A Trial Comparing Cardiovascular Safety of Insulin Deglud... | NCT01959529

NCT01959529

ID	Type	Description
2013-002371-17	EudraCT Number
U1111-1141-7614	Other Identifier	WHO
JapicCTI-142464	Registry Identifier	JAPIC

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Insulin degludec (IDeg)	Experimental	All subjects will continue their current antidiabetic therapy except for the basal insulin component (if any) that will be replaced by the investigational product.	Drug: insulin degludec
Insulin glargine (IGlar)	Active Comparator	All subjects will continue their current antidiabetic therapy except for the basal insulin component (if any) that will be replaced by the investigational product.	Drug: insulin glargine

Name	Type	Description	Arm Group Labels	Other Names
insulin degludec	Drug	Injected once daily subcutaneously (s.c., under the skin)	Insulin degludec (IDeg)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time From Randomisation to First Occurrence of a Major Adverse Cardiovascular Event (MACE): Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke	Time from randomisation to first occurrence of an event adjudication committee (EAC)-confirmed 3-component major adverse cardiovascular event (MACE): cardiovascular death, non-fatal myocardial infarction, or nonfatal stroke. Events with EAC-confirmed onset date between randomisation and individual end of trial were included in the analyses. The number of subjects experiencing first EAC-confirmed MACEs, date between randomisation to the end of trial, both days included were presented. The trial was event driven and planned to last up to a maximum of 60.5 months. The actual trial duration (time from first subject first visit to last subject last visit) was 35.6 months. The maximum trial duration for a single subject was 33.1 months.	From randomisation to individual end of trial date (maximum patient year observation: 2.75 years)

Secondary Outcomes

Measure	Description	Time Frame
Number of EAC-confirmed Severe Hypoglycaemic Episodes	Number of severe hypoglycaemic episodes from week 0 to the last assessment (up to 35.6 months). The episode of severe hypoglycaemia is an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. The trial was event driven and planned to last up to a maximum of 60.5 months. The actual trial duration (time from first subject first visit to last subject last visit) was 35.6 months. The maximum trial duration for a single subject was 33.1 months.

Eligibility Module

Name	Affiliation	Role
Global Clinical Registry (GCR, 1452)	Novo Nordisk A/S	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novo Nordisk Investigational Site		Birmingham	Alabama	35216	United States
Novo Nordisk Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30924579	Background	Pollock RF, Heller S, Pieber TR, Woo V, Gundgaard J, Hallen N, Luckevich M, Tutkunkardas D, Zinman B; DEVOTE Study Group. Short-term cost-utility of degludec versus glargine U100 for patients with type 2 diabetes at high risk of hypoglycaemia and cardiovascular events: A Canadian setting (DEVOTE 9). Diabetes Obes Metab. 2019 Jul;21(7):1706-1714. doi: 10.1111/dom.13730. Epub 2019 Apr 14.
31264138

Label	URL
Clinical Trials at Novo Nordisk	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Insulin Degludec	Subjects received insulin degludec (IDeg) 100 units/mL once daily (OD) subcutaneously (S.C.; under the skin) in the thigh, upper arm, or the abdominal wall between dinner and bedtime. Subjects continued their pre-trial medication except for the basal insulin, which was replaced by investigational medicinal product (IMP; IDeg). The pre-trial bolus insulin was allowed and could be replaced with insulin aspart (IAsp) at the discretion of the investigator. For subjects previously receiving premixed/biphasic insulin the basal component was calculated and switched to IDeg OD, and the bolus insulin component to bolus insulin. For subjects previously receiving premixed/biphasic insulin twice daily (BID), the total basal component was calculated, reduced by 20- 30% and switched to IDeg OD, and the bolus component was calculated and switched to IAsp. The trial was event driven for with a realised observation period up to 33 months.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Insulin Degludec	Subjects received IDeg 100 units/mL OD S.C. (under the skin) in the thigh, upper arm, or the abdominal wall between dinner and bedtime. Subjects continued their pre-trial medication except for the basal insulin, which was replaced by investigational medicinal product (IMP; IDeg). The pre-trial bolus insulin was allowed and could be replaced with IAsp at the discretion of the investigator. For subjects previously receiving premixed/biphasic insulin the basal component was calculated and switched to IDeg OD, and the bolus insulin component to bolus insulin. For subjects previously receiving premixed/biphasic insulin BID, the total basal component was calculated, reduced by 20- 30% and switched to IDeg OD, and the bolus component was calculated and switched to IAsp. The trial was event driven for with a realised observation period up to 33 months.
BG001	Insulin Glargine	Subjects received IGlar 100 units/mL OD subcutaneously (S.C.; under the skin) in the thigh, upper arm, or the abdominal wall between dinner and bedtime. Subjects continued their pretrial medication except for the basal insulin, which was replaced by investigational medicinal product (IMP; IGlar). The pre-trial bolus insulin was allowed and could be replaced with IAsp at the discretion of the investigator. For subjects previously receiving premixed/biphasic insulin the basal component was calculated and switched to IGlar OD, and the bolus insulin component to bolus insulin. For subjects previously receiving premixed/biphasic insulin BID, the total basal component was calculated, reduced by 20- 30% and switched to IGlar OD, and the bolus component was calculated and switched to IAsp. The trial was event driven with a realised observation period up to 33 months.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00064.9± 7.3 BG00165.0± 7.5 BG00265.0± 7.4

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0001422 BG0011437 BG002

HbA1c

Mean

Standard Deviation

percentage of HbA1c

Title

Denominators

Categories

Title	Measurements
	BG0008.44± 1.63 BG0018.41± 1.67 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Time From Randomisation to First Occurrence of a Major Adverse Cardiovascular Event (MACE): Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke

Time from randomisation to first occurrence of an event adjudication committee (EAC)-confirmed 3-component major adverse cardiovascular event (MACE): cardiovascular death, non-fatal myocardial infarction, or nonfatal stroke. Events with EAC-confirmed onset date between randomisation and individual end of trial were included in the analyses. The number of subjects experiencing first EAC-confirmed MACEs, date between randomisation to the end of trial, both days included were presented. The trial was event driven and planned to last up to a maximum of 60.5 months. The actual trial duration (time from first subject first visit to last subject last visit) was 35.6 months. The maximum trial duration for a single subject was 33.1 months.

The analysis was based on the FAS, which included all randomised subjects.

Posted

Count of Participants

Participants

From randomisation to individual end of trial date (maximum patient year observation: 2.75 years)

ID	Title	Description
OG000	Insulin Degludec	Subjects received IDeg 100 units/mL OD S.C. (under the skin) in the thigh, upper arm, or the abdominal wall between dinner and bedtime. Subjects continued their pre-trial medication except for the basal insulin, which was replaced by investigational medicinal product (IMP; IDeg). The pre-trial bolus insulin was allowed and could be replaced with IAsp at the discretion of the investigator. For subjects previously receiving premixed/biphasic insulin the basal component was calculated and switched to IDeg OD, and the bolus insulin component to bolus insulin. For subjects previously receiving premixed/biphasic insulin BID, the total basal component was calculated, reduced by 20- 30% and switched to IDeg OD, and the bolus component was calculated and switched to IAsp. The trial was event driven for with a realised observation period up to 33 months.
OG001	Insulin Glargine	Subjects received IGlar 100 units/mL OD subcutaneously (S.C.; under the skin) in the thigh, upper arm, or the abdominal wall between dinner and bedtime. Subjects continued their pretrial medication except for the basal insulin, which was replaced by investigational medicinal product (IMP; IGlar). The pre-trial bolus insulin was allowed and could be replaced with IAsp at the discretion of the investigator. For subjects previously receiving premixed/biphasic insulin the basal component was calculated and switched to IGlar OD, and the bolus insulin component to bolus insulin. For subjects previously receiving premixed/biphasic insulin BID, the total basal component was calculated, reduced by 20- 30% and switched to IGlar OD, and the bolus component was calculated and switched to IAsp. The trial was event driven with a realised observation period up to 33 months.

Units	Counts
Participants	OG0003818 OG0013819

Title

Denominators

Categories

First EAC-confirmed MACE

Title	Measurements
	OG000325 OG001356

Myocardial infarction (non-fatal)

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	The hazard ratio (HR) (IDeg vs IGlar) was based on Cox regression with investigational medicinal product as only factor for primary analysis.	Regression, Cox		<0.001	p value : Refers to one-sided test of HR >= 1.3 (against Ha: HR<1.3).	Hazard Ratio (HR)	0.908			2-Sided	95	0.781	1.055					Non-Inferiority	Non-inferiority of IDeg to IGlar was considered confirmed if the upper limit of the two-sided 95% confidence interval for the HR was below 1.3 or equivalent if the p-value for the one-sided test of null hypothesis (H0): HR≥1.3 against the alternative hypothesis (Ha): HR<1.3 was less than 2.5%.

Secondary

Number of EAC-confirmed Severe Hypoglycaemic Episodes

Number of severe hypoglycaemic episodes from week 0 to the last assessment (up to 35.6 months). The episode of severe hypoglycaemia is an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. The trial was event driven and planned to last up to a maximum of 60.5 months. The actual trial duration (time from first subject first visit to last subject last visit) was 35.6 months. The maximum trial duration for a single subject was 33.1 months.

