Caduet vs Usual Care in Subjects With Hypertension and Ad... | NCT00407537

NCT00407537

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Caduet	Experimental	Open label caduet added to usual care regimen followed by investigators.	Drug: Amlodipine besylate/atorvastatin calcium single pill combination

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Amlodipine besylate/atorvastatin calcium single pill combination	Drug	Open label amlodipine besylate/atorvastatin calcium single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Framingham 10-year Risk of Total Coronary Heart Disease (CHD) at Month 12	Framingham prediction of 10-year risk of CHD: Gender-specific prediction equations formulated to predict CHD risk according to age, diabetes, smoking, blood pressure categories, and total cholesterol and low density lipoprotein (LDL) cholesterol categories. The coefficients were used to derive the score calculated at the end of study treatment (Month 12).	Baseline, Month 12

Secondary Outcomes

Measure	Description	Time Frame
Framingham 10-year Risk of Total CHD at Month 4	Framingham prediction of 10-year risk of CHD: Gender-specific prediction equations formulated to predict CHD risk according to age, diabetes, smoking, blood pressure categories, and total cholesterol and low density lipoprotein (LDL) cholesterol categories. The coefficients were used to derive the score calculated after 4 months of treatment (Month 4).

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Desamparados	Provincia de San José		Costa Rica
Pfizer Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24339703	Derived	Cho EJ, Kim JH, Sutradhar S, Yunis C, Westergaard M; CRUCIAL Trial Investigators. Proactive multifactorial intervention strategy reduces the risk of cardiovascular disease estimated with region-specific risk assessment models in Pacific Asian patients participating in the CRUCIAL trial. J Korean Med Sci. 2013 Dec;28(12):1741-8. doi: 10.3346/jkms.2013.28.12.1741. Epub 2013 Nov 26.
23464930

Label	URL
To obtain contact information for a study center near you, click here.	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Caduet	Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
FG001	Usual Care

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.

Arm/Group Information

ID	Title	Description
BG000	Caduet as Assigned	Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
BG001	Usual Care as Assigned	Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
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, Customized

Number

participants

Title

Denominators

Categories

Title	Measurements
	OG00012.5± 8.26 OG00116.3± 10.51

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	It was estimated that each study site would on average complete 8 evaluable participants, therefore enrolling 164 sites, 1968 participants would provide at least 90% power to detect a 10% relative reduction in the 10-year predicted risk of total CHD at 12 months (as calculated from the Framingham model) from the control arm based on a two-sided t-test with a 5% significance level.	Mixed-effect linear model		<0.001	Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.	LSMean difference	-4.72			2-Sided	95	-5.55	-3.89			Value at a given visit as response. Baseline value, country, and treatment were used as fixed effect and site was used as a random effect and a compound-symmetry (CS) variance-covariance matrix was used for subjects from the same site.

Secondary

Framingham 10-year Risk of Total CHD at Month 4

FAS. Number of participants analyzed refers to number of participants contributing to data.

Posted

Mean

Standard Deviation

percent risk

Baseline, Month 4

ID	Title	Description
OG000	Caduet	Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
OG001	Usual Care	Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.

Units	Counts
Participants

Secondary

European Systematic COronary Risk Evaluation (SCORE) 10-year Risk of Fatal Cardiovascular Disease (CVD) at Month 12

European SCORE: designed to measure cardiovascular disease mortality; computed using age, gender, whether a person lives in a low risk or high risk region, measured total cholesterol, measured HDL cholesterol, systolic blood pressure, and current smoking status. The coefficients were used to derive the score calculated after 12 months of study treatment (Month 12).

FAS. Number of participants analyzed refers to number of participants contributing to data.

Posted

Mean

Standard Deviation

percent risk

Baseline, Month 12

ID	Title	Description
OG000	Caduet	Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
OG001	Usual Care	Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.

Units	Counts
Participants

Secondary

European SCORE 10-year Risk of Fatal CVD at Month 4

FAS. Number of participants analyzed refers to number of participants contributing to data.

Posted

Mean

Standard Deviation

percent risk

Baseline, Month 4

ID	Title	Description
OG000	Caduet	Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
OG001	Usual Care	Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.

Units	Counts
Participants

Secondary

Framingham 10-year Risk of Stroke at Month 12

Stroke risk calculated from the Framingham risk for CVD (CHD, stroke, intermittent claudication, congestive heart failure) multiplied by a gender-specific "calibration factor" for the stroke component risk. Coefficients were used to derive the score calculated at the end of study treatment (Month 12).

FAS. Number of participants analyzed refers to number of participants contributing to data.

Posted

Mean

Standard Deviation

percent risk

Baseline, Month 12

ID	Title	Description
OG000	Caduet	Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
OG001	Usual Care	Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.

