A Study to Assess Cardiovascular Outcomes Following Treat... | NCT01703208

ID	Type	Description	Link
2012-002414-39	EudraCT Number
MK-3102-018	Other Identifier	Merck study number

Label	Type	Description	Intervention Names
Omarigliptin	Experimental	Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly	Drug: Omarigliptin
Placebo	Placebo Comparator	Matching placebo to omarigliptin capsule or tablet administered orally once weekly	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Omarigliptin	Drug	Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly	Omarigliptin

Measure	Description	Time Frame
Number of Participants With MACE-plus (Confirmed Cardiovascular [CV]-Related Death, Nonfatal Myocardial Infarction [MI], Nonfatal Stroke, or Hospitalization Due to Unstable Angina)	Participants with confirmed MACE-plus events (confirmed cardiovascular, CV-related death, nonfatal myocardial infarction [MI], nonfatal stroke, or hospitalization due to unstable angina). In the MK-3102-018 study, MACE plus events had a data cut-off date of April 15, 2015.	Up to 156 weeks
Number of Participants With an Event of MACE (Confirmed CV-Related Death, Fatal and Nonfatal MI, and Fatal and Nonfatal Stroke)	Participants with an Event of MACE (confirmed cardiovascular, CV-related death, fatal and nonfatal myocardial infarction [MI], and fatal and nonfatal stroke).	Up to 179 weeks
Number of Participants With an Event Per 100 Person-Years for First Event of MACE (Confirmed CV-Related Death, Fatal and Nonfatal MI, and Fatal and Nonfatal Stroke)	Participants with an event of MACE (confirmed cardiovascular, CV-related death, fatal and nonfatal myocardial infarction [MI], and fatal and nonfatal stroke). Person-years were calculated as the sum of all participants' follow-up time to first event.	Up to 179 weeks
Change From Baseline in Hemoglobin A1C (A1C) at Week 18	A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 18 A1C minus the Week 0 A1C.	Baseline and Week 18
Change From Baseline in A1C at Week 18 in a Sub-Study of Participants Taking Insulin (With or Without Metformin)	A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 18 A1C minus the Week 0 A1C.

Measure	Description	Time Frame
Number of Participants With an Event of CV-Related Death	Participants with adjudicated and confirmed AEs of cardiovascular-related death.	Up to 179 weeks
Number of Participants With an Event Per 100 Person-Years of CV-Related Death

Measure	Description	Time Frame
Number of Participants With an Event of First Hospitalization for Heart Failure (Exploratory)	Participants with adjudicated and confirmed events of first hospitalization for heart failure.	Up to 179 weeks
Number of Participants With an Event Per 100 Person-years of the Event of the First Hospitalization for Heart Failure (Exploratory)

Name	Affiliation	Role
Medical Director	Merck Sharp & Dohme LLC	Study Director

PubMed Identifier	Type	Citation	Retractions
28893244	Result	Gantz I, Chen M, Suryawanshi S, Ntabadde C, Shah S, O'Neill EA, Engel SS, Kaufman KD, Lai E. A randomized, placebo-controlled study of the cardiovascular safety of the once-weekly DPP-4 inhibitor omarigliptin in patients with type 2 diabetes mellitus. Cardiovasc Diabetol. 2017 Sep 11;16(1):112. doi: 10.1186/s12933-017-0593-8.

ID	Title	Description
FG000	Omarigliptin 25 mg	Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
FG001	Placebo	Matching placebo to omarigliptin capsule or tablet administered once weekly.

ID	Title	Description
BG000	Omarigliptin 25 mg	Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
BG001	Placebo	Matching placebo to omarigliptin capsule or tablet administered once weekly.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG0002100 BG0012102 BG0024202

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With MACE-plus (Confirmed Cardiovascular [CV]-Related Death, Nonfatal Myocardial Infarction [MI], Nonfatal Stroke, or Hospitalization Due to Unstable Angina)

Participants with confirmed MACE-plus events (confirmed cardiovascular, CV-related death, nonfatal myocardial infarction [MI], nonfatal stroke, or hospitalization due to unstable angina). In the MK-3102-018 study, MACE plus events had a data cut-off date of April 15, 2015.

The analysis population included all randomized participants who took at least one dose of blinded study medication and were evaluated for MACE-plus events.

Posted

Number

Participants

Up to 156 weeks

ID	Title	Description
OG000	Omarigliptin 25 mg	Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
OG001	Placebo	Matching placebo to omarigliptin capsule or tablet administered once weekly.

Units	Counts
Participants	OG0002090 OG0012100

Title

Denominators

Categories

Title	Measurements
	OG00066(-1.14 to -0.90) OG00170(-1.20 to -0.96)

Primary

Number of Participants With an Event of MACE (Confirmed CV-Related Death, Fatal and Nonfatal MI, and Fatal and Nonfatal Stroke)

Participants with an Event of MACE (confirmed cardiovascular, CV-related death, fatal and nonfatal myocardial infarction [MI], and fatal and nonfatal stroke).

The analysis population included all randomized participants who took at least one dose of blinded trial medication.