The analysis was based on the FAS, which included all randomised subjects.

Posted

Number

Number of severe episodes

From randomisation to individual end of trial (maximum patient year observation: 2.75 years)

ID	Title	Description
OG000	Insulin Degludec	Subjects received IDeg 100 units/mL OD S.C. (under the skin) in the thigh, upper arm, or the abdominal wall between dinner and bedtime. Subjects continued their pre-trial medication except for the basal insulin, which was replaced by investigational medicinal product (IMP; IDeg). The pre-trial bolus insulin was allowed and could be replaced with IAsp at the discretion of the investigator. For subjects previously receiving premixed/biphasic insulin the basal component was calculated and switched to IDeg OD, and the bolus insulin component to bolus insulin. For subjects previously receiving premixed/biphasic insulin BID, the total basal component was calculated, reduced by 20- 30% and switched to IDeg OD, and the bolus component was calculated and switched to IAsp. The trial was event driven for with a realised observation period up to 33 months.

Secondary

Occurrence of at Least One EAC Confirmed Severe Hypoglycaemic Episode Within a Subject (Yes/no)

Occurrence of at least one EAC-confirmed severe hypoglycaemic episode within a subject from week 0 to the last assessment (up to 35.6 months). The episode of severe hypoglycaemia is an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions.

The analysis was based on the FAS, which included all randomised subjects.

Posted

Count of Participants

Participants

From randomisation to individual end of trial date (maximum patient year observation: 2.75 years)

ID	Title	Description
OG000	Insulin Degludec	Subjects received IDeg 100 units/mL OD S.C. (under the skin) in the thigh, upper arm, or the abdominal wall between dinner and bedtime. Subjects continued their pre-trial medication except for the basal insulin, which was replaced by investigational medicinal product (IMP; IDeg). The pre-trial bolus insulin was allowed and could be replaced with IAsp at the discretion of the investigator. For subjects previously receiving premixed/biphasic insulin the basal component was calculated and switched to IDeg OD, and the bolus insulin component to bolus insulin. For subjects previously receiving premixed/biphasic insulin BID, the total basal component was calculated, reduced by 20- 30% and switched to IDeg OD, and the bolus component was calculated and switched to IAsp. The trial was event driven for with a realised observation period up to 33 months.
OG001	Insulin Glargine

Secondary

Change in Glycosylated Haemoglobin (HbA1c)

Mean change in HbA1c from week 0 to month 24.

The analysis was based on the FAS. The number of subjects analysed are the number of subjects with the available data after 24 months.

Posted

Mean

Standard Deviation

percentage of HbA1c

Randomisation to 24 months

ID	Title	Description
OG000	Insulin Degludec	Subjects received IDeg 100 units/mL OD S.C. (under the skin) in the thigh, upper arm, or the abdominal wall between dinner and bedtime. Subjects continued their pre-trial medication except for the basal insulin, which was replaced by investigational medicinal product (IMP; IDeg). The pre-trial bolus insulin was allowed and could be replaced with IAsp at the discretion of the investigator. For subjects previously receiving premixed/biphasic insulin the basal component was calculated and switched to IDeg OD, and the bolus insulin component to bolus insulin. For subjects previously receiving premixed/biphasic insulin BID, the total basal component was calculated, reduced by 20- 30% and switched to IDeg OD, and the bolus component was calculated and switched to IAsp. The trial was event driven for with a realised observation period up to 33 months.
OG001	Insulin Glargine	Subjects received IGlar 100 units/mL OD subcutaneously (S.C.; under the skin) in the thigh, upper arm, or the abdominal wall between dinner and bedtime. Subjects continued their pretrial medication except for the basal insulin, which was replaced by investigational medicinal product (IMP; IGlar). The pre-trial bolus insulin was allowed and could be replaced with IAsp at the discretion of the investigator. For subjects previously receiving premixed/biphasic insulin the basal component was calculated and switched to IGlar OD, and the bolus insulin component to bolus insulin. For subjects previously receiving premixed/biphasic insulin BID, the total basal component was calculated, reduced by 20- 30% and switched to IGlar OD, and the bolus component was calculated and switched to IAsp. The trial was event driven with a realised observation period up to 33 months.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Insulin Degludec	Subjects received IDeg 100 units/mL OD S.C. (under the skin) in the thigh, upper arm, or the abdominal wall between dinner and bedtime. Subjects continued their pre-trial medication except for the basal insulin, which was replaced by investigational medicinal product (IMP; IDeg). The pre-trial bolus insulin was allowed and could be replaced with IAsp at the discretion of the investigator. For subjects previously receiving premixed/biphasic insulin the basal component was calculated and switched to IDeg OD, and the bolus insulin component to bolus insulin. For subjects previously receiving premixed/biphasic insulin BID, the total basal component was calculated, reduced by 20- 30% and switched to IDeg OD, and the bolus component was calculated and switched to IAsp. The trial was event driven for with a realised observation period up to 33 months.			1,473	3,818	0	3,818
EG001	Insulin Glargine	Subjects received IGlar 100 units/mL OD subcutaneously (S.C.; under the skin) in the thigh, upper arm, or the abdominal wall between dinner and bedtime. Subjects continued their pretrial medication except for the basal insulin, which was replaced by investigational medicinal product (IMP; IGlar). The pre-trial bolus insulin was allowed and could be replaced with IAsp at the discretion of the investigator. For subjects previously receiving premixed/biphasic insulin the basal component was calculated and switched to IGlar OD, and the bolus insulin component to bolus insulin. For subjects previously receiving premixed/biphasic insulin BID, the total basal component was calculated, reduced by 20- 30% and switched to IGlar OD, and the bolus component was calculated and switched to IAsp. The trial was event driven with a realised observation period up to 33 months.			1,517	3,819	0	3,819