Units	Counts
Participants

Secondary

Framingham 10-year Risk of Stroke at Month 4

FAS. Number of participants analyzed refers to number of participants contributing to data.

Posted

Mean

Standard Deviation

percent risk

Baseline, Month 4

ID	Title	Description
OG000	Caduet	Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
OG001	Usual Care	Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.

Units	Counts
Participants

Secondary

Change From Baseline in Framingham 10-year Risk of Developing Total CHD

Framingham prediction of 10-year risk of CHD: Gender-specific prediction equations formulated to predict CHD risk according to age, diabetes, smoking, blood pressure categories, and total cholesterol and low density lipoprotein (LDL) cholesterol categories. Change from baseline calculated as mean at observation minus mean at Baseline.

FAS. Number of participants analyzed refers to number of participants contributing to data.

Posted

Least Squares Mean

95% Confidence Interval

percent risk

Baseline, Month 4, Month 12

ID	Title	Description
OG000	Caduet	Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
OG001	Usual Care	Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.

Units	Counts
Participants

Secondary

Change From Baseline European SCORE 10-year Risk of Developing Fatal CVD

European SCORE: designed to measure cardiovascular disease mortality; computed using age, gender, whether a person lives in a low risk or high risk region, measured total cholesterol, measured HDL cholesterol, systolic blood pressure, and current smoking status. Change from baseline calculated as mean at observation minus mean at Baseline.

FAS. Number of participants analyzed refers to number of participants contributing to data.

Posted

Least Squares Mean

95% Confidence Interval

percent risk

Baseline, Month 4, Month 12

ID	Title	Description
OG000	Caduet	Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
OG001	Usual Care	Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.

Units	Counts
Participants

Secondary

Mean Systolic and Diastolic Blood Pressure at Month 4

FAS. Number of participants analyzed refers to number of participants contributing data.

Posted

Mean

Standard Deviation

mmHg

Month 4

ID	Title	Description
OG000	Caduet	Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
OG001	Usual Care	Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.

Units	Counts
Participants	OG000

Secondary

Mean Systolic and Diastolic Blood Pressure at Month 12

FAS. Number of participants analyzed refers to number of participants contributing to data.

Posted

Mean

Standard Deviation

mmHg

Month 12

ID	Title	Description
OG000	Caduet	Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
OG001	Usual Care	Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Systolic Blood Pressure (SBP) at Month 4

FAS. Number of participants analyzed refers to number of participants contributing to data.

Posted

Least Squares Mean

95% Confidence Interval

mmHG

Baseline, Month 4

ID	Title	Description
OG000	Caduet	Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
OG001	Usual Care	Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Diastolic Blood Pressure (DBP) at Month 4

FAS. Number of participants analyzed refers to number of participants contributing to data.

Posted

Least Squares Mean

95% Confidence Interval

mmHG

Baseline, Month 4

ID	Title	Description
OG000	Caduet	Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
OG001	Usual Care	Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in SBP at Month 12

FAS, number of participants analyzed refers to number of participants contributing to data.

Posted

Least Squares Mean

95% Confidence Interval

mmHg

Baseline, Month 12

ID	Title	Description
OG000	Caduet	Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
OG001	Usual Care	Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in DBP at Month 12

FAS. Number of participants analyzed refers to number of participants contributing to data.

Posted

Least Squares Mean

95% Confidence Interval

mmHg

Baseline, Month 12

ID	Title	Description
OG000	Caduet	Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
OG001	Usual Care	Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.

Units	Counts
Participants	OG000

Secondary

Mean Lipid Parameters at Month 4

Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations.

FAS. Number of participants analyzed refers to number of participants contributing data.

Posted

Mean

Standard Deviation

mg/dL

Month 4

ID	Title	Description
OG000	Caduet	Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
OG001	Usual Care	Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.

Units	Counts
Participants	OG000

Secondary

Mean Lipid Parameters at Month 12

Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations.

FAS. Number of participants analyzed refers to number of participants contributing data.

Posted

Mean

Standard Deviation

mg/dL

Month 12

ID	Title	Description
OG000	Caduet	Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
OG001	Usual Care	Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Lipid Parameters at Month 4

Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations. Change from baseline measured as mean at Month 4 minus mean at Baseline.

FAS. Number of participants analyzed refers to number of participants contributing data.

Posted

Least Squares Mean

95% Confidence Interval

mg/dL

Baseline, Month 4

ID	Title	Description
OG000	Caduet	Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
OG001	Usual Care	Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Lipid Parameters at Month 12

Mean Total Cholesterol (TC), Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), and Triglyceride blood concentrations.

FAS. Number of participants analyzed refers to number of participants contributing data.