Posted

Number

Participants

Up to 179 weeks

ID	Title	Description
OG000	Omarigliptin 25 mg	Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
OG001	Placebo	Matching placebo to omarigliptin capsule or tablet administered once weekly.

Units	Counts
Participants	OG000

Primary

Number of Participants With an Event Per 100 Person-Years for First Event of MACE (Confirmed CV-Related Death, Fatal and Nonfatal MI, and Fatal and Nonfatal Stroke)

Participants with an event of MACE (confirmed cardiovascular, CV-related death, fatal and nonfatal myocardial infarction [MI], and fatal and nonfatal stroke). Person-years were calculated as the sum of all participants' follow-up time to first event.

The analysis population included all randomized participants who took at least one dose of blinded trial medication.

Posted

Number

Participants/100 Person-years

Up to 179 weeks

ID	Title	Description
OG000	Omarigliptin 25 mg	Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
OG001	Placebo	Matching placebo to omarigliptin capsule or tablet administered once weekly.

Units	Counts
Participants	OG000

Primary

Change From Baseline in Hemoglobin A1C (A1C) at Week 18

A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 18 A1C minus the Week 0 A1C.

The analysis population consisted of all randomized participants who received at least one dose of blinded study medication and had a baseline or a post-randomization measurement.

Posted

Least Squares Mean

95% Confidence Interval

Percent

Baseline and Week 18

ID	Title	Description
OG000	Omarigliptin 25 mg	Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
OG001	Placebo	Matching placebo to omarigliptin capsule or tablet administered once weekly.

Units	Counts
Participants	OG000

Primary

Change From Baseline in A1C at Week 18 in a Sub-Study of Participants Taking Insulin (With or Without Metformin)

The analysis population consists of all randomized participants in a sub-study of participants taking insulin who received at least one dose of blinded study medication and had a baseline or a post-randomization measurement.

Posted

Least Squares Mean

95% Confidence Interval

Percentage

Baseline and Week 18

ID	Title	Description
OG000	Omarigliptin 25 mg	Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
OG001	Placebo	Matching placebo to omarigliptin capsule or tablet administered once weekly.

Units	Counts
Participants	OG000

Primary

Percentage of Participants Who Experienced at Least One Adverse Event in a Sub-study of Participants Taking Insulin Excluding Data After Background Antihyperglycemic Agent (AHA) Change

An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.

The analysis population included all randomized participants in a sub-study of participants taking insulin who received at least one dose of blinded study medication.

Posted

Number

Percentage of participants

Up to Week 18

ID	Title	Description
OG000	Omarigliptin 25 mg	Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
OG001	Placebo	Matching placebo to omarigliptin capsule or tablet administered once weekly.

Units	Counts
Participants

Primary

Percentage of Participants Who Discontinued From Study Drug Due to an Adverse Event in a Sub-Study of Participants Taking Insulin Excluding Data After Background AHA Change

The analysis population included all randomized participants in a sub-study of participants taking insulin who received at least one dose of blinded study medication.

Posted

Number

Percentage of participants

Up to Week 18

ID	Title	Description
OG000	Omarigliptin 25 mg	Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
OG001	Placebo	Matching placebo to omarigliptin capsule or tablet administered once weekly.

Units	Counts
Participants

Secondary

Number of Participants With an Event of CV-Related Death

Participants with adjudicated and confirmed AEs of cardiovascular-related death.

The analysis population consisted of all randomized participants who received at least one dose of blinded study medication.

Posted

Number

Participants

Up to 179 weeks

ID	Title	Description
OG000	Omarigliptin 25 mg	Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
OG001	Placebo	Matching placebo to omarigliptin capsule or tablet administered once weekly.

Units	Counts
Participants	OG000

Secondary

Number of Participants With an Event Per 100 Person-Years of CV-Related Death

Participants with adjudicated and confirmed AEs of cardiovascular-related death. Person-years were calculated as the sum of all participants' follow-up time to event.

The analysis population consisted of all participants who took at least one dose of blinded study medication.

Posted

Number

Participants/100 person-years

Up to 179 weeks

ID	Title	Description
OG000	Omarigliptin 25 mg	Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
OG001	Placebo	Matching placebo to omarigliptin capsule or tablet administered once weekly.

Units	Counts
Participants	OG000

Secondary

Number of Participants With an Event of First MI (Fatal and Non-fatal)

Participants with adjudicated and confirmed AEs of fatal and non-fatal MI.

The analysis population consisted of all participants who took at least one dose of blinded study medication.

Posted

Number

Participants

Up to 179 weeks

ID	Title	Description
OG000	Omarigliptin 25 mg	Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
OG001	Placebo	Matching placebo to omarigliptin capsule or tablet administered once weekly.

Units	Counts
Participants	OG000

Secondary

Number of Participants With an Event Per 100 Person-Years of First MI (Fatal and Non-fatal)

Participants with adjudicated and confirmed AEs of fatal and non-fatal MI. Person-years were calculated as the sum of all participants' follow-up time to first event.

The analysis population consisted of all participants who took at least one dose of blinded study medication.

Posted

Number

Participants/100 person-years

Up to 179 weeks

ID	Title	Description
OG000	Omarigliptin 25 mg	Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
OG001	Placebo	Matching placebo to omarigliptin capsule or tablet administered once weekly.