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Abdominal hernia obstructive	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0012 events2 affected3,819 at risk
Abdominal hernia repair	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Abdominal mass	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00010 events10 affected3,818 at risk EG00110 events10 affected3,819 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0003 events3 affected3,818 at risk EG0011 events1 affected3,819 at risk
Abdominal panniculectomy	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Abdominal sepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Abdominal wall abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0011 events1 affected3,819 at risk
Abdominal wall haematoma	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Abdominal wall infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Abscess limb	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0015 events5 affected3,819 at risk
Abscess rupture	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Abscess soft tissue	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Accelerated hypertension	Vascular disorders	MedDRA	Systematic Assessment	EG0004 events4 affected3,818 at risk EG0017 events7 affected3,819 at risk
Accident at work	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0012 events2 affected3,819 at risk
Accidental overdose	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0013 events3 affected3,819 at risk
Acid peptic disease	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Acquired diaphragmatic eventration	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Acute abdomen	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA	Systematic Assessment	EG00012 events11 affected3,818 at risk EG0018 events8 affected3,819 at risk
Acute endocarditis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Acute hepatic failure	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA	Systematic Assessment	EG00079 events70 affected3,818 at risk EG001110 events95 affected3,819 at risk
Acute left ventricular failure	Cardiac disorders	MedDRA	Systematic Assessment	EG0007 events7 affected3,818 at risk EG0016 events6 affected3,819 at risk
Acute leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Acute lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA	Systematic Assessment	EG000111 events98 affected3,818 at risk EG001123 events115 affected3,819 at risk
Acute prerenal failure	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0012 events2 affected3,819 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0009 events6 affected3,818 at risk EG0016 events6 affected3,819 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0003 events3 affected3,818 at risk EG0010 events0 affected3,819 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG00026 events24 affected3,818 at risk EG00135 events31 affected3,819 at risk
Acute stress disorder	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Adenocarcinoma gastric	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0011 events1 affected3,819 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0015 events5 affected3,819 at risk
Adenocarcinoma pancreas	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Adrenal adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Adrenal insufficiency	Endocrine disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Adrenal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Adult T-cell lymphoma/leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Affective disorder	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Aggression	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Agitation	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Alcohol poisoning	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0010 events0 affected3,819 at risk
Alcohol withdrawal syndrome	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0012 events2 affected3,819 at risk
Alcoholic liver disease	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Alcoholic pancreatitis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Altered state of consciousness	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Amputation	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG00012 events11 affected3,818 at risk EG00140 events34 affected3,819 at risk
Anaemia postoperative	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Anaesthetic complication	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Anaesthetic complication pulmonary	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Anaphylactic reaction	Immune system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Anaphylactic shock	Immune system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Anastomotic ulcer	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Aneurysm	Vascular disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Angina pectoris	Cardiac disorders	MedDRA	Systematic Assessment	EG00037 events36 affected3,818 at risk EG00153 events48 affected3,819 at risk
Angina unstable	Cardiac disorders	MedDRA	Systematic Assessment	EG00094 events87 affected3,818 at risk EG00193 events79 affected3,819 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0004 events3 affected3,818 at risk EG0019 events8 affected3,819 at risk
Angiopathy	Vascular disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Angioplasty	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0010 events0 affected3,819 at risk
Animal bite	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Ankle deformity	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0015 events5 affected3,819 at risk
Anuria	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0012 events2 affected3,819 at risk
Anxiety	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0012 events2 affected3,819 at risk
Aortic aneurysm	Vascular disorders	MedDRA	Systematic Assessment	EG0003 events3 affected3,818 at risk EG0013 events3 affected3,819 at risk
Aortic aneurysm repair	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Aortic stenosis	Vascular disorders	MedDRA	Systematic Assessment	EG0003 events3 affected3,818 at risk EG0013 events3 affected3,819 at risk
Aortic stent insertion	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Aortic valve disease	Cardiac disorders	MedDRA	Systematic Assessment	EG0003 events3 affected3,818 at risk EG0010 events0 affected3,819 at risk
Aortic valve replacement	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA	Systematic Assessment	EG0008 events7 affected3,818 at risk EG0015 events5 affected3,819 at risk
Aphasia	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Appendicitis	Infections and infestations	MedDRA	Systematic Assessment	EG0004 events4 affected3,818 at risk EG0016 events6 affected3,819 at risk
Appendix disorder	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Arrhythmia	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0015 events5 affected3,819 at risk
Arterial haemorrhage	Vascular disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0012 events2 affected3,819 at risk
Arteriogram coronary	Investigations	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0012 events2 affected3,819 at risk
Arteriosclerosis	Vascular disorders	MedDRA	Systematic Assessment	EG0003 events3 affected3,818 at risk EG0012 events2 affected3,819 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA	Systematic Assessment	EG0004 events4 affected3,818 at risk EG0017 events7 affected3,819 at risk
Arteriosclerotic gangrene	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Arteriospasm coronary	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Arteriovenous fistula operation	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0006 events5 affected3,818 at risk EG0019 events8 affected3,819 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0003 events3 affected3,818 at risk EG0018 events7 affected3,819 at risk
Arthritis bacterial	Infections and infestations	MedDRA	Systematic Assessment	EG0004 events4 affected3,818 at risk EG0013 events3 affected3,819 at risk
Arthropathy	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0010 events0 affected3,819 at risk
Ascites	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Asthenia	General disorders	MedDRA	Systematic Assessment	EG0003 events3 affected3,818 at risk EG0015 events5 affected3,819 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0007 events6 affected3,818 at risk EG0018 events8 affected3,819 at risk
Asthma-chronic obstructive pulmonary disease overlap syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Ataxia	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0014 events4 affected3,819 at risk
Atrial fibrillation	Cardiac disorders	MedDRA	Systematic Assessment	EG00055 events47 affected3,818 at risk EG00175 events56 affected3,819 at risk
Atrial flutter	Cardiac disorders	MedDRA	Systematic Assessment	EG00011 events11 affected3,818 at risk EG0016 events6 affected3,819 at risk
Atrial tachycardia	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0013 events3 affected3,819 at risk
Atrioventricular block	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0013 events3 affected3,819 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA	Systematic Assessment	EG0006 events6 affected3,818 at risk EG0013 events3 affected3,819 at risk
Atrioventricular block first degree	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0010 events0 affected3,819 at risk
Atrioventricular block second degree	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0011 events1 affected3,819 at risk
Atrioventricular dissociation	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0012 events2 affected3,819 at risk
Autoimmune haemolytic anaemia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Azotaemia	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0011 events1 affected3,819 at risk
B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0010 events0 affected3,819 at risk
B-cell lymphoma stage III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Back disorder	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0007 events7 affected3,818 at risk EG00112 events12 affected3,819 at risk
Bacteraemia	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Bacterial infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Bacterial pyelonephritis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Bacterial sepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Balance disorder	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Balanoposthitis	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Barrett's oesophagus	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0012 events2 affected3,819 at risk
Benign neoplasm of bladder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Benign neoplasm of thyroid gland	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Benign ovarian tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0009 events9 affected3,818 at risk EG0017 events7 affected3,819 at risk
Beta haemolytic streptococcal infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0012 events2 affected3,819 at risk
Bile duct adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Bile duct obstruction	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0012 events2 affected3,819 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Biliary dyskinesia	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Biopsy lung	Investigations	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Bipolar disorder	Psychiatric disorders	MedDRA	Systematic Assessment	EG0003 events3 affected3,818 at risk EG0013 events3 affected3,819 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0013 events3 affected3,819 at risk
Bladder cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Bladder cancer stage 0, with cancer in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Bladder neck obstruction	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Bladder outlet obstruction	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Bladder transitional cell carcinoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0010 events0 affected3,819 at risk
Bladder transitional cell carcinoma stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Blindness	Eye disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0012 events2 affected3,819 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Blood creatinine increased	Investigations	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Blood glucose decreased	Investigations	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Blood glucose increased	Investigations	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0012 events2 affected3,819 at risk
Blood magnesium decreased	Investigations	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Blood potassium decreased	Investigations	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0011 events1 affected3,819 at risk
Blood potassium increased	Investigations	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Blood pressure inadequately controlled	Vascular disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Blood pressure increased	Investigations	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Bone cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Bowen's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Brachial plexus injury	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Bradycardia	Cardiac disorders	MedDRA	Systematic Assessment	EG0009 events8 affected3,818 at risk EG0019 events9 affected3,819 at risk
Brain injury	Nervous system disorders	MedDRA	Systematic Assessment	EG0003 events3 affected3,818 at risk EG0010 events0 affected3,819 at risk
Brain neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Brain stem haemorrhage	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0012 events2 affected3,819 at risk
Brain stem infarction	Nervous system disorders	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0014 events4 affected3,819 at risk
Brain stem stroke	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Breast cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Breast cancer stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0012 events2 affected3,819 at risk
Breast cancer stage II	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Breast cancer stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Breast enlargement	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Bronchial hyperreactivity	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Bronchitis	Infections and infestations	MedDRA	Systematic Assessment	EG00017 events16 affected3,818 at risk EG00121 events21 affected3,819 at risk
Bronchitis bacterial	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Bronchitis viral	Infections and infestations	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0012 events2 affected3,819 at risk
Bundle branch block left	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0010 events0 affected3,819 at risk
Bundle branch block right	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Burns third degree	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0013 events3 affected3,819 at risk
Calculus bladder	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Calculus urinary	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Cardiac ablation	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0012 events2 affected3,819 at risk
Cardiac arrest	Cardiac disorders	MedDRA	Systematic Assessment	EG00026 events26 affected3,818 at risk EG00121 events20 affected3,819 at risk
Cardiac complication associated with device	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Cardiac death	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0012 events2 affected3,819 at risk