Posted

Least Squares Mean

95% Confidence Interval

mg/dL

Baseline, Month 12

ID	Title	Description
OG000	Caduet	Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
OG001	Usual Care	Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants at Conventional Treatment Goals According to Global and Local Guidelines for Blood Pressure at 4 and 12 Months

Goals set at <140/90 mmHg according to the seventh Joint National Committee (JNC) on prevention, detection, evaluation, and treatment of high blood pressure and <140/90 mm Hg or <130/80 mm Hg for diabetics ccording to the European Society of Cardiology (ESC) guidelines.

FAS. Number of participants analyzed refers to number of participants contributing data.

Posted

Number

percentage of participants

Month 4, Month 12

ID	Title	Description
OG000	Caduet	Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
OG001	Usual Care	Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.

Units	Counts
Participants

Secondary

Percentage of Participants at Conventional Treatment Goals According to Global and Local Guidelines for LDL at 4 and 12 Months

Goal set at <100 mg/dL according to the United States (US) National Cholesterol Education Program Adult Treatment Panel 3 and at <80 mg/dL according to the European (EU) Society of Cardiology guidelines.

FAS. Number of participants analyzed refers to number of participants contributing data.

Posted

Number

Percentage of participants

Month 4, Month 12

ID	Title	Description
OG000	Caduet	Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
OG001	Usual Care	Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.

Units	Counts
Participants

Secondary

Number of Participants With Lipid and Antihypertensive Treatments Used at 4 and 12 Months

Treatments indicative of prescribed medications other than study provided Caduet.

FAS. Number of participants analyzed refers to number of participants contributing data.

Posted

Number

participants

Month 4, Month 12

ID	Title	Description
OG000	Caduet	Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
OG001	Usual Care	Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Increase of Treatment Dosages After 4 Months.

Treatments indicative of prescribed medications other than study provided Caduet.

FAS. Number of participants analyzed refers to number of participants contributing data.

Posted

Number

Participants

Month 4

ID	Title	Description
OG000	Caduet	Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
OG001	Usual Care	Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Caduet	Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.			51	779	356	779
EG001	Usual Care	Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.			22	682	289	682