Units	Counts
Participants	OG000

Secondary

Number of Participants With an Event of Stroke (Fatal and Non-fatal)

Participants with adjudicated and confirmed AEs fatal and non-fatal stroke.

The analysis population consisted of all participants who took at least one dose of blinded study medication.

Posted

Number

Participants

Up to 179 weeks

ID	Title	Description
OG000	Omarigliptin 25 mg	Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
OG001	Placebo	Matching placebo to omarigliptin capsule or tablet administered once weekly.

Units	Counts
Participants	OG000

Secondary

Number of Participants With an Event Per 100 Person-Years of First Stroke (Fatal and Non-fatal)

Participants with adjudicated and confirmed AEs fatal and non-fatal stroke. Person-years were calculated as the sum of all participants' follow-up time to event.

The analysis population consisted of all participants who took at least one dose of blinded study medication.

Posted

Number

Participants/100 person-years

Up to 179 weeks

ID	Title	Description
OG000	Omarigliptin 25 mg	Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
OG001	Placebo	Matching placebo to omarigliptin capsule or tablet administered once weekly.

Units	Counts
Participants	OG000

Secondary

Number of Participants With an Event of All-Cause Death

All-cause death was death from any cause.

The analysis population included all randomized participants who took at least one dose of blinded trial medication.

Posted

Number

Participants

Up to 179 weeks

ID	Title	Description
OG000	Omarigliptin 25 mg	Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
OG001	Placebo	Matching placebo to omarigliptin capsule or tablet administered once weekly.

Units	Counts
Participants	OG000

Secondary

Number of Participants With an Event Per 100 Person-Years of the Event of All-Cause Death

All-cause death was death for any cause. Person-years were calculated as the sum of all participants' follow-up time to event.

The analysis population included all randomized participants who took at least one dose of blinded study medication.

Posted

Number

Participants/100 Person-years

Up to 179 weeks

ID	Title	Description
OG000	Omarigliptin 25 mg	Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
OG001	Placebo	Matching placebo to omarigliptin capsule or tablet administered once weekly.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in A1C at Week 142

A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). This change from baseline reflects the Week 142 A1C minus the Week 0 A1C.

The analysis population consisted of all randomized participants who received at least one dose of blinded study medication and had a baseline or a post-randomization measurement.

Posted

Least Squares Mean

95% Confidence Interval

Percent

Baseline and Week 142

ID	Title	Description
OG000	Omarigliptin 25 mg	Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
OG001	Placebo	Matching placebo to omarigliptin capsule or tablet administered once weekly.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants Achieving a Target A1C <7.0 % (53 mmol/Mol) at 4 Months

A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%).

Data for this efficacy endpoint was not collected, analyzed or summarized.

Posted

4 months

ID	Title	Description
OG000	Omarigliptin 25 mg	Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
OG001	Placebo	Matching placebo to omarigliptin capsule or tablet administered once weekly.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in Fasting Plasma Glucose (FPG) at 4 Months

This change from baseline reflects the Month 4 FPG minus the Week 0 FPG.

Data for this efficacy endpoint was not collected, analyzed or summarized.

Posted

Baseline and 4 months

ID	Title	Description
OG000	Omarigliptin 25 mg	Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
OG001	Placebo	Matching placebo to omarigliptin capsule or tablet administered once weekly.

Units	Counts
Participants	OG000

Secondary

Time to Initiation of Long-Term Insulin Therapy in Participants Not Receiving Insulin at Baseline

Long-term insulin therapy was defined as a continuous period of insulin use of more than 3 months.

Data for this efficacy endpoint was not collected, analyzed or summarized.

Posted

Up to 179 weeks

ID	Title	Description
OG000	Omarigliptin 25 mg	Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
OG001	Placebo	Matching placebo to omarigliptin capsule or tablet administered once weekly.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants Who Experienced at Least One Adverse Event

The analysis population included all randomized participants who took at least one dose of blinded study medication.

Posted

Number

Percentage of participants

Up to 234 weeks

ID	Title	Description
OG000	Omarigliptin 25 mg	Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
OG001	Placebo	Matching placebo to omarigliptin capsule or tablet administered once weekly.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants Who Discontinued From Study Drug Due to an Adverse Event

The analysis population included all randomized participants who took at least one dose of blinded study medication.

Posted

Number

Percentage of participants

Up to 212 weeks

ID	Title	Description
OG000	Omarigliptin 25 mg	Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
OG001	Placebo	Matching placebo to omarigliptin capsule or tablet administered once weekly.

Units	Counts
Participants	OG000

Secondary

Change From Baseline in FPG at Week 18 in a Sub-Study of Participants Taking Insulin

This change from baseline reflects the Week 18 FPG minus the Week 0 FPG.

The analysis population consisted of all randomized participants in a sub-study of participants taking insulin who received at least one dose of blinded study medication and had a baseline or a post-randomization measurement.

Posted

Least Squares Mean

95% Confidence Interval

mg/dL

Baseline and Week 18

ID	Title	Description
OG000	Omarigliptin 25 mg	Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
OG001	Placebo	Matching placebo to omarigliptin capsule or tablet administered once weekly.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants Achieving a Target A1C <7.0 % (53 mmol/Mol) at Week 18 in a Sub-Study of Participants Taking Insulin

A1C is blood marker used to report average blood glucose levels over prolonged periods of time and is reported as a percentage (%). Analysis was performed with multiple data imputation.

The analysis population consisted of all randomized participants in a sub-study of participants taking insulin who received at least one dose of blinded study medication.

Posted

Number

95% Confidence Interval

Percentage of participants

18 weeks

ID	Title	Description
OG000	Omarigliptin 25 mg	Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
OG001	Placebo	Matching placebo to omarigliptin capsule or tablet administered once weekly.

Units	Counts
Participants	OG000

Other Pre-specified

Number of Participants With an Event of First Hospitalization for Heart Failure (Exploratory)

Participants with adjudicated and confirmed events of first hospitalization for heart failure.

The analysis population consisted of all participants who took at least one dose of blinded study medication.

Posted

Number

Participants

Up to 179 weeks

ID	Title	Description
OG000	Omarigliptin 25 mg	Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
OG001	Placebo	Matching placebo to omarigliptin capsule or tablet administered once weekly.

Units	Counts
Participants	OG000

Other Pre-specified

Number of Participants With an Event Per 100 Person-years of the Event of the First Hospitalization for Heart Failure (Exploratory)

Participants with adjudicated and confirmed events of first hospitalization for heart failure. Person-years were calculated as the sum of all participants' follow-up time to event.

The analysis population consisted of all participants who took at least one dose of blinded study medication.

Posted

Number

Participants/100 Person-years

Up to 179 weeks

ID	Title	Description
OG000	Omarigliptin 25 mg	Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
OG001	Placebo	Matching placebo to omarigliptin capsule or tablet administered once weekly.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Agranulocytosis	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0006 events6 affected2,092 at risk EG0014 events4 affected2,100 at risk
Coagulation factor deficiency	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0002 events2 affected2,092 at risk EG0010 events0 affected2,100 at risk
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0013 events2 affected2,100 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0002 events2 affected2,092 at risk EG0010 events0 affected2,100 at risk
Lymphadenitis	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Splenic infarction	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0002 events2 affected2,092 at risk EG0010 events0 affected2,100 at risk
Thrombocytosis	Blood and lymphatic system disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0003 events3 affected2,092 at risk EG0017 events7 affected2,100 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG00035 events30 affected2,092 at risk EG00128 events27 affected2,100 at risk
Angina pectoris	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG00029 events27 affected2,092 at risk EG00136 events31 affected2,100 at risk
Angina unstable	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG00039 events33 affected2,092 at risk EG00146 events42 affected2,100 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0005 events5 affected2,092 at risk EG0011 events1 affected2,100 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG00014 events14 affected2,092 at risk EG00117 events16 affected2,100 at risk
Atrial flutter	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0007 events5 affected2,092 at risk EG0013 events3 affected2,100 at risk
Atrial tachycardia	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Atrioventricular block	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0011 events1 affected2,100 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0003 events3 affected2,092 at risk EG0010 events0 affected2,100 at risk
Bradyarrhythmia	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Bradycardia	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0002 events2 affected2,092 at risk EG0011 events1 affected2,100 at risk
Cardiac aneurysm	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Cardiac arrest	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0009 events9 affected2,092 at risk EG0014 events4 affected2,100 at risk
Cardiac failure	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG00021 events17 affected2,092 at risk EG00112 events12 affected2,100 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0006 events6 affected2,092 at risk EG0014 events4 affected2,100 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0008 events7 affected2,092 at risk EG0013 events3 affected2,100 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG00016 events14 affected2,092 at risk EG00125 events20 affected2,100 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0013 events3 affected2,100 at risk
Cardiogenic shock	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0002 events2 affected2,092 at risk EG0014 events4 affected2,100 at risk
Cardiomyopathy	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0012 events2 affected2,100 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0015 events4 affected2,100 at risk
Conduction disorder	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Cor pulmonale	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Coronary artery disease	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG00024 events22 affected2,092 at risk EG00124 events23 affected2,100 at risk
Coronary artery insufficiency	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0003 events3 affected2,092 at risk EG0014 events4 affected2,100 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0009 events9 affected2,092 at risk EG0016 events6 affected2,100 at risk
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0011 events1 affected2,100 at risk
Left ventricular failure	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0012 events2 affected2,100 at risk
Myocardial infarction	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG00019 events19 affected2,092 at risk EG00119 events17 affected2,100 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0006 events5 affected2,092 at risk EG0013 events3 affected2,100 at risk
Myocardial reperfusion injury	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Pericardial effusion	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Right ventricular failure	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Silent myocardial infarction	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0002 events2 affected2,092 at risk EG0011 events1 affected2,100 at risk
Sinus node dysfunction	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0004 events3 affected2,092 at risk EG0011 events1 affected2,100 at risk
Ventricular arrhythmia	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0013 events3 affected2,100 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0003 events3 affected2,092 at risk EG0010 events0 affected2,100 at risk
Ventricular tachyarrhythmia	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0002 events2 affected2,092 at risk EG0014 events3 affected2,100 at risk
Congenital claw toe	Congenital, familial and genetic disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Encephalocele	Congenital, familial and genetic disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Deafness neurosensory	Ear and labyrinth disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0012 events2 affected2,100 at risk
Deafness unilateral	Ear and labyrinth disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 19.0	Systematic Assessment	EG0002 events2 affected2,092 at risk EG0010 events0 affected2,100 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Vestibular disorder	Ear and labyrinth disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Goitre	Endocrine disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0011 events1 affected2,100 at risk
Cataract	Eye disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0012 events2 affected2,100 at risk
Keratitis	Eye disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Retinal detachment	Eye disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0013 events2 affected2,100 at risk
Retinal haemorrhage	Eye disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Retinal tear	Eye disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Vitreous haemorrhage	Eye disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0012 events2 affected2,100 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0002 events2 affected2,092 at risk EG0011 events1 affected2,100 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Acquired oesophageal web	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Anal spasm	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Chronic gastritis	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Colitis	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Constipation	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Crohn's disease	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Diabetic gastroenteropathy	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Diabetic gastroparesis	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0011 events1 affected2,100 at risk
Diverticular perforation	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Diverticulum	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Enterovesical fistula	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Food poisoning	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0011 events1 affected2,100 at risk
Gastric polyps	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0002 events2 affected2,092 at risk EG0011 events1 affected2,100 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0002 events2 affected2,092 at risk EG0011 events1 affected2,100 at risk
Gastric varices haemorrhage	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Gastritis	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0011 events1 affected2,100 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Gastroduodenitis	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0011 events1 affected2,100 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0002 events2 affected2,092 at risk EG0012 events2 affected2,100 at risk
Gastrointestinal ulcer haemorrhage	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Ileus	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Ileus paralytic	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0011 events1 affected2,100 at risk
Impaired gastric emptying	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Incarcerated umbilical hernia	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0006 events5 affected2,092 at risk EG0012 events2 affected2,100 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0002 events2 affected2,092 at risk EG0010 events0 affected2,100 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0014 events4 affected2,100 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0013 events2 affected2,100 at risk
Noninfective gingivitis	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0003 events3 affected2,092 at risk EG0010 events0 affected2,100 at risk
Pancreatic cyst	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0011 events1 affected2,100 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0002 events2 affected2,092 at risk EG0011 events1 affected2,100 at risk
Pancreatitis chronic	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Peptic ulcer	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0012 events2 affected2,100 at risk
Retroperitoneal haematoma	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0012 events2 affected2,100 at risk
Strangulated umbilical hernia	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0013 events3 affected2,100 at risk
Vomiting	Gastrointestinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Cardiac death	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Chest pain	General disorders	MedDRA 19.0	Systematic Assessment	EG0008 events6 affected2,092 at risk EG0011 events1 affected2,100 at risk
Complication associated with device	General disorders	MedDRA 19.0	Systematic Assessment	EG0002 events2 affected2,092 at risk EG0011 events1 affected2,100 at risk
Death	General disorders	MedDRA 19.0	Systematic Assessment	EG0004 events4 affected2,092 at risk EG0010 events0 affected2,100 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA 19.0	Systematic Assessment	EG0005 events5 affected2,092 at risk EG0011 events1 affected2,100 at risk
Non-cardiac chest pain	General disorders	MedDRA 19.0	Systematic Assessment	EG0005 events5 affected2,092 at risk EG00110 events8 affected2,100 at risk
Sudden cardiac death	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0014 events4 affected2,100 at risk
Sudden death	General disorders	MedDRA 19.0	Systematic Assessment	EG0006 events6 affected2,092 at risk EG0013 events3 affected2,100 at risk
Vascular stent restenosis	General disorders	MedDRA 19.0	Systematic Assessment	EG0002 events2 affected2,092 at risk EG0011 events1 affected2,100 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Cholangitis	Hepatobiliary disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0011 events1 affected2,100 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 19.0	Systematic Assessment	EG0007 events7 affected2,092 at risk EG0013 events3 affected2,100 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 19.0	Systematic Assessment	EG0004 events4 affected2,092 at risk EG0014 events4 affected2,100 at risk
Cholecystitis chronic	Hepatobiliary disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 19.0	Systematic Assessment	EG0005 events5 affected2,092 at risk EG0013 events3 affected2,100 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0012 events2 affected2,100 at risk
Hepatorenal syndrome	Hepatobiliary disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Hydrocholecystis	Hepatobiliary disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Jaundice	Hepatobiliary disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Hypersensitivity	Immune system disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0011 events1 affected2,100 at risk
Abdominal abscess	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0002 events2 affected2,092 at risk EG0010 events0 affected2,100 at risk
Abscess intestinal	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Abscess limb	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0002 events2 affected2,092 at risk EG0010 events0 affected2,100 at risk
Appendicitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0012 events2 affected2,100 at risk
Atypical pneumonia	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0011 events1 affected2,100 at risk
Bacterial sepsis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Bronchitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0006 events6 affected2,092 at risk EG0012 events2 affected2,100 at risk
Bronchitis viral	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Bronchopulmonary aspergillosis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Bronchopulmonary aspergillosis allergic	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Cellulitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG00011 events11 affected2,092 at risk EG0013 events2 affected2,100 at risk
Chronic hepatitis C	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Cystitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Diabetic foot infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Diabetic gangrene	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0011 events1 affected2,100 at risk
Diverticulitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0011 events1 affected2,100 at risk
Endocarditis bacterial	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Endophthalmitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Enterococcal sepsis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Epididymitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Erysipelas	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0012 events2 affected2,100 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0013 events3 affected2,100 at risk
Febrile infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Fungal infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Gangrene	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0007 events6 affected2,092 at risk EG0014 events4 affected2,100 at risk
Gas gangrene	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Gastroenteritis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0004 events3 affected2,092 at risk EG0013 events3 affected2,100 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0011 events1 affected2,100 at risk
HIV infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Infectious pleural effusion	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0002 events2 affected2,092 at risk EG0010 events0 affected2,100 at risk
Infective exacerbation of bronchiectasis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Kidney infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Klebsiella sepsis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0012 events2 affected2,100 at risk
Lung infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Mediastinitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Neuroborreliosis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Nosocomial infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Osteomyelitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0002 events2 affected2,092 at risk EG0011 events1 affected2,100 at risk
Paronychia	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0012 events2 affected2,100 at risk
Parotitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Pelvic sepsis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Perirectal abscess	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Pneumocystis jirovecii pneumonia	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Pneumonia	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG00037 events35 affected2,092 at risk EG00131 events31 affected2,100 at risk
Pneumonia respiratory syncytial viral	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Pneumonia streptococcal	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Pneumonia viral	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Postoperative abscess	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Pulmonary tuberculosis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Pyelonephritis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0013 events3 affected2,100 at risk
Pyelonephritis acute	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0011 events1 affected2,100 at risk
Respiratory tract infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0002 events2 affected2,092 at risk EG0010 events0 affected2,100 at risk
Respiratory tract infection viral	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Sepsis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0007 events7 affected2,092 at risk EG0015 events5 affected2,100 at risk
Septic shock	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0003 events3 affected2,092 at risk EG0011 events1 affected2,100 at risk
Sinusitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Subdural empyema	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Tuberculosis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0012 events2 affected2,100 at risk
Urinary tract infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0004 events4 affected2,092 at risk EG0016 events6 affected2,100 at risk
Urinary tract infection bacterial	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Urosepsis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Viral infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0002 events2 affected2,092 at risk EG0011 events1 affected2,100 at risk
Vulval abscess	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Wound infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Acetabulum fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Alcohol poisoning	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0013 events3 affected2,100 at risk
Avulsion fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Cardiac procedure complication	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Chemical peritonitis	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0002 events2 affected2,092 at risk EG0013 events2 affected2,100 at risk
Coronary artery restenosis	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Cystitis radiation	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Face injury	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0002 events2 affected2,092 at risk EG0010 events0 affected2,100 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Flail chest	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Forearm fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0002 events2 affected2,092 at risk EG0010 events0 affected2,100 at risk
Gastrointestinal anastomotic leak	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0002 events2 affected2,092 at risk EG0012 events2 affected2,100 at risk
Incarcerated incisional hernia	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Incisional hernia	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0002 events2 affected2,092 at risk EG0010 events0 affected2,100 at risk
Jaw fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0002 events2 affected2,092 at risk EG0010 events0 affected2,100 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0012 events2 affected2,100 at risk
Meniscus injury	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Multiple injuries	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Post procedural complication	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0011 events1 affected2,100 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0012 events2 affected2,100 at risk
Postoperative ileus	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0013 events3 affected2,100 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0003 events3 affected2,092 at risk EG0011 events1 affected2,100 at risk
Soft tissue injury	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Spinal cord injury cervical	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Stomal hernia	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0002 events2 affected2,092 at risk EG0011 events1 affected2,100 at risk
Synovial rupture	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0012 events2 affected2,100 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Traumatic haemorrhage	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0011 events1 affected2,100 at risk
Vascular graft occlusion	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Blood creatinine increased	Investigations	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Blood glucose increased	Investigations	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0016 events6 affected2,100 at risk
Blood sodium decreased	Investigations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Heart rate increased	Investigations	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Troponin increased	Investigations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0012 events2 affected2,100 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0013 events3 affected2,100 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0003 events3 affected2,092 at risk EG0011 events1 affected2,100 at risk
Diabetic metabolic decompensation	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Gout	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0005 events5 affected2,092 at risk EG0017 events7 affected2,100 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0004 events3 affected2,092 at risk EG0015 events5 affected2,100 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0012 events1 affected2,100 at risk
Obesity	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0011 events1 affected2,100 at risk
Amyotrophy	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0002 events2 affected2,092 at risk EG0012 events2 affected2,100 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0012 events2 affected2,100 at risk
Gouty arthritis	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0012 events2 affected2,100 at risk
Intervertebral disc disorder	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0002 events2 affected2,092 at risk EG0014 events4 affected2,100 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0011 events1 affected2,100 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0002 events2 affected2,092 at risk EG0011 events1 affected2,100 at risk
Osteitis	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0011 events1 affected2,100 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG00015 events14 affected2,092 at risk EG0019 events9 affected2,100 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Periarthritis	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0004 events4 affected2,092 at risk EG0010 events0 affected2,100 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0011 events1 affected2,100 at risk
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Trigger finger	Musculoskeletal and connective tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Adenocarcinoma gastric	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0006 events5 affected2,092 at risk EG00115 events10 affected2,100 at risk
Benign neoplasm of eyelid	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Benign renal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0002 events2 affected2,092 at risk EG0015 events5 affected2,100 at risk
Bladder cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Bladder neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0011 events1 affected2,100 at risk
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0011 events1 affected2,100 at risk
Bone cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Brain neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Breast cancer in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Breast cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Cholangiocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Colon adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0003 events3 affected2,092 at risk EG0011 events1 affected2,100 at risk
Colorectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0012 events2 affected2,100 at risk
Gastrooesophageal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Hepatic cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Hepatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Hodgkin's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Intraductal proliferative breast lesion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0013 events3 affected2,100 at risk
Lung carcinoma cell type unspecified stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0002 events2 affected2,092 at risk EG0010 events0 affected2,100 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0003 events3 affected2,092 at risk EG0011 events1 affected2,100 at risk
Lung squamous cell carcinoma stage II	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0003 events3 affected2,092 at risk EG0011 events1 affected2,100 at risk
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Metastatic gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0012 events2 affected2,100 at risk
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0012 events2 affected2,100 at risk
Neuroendocrine carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Non-Hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Oesophageal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0012 events2 affected2,100 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0003 events3 affected2,092 at risk EG0011 events1 affected2,100 at risk
Pancreatic carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0002 events2 affected2,092 at risk EG0010 events0 affected2,100 at risk
Pancreatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Parathyroid tumour benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0007 events7 affected2,092 at risk EG0014 events4 affected2,100 at risk
Prostate cancer stage 0	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Prostate cancer stage II	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Prostatic adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0013 events3 affected2,100 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0002 events2 affected2,092 at risk EG0010 events0 affected2,100 at risk
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0004 events4 affected2,092 at risk EG0012 events2 affected2,100 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0012 events2 affected2,100 at risk
Small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0002 events2 affected2,092 at risk EG0012 events1 affected2,100 at risk
Small cell lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0003 events2 affected2,092 at risk EG0019 events5 affected2,100 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0012 events2 affected2,100 at risk
Tonsil cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Urinary tract neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Vocal cord neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Altered state of consciousness	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0012 events2 affected2,100 at risk
Ataxia	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0011 events1 affected2,100 at risk
Basal ganglia infarction	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Basal ganglia stroke	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Brain stem infarction	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0002 events2 affected2,092 at risk EG0010 events0 affected2,100 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0004 events4 affected2,092 at risk EG0017 events7 affected2,100 at risk
Cauda equina syndrome	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0012 events2 affected2,100 at risk
Cerebral infarction	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0004 events4 affected2,092 at risk EG0012 events2 affected2,100 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0012 events2 affected2,100 at risk
Cerebral small vessel ischaemic disease	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG00010 events9 affected2,092 at risk EG0019 events9 affected2,100 at risk
Cerebrovascular insufficiency	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0002 events2 affected2,092 at risk EG0010 events0 affected2,100 at risk
Cervical radiculopathy	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Cervicobrachial syndrome	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Coma	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Dementia	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Dementia Alzheimer's type	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Diabetic neuropathy	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Dizziness	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0012 events2 affected2,100 at risk
Embolic stroke	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0011 events1 affected2,100 at risk
Encephalopathy	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0012 events2 affected2,100 at risk
Epilepsy	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Facial paralysis	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Haemorrhagic stroke	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0012 events2 affected2,100 at risk
Headache	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0011 events1 affected2,100 at risk
Hypertensive encephalopathy	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
IIIrd nerve paralysis	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Intracranial aneurysm	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG00011 events11 affected2,092 at risk EG00117 events17 affected2,100 at risk
Lacunar infarction	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0002 events2 affected2,092 at risk EG0010 events0 affected2,100 at risk
Loss of consciousness	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0011 events1 affected2,100 at risk
Lumbar radiculopathy	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Meralgia paraesthetica	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Migraine	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Monoparesis	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Myelitis transverse	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Nerve root compression	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Parkinson's disease	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Presyncope	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0012 events2 affected2,100 at risk
Radiculopathy	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Syncope	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0008 events7 affected2,092 at risk EG0014 events2 affected2,100 at risk
Thalamic infarction	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Toxic encephalopathy	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG00011 events11 affected2,092 at risk EG00111 events11 affected2,100 at risk
VIth nerve paralysis	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0012 events2 affected2,100 at risk
Vascular dementia	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Vertebrobasilar insufficiency	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0012 events2 affected2,100 at risk
Device breakage	Product Issues	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Device malfunction	Product Issues	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Abnormal behaviour	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Acute stress disorder	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Alcoholism	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Confusional state	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Depression	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0002 events2 affected2,092 at risk EG0013 events3 affected2,100 at risk
Major depression	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0012 events2 affected2,100 at risk
Mental disorder	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Panic attack	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Schizophrenia	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0003 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Somatic symptom disorder	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Stress	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Substance-induced mood disorder	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Suicide attempt	Psychiatric disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG00011 events11 affected2,092 at risk EG0016 events6 affected2,100 at risk
Calculus urethral	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Calculus urinary	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0002 events2 affected2,092 at risk EG0010 events0 affected2,100 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0002 events2 affected2,092 at risk EG0010 events0 affected2,100 at risk
Dysuria	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Haematuria	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Haemorrhage urinary tract	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0005 events5 affected2,092 at risk EG0012 events2 affected2,100 at risk
Renal colic	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Renal failure	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0011 events1 affected2,100 at risk
Stag horn calculus	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Ureteric stenosis	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Ureterolithiasis	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0002 events2 affected2,092 at risk EG0010 events0 affected2,100 at risk
Urethral stenosis	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0011 events1 affected2,100 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Urinary retention	Renal and urinary disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0011 events1 affected2,100 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 19.0	Systematic Assessment	EG0002 events2 affected2,092 at risk EG0011 events1 affected2,100 at risk
Breast fibrosis	Reproductive system and breast disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Genital prolapse	Reproductive system and breast disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Prostatic dysplasia	Reproductive system and breast disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Uterine haemorrhage	Reproductive system and breast disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Uterine prolapse	Reproductive system and breast disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0002 events2 affected2,092 at risk EG0012 events2 affected2,100 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0006 events6 affected2,092 at risk EG0011 events1 affected2,100 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0002 events2 affected2,092 at risk EG0011 events1 affected2,100 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0009 events7 affected2,092 at risk EG0016 events5 affected2,100 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0015 events5 affected2,100 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0011 events1 affected2,100 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0011 events1 affected2,100 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0003 events3 affected2,092 at risk EG0011 events1 affected2,100 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0012 events2 affected2,100 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0002 events2 affected2,092 at risk EG0010 events0 affected2,100 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0013 events3 affected2,100 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0003 events3 affected2,092 at risk EG0013 events3 affected2,100 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0002 events2 affected2,092 at risk EG0010 events0 affected2,100 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Dermatosis	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0014 events3 affected2,100 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 19.0	Systematic Assessment	EG0006 events6 affected2,092 at risk EG0010 events0 affected2,100 at risk
Aortic aneurysm	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0002 events2 affected2,092 at risk EG0011 events1 affected2,100 at risk
Aortic stenosis	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0012 events2 affected2,100 at risk
Arterial occlusive disease	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Circulatory collapse	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0002 events2 affected2,092 at risk EG0014 events3 affected2,100 at risk
Dry gangrene	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0002 events2 affected2,092 at risk EG0010 events0 affected2,100 at risk
Extremity necrosis	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0002 events2 affected2,092 at risk EG0012 events2 affected2,100 at risk
Haematoma	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Hypertension	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0007 events7 affected2,092 at risk EG0018 events8 affected2,100 at risk
Hypertensive crisis	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0002 events2 affected2,092 at risk EG0013 events3 affected2,100 at risk
Hypertensive emergency	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Hypotension	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Iliac artery occlusion	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Intermittent claudication	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG00017 events14 affected2,092 at risk EG00111 events10 affected2,100 at risk
Peripheral artery occlusion	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Peripheral artery stenosis	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0003 events3 affected2,092 at risk EG0012 events2 affected2,100 at risk
Peripheral artery thrombosis	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0002 events1 affected2,092 at risk EG0014 events4 affected2,100 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA 19.0	Systematic Assessment	EG0004 events4 affected2,092 at risk EG0011 events1 affected2,100 at risk
Trifascicular block	Cardiac disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Catheter site haemorrhage	General disorders	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Vascular stent thrombosis	General disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Bacteraemia	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG0000 events0 affected2,092 at risk EG0011 events1 affected2,100 at risk
Procedural pneumothorax	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Traumatic intracranial haemorrhage	Injury, poisoning and procedural complications	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Benign ear neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Bowen's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Ear neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk
Cerebellar infarction	Nervous system disorders	MedDRA 19.0	Systematic Assessment	EG0001 events1 affected2,092 at risk EG0010 events0 affected2,100 at risk

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Omarigliptin 25 mg	Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly			512	2,092	788	2,092
EG001	Placebo	Matching placebo to omarigliptin capsule or tablet administered once weekly.			503	2,100	794	2,100

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG000167 events123 affected2,092 at risk EG001195 events145 affected2,100 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG000163 events123 affected2,092 at risk EG001150 events120 affected2,100 at risk
Blood glucose increased	Investigations	MedDRA 19.0	Systematic Assessment	EG000139 events97 affected2,092 at risk EG001199 events139 affected2,100 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 19.0	Systematic Assessment	EG0003,990 events530 affected2,092 at risk EG0013,688 events473 affected2,100 at risk
Urinary tract infection	Infections and infestations	MedDRA 19.0	Systematic Assessment	EG000131 events108 affected2,092 at risk EG001141 events98 affected2,100 at risk