Cardiac discomfort	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Cardiac disorder	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Cardiac failure	Cardiac disorders	MedDRA	Systematic Assessment	EG00026 events24 affected3,818 at risk EG00133 events30 affected3,819 at risk
Cardiac failure acute	Cardiac disorders	MedDRA	Systematic Assessment	EG0007 events7 affected3,818 at risk EG0018 events8 affected3,819 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA	Systematic Assessment	EG00012 events8 affected3,818 at risk EG00111 events10 affected3,819 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA	Systematic Assessment	EG000177 events134 affected3,818 at risk EG001206 events143 affected3,819 at risk
Cardiac hypertrophy	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Cardiac monitoring	Investigations	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Cardiac pacemaker battery replacement	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Cardiac pacemaker insertion	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Cardiac pacemaker replacement	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0014 events4 affected3,819 at risk
Cardiac valve fibroelastoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Cardiac valve replacement complication	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Cardiac ventricular thrombosis	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA	Systematic Assessment	EG00012 events12 affected3,818 at risk EG0019 events9 affected3,819 at risk
Cardiogenic shock	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Cardiomegaly	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0012 events2 affected3,819 at risk
Cardiomyopathy	Cardiac disorders	MedDRA	Systematic Assessment	EG0004 events4 affected3,818 at risk EG0017 events7 affected3,819 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0012 events2 affected3,819 at risk
Cardiorenal syndrome	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Cardiovascular disorder	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Carotid artery disease	Nervous system disorders	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0012 events2 affected3,819 at risk
Carotid artery occlusion	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0013 events3 affected3,819 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA	Systematic Assessment	EG00015 events15 affected3,818 at risk EG00115 events14 affected3,819 at risk
Cataract	Eye disorders	MedDRA	Systematic Assessment	EG00013 events9 affected3,818 at risk EG0014 events3 affected3,819 at risk
Cataract diabetic	Eye disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Cataract operation	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Catheter site haematoma	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Catheter site infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Catheterisation cardiac	Investigations	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Cellulitis	Infections and infestations	MedDRA	Systematic Assessment	EG00064 events52 affected3,818 at risk EG00172 events61 affected3,819 at risk
Cellulitis orbital	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Cellulitis staphylococcal	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0012 events2 affected3,819 at risk
Cellulitis streptococcal	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Cerebellar infarction	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0013 events3 affected3,819 at risk
Cerebral arteriosclerosis	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA	Systematic Assessment	EG0003 events3 affected3,818 at risk EG0014 events4 affected3,819 at risk
Cerebral infarction	Nervous system disorders	MedDRA	Systematic Assessment	EG0005 events5 affected3,818 at risk EG0015 events4 affected3,819 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Cerebral small vessel ischaemic disease	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA	Systematic Assessment	EG00011 events11 affected3,818 at risk EG00123 events22 affected3,819 at risk
Cervical cyst	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Cervical dysplasia	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0012 events2 affected3,819 at risk
Cervical myelopathy	Nervous system disorders	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0011 events1 affected3,819 at risk
Cervical spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0005 events5 affected3,818 at risk EG0013 events3 affected3,819 at risk
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Cervix haemorrhage uterine	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Chest discomfort	General disorders	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0015 events5 affected3,819 at risk
Chest pain	General disorders	MedDRA	Systematic Assessment	EG00016 events16 affected3,818 at risk EG00122 events21 affected3,819 at risk
Chest wall abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Cholangiocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Cholangitis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0012 events2 affected3,819 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0008 events8 affected3,818 at risk EG0014 events4 affected3,819 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0006 events6 affected3,818 at risk EG0014 events4 affected3,819 at risk
Cholecystitis chronic	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0003 events3 affected3,818 at risk EG0015 events5 affected3,819 at risk
Cholecystitis infective	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0008 events8 affected3,818 at risk EG0018 events8 affected3,819 at risk
Chondrocalcinosis pyrophosphate	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0012 events2 affected3,819 at risk
Chordae tendinae rupture	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Choroid melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Chronic gastritis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0012 events2 affected3,819 at risk
Chronic hepatic failure	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA	Systematic Assessment	EG00018 events16 affected3,818 at risk EG00130 events26 affected3,819 at risk
Chronic left ventricular failure	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Chronic myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG00054 events42 affected3,818 at risk EG00170 events56 affected3,819 at risk
Chronic respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0010 events0 affected3,819 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA	Systematic Assessment	EG0008 events8 affected3,818 at risk EG0014 events4 affected3,819 at risk
Clostridium difficile infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Coagulation time prolonged	Investigations	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Coagulopathy	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Colectomy	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Colitis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0006 events6 affected3,818 at risk EG0016 events6 affected3,819 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0006 events3 affected3,818 at risk EG0012 events2 affected3,819 at risk
Colon adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0003 events3 affected3,818 at risk EG0012 events2 affected3,819 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0011 events1 affected3,819 at risk
Colon cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0011 events1 affected3,819 at risk
Colon cancer stage III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Colonic abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Colorectal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Colostomy closure	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Completed suicide	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0012 events2 affected3,819 at risk
Complication associated with device	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Confusional state	Psychiatric disorders	MedDRA	Systematic Assessment	EG0003 events3 affected3,818 at risk EG0014 events4 affected3,819 at risk
Congenital ureterocele	Congenital, familial and genetic disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Congestive cardiomyopathy	Cardiac disorders	MedDRA	Systematic Assessment	EG0003 events3 affected3,818 at risk EG0010 events0 affected3,819 at risk
Conjunctivitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Constipation	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0004 events4 affected3,818 at risk EG0010 events0 affected3,819 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Coombs negative haemolytic anaemia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Cor pulmonale	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0012 events2 affected3,819 at risk
Cor pulmonale acute	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Coronary arterial stent insertion	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Coronary artery bypass	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0012 events2 affected3,819 at risk
Coronary artery disease	Cardiac disorders	MedDRA	Systematic Assessment	EG00085 events80 affected3,818 at risk EG00191 events89 affected3,819 at risk
Coronary artery dissection	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Coronary artery embolism	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Coronary artery insufficiency	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA	Systematic Assessment	EG00012 events12 affected3,818 at risk EG0016 events5 affected3,819 at risk
Coronary artery restenosis	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0011 events1 affected3,819 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA	Systematic Assessment	EG00012 events12 affected3,818 at risk EG0015 events5 affected3,819 at risk
Coronary ostial stenosis	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Coronary vascular graft occlusion	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0011 events1 affected3,819 at risk
Costochondritis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0010 events0 affected3,819 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0011 events1 affected3,819 at risk
Cranial nerve paralysis	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Crohn's disease	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0012 events2 affected3,819 at risk
Cyst	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Cystitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0013 events3 affected3,819 at risk
Cystitis noninfective	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Cystocele	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0010 events0 affected3,819 at risk
Dactylitis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Deafness neurosensory	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Death	General disorders	MedDRA	Systematic Assessment	EG00027 events27 affected3,818 at risk EG00121 events21 affected3,819 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0012 events2 affected3,819 at risk
Deep vein thrombosis	Vascular disorders	MedDRA	Systematic Assessment	EG00013 events13 affected3,818 at risk EG00110 events10 affected3,819 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG00023 events23 affected3,818 at risk EG00116 events16 affected3,819 at risk
Delirium	Psychiatric disorders	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0015 events5 affected3,819 at risk
Dementia	Nervous system disorders	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0011 events1 affected3,819 at risk
Dementia Alzheimer's type	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0012 events2 affected3,819 at risk
Dengue fever	Infections and infestations	MedDRA	Systematic Assessment	EG0003 events3 affected3,818 at risk EG0010 events0 affected3,819 at risk
Depression	Psychiatric disorders	MedDRA	Systematic Assessment	EG0005 events5 affected3,818 at risk EG0014 events4 affected3,819 at risk
Depression suicidal	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Dermal cyst	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Dermatitis infected	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Device dislocation	Product Issues	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0012 events2 affected3,819 at risk
Device failure	Product Issues	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Device fastener issue	Product Issues	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Device inappropriate shock delivery	Product Issues	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Device lead damage	Product Issues	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Device loosening	Product Issues	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Device malfunction	Product Issues	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0013 events2 affected3,819 at risk
Device related infection	Infections and infestations	MedDRA	Systematic Assessment	EG0003 events3 affected3,818 at risk EG0011 events1 affected3,819 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0014 events4 affected3,819 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0005 events5 affected3,818 at risk EG0014 events4 affected3,819 at risk
Diabetic complication	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG00010 events10 affected3,818 at risk EG00111 events11 affected3,819 at risk
Diabetic foot infection	Infections and infestations	MedDRA	Systematic Assessment	EG0004 events4 affected3,818 at risk EG0018 events8 affected3,819 at risk
Diabetic gangrene	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0012 events2 affected3,819 at risk
Diabetic gastroparesis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0012 events2 affected3,819 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0005 events5 affected3,818 at risk EG00114 events14 affected3,819 at risk
Diabetic metabolic decompensation	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0012 events2 affected3,819 at risk
Diabetic mononeuropathy	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Diabetic nephropathy	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0013 events3 affected3,819 at risk
Diabetic neuropathic ulcer	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Diabetic neuropathy	Nervous system disorders	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0010 events0 affected3,819 at risk
Diabetic retinopathy	Eye disorders	MedDRA	Systematic Assessment	EG0004 events4 affected3,818 at risk EG0011 events1 affected3,819 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00014 events11 affected3,818 at risk EG0013 events3 affected3,819 at risk
Diastolic dysfunction	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Diffuse large B-cell lymphoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Dilatation intrahepatic duct acquired	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Disseminated cryptococcosis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Diverticular perforation	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Diverticulitis	Infections and infestations	MedDRA	Systematic Assessment	EG00013 events11 affected3,818 at risk EG00114 events14 affected3,819 at risk
Diverticulum	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0005 events5 affected3,818 at risk EG0010 events0 affected3,819 at risk
Diverticulum intestinal	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0010 events0 affected3,819 at risk
Diverticulum intestinal haemorrhagic	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Dizziness	Nervous system disorders	MedDRA	Systematic Assessment	EG0007 events7 affected3,818 at risk EG0014 events4 affected3,819 at risk
Drug administration error	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Drug hypersensitivity	Immune system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0012 events2 affected3,819 at risk