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA v12.1	Systematic Assessment	EG0002 affected779 at risk EG0012 affected682 at risk
Angina pectoris	Cardiac disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Angina unstable	Cardiac disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0011 affected682 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Atrial fibrillation	Cardiac disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0011 affected682 at risk
Bradycardia	Cardiac disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Cardiac arrest	Cardiac disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Cardiac failure	Cardiac disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Coronary artery disease	Cardiac disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Myocardial infarction	Cardiac disorders	MedDRA v12.1	Systematic Assessment	EG0002 affected779 at risk EG0010 affected682 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0012 affected682 at risk
Vertigo	Ear and labyrinth disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Macular hole	Eye disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Normal tension glaucoma	Eye disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Vitreous haemorrhage	Eye disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Dysphagia	Gastrointestinal disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Chest discomfort	General disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Chest pain	General disorders	MedDRA v12.1	Systematic Assessment	EG0002 affected779 at risk EG0010 affected682 at risk
Oedema	General disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Oedema peripheral	General disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Sudden cardiac death	General disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Biliary colic	Hepatobiliary disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Cholestasis	Hepatobiliary disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Jaundice	Hepatobiliary disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Acute sinusitis	Infections and infestations	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Appendicitis	Infections and infestations	MedDRA v12.1	Systematic Assessment	EG0002 affected779 at risk EG0011 affected682 at risk
Arthritis infective	Infections and infestations	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Infection	Infections and infestations	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Pneumonia	Infections and infestations	MedDRA v12.1	Systematic Assessment	EG0002 affected779 at risk EG0010 affected682 at risk
Urinary tract infection	Infections and infestations	MedDRA v12.1	Systematic Assessment	EG0003 affected779 at risk EG0010 affected682 at risk
Fall	Injury, poisoning and procedural complications	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Fractured coccyx	Injury, poisoning and procedural complications	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Electrocardiogram T wave inversion	Investigations	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA v12.1	Systematic Assessment	EG0002 affected779 at risk EG0010 affected682 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Adrenal adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Metastases to peritoneum	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Non-Hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v12.1	Systematic Assessment	EG0002 affected779 at risk EG0010 affected682 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Cerebellar infarction	Nervous system disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0011 affected682 at risk
Cerebrovascular disorder	Nervous system disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Facial palsy	Nervous system disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Hemiparesis	Nervous system disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Ischaemic stroke	Nervous system disorders	MedDRA v12.1	Systematic Assessment	EG0002 affected779 at risk EG0010 affected682 at risk
Thrombotic stroke	Nervous system disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Upper motor neurone lesion	Nervous system disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Depression	Psychiatric disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Panic attack	Psychiatric disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Choluria	Renal and urinary disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Renal cyst	Renal and urinary disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Renal disorder	Renal and urinary disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Renal failure	Renal and urinary disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Renal mass	Renal and urinary disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Endometriosis	Reproductive system and breast disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Hypertensive crisis	Vascular disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Thrombophlebitis	Vascular disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0011 affected682 at risk
Lymphadenitis	Blood and lymphatic system disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Normochromic normocytic anaemia	Blood and lymphatic system disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Angina pectoris	Cardiac disorders	MedDRA v12.1	Systematic Assessment	EG0002 affected779 at risk EG0010 affected682 at risk
Angina unstable	Cardiac disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Atrial fibrillation	Cardiac disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0011 affected682 at risk
Bradyarrhythmia	Cardiac disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Bradycardia	Cardiac disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Coronary artery disease	Cardiac disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Left ventricular hypertrophy	Cardiac disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Palpitations	Cardiac disorders	MedDRA v12.1	Systematic Assessment	EG0009 affected779 at risk EG0015 affected682 at risk
Supraventricular tachyarrhythmia	Cardiac disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Tachycardia	Cardiac disorders	MedDRA v12.1	Systematic Assessment	EG0002 affected779 at risk EG0010 affected682 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0011 affected682 at risk
Corneal dystrophy	Congenital, familial and genetic disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Deafness unilateral	Ear and labyrinth disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Hearing impaired	Ear and labyrinth disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Hypoacusis	Ear and labyrinth disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Inner ear disorder	Ear and labyrinth disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Otosclerosis	Ear and labyrinth disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Vertigo	Ear and labyrinth disorders	MedDRA v12.1	Systematic Assessment	EG0003 affected779 at risk EG0014 affected682 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Goitre	Endocrine disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Thyroid cyst	Endocrine disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Thyroid mass	Endocrine disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Abnormal sensation in eye	Eye disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Cataract	Eye disorders	MedDRA v12.1	Systematic Assessment	EG0005 affected779 at risk EG0013 affected682 at risk
Chalazion	Eye disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Conjunctivitis	Eye disorders	MedDRA v12.1	Systematic Assessment	EG0004 affected779 at risk EG0013 affected682 at risk
Conjunctivitis allergic	Eye disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0012 affected682 at risk
Diabetic retinopathy	Eye disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Iridocyclitis	Eye disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Iritis	Eye disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Keratitis	Eye disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Macular hole	Eye disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Posterior capsule opacification	Eye disorders	MedDRA v12.1	Systematic Assessment	EG0002 affected779 at risk EG0010 affected682 at risk
Refraction disorder	Eye disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Retinal vein occlusion	Eye disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Retinopathy	Eye disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Trichiasis	Eye disorders	MedDRA v12.1	Systematic Assessment	EG0002 affected779 at risk EG0010 affected682 at risk
Vision blurred	Eye disorders	MedDRA v12.1	Systematic Assessment	EG0003 affected779 at risk EG0010 affected682 at risk
Visual impairment	Eye disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA v12.1	Systematic Assessment	EG0002 affected779 at risk EG0012 affected682 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA v12.1	Systematic Assessment	EG0007 affected779 at risk EG0017 affected682 at risk
Colitis	Gastrointestinal disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0012 affected682 at risk
Colonic polyp	Gastrointestinal disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Constipation	Gastrointestinal disorders	MedDRA v12.1	Systematic Assessment	EG0009 affected779 at risk EG0014 affected682 at risk
Diabetic enteropathy	Gastrointestinal disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA v12.1	Systematic Assessment	EG0007 affected779 at risk EG0011 affected682 at risk
Dry mouth	Gastrointestinal disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA v12.1	Systematic Assessment	EG0005 affected779 at risk EG00110 affected682 at risk
Epigastric discomfort	Gastrointestinal disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Flatulence	Gastrointestinal disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA v12.1	Systematic Assessment	EG0002 affected779 at risk EG0011 affected682 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Gastritis	Gastrointestinal disorders	MedDRA v12.1	Systematic Assessment	EG0004 affected779 at risk EG0016 affected682 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0011 affected682 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA v12.1	Systematic Assessment	EG0002 affected779 at risk EG0010 affected682 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA v12.1	Systematic Assessment	EG0002 affected779 at risk EG0012 affected682 at risk
Gingival erythema	Gastrointestinal disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Gingival hyperplasia	Gastrointestinal disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Gingival swelling	Gastrointestinal disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Glossodynia	Gastrointestinal disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA v12.1	Systematic Assessment	EG0002 affected779 at risk EG0011 affected682 at risk
Irritable bowel syndrome	Gastrointestinal disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0013 affected682 at risk
Lip swelling	Gastrointestinal disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0012 affected682 at risk
Nausea	Gastrointestinal disorders	MedDRA v12.1	Systematic Assessment	EG0002 affected779 at risk EG0011 affected682 at risk
Oedema mouth	Gastrointestinal disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Peptic ulcer	Gastrointestinal disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0013 affected682 at risk
Periodontitis	Gastrointestinal disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0011 affected682 at risk
Rectal polyp	Gastrointestinal disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Reflux oesophagitis	Gastrointestinal disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0011 affected682 at risk
Vomiting	Gastrointestinal disorders	MedDRA v12.1	Systematic Assessment	EG0002 affected779 at risk EG0010 affected682 at risk
Asthenia	General disorders	MedDRA v12.1	Systematic Assessment	EG0003 affected779 at risk EG0011 affected682 at risk
Chest discomfort	General disorders	MedDRA v12.1	Systematic Assessment	EG0004 affected779 at risk EG0014 affected682 at risk
Chest pain	General disorders	MedDRA v12.1	Systematic Assessment	EG00016 affected779 at risk EG00110 affected682 at risk
Drug ineffective	General disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Face oedema	General disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Fatigue	General disorders	MedDRA v12.1	Systematic Assessment	EG0004 affected779 at risk EG0013 affected682 at risk
Generalised oedema	General disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Impaired healing	General disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Malaise	General disorders	MedDRA v12.1	Systematic Assessment	EG0002 affected779 at risk EG0010 affected682 at risk
Oedema	General disorders	MedDRA v12.1	Systematic Assessment	EG00011 affected779 at risk EG0011 affected682 at risk
Oedema peripheral	General disorders	MedDRA v12.1	Systematic Assessment	EG00052 affected779 at risk EG00111 affected682 at risk
Pain	General disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Pyrexia	General disorders	MedDRA v12.1	Systematic Assessment	EG0003 affected779 at risk EG0012 affected682 at risk
Swelling	General disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Tenderness	General disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Thirst	General disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Biliary colic	Hepatobiliary disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0011 affected682 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0013 affected682 at risk
Hepatic steatosis	Hepatobiliary disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0013 affected682 at risk
Allergy to arthropod sting	Immune system disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0011 affected682 at risk
Hypersensitivity	Immune system disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Acute sinusitis	Infections and infestations	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0015 affected682 at risk
Bacterial infection	Infections and infestations	MedDRA v12.1	Systematic Assessment	EG0002 affected779 at risk EG0010 affected682 at risk
Borrelia infection	Infections and infestations	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Bronchitis	Infections and infestations	MedDRA v12.1	Systematic Assessment	EG00012 affected779 at risk EG00115 affected682 at risk
Bronchitis viral	Infections and infestations	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Campylobacter intestinal infection	Infections and infestations	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Catheter site infection	Infections and infestations	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Cellulitis	Infections and infestations	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0011 affected682 at risk
Conjunctivitis infective	Infections and infestations	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Cystitis	Infections and infestations	MedDRA v12.1	Systematic Assessment	EG0004 affected779 at risk EG0012 affected682 at risk
Eczema infected	Infections and infestations	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Folliculitis	Infections and infestations	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Fungal skin infection	Infections and infestations	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Gastroenteritis	Infections and infestations	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0013 affected682 at risk
Gingival infection	Infections and infestations	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Hepatitis B	Infections and infestations	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Herpes zoster	Infections and infestations	MedDRA v12.1	Systematic Assessment	EG0002 affected779 at risk EG0013 affected682 at risk
Influenza	Infections and infestations	MedDRA v12.1	Systematic Assessment	EG0007 affected779 at risk EG0013 affected682 at risk
Labyrinthitis	Infections and infestations	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Laryngitis	Infections and infestations	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Localised infection	Infections and infestations	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Nasopharyngitis	Infections and infestations	MedDRA v12.1	Systematic Assessment	EG00022 affected779 at risk EG00110 affected682 at risk
Onychomycosis	Infections and infestations	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0012 affected682 at risk
Oral herpes	Infections and infestations	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Otitis media	Infections and infestations	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0011 affected682 at risk
Paronychia	Infections and infestations	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Peritonsillar abscess	Infections and infestations	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Pharyngitis	Infections and infestations	MedDRA v12.1	Systematic Assessment	EG0006 affected779 at risk EG00113 affected682 at risk
Pharyngotonsillitis	Infections and infestations	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Pneumonia	Infections and infestations	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Pulpitis dental	Infections and infestations	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Pyelonephritis acute	Infections and infestations	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Rash pustular	Infections and infestations	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Respiratory tract infection	Infections and infestations	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0012 affected682 at risk
Respiratory tract infection bacterial	Infections and infestations	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Respiratory tract infection viral	Infections and infestations	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0017 affected682 at risk
Rhinitis	Infections and infestations	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Sinusitis	Infections and infestations	MedDRA v12.1	Systematic Assessment	EG0002 affected779 at risk EG0010 affected682 at risk
Sinusitis bacterial	Infections and infestations	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Skin candida	Infections and infestations	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Skin infection	Infections and infestations	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0011 affected682 at risk
Tinea pedis	Infections and infestations	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Tonsillitis	Infections and infestations	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Tracheitis	Infections and infestations	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Tracheobronchitis	Infections and infestations	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA v12.1	Systematic Assessment	EG00016 affected779 at risk EG00114 affected682 at risk
Urethritis	Infections and infestations	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Urinary tract infection	Infections and infestations	MedDRA v12.1	Systematic Assessment	EG0002 affected779 at risk EG0016 affected682 at risk
Urogenital infection fungal	Infections and infestations	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Vaginal infection	Infections and infestations	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Viral infection	Infections and infestations	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Brain contusion	Injury, poisoning and procedural complications	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0013 affected682 at risk
Excoriation	Injury, poisoning and procedural complications	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0011 affected682 at risk
Eye injury	Injury, poisoning and procedural complications	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Foreign body trauma	Injury, poisoning and procedural complications	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Injury	Injury, poisoning and procedural complications	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Joint sprain	Injury, poisoning and procedural complications	MedDRA v12.1	Systematic Assessment	EG0002 affected779 at risk EG0013 affected682 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Medication error	Injury, poisoning and procedural complications	MedDRA v12.1	Systematic Assessment	EG0003 affected779 at risk EG0010 affected682 at risk
Muscle injury	Injury, poisoning and procedural complications	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Nerve root injury cervical	Injury, poisoning and procedural complications	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA v12.1	Systematic Assessment	EG0002 affected779 at risk EG0010 affected682 at risk
Skin laceration	Injury, poisoning and procedural complications	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0011 affected682 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Tooth injury	Injury, poisoning and procedural complications	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Wound	Injury, poisoning and procedural complications	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Alanine aminotransferase decreased	Investigations	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Alanine aminotransferase increased	Investigations	MedDRA v12.1	Systematic Assessment	EG0005 affected779 at risk EG0012 affected682 at risk
Aspartate aminotransferase increased	Investigations	MedDRA v12.1	Systematic Assessment	EG0005 affected779 at risk EG0012 affected682 at risk
Blood albumin decreased	Investigations	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA v12.1	Systematic Assessment	EG0003 affected779 at risk EG0012 affected682 at risk
Blood calcium decreased	Investigations	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Blood calcium increased	Investigations	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Blood cholesterol increased	Investigations	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0012 affected682 at risk
Blood creatine increased	Investigations	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0011 affected682 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA v12.1	Systematic Assessment	EG00015 affected779 at risk EG0015 affected682 at risk
Blood creatinine increased	Investigations	MedDRA v12.1	Systematic Assessment	EG0006 affected779 at risk EG0010 affected682 at risk
Blood glucose decreased	Investigations	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Blood glucose increased	Investigations	MedDRA v12.1	Systematic Assessment	EG0008 affected779 at risk EG0013 affected682 at risk
Blood potassium decreased	Investigations	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Blood potassium increased	Investigations	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0013 affected682 at risk
Blood pressure abnormal	Investigations	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Blood pressure increased	Investigations	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0012 affected682 at risk
Blood triglycerides increased	Investigations	MedDRA v12.1	Systematic Assessment	EG00011 affected779 at risk EG00114 affected682 at risk
Blood urea increased	Investigations	MedDRA v12.1	Systematic Assessment	EG0002 affected779 at risk EG0011 affected682 at risk
Blood uric acid increased	Investigations	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0012 affected682 at risk
ECG signs of myocardial ischaemia	Investigations	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Glycosylated haemoglobin increased	Investigations	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Heart rate irregular	Investigations	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
High density lipoprotein increased	Investigations	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Lipids increased	Investigations	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Platelet aggregation increased	Investigations	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Weight decreased	Investigations	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Weight increased	Investigations	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA v12.1	Systematic Assessment	EG0004 affected779 at risk EG0013 affected682 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Dyslipidaemia	Metabolism and nutrition disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG00111 affected682 at risk
Food intolerance	Metabolism and nutrition disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Glucose tolerance impaired	Metabolism and nutrition disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Gout	Metabolism and nutrition disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0012 affected682 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG00112 affected682 at risk
Hypercreatininaemia	Metabolism and nutrition disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0013 affected682 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA v12.1	Systematic Assessment	EG0005 affected779 at risk EG0018 affected682 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG00110 affected682 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0017 affected682 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0014 affected682 at risk
Hypo HDL cholesterolaemia	Metabolism and nutrition disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0011 affected682 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0015 affected682 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0013 affected682 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA v12.1	Systematic Assessment	EG00010 affected779 at risk EG0018 affected682 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA v12.1	Systematic Assessment	EG00012 affected779 at risk EG0016 affected682 at risk
Bone disorder	Musculoskeletal and connective tissue disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA v12.1	Systematic Assessment	EG0002 affected779 at risk EG0011 affected682 at risk
Crystal arthropathy	Musculoskeletal and connective tissue disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Exostosis	Musculoskeletal and connective tissue disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0012 affected682 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA v12.1	Systematic Assessment	EG0002 affected779 at risk EG0010 affected682 at risk
Monarthritis	Musculoskeletal and connective tissue disorders	MedDRA v12.1	Systematic Assessment	EG0002 affected779 at risk EG0010 affected682 at risk
Muscle contracture	Musculoskeletal and connective tissue disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Muscle haemorrhage	Musculoskeletal and connective tissue disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA v12.1	Systematic Assessment	EG0004 affected779 at risk EG0011 affected682 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA v12.1	Systematic Assessment	EG0005 affected779 at risk EG0012 affected682 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA v12.1	Systematic Assessment	EG0007 affected779 at risk EG0015 affected682 at risk
Myositis	Musculoskeletal and connective tissue disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0011 affected682 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA v12.1	Systematic Assessment	EG0003 affected779 at risk EG0014 affected682 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA v12.1	Systematic Assessment	EG00010 affected779 at risk EG0018 affected682 at risk
Osteochondrosis	Musculoskeletal and connective tissue disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0013 affected682 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0012 affected682 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA v12.1	Systematic Assessment	EG0005 affected779 at risk EG0015 affected682 at risk
Periarthritis	Musculoskeletal and connective tissue disorders	MedDRA v12.1	Systematic Assessment	EG0003 affected779 at risk EG0010 affected682 at risk
Plantar fasciitis	Musculoskeletal and connective tissue disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Polyarthritis	Musculoskeletal and connective tissue disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Senile osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA v12.1	Systematic Assessment	EG0003 affected779 at risk EG0011 affected682 at risk
Sympathetic posterior cervical syndrome	Musculoskeletal and connective tissue disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0012 affected682 at risk
Temporomandibular joint syndrome	Musculoskeletal and connective tissue disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0012 affected682 at risk
Balance disorder	Nervous system disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Carotid arteriosclerosis	Nervous system disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Cerebral atrophy	Nervous system disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Cervicobrachial syndrome	Nervous system disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0011 affected682 at risk
Dementia	Nervous system disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Diabetic neuropathy	Nervous system disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0012 affected682 at risk
Dizziness	Nervous system disorders	MedDRA v12.1	Systematic Assessment	EG00017 affected779 at risk EG0019 affected682 at risk
Dizziness postural	Nervous system disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0012 affected682 at risk
Head discomfort	Nervous system disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Headache	Nervous system disorders	MedDRA v12.1	Systematic Assessment	EG00023 affected779 at risk EG00115 affected682 at risk
Hypoaesthesia	Nervous system disorders	MedDRA v12.1	Systematic Assessment	EG0008 affected779 at risk EG0010 affected682 at risk
Lumbar radiculopathy	Nervous system disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Nerve root lesion	Nervous system disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0012 affected682 at risk
Paraesthesia	Nervous system disorders	MedDRA v12.1	Systematic Assessment	EG0002 affected779 at risk EG0012 affected682 at risk
Restless legs syndrome	Nervous system disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Sciatica	Nervous system disorders	MedDRA v12.1	Systematic Assessment	EG0003 affected779 at risk EG0011 affected682 at risk
Tension headache	Nervous system disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Tremor	Nervous system disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Anxiety	Psychiatric disorders	MedDRA v12.1	Systematic Assessment	EG0002 affected779 at risk EG0015 affected682 at risk
Bruxism	Psychiatric disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Depression	Psychiatric disorders	MedDRA v12.1	Systematic Assessment	EG0004 affected779 at risk EG0014 affected682 at risk
Insomnia	Psychiatric disorders	MedDRA v12.1	Systematic Assessment	EG0008 affected779 at risk EG00111 affected682 at risk
Neurosis	Psychiatric disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Tic	Psychiatric disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Calculus bladder	Renal and urinary disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Calculus ureteric	Renal and urinary disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Cystitis haemorrhagic	Renal and urinary disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Diabetic nephropathy	Renal and urinary disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0011 affected682 at risk
Dysuria	Renal and urinary disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0011 affected682 at risk
Haematuria	Renal and urinary disorders	MedDRA v12.1	Systematic Assessment	EG0002 affected779 at risk EG0010 affected682 at risk
Nocturia	Renal and urinary disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Renal cyst	Renal and urinary disorders	MedDRA v12.1	Systematic Assessment	EG0002 affected779 at risk EG0010 affected682 at risk
Renal disorder	Renal and urinary disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Renal failure	Renal and urinary disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Renal failure chronic	Renal and urinary disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Renal impairment	Renal and urinary disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Atrophic vulvovaginitis	Reproductive system and breast disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Endometrial hypertrophy	Reproductive system and breast disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Erectile dysfunction	Reproductive system and breast disorders	MedDRA v12.1	Systematic Assessment	EG0002 affected779 at risk EG0011 affected682 at risk
Metrorrhagia	Reproductive system and breast disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Pelvic pain	Reproductive system and breast disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Prostatomegaly	Reproductive system and breast disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0011 affected682 at risk
Bronchial hyperreactivity	Respiratory, thoracic and mediastinal disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0012 affected682 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA v12.1	Systematic Assessment	EG0009 affected779 at risk EG0018 affected682 at risk
Diaphragmatic hernia	Respiratory, thoracic and mediastinal disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA v12.1	Systematic Assessment	EG0005 affected779 at risk EG0014 affected682 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0012 affected682 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Oropharyngeal discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Paranasal cyst	Respiratory, thoracic and mediastinal disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	MedDRA v12.1	Systematic Assessment	EG0005 affected779 at risk EG0010 affected682 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA v12.1	Systematic Assessment	EG0002 affected779 at risk EG0011 affected682 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA v12.1	Systematic Assessment	EG0002 affected779 at risk EG0011 affected682 at risk
Throat irritation	Respiratory, thoracic and mediastinal disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Tonsillar inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Upper airway obstruction	Respiratory, thoracic and mediastinal disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Vocal cord polyp	Respiratory, thoracic and mediastinal disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA v12.1	Systematic Assessment	EG0002 affected779 at risk EG0011 affected682 at risk
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Dermatitis atopic	Skin and subcutaneous tissue disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Dermatosis	Skin and subcutaneous tissue disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA v12.1	Systematic Assessment	EG0005 affected779 at risk EG0012 affected682 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Neurodermatitis	Skin and subcutaneous tissue disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA v12.1	Systematic Assessment	EG0005 affected779 at risk EG0011 affected682 at risk
Pruritus allergic	Skin and subcutaneous tissue disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA v12.1	Systematic Assessment	EG0004 affected779 at risk EG0011 affected682 at risk
Rash papular	Skin and subcutaneous tissue disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Seborrhoeic dermatitis	Skin and subcutaneous tissue disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Skin hypopigmentation	Skin and subcutaneous tissue disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0011 affected682 at risk
Cataract operation	Surgical and medical procedures	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Circumcision	Surgical and medical procedures	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Intraocular lens implant	Surgical and medical procedures	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0011 affected682 at risk
Lipoma excision	Surgical and medical procedures	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Flushing	Vascular disorders	MedDRA v12.1	Systematic Assessment	EG0003 affected779 at risk EG0010 affected682 at risk
Haematoma	Vascular disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0012 affected682 at risk
Hypertension	Vascular disorders	MedDRA v12.1	Systematic Assessment	EG0006 affected779 at risk EG00112 affected682 at risk
Hypotension	Vascular disorders	MedDRA v12.1	Systematic Assessment	EG0009 affected779 at risk EG0014 affected682 at risk
Intermittent claudication	Vascular disorders	MedDRA v12.1	Systematic Assessment	EG0002 affected779 at risk EG0010 affected682 at risk
Labile blood pressure	Vascular disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0011 affected682 at risk
Orthostatic hypotension	Vascular disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0011 affected682 at risk
Peripheral ischaemia	Vascular disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0010 affected682 at risk
Thrombophlebitis superficial	Vascular disorders	MedDRA v12.1	Systematic Assessment	EG0001 affected779 at risk EG0011 affected682 at risk
Venous insufficiency	Vascular disorders	MedDRA v12.1	Systematic Assessment	EG0000 affected779 at risk EG0012 affected682 at risk

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D006949	Hyperlipidemias
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

ID	Term
D004095	Dihydropyridines
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds