochezia	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0011 events1 affected1,237 at risk
Ileus	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Inguinal hernia	Gastrointestinal disorders	Systematic Assessment	EG0004 events4 affected1,229 at risk EG0014 events4 affected1,237 at risk
Intestinal haemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0013 events3 affected1,237 at risk
Intestinal polyp	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Intestinal pseudo-obstruction	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Large intestine polyp	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Nausea	Gastrointestinal disorders	Systematic Assessment	EG0006 events6 affected1,229 at risk EG0014 events4 affected1,237 at risk
Pancreatic failure	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Pancreatitis	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0012 events2 affected1,237 at risk
Papilla of Vater stenosis	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Pelvic floor dysfunction	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Rectal haemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected1,229 at risk EG0013 events2 affected1,237 at risk
Tongue oedema	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0012 events1 affected1,237 at risk
Umbilical hernia	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0013 events2 affected1,237 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Vomiting	Gastrointestinal disorders	Systematic Assessment	EG0007 events6 affected1,229 at risk EG0014 events4 affected1,237 at risk
Adverse event	General disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Asthenia	General disorders	Systematic Assessment	EG0002 events2 affected1,229 at risk EG0015 events5 affected1,237 at risk
Chest discomfort	General disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0011 events1 affected1,237 at risk
Chest pain	General disorders	Systematic Assessment	EG00031 events28 affected1,229 at risk EG00120 events16 affected1,237 at risk
Discomfort	General disorders	Systematic Assessment	EG0002 events2 affected1,229 at risk EG0010 events0 affected1,237 at risk
Drug intolerance	General disorders	Systematic Assessment	EG0003 events2 affected1,229 at risk EG0014 events4 affected1,237 at risk
Drug therapeutic incompatibility	General disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Face oedema	General disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Fatigue	General disorders	Systematic Assessment	EG0003 events2 affected1,229 at risk EG0011 events1 affected1,237 at risk
Gait disturbance	General disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0011 events1 affected1,237 at risk
General physical health deterioration	General disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Hernia	General disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Malaise	General disorders	Systematic Assessment	EG0003 events3 affected1,229 at risk EG0010 events0 affected1,237 at risk
Oedema	General disorders	Systematic Assessment	EG0002 events2 affected1,229 at risk EG0012 events2 affected1,237 at risk
Oedema peripheral	General disorders	Systematic Assessment	EG00012 events12 affected1,229 at risk EG00113 events13 affected1,237 at risk
Pacemaker generated arrhythmia	General disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Peripheral swelling	General disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Pyrexia	General disorders	Systematic Assessment	EG0002 events2 affected1,229 at risk EG0011 events1 affected1,237 at risk
Stenosis	General disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Biloma	Hepatobiliary disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Cholecystitis	Hepatobiliary disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Cholecystitis acute	Hepatobiliary disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Cholelithiasis	Hepatobiliary disorders	Systematic Assessment	EG0002 events2 affected1,229 at risk EG0010 events0 affected1,237 at risk
Cholestasis	Hepatobiliary disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0011 events1 affected1,237 at risk
Granulomatous liver disease	Hepatobiliary disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Hepatic function abnormal	Hepatobiliary disorders	Systematic Assessment	EG0002 events2 affected1,229 at risk EG0010 events0 affected1,237 at risk
Hepatitis	Hepatobiliary disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Hepatitis acute	Hepatobiliary disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Hepatotoxicity	Hepatobiliary disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0011 events1 affected1,237 at risk
Liver disorder	Hepatobiliary disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Contrast media reaction	Immune system disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Drug hypersensitivity	Immune system disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0011 events1 affected1,237 at risk
Hypersensitivity	Immune system disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0013 events3 affected1,237 at risk
Abscess limb	Infections and infestations	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Anal abscess	Infections and infestations	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Anal fungal infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0012 events1 affected1,237 at risk
Appendicitis	Infections and infestations	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Arthritis infective	Infections and infestations	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Bacterial infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Bronchitis	Infections and infestations	Systematic Assessment	EG0007 events4 affected1,229 at risk EG0013 events3 affected1,237 at risk
COVID-19	Infections and infestations	Systematic Assessment	EG0009 events9 affected1,229 at risk EG0015 events5 affected1,237 at risk
COVID-19 pneumonia	Infections and infestations	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0012 events2 affected1,237 at risk
Cellulitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Conjunctivitis	Infections and infestations	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Epididymitis	Infections and infestations	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Erysipelas	Infections and infestations	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Fungal infection	Infections and infestations	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Gastroenteritis	Infections and infestations	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0011 events1 affected1,237 at risk
Gastroenteritis salmonella	Infections and infestations	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Gingivitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Hepatitis E	Infections and infestations	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Herpes virus infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Herpes zoster	Infections and infestations	Systematic Assessment	EG0003 events3 affected1,229 at risk EG0011 events1 affected1,237 at risk
Infectious pleural effusion	Infections and infestations	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Influenza	Infections and infestations	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0011 events1 affected1,237 at risk
Lung abscess	Infections and infestations	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Mumps	Infections and infestations	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Nasopharyngitis	Infections and infestations	Systematic Assessment	EG0003 events2 affected1,229 at risk EG0012 events2 affected1,237 at risk
Onychomycosis	Infections and infestations	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Oral candidiasis	Infections and infestations	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Orchitis	Infections and infestations	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Peritonsillar abscess	Infections and infestations	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Pharyngitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Pilonidal disease	Infections and infestations	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Pneumonia	Infections and infestations	Systematic Assessment	EG0005 events4 affected1,229 at risk EG0015 events5 affected1,237 at risk
Respiratory tract infection	Infections and infestations	Systematic Assessment	EG00010 events9 affected1,229 at risk EG0011 events1 affected1,237 at risk
Septic shock	Infections and infestations	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Tracheobronchitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Upper respiratory tract infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Urinary tract infection	Infections and infestations	Systematic Assessment	EG00012 events12 affected1,229 at risk EG00113 events10 affected1,237 at risk
Urosepsis	Infections and infestations	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0011 events1 affected1,237 at risk
Vulvovaginal mycotic infection	Infections and infestations	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Arthropod bite	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Bone contusion	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Contusion	Injury, poisoning and procedural complications	Systematic Assessment	EG0007 events6 affected1,229 at risk EG0011 events1 affected1,237 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Discontinued product administered	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Fall	Injury, poisoning and procedural complications	Systematic Assessment	EG0009 events9 affected1,229 at risk EG0015 events5 affected1,237 at risk
Femur fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0012 events2 affected1,237 at risk
Head injury	Injury, poisoning and procedural complications	Systematic Assessment	EG0002 events2 affected1,229 at risk EG0010 events0 affected1,237 at risk
Hip fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0012 events2 affected1,237 at risk
Injury	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0011 events1 affected1,237 at risk
Joint dislocation	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0012 events2 affected1,237 at risk
Joint injury	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0012 events2 affected1,237 at risk
Limb injury	Injury, poisoning and procedural complications	Systematic Assessment	EG0002 events2 affected1,229 at risk EG0011 events1 affected1,237 at risk
Lower limb fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Muscle strain	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Periorbital haematoma	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Radius fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Skin wound	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Subdural haematoma	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0011 events1 affected1,237 at risk
Sunburn	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Ulna fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Wound haematoma	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Wrist fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Angiocardiogram	Investigations	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Angiogram	Investigations	Systematic Assessment	EG0002 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Aspartate aminotransferase increased	Investigations	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Biopsy breast	Investigations	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Blood creatine increased	Investigations	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Blood creatine phosphokinase increased	Investigations	Systematic Assessment	EG0003 events3 affected1,229 at risk EG0018 events7 affected1,237 at risk
Blood creatinine increased	Investigations	Systematic Assessment	EG0002 events1 affected1,229 at risk EG0012 events2 affected1,237 at risk
Blood potassium increased	Investigations	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Blood pressure abnormal	Investigations	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Blood pressure increased	Investigations	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Bronchoscopy	Investigations	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
C-reactive protein increased	Investigations	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Colonoscopy	Investigations	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Computerised tomogram thorax	Investigations	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Cystoscopy	Investigations	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Electrocardiogram T wave inversion	Investigations	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Endoscopy gastrointestinal	Investigations	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Gamma-glutamyltransferase increased	Investigations	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Haemoglobin increased	Investigations	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Low density lipoprotein increased	Investigations	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Muscle enzyme increased	Investigations	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Occult blood	Investigations	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0011 events1 affected1,237 at risk
Platelet count decreased	Investigations	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Platelet count increased	Investigations	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Renal function test abnormal	Investigations	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Transaminases increased	Investigations	Systematic Assessment	EG0004 events4 affected1,229 at risk EG0014 events4 affected1,237 at risk
Weight decreased	Investigations	Systematic Assessment	EG0002 events1 affected1,229 at risk EG0012 events2 affected1,237 at risk
Weight increased	Investigations	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Abnormal loss of weight	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Cachexia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Decreased appetite	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0012 events2 affected1,237 at risk
Dehydration	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Diabetes mellitus	Metabolism and nutrition disorders	Systematic Assessment	EG0003 events3 affected1,229 at risk EG0011 events1 affected1,237 at risk
Diabetic metabolic decompensation	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Gout	Metabolism and nutrition disorders	Systematic Assessment	EG0002 events2 affected1,229 at risk EG0015 events5 affected1,237 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Hyperkalaemia	Metabolism and nutrition disorders	Systematic Assessment	EG00010 events10 affected1,229 at risk EG0019 events9 affected1,237 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0002 events2 affected1,229 at risk EG0010 events0 affected1,237 at risk
Hypoglycaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Impaired fasting glucose	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Iron deficiency	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0011 events1 affected1,237 at risk
Vitamin D deficiency	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0007 events7 affected1,229 at risk EG0016 events6 affected1,237 at risk
Arthritis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0011 events1 affected1,237 at risk
Back pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0002 events2 affected1,229 at risk EG0012 events2 affected1,237 at risk
Bursitis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0012 events2 affected1,237 at risk
Dupuytren's contracture	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0011 events1 affected1,237 at risk
Gouty arthritis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0003 events3 affected1,229 at risk EG0010 events0 affected1,237 at risk
Intervertebral disc disorder	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Limb discomfort	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0002 events2 affected1,229 at risk EG0010 events0 affected1,237 at risk
Mobility decreased	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Muscle contracture	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0011 events1 affected1,237 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0011 events1 affected1,237 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Musculoskeletal disorder	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Myalgia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG00028 events25 affected1,229 at risk EG00115 events14 affected1,237 at risk
Myopathy	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0002 events2 affected1,229 at risk EG0011 events1 affected1,237 at risk
Neck pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0002 events2 affected1,229 at risk EG0011 events1 affected1,237 at risk
Oligoarthritis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Osteitis deformans	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0003 events3 affected1,229 at risk EG0012 events2 affected1,237 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0002 events2 affected1,229 at risk EG0016 events6 affected1,237 at risk
Polymyalgia rheumatica	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0012 events2 affected1,237 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Spinal pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0012 events2 affected1,237 at risk
Synovitis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Adenoma benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0012 events2 affected1,237 at risk
Bladder cancer	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0002 events2 affected1,229 at risk EG0011 events1 affected1,237 at risk
Brain neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Essential thrombocythaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Keratoacanthoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0011 events1 affected1,237 at risk
Lymphoproliferative disorder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Metastasis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Monoclonal gammopathy	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Non-Hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0011 events1 affected1,237 at risk
Osteochondroma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Osteoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Parathyroid tumour benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Pituitary tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Pituitary tumour benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0004 events4 affected1,229 at risk EG0010 events0 affected1,237 at risk
Prostatic adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Renal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Testis cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Amnesia	Nervous system disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Balance disorder	Nervous system disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0011 events1 affected1,237 at risk
Carotid artery stenosis	Nervous system disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Carpal tunnel syndrome	Nervous system disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Cerebral ischaemia	Nervous system disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Cerebrovascular accident	Nervous system disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Cerebrovascular insufficiency	Nervous system disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Cognitive disorder	Nervous system disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0011 events1 affected1,237 at risk
Dementia	Nervous system disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Dizziness	Nervous system disorders	Systematic Assessment	EG00010 events9 affected1,229 at risk EG00113 events13 affected1,237 at risk
Dizziness postural	Nervous system disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Dysarthria	Nervous system disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Headache	Nervous system disorders	Systematic Assessment	EG0004 events4 affected1,229 at risk EG0012 events2 affected1,237 at risk
Hypoaesthesia	Nervous system disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0011 events1 affected1,237 at risk
Hypoglycaemic coma	Nervous system disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Hypotonia	Nervous system disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Intercostal neuralgia	Nervous system disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Intracranial aneurysm	Nervous system disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Loss of consciousness	Nervous system disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Memory impairment	Nervous system disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Monoplegia	Nervous system disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Movement disorder	Nervous system disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Parkinson's disease	Nervous system disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Presyncope	Nervous system disorders	Systematic Assessment	EG0005 events4 affected1,229 at risk EG0013 events3 affected1,237 at risk
Sciatica	Nervous system disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Subarachnoid haemorrhage	Nervous system disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Syncope	Nervous system disorders	Systematic Assessment	EG00017 events15 affected1,229 at risk EG0019 events8 affected1,237 at risk
Transient ischaemic attack	Nervous system disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Vascular dementia	Nervous system disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Device leakage	Product Issues	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Affect lability	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Anxiety	Psychiatric disorders	Systematic Assessment	EG0003 events3 affected1,229 at risk EG0013 events3 affected1,237 at risk
Depression	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0016 events3 affected1,237 at risk
Insomnia	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Major depression	Psychiatric disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Mixed anxiety and depressive disorder	Psychiatric disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Acute kidney injury	Renal and urinary disorders	Systematic Assessment	EG0004 events4 affected1,229 at risk EG0012 events2 affected1,237 at risk
Chronic kidney disease	Renal and urinary disorders	Systematic Assessment	EG0002 events2 affected1,229 at risk EG0011 events1 affected1,237 at risk
Cystitis haemorrhagic	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Haematuria	Renal and urinary disorders	Systematic Assessment	EG0003 events3 affected1,229 at risk EG0017 events5 affected1,237 at risk
Nephrolithiasis	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Nocturia	Renal and urinary disorders	Systematic Assessment	EG0002 events2 affected1,229 at risk EG0010 events0 affected1,237 at risk
Oliguria	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Renal colic	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0011 events1 affected1,237 at risk
Renal cyst	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Renal failure	Renal and urinary disorders	Systematic Assessment	EG0006 events6 affected1,229 at risk EG0013 events3 affected1,237 at risk
Renal impairment	Renal and urinary disorders	Systematic Assessment	EG00010 events7 affected1,229 at risk EG0018 events7 affected1,237 at risk
Ureterolithiasis	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Urethral meatus stenosis	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Urinary bladder haemorrhage	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Urinary incontinence	Renal and urinary disorders	Systematic Assessment	EG0002 events2 affected1,229 at risk EG0010 events0 affected1,237 at risk
Urinary retention	Renal and urinary disorders	Systematic Assessment	EG0004 events4 affected1,229 at risk EG0010 events0 affected1,237 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0013 events3 affected1,237 at risk
Epididymal cyst	Reproductive system and breast disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Erectile dysfunction	Reproductive system and breast disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0013 events3 affected1,237 at risk
Gynaecomastia	Reproductive system and breast disorders	Systematic Assessment	EG0002 events2 affected1,229 at risk EG0011 events1 affected1,237 at risk
Haematospermia	Reproductive system and breast disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Pelvic haematoma	Reproductive system and breast disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0012 events2 affected1,237 at risk
Prostatitis	Reproductive system and breast disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Rectocele	Reproductive system and breast disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Uterine prolapse	Reproductive system and breast disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Varicocele	Reproductive system and breast disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Bendopnoea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Bronchitis chronic	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Catarrh	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0012 events1 affected1,237 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0011 events1 affected1,237 at risk
Cough	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG00046 events43 affected1,229 at risk EG00149 events49 affected1,237 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG00021 events20 affected1,229 at risk EG00119 events17 affected1,237 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0012 events2 affected1,237 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG00014 events14 affected1,229 at risk EG00113 events13 affected1,237 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 events2 affected1,229 at risk EG0010 events0 affected1,237 at risk
Laryngospasm	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Lung consolidation	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 events2 affected1,229 at risk EG0011 events1 affected1,237 at risk
Painful respiration	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0011 events1 affected1,237 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0012 events2 affected1,237 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Throat irritation	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Actinic keratosis	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Angioedema	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0012 events2 affected1,237 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0002 events2 affected1,229 at risk EG0010 events0 affected1,237 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Eczema	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0013 events3 affected1,237 at risk
Erythema	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0011 events1 affected1,237 at risk
Hyperkeratosis	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Petechiae	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Pruritus	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0005 events5 affected1,229 at risk EG0016 events6 affected1,237 at risk
Rash	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0014 events4 affected1,237 at risk
Rash pruritic	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Skin haemorrhage	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Skin reaction	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Urticaria	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Bladder catheterisation	Surgical and medical procedures	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Bladder neoplasm surgery	Surgical and medical procedures	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Cardiac pacemaker insertion	Surgical and medical procedures	Systematic Assessment	EG0002 events2 affected1,229 at risk EG0012 events2 affected1,237 at risk
Cardiac pacemaker replacement	Surgical and medical procedures	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Cardiac resynchronisation therapy	Surgical and medical procedures	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0011 events1 affected1,237 at risk
Cardioversion	Surgical and medical procedures	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Carpal tunnel decompression	Surgical and medical procedures	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Cataract operation	Surgical and medical procedures	Systematic Assessment	EG0002 events2 affected1,229 at risk EG0011 events1 affected1,237 at risk
Chemotherapy	Surgical and medical procedures	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0012 events1 affected1,237 at risk
Coronary angioplasty	Surgical and medical procedures	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Glaucoma surgery	Surgical and medical procedures	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Hip arthroplasty	Surgical and medical procedures	Systematic Assessment	EG0002 events2 affected1,229 at risk EG0012 events2 affected1,237 at risk
Intra-ocular injection	Surgical and medical procedures	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0015 events3 affected1,237 at risk
Lymphadenectomy	Surgical and medical procedures	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Medical counselling	Surgical and medical procedures	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Prostatectomy	Surgical and medical procedures	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0011 events1 affected1,237 at risk
Pulmonary resection	Surgical and medical procedures	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Radiotherapy	Surgical and medical procedures	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Skin neoplasm excision	Surgical and medical procedures	Systematic Assessment	EG0002 events1 affected1,229 at risk EG0011 events1 affected1,237 at risk
Spinal decompression	Surgical and medical procedures	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Stent placement	Surgical and medical procedures	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Toe amputation	Surgical and medical procedures	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Tooth extraction	Surgical and medical procedures	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0012 events1 affected1,237 at risk
Transcatheter aortic valve implantation	Surgical and medical procedures	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0012 events2 affected1,237 at risk
Transfusion	Surgical and medical procedures	Systematic Assessment	EG0006 events2 affected1,229 at risk EG0010 events0 affected1,237 at risk
Transurethral prostatectomy	Surgical and medical procedures	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0012 events2 affected1,237 at risk
Aortic aneurysm	Vascular disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0011 events1 affected1,237 at risk
Aortic stenosis	Vascular disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0012 events2 affected1,237 at risk
Arterial stenosis	Vascular disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Arteriosclerosis	Vascular disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Arteriovenous fistula	Vascular disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Blood pressure fluctuation	Vascular disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Blood pressure inadequately controlled	Vascular disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0011 events1 affected1,237 at risk
Circulatory collapse	Vascular disorders	Systematic Assessment	EG0002 events2 affected1,229 at risk EG0011 events1 affected1,237 at risk
Deep vein thrombosis	Vascular disorders	Systematic Assessment	EG0002 events2 affected1,229 at risk EG0012 events2 affected1,237 at risk
Haematoma	Vascular disorders	Systematic Assessment	EG0002 events2 affected1,229 at risk EG0011 events1 affected1,237 at risk
Haemorrhage	Vascular disorders	Systematic Assessment	EG0005 events5 affected1,229 at risk EG0013 events3 affected1,237 at risk
Haemorrhoids	Vascular disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Hypertension	Vascular disorders	Systematic Assessment	EG00022 events20 affected1,229 at risk EG00125 events22 affected1,237 at risk
Hypertensive crisis	Vascular disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0014 events3 affected1,237 at risk
Hypotension	Vascular disorders	Systematic Assessment	EG00015 events15 affected1,229 at risk EG00126 events26 affected1,237 at risk
Intermittent claudication	Vascular disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0011 events1 affected1,237 at risk
Myocardial ischaemia	Vascular disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Peripheral arterial occlusive disease	Vascular disorders	Systematic Assessment	EG0002 events2 affected1,229 at risk EG0012 events2 affected1,237 at risk
Peripheral artery thrombosis	Vascular disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0012 events2 affected1,237 at risk
Peripheral ischaemia	Vascular disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0010 events0 affected1,237 at risk
Peripheral venous disease	Vascular disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0011 events1 affected1,237 at risk
Thrombophlebitis	Vascular disorders	Systematic Assessment	EG0001 events1 affected1,229 at risk EG0011 events1 affected1,237 at risk
Thrombosis	Vascular disorders	Systematic Assessment	EG0000 events0 affected1,229 at risk EG0012 events2 affected1,237 at risk

Patients allocated to the experimental arm will receive a cardiovascular polypill containing aspirin 100 mg, atorvastatin (40 or 20 mg) and ramipril (2.5, 5 or 10 mg) taken orally once a day.

Cardiovascular Polypill: Cardiovascular Polypill contains Aspirin, Atorvastatin and Ramipril.

Participants will receive one of the following cardiovascular polypill:

(A) Aspirin 100 mg, Atorvastatin 40mg, and Ramipril (2.5 mg, or 5 mg, or 10mg).

(B) Aspirin 100 mg, Atorvastatin 20mg, and Ramipril (2.5 mg, or 5 mg, or 10mg).

Patients allocated to the experimental arm will receive a cardiovascular polypill containing aspirin 100 mg, atorvastatin (40 or 20 mg) and ramipril (2.5, 5 or 10 mg) taken orally once a day.

Cardiovascular Polypill: Cardiovascular Polypill contains Aspirin, Atorvastatin and Ramipril.

Participants will receive one of the following cardiovascular polypill:

(A) Aspirin 100 mg, Atorvastatin 40mg, and Ramipril (2.5 mg, or 5 mg, or 10mg).

(B) Aspirin 100 mg, Atorvastatin 20mg, and Ramipril (2.5 mg, or 5 mg, or 10mg).

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D014652	Vascular Diseases
D007238	Infarction
D007511	Ischemia
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009336	Necrosis

ID	Term
D010975	Platelet Aggregation Inhibitors
D000960	Hypolipidemic Agents

ID	Term
D006401	Hematologic Agents
D045506	Therapeutic Uses
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses
D000963	Antimetabolites
D045504	Molecular Mechanisms of Pharmacological Action
D057847	Lipid Regulating Agents