Dry gangrene	Vascular disorders	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0011 events1 affected3,819 at risk
Duodenal stenosis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Duodenal switch	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Duodenal vascular ectasia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Duodenitis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Dysarthria	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Dysentery	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Dysphagia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0013 events3 affected3,819 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG00011 events11 affected3,818 at risk EG00119 events17 affected3,819 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0004 events4 affected3,818 at risk EG0011 events1 affected3,819 at risk
Dyspnoea paroxysmal nocturnal	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Eczema infected	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0012 events2 affected3,819 at risk
Ejection fraction decreased	Investigations	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Electrocardiogram ST segment abnormal	Investigations	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Electrocardiogram ST segment elevation	Investigations	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Electrocardiogram ST-T change	Investigations	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0011 events1 affected3,819 at risk
Embolic cerebral infarction	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Embolic stroke	Nervous system disorders	MedDRA	Systematic Assessment	EG0004 events4 affected3,818 at risk EG0012 events2 affected3,819 at risk
Embolism	Vascular disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Embolism arterial	Vascular disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0012 events2 affected3,819 at risk
Embolism venous	Vascular disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Empyema	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Encephalopathy	Nervous system disorders	MedDRA	Systematic Assessment	EG0006 events6 affected3,818 at risk EG0014 events4 affected3,819 at risk
End stage renal disease	Renal and urinary disorders	MedDRA	Systematic Assessment	EG00012 events12 affected3,818 at risk EG0019 events9 affected3,819 at risk
Endocarditis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Endometrial adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0003 events3 affected3,818 at risk EG0013 events3 affected3,819 at risk
Endometrial hyperplasia	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0003 events3 affected3,818 at risk EG0010 events0 affected3,819 at risk
Enteritis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Enterocele	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Enthesopathy	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Epidural lipomatosis	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Epigastric discomfort	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Epiglottitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0014 events3 affected3,819 at risk
Erosive duodenitis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Erysipelas	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Escherichia sepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0012 events2 affected3,819 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Essential hypertension	Vascular disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Essential tremor	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Evans syndrome	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Exostosis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
External ear cellulitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Extra dose administered	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Extradural abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0012 events2 affected3,819 at risk
Extremity necrosis	Vascular disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0013 events3 affected3,819 at risk
Eye injury	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0012 events2 affected3,819 at risk
Facial paralysis	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Factor V deficiency	Congenital, familial and genetic disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Fall	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG00057 events54 affected3,818 at risk EG00159 events55 affected3,819 at risk
Fatigue	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0012 events2 affected3,819 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0003 events3 affected3,818 at risk EG0015 events5 affected3,819 at risk
Fibroma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0012 events2 affected3,819 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0005 events4 affected3,818 at risk EG0015 events2 affected3,819 at risk
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0014 events4 affected3,819 at risk
Foreign body reaction	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Gait disturbance	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Gallbladder adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Gallbladder cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Gangrene	Infections and infestations	MedDRA	Systematic Assessment	EG0005 events5 affected3,818 at risk EG00116 events13 affected3,819 at risk
Gas gangrene	Infections and infestations	MedDRA	Systematic Assessment	EG0002 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Gastrectomy	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0004 events4 affected3,818 at risk EG0013 events3 affected3,819 at risk
Gastric antral vascular ectasia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Gastric bypass	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0003 events3 affected3,818 at risk EG0014 events4 affected3,819 at risk
Gastric perforation	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0013 events3 affected3,819 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Gastric ulcer perforation	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0012 events1 affected3,819 at risk
Gastritis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0008 events8 affected3,818 at risk EG0017 events6 affected3,819 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0010 events0 affected3,819 at risk
Gastroduodenitis haemorrhagic	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Gastroenteritis	Infections and infestations	MedDRA	Systematic Assessment	EG00013 events13 affected3,818 at risk EG00112 events12 affected3,819 at risk
Gastroenteritis Escherichia coli	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Gastroenteritis viral	Infections and infestations	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0017 events7 affected3,819 at risk
Gastrointestinal anastomotic leak	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Gastrointestinal angiodysplasia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Gastrointestinal arteriovenous malformation	Congenital, familial and genetic disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Gastrointestinal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00010 events10 affected3,818 at risk EG00116 events15 affected3,819 at risk
Gastrointestinal injury	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Gastrointestinal polyp haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Gastrointestinal stoma complication	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Gastrointestinal tract adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Gastrointestinal ulcer haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0012 events2 affected3,819 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0007 events6 affected3,818 at risk EG00110 events9 affected3,819 at risk
Gastrostomy tube site complication	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Generalised oedema	General disorders	MedDRA	Systematic Assessment	EG0004 events4 affected3,818 at risk EG0013 events3 affected3,819 at risk
Generalised tonic-clonic seizure	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0012 events2 affected3,819 at risk
Glaucoma	Eye disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Glomerulonephritis rapidly progressive	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Goitre	Endocrine disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Gout	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0004 events4 affected3,818 at risk EG0017 events7 affected3,819 at risk
Gouty arthritis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0012 events2 affected3,819 at risk
Graft infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Groin abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Guillain-Barre syndrome	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
H1N1 influenza	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Haemarthrosis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Haematochezia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 events1 affected3,818 at risk EG0014 events4 affected3,819 at risk
Haematuria	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0013 events3 affected3,819 at risk
Haemolytic anaemia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0012 events1 affected3,819 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0013 events3 affected3,819 at risk
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0007 events7 affected3,818 at risk EG0019 events9 affected3,819 at risk
Haemorrhagic arteriovenous malformation	Congenital, familial and genetic disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0012 events2 affected3,819 at risk
Haemorrhagic cerebral infarction	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Haemorrhagic stroke	Nervous system disorders	MedDRA	Systematic Assessment	EG0003 events3 affected3,818 at risk EG0014 events4 affected3,819 at risk
Haemorrhagic transformation stroke	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0004 events4 affected3,818 at risk EG0011 events1 affected3,819 at risk
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Hallucination, visual	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Headache	Nervous system disorders	MedDRA	Systematic Assessment	EG0004 events4 affected3,818 at risk EG0016 events6 affected3,819 at risk
Heart valve incompetence	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Helicobacter gastritis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Hemiparesis	Nervous system disorders	MedDRA	Systematic Assessment	EG0003 events3 affected3,818 at risk EG0012 events2 affected3,819 at risk
Hemiplegic migraine	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Hepatic cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0012 events2 affected3,819 at risk
Hepatic cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0012 events2 affected3,819 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0003 events3 affected3,818 at risk EG0011 events1 affected3,819 at risk
Hepatic encephalopathy	Nervous system disorders	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0013 events3 affected3,819 at risk
Hepatic enzyme increased	Investigations	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Hepatic lesion	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Hepatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Hepatitis chronic active	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Hepatocellular carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0003 events3 affected3,818 at risk EG0014 events4 affected3,819 at risk
Hepatorenal failure	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Hepatorenal syndrome	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Hernia repair	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Herpes zoster	Infections and infestations	MedDRA	Systematic Assessment	EG0003 events3 affected3,818 at risk EG0010 events0 affected3,819 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0012 events2 affected3,819 at risk
Hidradenitis	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Hip arthroplasty	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0010 events0 affected3,819 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0013 events3 affected3,819 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0012 events2 affected3,819 at risk
Hydrocephalus	Nervous system disorders	MedDRA	Systematic Assessment	EG0002 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0013 events3 affected3,819 at risk
Hyperammonaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0002 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG00012 events11 affected3,818 at risk EG00116 events16 affected3,819 at risk
Hyperglycaemic seizure	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG00021 events18 affected3,818 at risk EG00124 events22 affected3,819 at risk
Hypernatraemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Hypersensitivity vasculitis	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Hypertension	Vascular disorders	MedDRA	Systematic Assessment	EG00019 events17 affected3,818 at risk EG00124 events23 affected3,819 at risk
Hypertensive cardiomyopathy	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Hypertensive crisis	Vascular disorders	MedDRA	Systematic Assessment	EG0008 events8 affected3,818 at risk EG0018 events8 affected3,819 at risk
Hypertensive emergency	Vascular disorders	MedDRA	Systematic Assessment	EG0003 events3 affected3,818 at risk EG0013 events3 affected3,819 at risk
Hypertensive encephalopathy	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Hypertensive heart disease	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0014 events4 affected3,819 at risk
Hypertrophic cardiomyopathy	Congenital, familial and genetic disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Hypoaesthesia	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Hypochromic anaemia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG00077 events64 affected3,818 at risk EG00166 events49 affected3,819 at risk
Hypoglycaemic coma	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0012 events1 affected3,819 at risk
Hypoglycaemic seizure	Nervous system disorders	MedDRA	Systematic Assessment	EG0005 events3 affected3,818 at risk EG0010 events0 affected3,819 at risk
Hypoglycaemic unconsciousness	Nervous system disorders	MedDRA	Systematic Assessment	EG00029 events27 affected3,818 at risk EG00133 events29 affected3,819 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0003 events3 affected3,818 at risk EG0015 events5 affected3,819 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0008 events8 affected3,818 at risk EG0017 events7 affected3,819 at risk
Hypotension	Vascular disorders	MedDRA	Systematic Assessment	EG00014 events14 affected3,818 at risk EG00115 events14 affected3,819 at risk
Hypothyroidism	Endocrine disorders	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0010 events0 affected3,819 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0013 events2 affected3,819 at risk
Hypovolaemic shock	Vascular disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0012 events2 affected3,819 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0003 events3 affected3,818 at risk EG0018 events8 affected3,819 at risk
Hypoxic-ischaemic encephalopathy	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Hysterectomy	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
IIIrd nerve paralysis	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Idiopathic pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Ileus	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0010 events0 affected3,819 at risk
Ileus paralytic	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Ilium fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Impaired gastric emptying	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0005 events4 affected3,818 at risk EG0019 events7 affected3,819 at risk
Impaired healing	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0012 events2 affected3,819 at risk
Implantable defibrillator insertion	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0011 events1 affected3,819 at risk
Implantable defibrillator replacement	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Incarcerated incisional hernia	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Incision site haemorrhage	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Incision site infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Incisional hernia	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Infected bite	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Infected dermal cyst	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Infected seroma	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Infected skin ulcer	Infections and infestations	MedDRA	Systematic Assessment	EG0003 events3 affected3,818 at risk EG0012 events2 affected3,819 at risk
Infectious colitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0012 events2 affected3,819 at risk
Influenza	Infections and infestations	MedDRA	Systematic Assessment	EG0005 events5 affected3,818 at risk EG0013 events3 affected3,819 at risk
Infusion site infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0012 events1 affected3,819 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0003 events3 affected3,818 at risk EG0014 events4 affected3,819 at risk
Inguinal hernia repair	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0011 events1 affected3,819 at risk
Injury	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Inner ear disorder	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Intensive care unit acquired weakness	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Intentional overdose	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Intentional self-injury	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Intermittent claudication	Vascular disorders	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0016 events6 affected3,819 at risk
International normalised ratio increased	Investigations	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0012 events2 affected3,819 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0013 events3 affected3,819 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0004 events4 affected3,818 at risk EG0014 events4 affected3,819 at risk
Intervertebral disc disorder	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Intervertebral disc operation	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0009 events9 affected3,818 at risk EG0013 events3 affected3,819 at risk
Intervertebral discitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Intestinal ischaemia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0011 events1 affected3,819 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0004 events4 affected3,818 at risk EG0012 events2 affected3,819 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0012 events2 affected3,819 at risk
Intra-abdominal haematoma	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Intra-ocular injection	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Intracardiac thrombus	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Intracranial aneurysm	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Intracranial pressure increased	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Intraductal proliferative breast lesion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0003 events3 affected3,818 at risk EG0012 events2 affected3,819 at risk
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0015 events5 affected3,819 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0003 events3 affected3,818 at risk EG0014 events4 affected3,819 at risk
Irritable bowel syndrome	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA	Systematic Assessment	EG0003 events3 affected3,818 at risk EG0017 events7 affected3,819 at risk
Ischaemic cerebral infarction	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Ischaemic hepatitis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Ischaemic limb pain	Vascular disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Ischaemic stroke	Nervous system disorders	MedDRA	Systematic Assessment	EG00044 events43 affected3,818 at risk EG00150 events45 affected3,819 at risk
Jaundice	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Jaundice cholestatic	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Jejunostomy	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Joint abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Joint arthroplasty	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0012 events2 affected3,819 at risk
Joint effusion	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Klebsiella sepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Knee arthroplasty	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0005 events4 affected3,818 at risk EG0018 events7 affected3,819 at risk
Knee operation	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Labyrinthitis	Infections and infestations	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0010 events0 affected3,819 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0003 events3 affected3,818 at risk EG0014 events4 affected3,819 at risk
Lactic acidosis	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0012 events2 affected3,819 at risk
Lacunar infarction	Nervous system disorders	MedDRA	Systematic Assessment	EG0005 events5 affected3,818 at risk EG0012 events2 affected3,819 at risk
Lacunar stroke	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Large intestinal haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Large intestinal ulcer haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0004 events4 affected3,818 at risk EG0013 events3 affected3,819 at risk
Laryngeal stenosis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Lead dislodgement	Product Issues	MedDRA	Systematic Assessment	EG0002 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Left ventricular dysfunction	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0013 events3 affected3,819 at risk
Left ventricular failure	Cardiac disorders	MedDRA	Systematic Assessment	EG0007 events6 affected3,818 at risk EG0013 events3 affected3,819 at risk
Left ventricular hypertrophy	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Leg amputation	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Leriche syndrome	Vascular disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Lethargy	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0004 events3 affected3,818 at risk EG0012 events2 affected3,819 at risk
Ligament rupture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Liver abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Liver disorder	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Local swelling	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Localised infection	Infections and infestations	MedDRA	Systematic Assessment	EG0004 events4 affected3,818 at risk EG0013 events3 affected3,819 at risk
Long QT syndrome	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Loss of consciousness	Nervous system disorders	MedDRA	Systematic Assessment	EG0004 events4 affected3,818 at risk EG0014 events4 affected3,819 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0003 events3 affected3,818 at risk EG0013 events3 affected3,819 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0010 events0 affected3,819 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0013 events3 affected3,819 at risk
Lumbar radiculopathy	Nervous system disorders	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0012 events2 affected3,819 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00013 events12 affected3,818 at risk EG0017 events7 affected3,819 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Lung adenocarcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0012 events2 affected3,819 at risk
Lung adenocarcinoma stage II	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Lung adenocarcinoma stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0010 events0 affected3,819 at risk
Lyme disease	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Lymphocele	Vascular disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Macular fibrosis	Eye disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0012 events2 affected3,819 at risk
Major depression	Psychiatric disorders	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0012 events2 affected3,819 at risk
Malignant hypertension	Vascular disorders	MedDRA	Systematic Assessment	EG0003 events3 affected3,818 at risk EG0015 events5 affected3,819 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Malignant melanoma in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Malignant peritoneal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Mallory-Weiss syndrome	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Medical device site haemorrhage	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Medical observation	Investigations	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Memory impairment	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Meniere's disease	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Meningioma benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0003 events3 affected3,818 at risk EG0010 events0 affected3,819 at risk
Meningitis aseptic	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Meningitis viral	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Meniscus injury	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0012 events2 affected3,819 at risk
Mental status changes	Psychiatric disorders	MedDRA	Systematic Assessment	EG0007 events7 affected3,818 at risk EG0018 events8 affected3,819 at risk
Mesenteric haematoma	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Mesothelioma malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0003 events3 affected3,818 at risk EG0011 events1 affected3,819 at risk
Metabolic encephalopathy	Nervous system disorders	MedDRA	Systematic Assessment	EG0007 events7 affected3,818 at risk EG00110 events9 affected3,819 at risk
Metabolic surgery	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0012 events2 affected3,819 at risk
Metastases to lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Metastases to lymph nodes	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Metastatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Metastatic renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0003 events3 affected3,818 at risk EG0010 events0 affected3,819 at risk
Metastatic squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Microangiopathy	Vascular disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Migraine	Nervous system disorders	MedDRA	Systematic Assessment	EG0003 events3 affected3,818 at risk EG0010 events0 affected3,819 at risk
Migraine-triggered seizure	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0012 events2 affected3,819 at risk
Mononeuropathy multiplex	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Motor neurone disease	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Mucinous endometrial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Mucormycosis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Multiple fractures	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Multiple injuries	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0012 events2 affected3,819 at risk
Multiple sclerosis relapse	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0012 events1 affected3,819 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0012 events2 affected3,819 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0004 events4 affected3,818 at risk EG0014 events4 affected3,819 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0003 events3 affected3,818 at risk EG0016 events6 affected3,819 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0003 events3 affected3,818 at risk EG0013 events3 affected3,819 at risk
Myasthenia gravis	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Myocardial infarction	Cardiac disorders	MedDRA	Systematic Assessment	EG00051 events48 affected3,818 at risk EG00168 events66 affected3,819 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA	Systematic Assessment	EG0007 events7 affected3,818 at risk EG0019 events9 affected3,819 at risk
Myopathy	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Nasal polyps	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Nasal septum deviation	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Nausea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0012 events2 affected3,819 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0011 events1 affected3,819 at risk
Necrotising fasciitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Nephrogenic anaemia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG00011 events11 affected3,818 at risk EG0019 events9 affected3,819 at risk
Nephropathy	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Nephropathy toxic	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Nephrosclerosis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Nephrotic syndrome	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0012 events2 affected3,819 at risk
Nerve root compression	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Neuroendocrine carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Neuropathic ulcer	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0011 events1 affected3,819 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Neurotrophic keratopathy	Eye disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0013 events3 affected3,819 at risk
Neutropenic colitis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Nodal arrhythmia	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Non-alcoholic steatohepatitis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Non-cardiac chest pain	General disorders	MedDRA	Systematic Assessment	EG00048 events47 affected3,818 at risk EG00163 events54 affected3,819 at risk
Non-cardiogenic pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Non-small cell lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Non-small cell lung cancer stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Normal pressure hydrocephalus	Nervous system disorders	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0010 events0 affected3,819 at risk
Normochromic normocytic anaemia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0012 events2 affected3,819 at risk
Obesity	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0003 events3 affected3,818 at risk EG0011 events1 affected3,819 at risk
Obstructive airways disorder	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Obstructive shock	Vascular disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Oedema	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0014 events3 affected3,819 at risk
Oedema due to cardiac disease	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Oedema peripheral	General disorders	MedDRA	Systematic Assessment	EG0004 events4 affected3,818 at risk EG0014 events4 affected3,819 at risk
Oesophageal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0012 events2 affected3,819 at risk
Oesophageal candidiasis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0013 events3 affected3,819 at risk
Oesophageal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0010 events0 affected3,819 at risk
Oesophageal rupture	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Oesophageal ulcer haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Oesophageal varices haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Oesophagectomy	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0012 events2 affected3,819 at risk
Optic ischaemic neuropathy	Eye disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Oral candidiasis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Orchitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0012 events2 affected3,819 at risk
Orthostatic hypotension	Vascular disorders	MedDRA	Systematic Assessment	EG0006 events6 affected3,818 at risk EG0018 events8 affected3,819 at risk
Osteitis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00035 events32 affected3,818 at risk EG00131 events30 affected3,819 at risk
Osteogenesis imperfecta	Congenital, familial and genetic disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Osteomyelitis	Infections and infestations	MedDRA	Systematic Assessment	EG00026 events20 affected3,818 at risk EG00123 events22 affected3,819 at risk
Osteomyelitis acute	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Osteomyelitis chronic	Infections and infestations	MedDRA	Systematic Assessment	EG0003 events3 affected3,818 at risk EG0014 events4 affected3,819 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Osteopenia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0002 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Otitis externa	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0012 events1 affected3,819 at risk
Otitis media chronic	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Ovarian cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Ovarian cancer stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0012 events2 affected3,819 at risk
Pain	General disorders	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0010 events0 affected3,819 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0003 events3 affected3,818 at risk EG0013 events3 affected3,819 at risk
Palpitations	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0003 events3 affected3,818 at risk EG0011 events1 affected3,819 at risk
Pancreatic carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0003 events3 affected3,818 at risk EG0010 events0 affected3,819 at risk
Pancreatic carcinoma stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Pancreatic mass	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0008 events7 affected3,818 at risk EG0015 events5 affected3,819 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0007 events6 affected3,818 at risk EG00116 events11 affected3,819 at risk
Pancreatitis chronic	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0012 events2 affected3,819 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Papillary cystadenoma lymphomatosum	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Papillary thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Paraesthesia	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Paranoia	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Paraspinal abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Parathyroid tumour benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Parkinson's disease	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0014 events4 affected3,819 at risk
Paronychia	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0013 events3 affected3,819 at risk
Pemphigoid	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Penile squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Peptic ulcer	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0012 events1 affected3,819 at risk
Peptic ulcer perforation	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Pericardial effusion	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0012 events2 affected3,819 at risk
Pericarditis	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Perineal abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Periodontal disease	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA	Systematic Assessment	EG00013 events13 affected3,818 at risk EG00112 events12 affected3,819 at risk
Peripheral artery aneurysm	Vascular disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Peripheral artery occlusion	Vascular disorders	MedDRA	Systematic Assessment	EG0004 events4 affected3,818 at risk EG0015 events4 affected3,819 at risk
Peripheral artery stenosis	Vascular disorders	MedDRA	Systematic Assessment	EG0003 events2 affected3,818 at risk EG0014 events4 affected3,819 at risk
Peripheral artery thrombosis	Vascular disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Peripheral embolism	Vascular disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Peripheral ischaemia	Vascular disorders	MedDRA	Systematic Assessment	EG0003 events3 affected3,818 at risk EG0017 events7 affected3,819 at risk
Peripheral sensory neuropathy	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Peripheral swelling	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0012 events2 affected3,819 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA	Systematic Assessment	EG00012 events11 affected3,818 at risk EG00117 events14 affected3,819 at risk
Peripheral venous disease	Vascular disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0012 events2 affected3,819 at risk
Perirectal abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0012 events2 affected3,819 at risk
Peritoneal abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Peritonitis	Infections and infestations	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0010 events0 affected3,819 at risk
Peritonitis bacterial	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Personality change due to a general medical condition	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Phaeochromocytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Pharyngeal oedema	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0010 events0 affected3,819 at risk
Pharyngitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Phimosis	Congenital, familial and genetic disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0012 events2 affected3,819 at risk
Phlebitis	Vascular disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Pickwickian syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Pilonidal cyst	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Pituitary tumour benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0003 events3 affected3,818 at risk EG0010 events0 affected3,819 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0016 events6 affected3,819 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0013 events3 affected3,819 at risk
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Pneumatosis intestinalis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Pneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG00099 events90 affected3,818 at risk EG001102 events90 affected3,819 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0013 events3 affected3,819 at risk
Pneumonia bacterial	Infections and infestations	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0014 events4 affected3,819 at risk
Pneumonia influenzal	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0012 events2 affected3,819 at risk
Pneumonia klebsiella	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0012 events2 affected3,819 at risk
Pneumonia mycoplasmal	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Pneumonia pneumococcal	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Pneumonia pseudomonal	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0012 events2 affected3,819 at risk
Pneumonia staphylococcal	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0012 events2 affected3,819 at risk
Pneumonia streptococcal	Infections and infestations	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0010 events0 affected3,819 at risk
Pneumonia viral	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0003 events3 affected3,818 at risk EG0011 events1 affected3,819 at risk
Pneumothorax spontaneous	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Pneumothorax traumatic	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Polyarthritis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0010 events0 affected3,819 at risk
Polymyalgia rheumatica	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Polyp	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Portal vein thrombosis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Post concussion syndrome	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Post procedural cellulitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Post procedural complication	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0012 events2 affected3,819 at risk
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0010 events0 affected3,819 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0005 events5 affected3,818 at risk EG0012 events2 affected3,819 at risk
Post procedural infection	Infections and infestations	MedDRA	Systematic Assessment	EG0008 events8 affected3,818 at risk EG0012 events2 affected3,819 at risk
Post procedural myocardial infarction	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0010 events0 affected3,819 at risk
Post procedural sepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Post stroke depression	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Post-injection delirium sedation syndrome	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Post-traumatic stress disorder	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Postoperative abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0003 events3 affected3,818 at risk EG0010 events0 affected3,819 at risk
Postoperative fever	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Postoperative ileus	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Postoperative respiratory failure	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0011 events1 affected3,819 at risk
Postoperative thoracic procedure complication	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Postoperative wound complication	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Postoperative wound infection	Infections and infestations	MedDRA	Systematic Assessment	EG00012 events11 affected3,818 at risk EG0012 events2 affected3,819 at risk
Presyncope	Nervous system disorders	MedDRA	Systematic Assessment	EG0003 events3 affected3,818 at risk EG00112 events12 affected3,819 at risk
Prinzmetal angina	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Procedural complication	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Procedural hypotension	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Procedural intestinal perforation	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG00011 events11 affected3,818 at risk EG0015 events5 affected3,819 at risk
Prostate cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0012 events2 affected3,819 at risk
Prostate cancer stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0013 events3 affected3,819 at risk
Prostate cancer stage II	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Prostate infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Prostatitis Escherichia coli	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Prostatomegaly	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Pseudarthrosis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Pseudohyponatraemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Pseudomonal bacteraemia	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Psychotic disorder	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Pterygium	Eye disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Pulmonary contusion	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG00015 events15 affected3,818 at risk EG00110 events10 affected3,819 at risk
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0006 events6 affected3,818 at risk EG0015 events5 affected3,819 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0012 events2 affected3,819 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0006 events6 affected3,818 at risk EG0019 events9 affected3,819 at risk
Pulmonary sarcoidosis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Pulmonary sepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0014 events4 affected3,819 at risk
Pulmonary veno-occlusive disease	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Pulseless electrical activity	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Pyelonephritis	Infections and infestations	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG00111 events11 affected3,819 at risk
Pyelonephritis acute	Infections and infestations	MedDRA	Systematic Assessment	EG0004 events4 affected3,818 at risk EG0011 events1 affected3,819 at risk
Pyrexia	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Pyuria	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Radicular pain	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Radiculopathy	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0012 events2 affected3,819 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0010 events0 affected3,819 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Rectal abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Rectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0010 events0 affected3,819 at risk
Rectal adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0012 events2 affected3,819 at risk
Rectal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0013 events3 affected3,819 at risk
Rectal ulcer haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Rectocele	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Renal abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Renal artery stenosis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0010 events0 affected3,819 at risk
Renal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0013 events3 affected3,819 at risk
Renal colic	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Renal failure	Renal and urinary disorders	MedDRA	Systematic Assessment	EG00014 events14 affected3,818 at risk EG00117 events17 affected3,819 at risk
Renal impairment	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0003 events3 affected3,818 at risk EG0014 events4 affected3,819 at risk
Renal mass	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Renal transplant failure	Immune system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Renal tubular necrosis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Reperfusion injury	Vascular disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0012 events2 affected3,819 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG00023 events22 affected3,818 at risk EG00119 events18 affected3,819 at risk
Respiratory syncytial virus bronchitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0011 events1 affected3,819 at risk
Respiratory tract infection viral	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Respiratory tract inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Restrictive cardiomyopathy	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Retinal artery occlusion	Eye disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Retinal detachment	Eye disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Retinal vein occlusion	Eye disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Retinopathy	Eye disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Retinopathy proliferative	Eye disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Reversible ischaemic neurological deficit	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0004 events4 affected3,818 at risk EG0014 events4 affected3,819 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0004 events4 affected3,818 at risk EG0012 events2 affected3,819 at risk
Right ventricular failure	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0012 events2 affected3,819 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG00021 events20 affected3,818 at risk EG00118 events18 affected3,819 at risk
Rotator cuff repair	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0013 events2 affected3,819 at risk
Roux loop conversion	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Salivary gland calculus	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Salivary gland cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Salivary gland mass	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Salpingitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Schizoaffective disorder	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Schizoaffective disorder bipolar type	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0012 events1 affected3,819 at risk
Schizophrenia	Psychiatric disorders	MedDRA	Systematic Assessment	EG0003 events3 affected3,818 at risk EG0010 events0 affected3,819 at risk
Sciatica	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0012 events2 affected3,819 at risk
Seizure	Nervous system disorders	MedDRA	Systematic Assessment	EG0008 events6 affected3,818 at risk EG0016 events6 affected3,819 at risk
Senile dementia	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Sepsis	Infections and infestations	MedDRA	Systematic Assessment	EG00037 events36 affected3,818 at risk EG00131 events31 affected3,819 at risk
Sepsis pasteurella	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Sepsis syndrome	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Septic arthritis staphylococcal	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Septic embolus	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Septic shock	Infections and infestations	MedDRA	Systematic Assessment	EG00011 events11 affected3,818 at risk EG00113 events12 affected3,819 at risk
Seroma	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Shock haemorrhagic	Vascular disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0012 events2 affected3,819 at risk
Sialoadenitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Silent myocardial infarction	Cardiac disorders	MedDRA	Systematic Assessment	EG0004 events4 affected3,818 at risk EG0012 events2 affected3,819 at risk
Sinus arrest	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Sinus bradycardia	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0013 events3 affected3,819 at risk
Sinus node dysfunction	Cardiac disorders	MedDRA	Systematic Assessment	EG0006 events6 affected3,818 at risk EG0015 events5 affected3,819 at risk
Sinus tachycardia	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Sinusitis	Infections and infestations	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0012 events2 affected3,819 at risk
Skin necrosis	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG00013 events13 affected3,818 at risk EG0016 events6 affected3,819 at risk
Skin ulcer haemorrhage	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0017 events7 affected3,819 at risk
Small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0011 events1 affected3,819 at risk
Small cell lung cancer extensive stage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Small cell lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0003 events3 affected3,818 at risk EG0010 events0 affected3,819 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00010 events9 affected3,818 at risk EG0016 events6 affected3,819 at risk
Social stay hospitalisation	Social circumstances	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Soft tissue infection	Infections and infestations	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0010 events0 affected3,819 at risk
Soft tissue necrosis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Soft tissue sarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Sphincter of Oddi dysfunction	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Spigelian hernia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0004 events4 affected3,818 at risk EG0014 events4 affected3,819 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Spinal cord compression	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0012 events2 affected3,819 at risk
Spinal decompression	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Spinal fusion surgery	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Spinal laminectomy	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0010 events0 affected3,819 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0003 events3 affected3,818 at risk EG0012 events2 affected3,819 at risk
Spondylitic myelopathy	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Spondylitis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0012 events2 affected3,819 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0012 events2 affected3,819 at risk
Squamous cell carcinoma of lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0011 events1 affected3,819 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Squamous cell carcinoma of the tongue	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Stab wound	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Stag horn calculus	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0010 events0 affected3,819 at risk
Staphylococcal abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0012 events2 affected3,819 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0012 events2 affected3,819 at risk
Staphylococcal infection	Infections and infestations	MedDRA	Systematic Assessment	EG0003 events3 affected3,818 at risk EG0016 events5 affected3,819 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0015 events5 affected3,819 at risk
Stasis dermatitis	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0010 events0 affected3,819 at risk
Status epilepticus	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Steatohepatitis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Stoma site reaction	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Streptococcal bacteraemia	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0013 events3 affected3,819 at risk
Streptococcal sepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0003 events3 affected3,818 at risk EG0010 events0 affected3,819 at risk
Stress cardiomyopathy	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Stress fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Stress urinary incontinence	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0010 events0 affected3,819 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0012 events2 affected3,819 at risk
Subclavian steal syndrome	Vascular disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Subcutaneous abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0013 events3 affected3,819 at risk
Subdiaphragmatic abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0005 events5 affected3,818 at risk EG0014 events4 affected3,819 at risk
Subdural haemorrhage	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Sudden cardiac death	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0013 events3 affected3,819 at risk
Sudden death	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0018 events8 affected3,819 at risk
Sudden hearing loss	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Suicidal ideation	Psychiatric disorders	MedDRA	Systematic Assessment	EG0006 events5 affected3,818 at risk EG0013 events3 affected3,819 at risk
Suicide attempt	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0013 events3 affected3,819 at risk
Superior vena cava stenosis	Vascular disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA	Systematic Assessment	EG0004 events4 affected3,818 at risk EG0014 events4 affected3,819 at risk
Surgical failure	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Syncope	Nervous system disorders	MedDRA	Systematic Assessment	EG00027 events25 affected3,818 at risk EG00129 events24 affected3,819 at risk
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0013 events3 affected3,819 at risk
Systolic dysfunction	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Tachyarrhythmia	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Tachycardia	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0015 events5 affected3,819 at risk
Temporal arteritis	Vascular disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Tendon disorder	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Testicular seminoma (pure) stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Testis cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Thalamic infarction	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0013 events3 affected3,819 at risk
Thalamus haemorrhage	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0010 events0 affected3,819 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Thrombosis	Vascular disorders	MedDRA	Systematic Assessment	EG0004 events4 affected3,818 at risk EG0014 events2 affected3,819 at risk
Thrombotic stroke	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Thyroid mass	Endocrine disorders	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0010 events0 affected3,819 at risk
Thyroidectomy	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0012 events2 affected3,819 at risk
Tonsil cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Tooth abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Toxic encephalopathy	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0012 events2 affected3,819 at risk
Toxic goitre	Endocrine disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Toxic nodular goitre	Endocrine disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Tracheobronchitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0012 events2 affected3,819 at risk
Transfusion-related acute lung injury	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Transient global amnesia	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA	Systematic Assessment	EG00029 events28 affected3,818 at risk EG00144 events42 affected3,819 at risk
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Transurethral prostatectomy	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Traumatic haematoma	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Tremor	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Tricuspid valve incompetence	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Trifascicular block	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0012 events2 affected3,819 at risk
Troponin increased	Investigations	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0012 events2 affected3,819 at risk
Tuberculosis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Tubulointerstitial nephritis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Tumour of ampulla of Vater	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Ulnar nerve palsy	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0012 events2 affected3,819 at risk
Umbilical hernia repair	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0018 events8 affected3,819 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0012 events2 affected3,819 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0005 events5 affected3,818 at risk EG0015 events5 affected3,819 at risk
Upper respiratory tract inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Ureteric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Ureteric injury	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Ureterolithiasis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0003 events3 affected3,818 at risk EG0015 events5 affected3,819 at risk
Urethral stenosis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Urinary hesitation	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Urinary retention	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0009 events9 affected3,818 at risk EG0012 events2 affected3,819 at risk
Urinary tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG00037 events34 affected3,818 at risk EG00137 events30 affected3,819 at risk
Urinary tract infection bacterial	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0013 events2 affected3,819 at risk
Urosepsis	Infections and infestations	MedDRA	Systematic Assessment	EG00011 events10 affected3,818 at risk EG0019 events9 affected3,819 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Uterine cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0011 events1 affected3,819 at risk
Uterine mass	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Uterine prolapse	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
VIth nerve paralysis	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Varices oesophageal	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Vascular dementia	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0012 events2 affected3,819 at risk
Vascular headache	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Vascular insufficiency	Vascular disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0013 events1 affected3,819 at risk
Vascular procedure complication	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Vascular stent restenosis	General disorders	MedDRA	Systematic Assessment	EG0003 events3 affected3,818 at risk EG0013 events2 affected3,819 at risk
Vascular stent stenosis	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Vascular stent thrombosis	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Ventricular arrhythmia	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0012 events2 affected3,819 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA	Systematic Assessment	EG0007 events6 affected3,818 at risk EG0015 events5 affected3,819 at risk
Ventricular hypokinesia	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA	Systematic Assessment	EG0009 events8 affected3,818 at risk EG00116 events12 affected3,819 at risk
Vertebral foraminal stenosis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Vertebrobasilar insufficiency	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Vertigo	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0005 events5 affected3,818 at risk EG0013 events3 affected3,819 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0013 events3 affected3,819 at risk
Vestibular disorder	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Viraemia	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Viral infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0013 events3 affected3,819 at risk
Viral pericarditis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Visual field defect	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Visual impairment	Eye disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0011 events1 affected3,819 at risk
Vitreous haemorrhage	Eye disorders	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0012 events2 affected3,819 at risk
Vomiting	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0005 events5 affected3,818 at risk EG0017 events7 affected3,819 at risk
Vulval abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0011 events1 affected3,819 at risk
Weight decreased	Investigations	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk
Wound	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0012 events2 affected3,819 at risk
Wound infection	Infections and infestations	MedDRA	Systematic Assessment	EG0002 events2 affected3,818 at risk EG0014 events4 affected3,819 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected3,818 at risk EG0012 events2 affected3,819 at risk
Wrong drug administered	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected3,818 at risk EG0010 events0 affected3,819 at risk

ID	Term
D003920	Diabetes Mellitus
D003924	Diabetes Mellitus, Type 2

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

ID	Term
D049528	Insulin, Long-Acting
D061385	Insulins
D010187	Pancreatic Hormones
D036361	Peptide Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins