A Study to Evaluate the Effect of Testosterone Replacemen... | NCT03518034

Status Module

Name	Class
Endo USA Inc., a Keenova Therapeutics Company	INDUSTRY
Acerus Pharmaceuticals Corporation	INDUSTRY
Allergan Sales, LLC	INDUSTRY
Upsher-Smith Laboratories

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
AndroGel 1.62%	Active Comparator	Participants receive topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug once daily (OD). Participants may receive a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations are necessary.	Drug: AndroGel®
Placebo	Placebo Comparator	Participants receive matching placebo OD.	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
AndroGel®	Drug	testosterone administered topically	AndroGel 1.62%

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time From Randomization to the First Component Event of Major Adverse Cardiac Event (MACE): Number and Percentage of Participants With an Event	MACE is a composite endpoint including non-fatal myocardial infraction (MI), non-fatal stroke and cardiovascular (CV) death as adjudicated by Clinical Events Committee (CEC).	Randomization to event or last known date if no event (up to approximately 52 months)
Time From Randomization to the First Component Event of MACE	MACE is a composite endpoint including non-fatal MI, non-fatal stroke and CV death as adjudicated by CEC.	Randomization to event or last known date if no event (up to approximately 52 months)

Secondary Outcomes

Measure	Description	Time Frame
Time From Randomization to the First Component Event of CV Safety Endpoint: Number and Percentage of Participants With an Event	The CV safety endpoint is a composite endpoint including non-fatal MI, non-fatal stroke, CV death, and coronary revascularization procedures/cardiac percutaneous coronary intervention (PCI), or coronary artery bypass graft (CABG) as adjudicated by CEC.	Randomization to event or last known date if no event (up to approximately 52 months).

Other Outcomes

Measure	Description	Time Frame
Change in Psychosexual Daily Questionnaire Question 4 (PDQ-Q4) From Baseline to Months 6, 12 and 24	PDQ-Q4 asks 12 yes/no questions about sexual activity. Scores on the PDQ-Q4 range from 0 to 12, with higher scores indicating more activity.	From Baseline to Months 6, 12, and 24
Number and Percentage of Participants Whose Persistent Depressive Disorder (PDD) Remits During Intervention Per Remission Definition

Eligibility Module

Name	Affiliation	Role
ABBVIE INC.	AbbVie	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Wright Clinical Research, LLC /ID# 210864		Alabaster	Alabama	35007-8978	United States
Simon-Williamson Clinic /ID# 210249

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40246046	Derived	Gagliano-Juca T, Pencina KM, Shang YV, Travison TG, Lincoff AM, Nissen SE, Artz AS, Li X, Chan A, Patel R, Miller MG, Bhasin S. Association of testosterone-induced increase in neutrophil and monocyte counts with thromboembolic events: The TRAVERSE trial. Am Heart J. 2025 Oct;288:77-88. doi: 10.1016/j.ahj.2025.04.004. Epub 2025 Apr 15.
38315466

Label	URL
Related Info	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	AndroGel 1.62%	Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug once daily (OD). Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	May 6, 2021	Jan 5, 2024

Arm/Group Information

ID	Title	Description
BG000	AndroGel 1.62%	Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug OD. Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary.
BG001	Placebo	Participants received matching placebo OD.
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
	BG00063.3± 7.93 BG00163.3± 7.85 BG00263.3± 7.89

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0000 BG0010 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG000409 BG001439 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG00016 BG00114 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 Randomization to the First Component Event of Major Adverse Cardiac Event (MACE): Number and Percentage of Participants With an Event

MACE is a composite endpoint including non-fatal myocardial infraction (MI), non-fatal stroke and cardiovascular (CV) death as adjudicated by Clinical Events Committee (CEC).

TRAVERSE Main Study Safety Set: all randomized participants who received at least one dose of study drug and have no duplicate/triplicate participant IDs.

Posted

Count of Participants

Participants

Randomization to event or last known date if no event (up to approximately 52 months)

ID	Title	Description
OG000	AndroGel 1.62%	Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug OD. Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary.
OG001	Placebo	Participants received matching placebo OD.

Units	Counts
Participants	OG0002596 OG0012602

Title

Denominators

Categories

Title	Measurements
	OG000182 OG001190

Primary

Time From Randomization to the First Component Event of MACE

MACE is a composite endpoint including non-fatal MI, non-fatal stroke and CV death as adjudicated by CEC.

TRAVERSE Main Study Safety Set: all randomized participants who received at least one dose of study drug and have no duplicate/triplicate participant IDs.

Posted

Median

95% Confidence Interval

months

Randomization to event or last known date if no event (up to approximately 52 months)

ID	Title	Description
OG000	AndroGel 1.62%	Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug OD. Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary.
OG001	Placebo	Participants received matching placebo OD.

Units	Counts
Participants	OG000

Secondary

Time From Randomization to the First Component Event of CV Safety Endpoint: Number and Percentage of Participants With an Event

The CV safety endpoint is a composite endpoint including non-fatal MI, non-fatal stroke, CV death, and coronary revascularization procedures/cardiac percutaneous coronary intervention (PCI), or coronary artery bypass graft (CABG) as adjudicated by CEC.

TRAVERSE Main Study Safety Set: all randomized participants who received at least one dose of study drug and have no duplicate/triplicate participant IDs.

Posted

Count of Participants

Participants

Randomization to event or last known date if no event (up to approximately 52 months).

ID	Title	Description
OG000	AndroGel 1.62%	Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug OD. Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary.
OG001	Placebo	Participants received matching placebo OD.

Units	Counts
Participants

Secondary

Time From Randomization to the First Component Event of CV Safety Endpoint

The CV safety endpoint is a composite endpoint including non-fatal MI, non-fatal stroke, CV death, and coronary revascularization procedures/cardiac PCI, or CABG as adjudicated by CEC.

TRAVERSE Main Study Safety Set: all randomized participants who received at least one dose of study drug and have no duplicate/triplicate participant IDs.

Posted

Median

95% Confidence Interval

months

Randomization to event or last known date if no event (up to approximately 52 months).

ID	Title	Description
OG000	AndroGel 1.62%	Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug OD. Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary.
OG001	Placebo	Participants received matching placebo OD.

Units	Counts
Participants

Secondary

Incidence of High-Grade Prostate Cancer

Presented as the number and percentage of participants with any high grade prostate cancer, defined as Gleason grade of 4 + 3 or higher, as adjudicated by Prostate Safety Events Committee (PAC). This grade is based on how abnormal prostate cells appear. Grade 1: cells look almost like normal prostate cells; Grade 5; cells look very different from normal prostate cells. Since most prostate cancers contain cells of different grades, the 2 most common grades are used. Gleason score is determined by adding the 2 most common grades. Higher numbers indicate a faster growing cancer that is more likely to spread. Currently the lowest score assigned to a tumor is grade 3. Grades below 3 show normal to near normal cells. Most cancers have a Gleason score (the sum of the 2 most common grades) of 6 (Gleason scores of 3+3) or 7 (Gleason scores of 3+4 or 4+3).

TRAVERSE Main Study Safety Set: all randomized participants who received at least one dose of study drug and have no duplicate/triplicate participant IDs.

Posted

Count of Participants

Participants

Randomization to event or last known date if no event (up to approximately 52 months).

ID	Title	Description
OG000	AndroGel 1.62%	Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug OD. Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary.
OG001	Placebo

Other Pre-specified

Change in Psychosexual Daily Questionnaire Question 4 (PDQ-Q4) From Baseline to Months 6, 12 and 24

PDQ-Q4 asks 12 yes/no questions about sexual activity. Scores on the PDQ-Q4 range from 0 to 12, with higher scores indicating more activity.

TRAVERSE Sexual Function Sub-Study: participants in the TRAVERSE main study full analysis set (i.e., randomized, no duplicate/triplicate participant IDs) who were eligible for the sexual function sub-study.

Posted

Least Squares Mean

95% Confidence Interval

score on a scale

From Baseline to Months 6, 12, and 24

ID	Title	Description
OG000	AndroGel 1.62%	Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug OD. Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary.
OG001	Placebo	Participants received matching placebo OD.

Units	Counts
Participants

Other Pre-specified

Number and Percentage of Participants Whose Persistent Depressive Disorder (PDD) Remits During Intervention Per Remission Definition

The remission of low-grade, late-onset PDD was defined as: a) Patient Health Questionnaire (PHQ-9) score less than 4 and Geriatric Depression Scale-15 (GDS-15) score <5, and b) answer "no" to the question "Give your best guess: Over the past 6 months, have you been feeling sad or depressed more days than not, even if you felt okay sometimes?" The PHQ-9 is a 9-item depression scale. Total scores can range from 0 to 27, with higher scores indicating a worse outcome. A total score of 0-4 indicates minimal depression severity. The GDS-15 is a series of 15 yes/no questions asking how the participant felt in the past week. A score greater that 5 indicates depression; a higher score indicates a worse outcome.

PDD Sub-Study participants (those included TRAVERSE main study full analysis set participants [i.e., randomized, no duplicate/triplicate participant IDs] who met the criteria for low-grade PDD) with an assessment at given time point.

Posted

Count of Participants

Participants

Months 6, 12, 24

ID	Title	Description
OG000	AndroGel 1.62%	Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug OD. Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary.
OG001	Placebo

Other Pre-specified

Time From Randomization to First Clinical Fracture: Number and Percentage of Participants With an Event

Clinical fracture is defined as a clinical spine or non-spine fracture, documented by imaging or surgery, and confirmed by the Fracture Adjudication Committee (FAC). Fractures of the sternum, fingers, toes, facial bones and skull were excluded.

TRAVERSE Main Study Full Analysis Set: all randomized participants without duplicate/triplicate participant IDs.

Posted

Count of Participants

Participants

Randomization to event or last known date if no event (up to approximately 52 months).

ID	Title	Description
OG000	AndroGel 1.62%	Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug OD. Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary.
OG001	Placebo	Participants received matching placebo OD.

Units	Counts
Participants

Other Pre-specified

Time From Randomization to First Clinical Fracture

Clinical fracture is defined as a clinical spine or non-spine fracture, documented by imaging or surgery, and confirmed by the FAC. Fractures of the sternum, fingers, toes, facial bones and skull were excluded.

TRAVERSE Main Study Full Analysis Set: all randomized participants without duplicate/triplicate participant IDs.

Posted

Median

95% Confidence Interval

months

Randomization to event or maximum follow-up (up to approximately 52 months).

ID	Title	Description
OG000	AndroGel 1.62%	Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug OD. Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary.
OG001	Placebo	Participants received matching placebo OD.

Units	Counts
Participants

Other Pre-specified

Number and Percentage of Anemic Participants Whose Baseline Anemia Was Corrected During the Intervention Period

The correction of anemia was defined as an increase in hemoglobin level >12.7 g/dL during the intervention period (at Months 6, 12, 24, 36 and 48) for participants in TRAVERSE main study with anemia at baseline.

All randomized participants in TRAVERSE main study who had anemia at baseline; participants with an assessment at given time point.

Posted

Count of Participants

Participants

Baseline, Months 6, 12, 24, 36 and 48

ID	Title	Description
OG000	AndroGel 1.62%	Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug OD. Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary.
OG001	Placebo	Participants received matching placebo OD.

Units	Counts
Participants

Other Pre-specified

Number and Percentage of Participants With Pre-Diabetes at Baseline Who Progressed to Diabetes at Months 6, 12, 24, 36 and 48

Number and percentage of participants in each arm who had prediabetes at baseline progressing to diabetes, defined as hemoglobin A1C (HbA1C) equal to or higher than 6.5%, initiation of diabetes medication, or two consecutive fasting glucose levels >125 mg/dL, assessed at all available time points after baseline.

All randomized participants in TRAVERSE main study who had prediabetes at baseline; participants with an assessment at given time point.

Posted

Count of Participants

Participants

Baseline, Months 6, 12, 24, 36 and 48

ID	Title	Description
OG000	AndroGel 1.62%	Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug OD. Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary.
OG001	Placebo	Participants received matching placebo OD.

Units	Counts
Participants

Other Pre-specified

Tertiary Endpoint: Incidence Rate of All Cause Mortality

Presented as the number and percentage of participants who died, regardless of cause.

TRAVERSE Main Study Safety Set: all randomized participants who received at least one dose of study drug and have no duplicate/triplicate participant IDs.

Posted

Count of Participants

Participants

Randomization to event or last known date if no date (up to approximately 52 months).

ID	Title	Description
OG000	AndroGel 1.62%	Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug OD. Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary.
OG001	Placebo	Participants received matching placebo OD.

Units	Counts
Participants	OG000

Other Pre-specified

Tertiary Endpoint: Incidence Rate of Heart Failure

Presented as the number and percentage of participants with heart failure events (requiring hospitalization and/or urgent visit), as adjudicated by CEC.

TRAVERSE Main Study Safety Set: all randomized participants who received at least one dose of study drug and have no duplicate/triplicate participant IDs.

Posted

Count of Participants

Participants

Randomization to event or last known date if no date (up to approximately 52 months).

ID	Title	Description
OG000	AndroGel 1.62%	Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug OD. Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary.
OG001	Placebo	Participants received matching placebo OD.

Units	Counts
Participants

Other Pre-specified

Tertiary Endpoint: Incidence Rate of Venous Thromboembolic Events

Presented as the number and percentage of participants with venous thromboembolic events, as adjudicated by CEC. Events include deep vein thrombosis, pulmonary embolism, venous thromboembolism (excluding superficial thrombophlebitis).

TRAVERSE Main Study Safety Set: all randomized participants who received at least one dose of study drug and have no duplicate/triplicate participant IDs.

Posted

Count of Participants

Participants

Randomization to event or last known date if no date (up to approximately 52 months).

ID	Title	Description
OG000	AndroGel 1.62%	Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug OD. Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary.
OG001	Placebo	Participants received matching placebo OD.

Units	Counts
Participants

Other Pre-specified

Tertiary Endpoint: Incidence Rate of Peripheral Arterial Revascularization

Presented as the number and percentage of participants with peripheral arterial revascularization, as adjudicated by CEC.

TRAVERSE Main Study Safety Set: all randomized participants who received at least one dose of study drug and have no duplicate/triplicate participant IDs.

Posted

Count of Participants

Participants

Randomization to event or last known date if no event (up to approximately 52 months).

ID	Title	Description
OG000	AndroGel 1.62%	Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug OD. Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary.
OG001	Placebo	Participants received matching placebo OD.

Units	Counts
Participants

Other Pre-specified

Tertiary Endpoint: Incidence Rate of Prostate Biopsy

Presented as the number and percentage of participants who underwent prostate biopsy.

TRAVERSE Main Study Safety Set: all randomized participants who received at least one dose of study drug and have no duplicate/triplicate participant IDs.

Posted

Count of Participants

Participants

Randomization to event or last known date if no event (up to approximately 52 months).

ID	Title	Description
OG000	AndroGel 1.62%	Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug OD. Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary.
OG001	Placebo	Participants received matching placebo OD.

Units	Counts
Participants	OG000

Other Pre-specified

Tertiary Endpoint: Incidence Rate of Prostate Cancer

Presented as the number and percentage of participants who with prostate cancer, as adjudicated by Prostate Safety Events Committee (PAC).

TRAVERSE Main Study Safety Set: all randomized participants who received at least one dose of study drug and have no duplicate/triplicate participant IDs.

Posted

Count of Participants

Participants

Randomization to event or last known date if no event (up to approximately 52 months).

ID	Title	Description
OG000	AndroGel 1.62%	Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug OD. Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary.
OG001	Placebo	Participants received matching placebo OD.

Units	Counts
Participants

Other Pre-specified

Tertiary Endpoint: Incidence Rate of Acute Urinary Retention

Presented as the number and percentage of participants with acute urinary retention, as adjudicated by PAC.

TRAVERSE Main Study Safety Set: all randomized participants who received at least one dose of study drug and have no duplicate/triplicate participant IDs.

Posted

Count of Participants

Participants

Randomization to event or last known date if no event (up to approximately 52 months).

ID	Title	Description
OG000	AndroGel 1.62%	Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug OD. Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary.
OG001	Placebo	Participants received matching placebo OD.

Units	Counts
Participants	OG000

Other Pre-specified

Tertiary Endpoint: Incidence Rate of Pharmacologic Treatment for Lower Urinary Tract Symptoms

Presented as the number and percentage of participants who started pharmacologic treatment for lower urinary tract symptoms.

TRAVERSE Main Study Safety Set: all randomized participants who received at least one dose of study drug and have no duplicate/triplicate participant IDs.

Posted

Count of Participants

Participants

Randomization to event or last known date if no event (up to approximately 52 months).

ID	Title	Description
OG000	AndroGel 1.62%	Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug OD. Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary.
OG001	Placebo	Participants received matching placebo OD.

Units	Counts
Participants

Other Pre-specified

Tertiary Endpoint: Incidence Rate of Invasive Prostate Surgical Procedures for Benign Prostatic Hyperplasia

Presented as the number and percentage of participants who underwent invasive prostate surgical procedures for benign prostate hyperplasia, as adjudicated by Prostate Safety Events Committee (PAC). Invasive prostate surgical procedures include prostatectomy, transurethral prostate resection, brachytherapy or other prostate surgical procedure.

TRAVERSE Main Study Safety Set: all randomized participants who received at least one dose of study drug and have no duplicate/triplicate participant IDs.

Posted

Count of Participants

Participants

Randomization to event or last known date if no event (up to approximately 52 months).

ID	Title	Description
OG000	AndroGel 1.62%	Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug OD. Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary.
OG001	Placebo	Participants received matching placebo OD.

Units	Counts

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	AndroGel 1.62% Predose	Participants randomized to the AndroGel 1.62% arm, prior to first dose.	0	2,601	19	2,601	0	0
EG001	Placebo Predose	Participants randomized to the Placebo arm, prior to first dose.	0	2,603	10	2,603	0	0
EG002	AndroGel 1.62%	Participants received topical testosterone starting with a 40.5 mg dose (2 pump actuations) of the study drug OD. Participants may have received a dose in the range of 20.25 mg (1 actuation) to 101.25 mg (5 actuations) in 20.25 mg increments during the course of the study if titrations were necessary.	144	2,601	585	2,601	160	2,601
EG003	Placebo	Participants received matching placebo OD.	148	2,603	562	2,603	170	2,603

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0027 events7 affected2,601 at risk EG0037 events6 affected2,603 at risk
BLOOD LOSS ANAEMIA	Blood and lymphatic system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
IRON DEFICIENCY ANAEMIA	Blood and lymphatic system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
LEUKOCYTOSIS	Blood and lymphatic system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
NEUTROPENIA	Blood and lymphatic system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
POLYCYTHAEMIA	Blood and lymphatic system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
ACUTE CORONARY SYNDROME	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0023 events3 affected2,601 at risk EG003
ACUTE LEFT VENTRICULAR FAILURE	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0024 events4 affected2,601 at risk EG003
ACUTE MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0011 events1 affected2,603 at risk EG00231 events30 affected2,601 at risk EG003
ANGINA PECTORIS	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,601 at risk EG0010 events0 affected2,603 at risk EG00210 events10 affected2,601 at risk EG003
ANGINA UNSTABLE	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,601 at risk EG0010 events0 affected2,603 at risk EG00220 events19 affected2,601 at risk EG003
AORTIC VALVE INCOMPETENCE	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events1 affected2,601 at risk EG003
AORTIC VALVE STENOSIS	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0023 events3 affected2,601 at risk EG003
ARTERIOSCLEROSIS CORONARY ARTERY	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
ATRIAL FIBRILLATION	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,601 at risk EG0010 events0 affected2,603 at risk EG00240 events37 affected2,601 at risk EG003
ATRIAL FLUTTER	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0011 events1 affected2,603 at risk EG0029 events9 affected2,601 at risk EG003
ATRIAL TACHYCARDIA	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
ATRIOVENTRICULAR BLOCK	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
ATRIOVENTRICULAR BLOCK COMPLETE	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0024 events3 affected2,601 at risk EG003
ATRIOVENTRICULAR BLOCK FIRST DEGREE	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0028 events8 affected2,601 at risk EG003
ATRIOVENTRICULAR BLOCK SECOND DEGREE	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
BRADYCARDIA	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0025 events5 affected2,601 at risk EG003
BUNDLE BRANCH BLOCK LEFT	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0028 events8 affected2,601 at risk EG003
BUNDLE BRANCH BLOCK RIGHT	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG00211 events10 affected2,601 at risk EG003
CARDIAC ARREST	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG00213 events13 affected2,601 at risk EG003
CARDIAC FAILURE	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0027 events6 affected2,601 at risk EG003
CARDIAC FAILURE ACUTE	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG00214 events14 affected2,601 at risk EG003
CARDIAC FAILURE CHRONIC	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
CARDIAC FAILURE CONGESTIVE	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG00229 events23 affected2,601 at risk EG003
CARDIO-RESPIRATORY ARREST	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0024 events4 affected2,601 at risk EG003
CARDIOGENIC SHOCK	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0024 events4 affected2,601 at risk EG003
CARDIOMYOPATHY	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0023 events3 affected2,601 at risk EG003
CARDIOPULMONARY FAILURE	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
CARDIOVASCULAR DISORDER	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
CHRONIC LEFT VENTRICULAR FAILURE	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
CORONARY ARTERY DISEASE	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0011 events1 affected2,603 at risk EG00233 events32 affected2,601 at risk EG003
CORONARY ARTERY OCCLUSION	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0027 events7 affected2,601 at risk EG003
CORONARY ARTERY STENOSIS	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0028 events8 affected2,601 at risk EG003
DEFECT CONDUCTION INTRAVENTRICULAR	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
ENDOCARDITIS NONINFECTIVE	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
HYPERTENSIVE HEART DISEASE	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
INTRACARDIAC THROMBUS	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
ISCHAEMIC CARDIOMYOPATHY	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
LEFT VENTRICULAR FAILURE	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
MITRAL VALVE INCOMPETENCE	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
MYOCARDIAL INFARCTION	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG00225 events24 affected2,601 at risk EG003
MYOCARDIAL INJURY	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
MYOCARDIAL ISCHAEMIA	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
PALPITATIONS	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
PERICARDIAL EFFUSION	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
PERICARDITIS	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
PULSELESS ELECTRICAL ACTIVITY	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0023 events3 affected2,601 at risk EG003
SINUS ARRHYTHMIA	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
SINUS BRADYCARDIA	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0026 events6 affected2,601 at risk EG003
SINUS NODE DYSFUNCTION	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
SINUS TACHYCARDIA	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0027 events7 affected2,601 at risk EG003
SUPRAVENTRICULAR EXTRASYSTOLES	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
SUPRAVENTRICULAR TACHYCARDIA	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0023 events2 affected2,601 at risk EG003
TACHYCARDIA	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0029 events9 affected2,601 at risk EG003
TRICUSPID VALVE INCOMPETENCE	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
VENTRICULAR ARRHYTHMIA	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
VENTRICULAR EXTRASYSTOLES	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0023 events3 affected2,601 at risk EG003
VENTRICULAR FIBRILLATION	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0023 events3 affected2,601 at risk EG003
VENTRICULAR TACHYCARDIA	Cardiac disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0029 events9 affected2,601 at risk EG003
CEREBRAL CAVERNOUS MALFORMATION	Congenital, familial and genetic disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
GASTROINTESTINAL ARTERIOVENOUS MALFORMATION	Congenital, familial and genetic disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
PHIMOSIS	Congenital, familial and genetic disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
VERTIGO	Ear and labyrinth disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
HYPERPARATHYROIDISM	Endocrine disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
THYROID CYST	Endocrine disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
BLINDNESS	Eye disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
BLINDNESS UNILATERAL	Eye disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
DIPLOPIA	Eye disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
RETINAL ARTERY OCCLUSION	Eye disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
VISION BLURRED	Eye disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
VISUAL IMPAIRMENT	Eye disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
VERTIGO POSITIONAL	Ear and labyrinth disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
ABDOMINAL WALL HAEMATOMA	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
ASCITES	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
BARRETT'S OESOPHAGUS	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
COLITIS ULCERATIVE	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
COLON DYSPLASIA	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
CONSTIPATION	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0023 events3 affected2,601 at risk EG003
CROHN'S DISEASE	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
DIVERTICULUM	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
DIVERTICULUM INTESTINAL HAEMORRHAGIC	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
DUODENAL PERFORATION	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
DUODENAL STENOSIS	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
DUODENAL ULCER	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
DUODENAL ULCER HAEMORRHAGE	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
DYSPHAGIA	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
GASTRIC HAEMORRHAGE	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
GASTRIC ULCER	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0011 events1 affected2,603 at risk EG0023 events3 affected2,601 at risk EG003
GASTRIC ULCER HAEMORRHAGE	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
GASTRITIS	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
GASTROINTESTINAL DISORDER	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0026 events6 affected2,601 at risk EG003
GASTROOESOPHAGEAL REFLUX DISEASE	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0011 events1 affected2,603 at risk EG0023 events2 affected2,601 at risk EG003
HAEMATOCHEZIA	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
HYPOAESTHESIA ORAL	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
IMPAIRED GASTRIC EMPTYING	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
INGUINAL HERNIA	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
INTESTINAL ISCHAEMIA	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
INTESTINAL OBSTRUCTION	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
LARGE INTESTINE POLYP	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
LOWER GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
NAUSEA	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
OBSTRUCTIVE PANCREATITIS	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
OESOPHAGITIS	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
PANCREATIC MASS	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
PANCREATITIS	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0025 events5 affected2,601 at risk EG003
PANCREATITIS ACUTE	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0023 events3 affected2,601 at risk EG003
PNEUMOPERITONEUM	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
RECTAL FISSURE	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
RECTAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
SMALL INTESTINAL OBSTRUCTION	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
UPPER GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
VOMITING	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
ASTHENIA	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0024 events4 affected2,601 at risk EG003
CARDIAC DEATH	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
CHEST DISCOMFORT	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0024 events3 affected2,601 at risk EG003
CHEST PAIN	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
DEATH	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0025 events5 affected2,601 at risk EG003
DROWNING	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
ELECTROCUTION	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
FATIGUE	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
HERNIA	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
HYPOTHERMIA	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
IMPAIRED HEALING	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0023 events3 affected2,601 at risk EG003
INFLAMMATION	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
MEDICAL DEVICE PAIN	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
MULTIPLE ORGAN DYSFUNCTION SYNDROME	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
NON-CARDIAC CHEST PAIN	General disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,601 at risk EG0010 events0 affected2,603 at risk EG00221 events20 affected2,601 at risk EG003
OEDEMA PERIPHERAL	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
ORGAN FAILURE	General disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
PAIN	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
PELVIC MASS	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
PERIPHERAL SWELLING	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
PYREXIA	General disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0023 events3 affected2,601 at risk EG003
SOFT TISSUE INFLAMMATION	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
STENT-GRAFT ENDOLEAK	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0023 events2 affected2,601 at risk EG003
SUDDEN CARDIAC DEATH	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
SYSTEMIC INFLAMMATORY RESPONSE SYNDROME	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
TREATMENT NONCOMPLIANCE	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
UNEVALUABLE EVENT	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
VASCULAR STENT OCCLUSION	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
VASCULAR STENT STENOSIS	General disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
DIARRHOEA HAEMORRHAGIC	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
IRRITABLE BOWEL SYNDROME	Gastrointestinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
BILE DUCT STONE	Hepatobiliary disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
BILIARY DYSKINESIA	Hepatobiliary disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
CHOLECYSTITIS	Hepatobiliary disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0025 events5 affected2,601 at risk EG003
CHOLECYSTITIS ACUTE	Hepatobiliary disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
CHOLECYSTITIS CHRONIC	Hepatobiliary disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
CHOLELITHIASIS	Hepatobiliary disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0024 events4 affected2,601 at risk EG003
HEPATIC CIRRHOSIS	Hepatobiliary disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
HEPATIC MASS	Hepatobiliary disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
ANAPHYLACTIC REACTION	Immune system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
CONTRAST MEDIA ALLERGY	Immune system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
IMMUNISATION REACTION	Immune system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
ABSCESS	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
ABSCESS LIMB	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
ACINETOBACTER INFECTION	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
APPENDICITIS	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
APPENDICITIS PERFORATED	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
ARTHRITIS BACTERIAL	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
ARTHRITIS INFECTIVE	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
ATYPICAL PNEUMONIA	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
BACTERAEMIA	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
BRONCHITIS	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
CANDIDA SEPSIS	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
CELLULITIS	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0011 events1 affected2,603 at risk EG00224 events22 affected2,601 at risk EG003
CELLULITIS GANGRENOUS	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
CELLULITIS OF MALE EXTERNAL GENITAL ORGAN	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
CELLULITIS STAPHYLOCOCCAL	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
CITROBACTER INFECTION	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
CLOSTRIDIUM DIFFICILE COLITIS	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
CLOSTRIDIUM DIFFICILE INFECTION	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
CORONAVIRUS INFECTION	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
COVID-19	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG00238 events38 affected2,601 at risk EG003
COVID-19 PNEUMONIA	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG00227 events27 affected2,601 at risk EG003
DEVICE RELATED BACTERAEMIA	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
DEVICE RELATED INFECTION	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
DIABETIC FOOT INFECTION	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
DIVERTICULITIS	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0026 events6 affected2,601 at risk EG003
EMPYEMA	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
ENDOCARDITIS	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0024 events4 affected2,601 at risk EG003
ENDOCARDITIS BACTERIAL	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
ENDOPHTHALMITIS	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
ENTEROBACTER INFECTION	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
ENTEROCOCCAL BACTERAEMIA	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
EPIDIDYMITIS	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
ERYSIPELAS	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
ESCHERICHIA SEPSIS	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
ESCHERICHIA URINARY TRACT INFECTION	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0023 events3 affected2,601 at risk EG003
EXTRADURAL ABSCESS	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
GANGRENE	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0027 events6 affected2,601 at risk EG003
GASTROENTERITIS	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
GASTROENTERITIS VIRAL	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
HAEMATOMA INFECTION	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
HEPATITIS A	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
INFECTION	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
INFLUENZA	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0026 events6 affected2,601 at risk EG003
INTERVERTEBRAL DISCITIS	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
KLEBSIELLA INFECTION	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
KLEBSIELLA SEPSIS	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
LOCALISED INFECTION	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0023 events3 affected2,601 at risk EG003
MASTOIDITIS	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
MEDICAL DEVICE SITE INFECTION	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
MENINGITIS BACTERIAL	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
NECROTISING SOFT TISSUE INFECTION	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
ORCHITIS	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
OSTEOMYELITIS	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG00218 events14 affected2,601 at risk EG003
OSTEOMYELITIS ACUTE	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
PNEUMOCOCCAL BACTERAEMIA	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
PNEUMONIA	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG00242 events37 affected2,601 at risk EG003
PNEUMONIA ASPIRATION	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0025 events5 affected2,601 at risk EG003
PNEUMONIA BACTERIAL	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
PNEUMONIA KLEBSIELLA	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
PNEUMONIA LEGIONELLA	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
PNEUMONIA PSEUDOMONAL	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
PNEUMONIA STAPHYLOCOCCAL	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
PNEUMONIA VIRAL	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
POST PROCEDURAL INFECTION	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
POST-ACUTE COVID-19 SYNDROME	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
PROSTATIC ABSCESS	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
PROTEUS INFECTION	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
PSEUDOMONAS INFECTION	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
PYELONEPHRITIS	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
PYELONEPHRITIS ACUTE	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0023 events3 affected2,601 at risk EG003
RHINOVIRUS INFECTION	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
SCROTAL ABSCESS	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
SCROTAL CELLULITIS	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
SCROTAL INFECTION	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
SEPSIS	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0002 events2 affected2,601 at risk EG0010 events0 affected2,603 at risk EG00220 events20 affected2,601 at risk EG003
SEPSIS SYNDROME	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
SEPTIC CEREBRAL EMBOLISM	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
SEPTIC ENCEPHALOPATHY	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
SEPTIC SHOCK	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0028 events8 affected2,601 at risk EG003
STAPHYLOCOCCAL BACTERAEMIA	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0023 events3 affected2,601 at risk EG003
STAPHYLOCOCCAL INFECTION	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0023 events3 affected2,601 at risk EG003
STAPHYLOCOCCAL OSTEOMYELITIS	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events1 affected2,601 at risk EG003
STAPHYLOCOCCAL SEPSIS	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
STREPTOCOCCAL BACTERAEMIA	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
STREPTOCOCCAL SEPSIS	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
SUBACUTE ENDOCARDITIS	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
TOOTH ABSCESS	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
URETHRAL ABSCESS	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
URINARY TRACT INFECTION	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0024 events4 affected2,601 at risk EG003
UROSEPSIS	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
WOUND INFECTION	Infections and infestations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0023 events3 affected2,601 at risk EG003
ACCIDENT	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
ACCIDENTAL OVERDOSE	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
ANAEMIA POSTOPERATIVE	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
ANKLE FRACTURE	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
ARTERIAL INJURY	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
ARTHROPOD BITE	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
AVULSION FRACTURE	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
CERVICAL VERTEBRAL FRACTURE	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
CLAVICLE FRACTURE	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
COMMINUTED FRACTURE	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
CONTUSION	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0023 events3 affected2,601 at risk EG003
CRANIOCEREBRAL INJURY	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
CRUSH INJURY	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
DEEP VEIN THROMBOSIS POSTOPERATIVE	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
DIFFUSE AXONAL INJURY	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
FACIAL BONES FRACTURE	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
FALL	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0025 events5 affected2,601 at risk EG003
FEMORAL NECK FRACTURE	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
FEMUR FRACTURE	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0011 events1 affected2,603 at risk EG0023 events3 affected2,601 at risk EG003
FIBULA FRACTURE	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
FOOT FRACTURE	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0023 events3 affected2,601 at risk EG003
FOREIGN BODY IN THROAT	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
FRACTURE DISPLACEMENT	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
GASTROINTESTINAL INJURY	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
HAND FRACTURE	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
HEAD INJURY	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
HEAT STROKE	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
HIP FRACTURE	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0023 events3 affected2,601 at risk EG003
HUMERUS FRACTURE	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0023 events3 affected2,601 at risk EG003
IATROGENIC INJURY	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
JOINT DISLOCATION	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
LIGAMENT RUPTURE	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
LIMB TRAUMATIC AMPUTATION	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
LOWER LIMB FRACTURE	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
LUMBAR VERTEBRAL FRACTURE	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
MULTIPLE FRACTURES	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
MULTIPLE INJURIES	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
MUSCLE STRAIN	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
OPEN FRACTURE	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
OVERDOSE	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
PATELLA FRACTURE	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
PELVIC FRACTURE	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
PERIPROSTHETIC FRACTURE	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
POST PROCEDURAL HAEMATOMA	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
POST PROCEDURAL HAEMORRHAGE	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
POSTOPERATIVE RESPIRATORY FAILURE	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
POSTOPERATIVE THORACIC PROCEDURE COMPLICATION	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
PROCEDURAL HAEMORRHAGE	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
PROCEDURAL PAIN	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
PULMONARY CONTUSION	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
RADIUS FRACTURE	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
RIB FRACTURE	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0024 events4 affected2,601 at risk EG003
ROAD TRAFFIC ACCIDENT	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0028 events8 affected2,601 at risk EG003
SCAPULA FRACTURE	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
SKIN ABRASION	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
SKIN LACERATION	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
SKULL FRACTURE	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
SPINAL FRACTURE	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
SPLENIC RUPTURE	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
STERNAL FRACTURE	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
SUBDURAL HAEMATOMA	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
THIRD DEGREE CHEMICAL BURN OF SKIN	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
THORACIC VERTEBRAL FRACTURE	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
TIBIA FRACTURE	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
TOXICITY TO VARIOUS AGENTS	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
TRAUMATIC LIVER INJURY	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
ULNA FRACTURE	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
UPPER LIMB FRACTURE	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
URINARY TRACT PROCEDURAL COMPLICATION	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
VASCULAR GRAFT OCCLUSION	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
VASCULAR PSEUDOANEURYSM	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
WOUND	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
WOUND DEHISCENCE	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
WRIST FRACTURE	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
BLOOD PRESSURE INCREASED	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
BRAIN NATRIURETIC PEPTIDE INCREASED	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
EJECTION FRACTION DECREASED	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
HAEMOGLOBIN DECREASED	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
LIVER FUNCTION TEST INCREASED	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
PROCALCITONIN INCREASED	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
PROSTATIC SPECIFIC ANTIGEN INCREASED	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
SARS-COV-2 TEST NEGATIVE	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
TROPONIN INCREASED	Investigations	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
JAW FRACTURE	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
PROCEDURAL COMPLICATION	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
STRESS FRACTURE	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
TRAUMATIC RENAL INJURY	Injury, poisoning and procedural complications	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
SINUS RHYTHM	Investigations	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
DEHYDRATION	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0026 events6 affected2,601 at risk EG003
DIABETES MELLITUS	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0025 events5 affected2,601 at risk EG003
DIABETIC KETOACIDOSIS	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0023 events3 affected2,601 at risk EG003
FAILURE TO THRIVE	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
HYPERGLYCAEMIA	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
HYPERGLYCAEMIC HYPEROSMOLAR NONKETOTIC SYNDROME	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
HYPERKALAEMIA	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
HYPERLIPIDAEMIA	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
HYPERNATRAEMIA	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
HYPERPHOSPHATAEMIA	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
HYPERVOLAEMIA	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
HYPOGLYCAEMIA	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0011 events1 affected2,603 at risk EG0023 events3 affected2,601 at risk EG003
HYPOKALAEMIA	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
HYPOMAGNESAEMIA	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
HYPONATRAEMIA	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
HYPOVOLAEMIA	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
KETOACIDOSIS	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
LACTIC ACIDOSIS	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
METABOLIC ACIDOSIS	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
OBESITY	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
POLYDIPSIA	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
TYPE 2 DIABETES MELLITUS	Metabolism and nutrition disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0026 events6 affected2,601 at risk EG003
ARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0023 events3 affected2,601 at risk EG003
CERVICAL SPINAL STENOSIS	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0023 events3 affected2,601 at risk EG003
COSTOCHONDRITIS	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
GROIN PAIN	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
INTERVERTEBRAL DISC DEGENERATION	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
INTERVERTEBRAL DISC DISORDER	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
INTERVERTEBRAL DISC PROTRUSION	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0023 events3 affected2,601 at risk EG003
LIMB DISCOMFORT	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
LUMBAR SPINAL STENOSIS	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0026 events6 affected2,601 at risk EG003
MUSCLE SPASMS	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
MUSCULAR WEAKNESS	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0023 events3 affected2,601 at risk EG003
MUSCULOSKELETAL CHEST PAIN	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
MUSCULOSKELETAL PAIN	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
NECK DEFORMITY	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
NECK PAIN	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
OSTEOARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG00216 events14 affected2,601 at risk EG003
OSTEONECROSIS	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
PATHOLOGICAL FRACTURE	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
PERIARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
POLYMYALGIA RHEUMATICA	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
RHABDOMYOLYSIS	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
ROTATOR CUFF SYNDROME	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
SPINAL OSTEOARTHRITIS	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
SPINAL STENOSIS	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
SPONDYLOLISTHESIS	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
TEMPOROMANDIBULAR JOINT SYNDROME	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
VERTEBRAL FORAMINAL STENOSIS	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
CHEST WALL HAEMATOMA	Musculoskeletal and connective tissue disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
ACUTE MYELOID LEUKAEMIA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
ADENOCARCINOMA GASTRIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0023 events2 affected2,601 at risk EG003
ADENOCARCINOMA METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
ADENOCARCINOMA OF COLON	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
BASAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
BLADDER CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
BLADDER TRANSITIONAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
BONE CANCER METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
CARCINOID TUMOUR OF THE SMALL BOWEL	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
CHOLANGIOCARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
CHRONIC LYMPHOCYTIC LEUKAEMIA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
CLEAR CELL RENAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
COLON CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0011 events1 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
COLON CANCER METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
COLORECTAL ADENOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
DIFFUSE LARGE B-CELL LYMPHOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
FOLLICULAR THYROID CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
GASTROINTESTINAL NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
GASTROINTESTINAL STROMAL TUMOUR	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
HEPATIC CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
HEPATIC CANCER METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
HODGKIN'S DISEASE	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
LARYNGEAL SQUAMOUS CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events1 affected2,601 at risk EG003
LEUKAEMIA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
LIPOSARCOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
LUNG ADENOCARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
LUNG CANCER METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
LUNG NEOPLASM MALIGNANT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
LUNG SQUAMOUS CELL CARCINOMA STAGE II	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
MALIGNANT ASCITES	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
MALIGNANT MELANOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
MALIGNANT MELANOMA STAGE IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
MANTLE CELL LYMPHOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0026 events1 affected2,601 at risk EG003
MENINGIOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
MENINGIOMA BENIGN	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
METASTASES TO LIVER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
METASTASES TO LUNG	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
METASTASES TO LYMPH NODES	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
MONOCLONAL GAMMOPATHY	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
NEOPLASM	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
NEUROENDOCRINE CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
NON-SMALL CELL LUNG CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
NON-SMALL CELL LUNG CANCER METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
NON-SMALL CELL LUNG CANCER STAGE IIIA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
NON-SMALL CELL LUNG CANCER STAGE IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
OESOPHAGEAL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
OROPHARYNGEAL SQUAMOUS CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
PANCREATIC CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
PANCREATIC CARCINOMA METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
PARATHYROID TUMOUR BENIGN	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
PITUITARY TUMOUR	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
PITUITARY TUMOUR BENIGN	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
PLASMA CELL MYELOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
PLASMA CELL MYELOMA RECURRENT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
PROSTATE CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0026 events6 affected2,601 at risk EG003
RECTAL CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
RECTAL CANCER METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
RECTAL CANCER STAGE III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
RENAL CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0023 events3 affected2,601 at risk EG003
RENAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
SALIVARY GLAND CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
SKIN CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
SMALL CELL LUNG CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
SQUAMOUS CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
THROAT CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
TRANSITIONAL CELL CARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
ALTERED STATE OF CONSCIOUSNESS	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
AMNESIA	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
APHASIA	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
ATAXIA	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
AUTONOMIC NEUROPATHY	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
BELL'S PALSY	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
BRAIN STEM HAEMORRHAGE	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
CAROTID ARTERY OCCLUSION	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
CAROTID ARTERY STENOSIS	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0023 events3 affected2,601 at risk EG003
CARPAL TUNNEL SYNDROME	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
CAUDA EQUINA SYNDROME	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
CEREBELLAR INFARCTION	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
CEREBELLAR STROKE	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
CEREBRAL HAEMATOMA	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
CEREBRAL HAEMORRHAGE	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
CEREBRAL INFARCTION	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
CEREBRAL VENTRICLE DILATATION	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
CEREBROVASCULAR ACCIDENT	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0029 events9 affected2,601 at risk EG003
CERVICAL CORD COMPRESSION	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
CERVICAL RADICULOPATHY	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0011 events1 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
CLONIC CONVULSION	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
CRANIAL NERVE PARALYSIS	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
DIABETIC NEUROPATHY	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
DIZZINESS	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0026 events6 affected2,601 at risk EG003
DYSARTHRIA	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
ENCEPHALOPATHY	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
ESSENTIAL TREMOR	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
GUILLAIN-BARRE SYNDROME	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
HAEMORRHAGIC STROKE	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
HAEMORRHAGIC TRANSFORMATION STROKE	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
HEADACHE	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
HEMIPARESIS	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0023 events3 affected2,601 at risk EG003
HEPATIC ENCEPHALOPATHY	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
HYPOAESTHESIA	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0023 events3 affected2,601 at risk EG003
HYPOXIC-ISCHAEMIC ENCEPHALOPATHY	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
INTRACRANIAL HAEMATOMA	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
ISCHAEMIC CEREBRAL INFARCTION	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
ISCHAEMIC STROKE	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG00212 events12 affected2,601 at risk EG003
LACUNAR INFARCTION	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
LACUNAR STROKE	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
LOSS OF CONSCIOUSNESS	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
LUMBAR RADICULOPATHY	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
MENINGEAL THICKENING	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
METABOLIC ENCEPHALOPATHY	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
MIGRAINE	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
MULTIPLE SCLEROSIS RELAPSE	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
MYASTHENIA GRAVIS	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
MYELOPATHY	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
NERVOUS SYSTEM DISORDER	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
NEUROPATHY PERIPHERAL	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
NORMAL PRESSURE HYDROCEPHALUS	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
PARAESTHESIA	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
PARALYSIS	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
PRESYNCOPE	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0025 events5 affected2,601 at risk EG003
QUADRIPARESIS	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
RADIAL NERVE PALSY	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
RADICULOPATHY	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
SCIATICA	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
SEIZURE	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
SPEECH DISORDER	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
SPINAL CLAUDICATION	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
SUBARACHNOID HAEMORRHAGE	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
SYNCOPE	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,601 at risk EG0010 events0 affected2,603 at risk EG00227 events22 affected2,601 at risk EG003
THROMBOTIC STROKE	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
TOXIC ENCEPHALOPATHY	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
TRANSIENT GLOBAL AMNESIA	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
TRANSIENT ISCHAEMIC ATTACK	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0026 events6 affected2,601 at risk EG003
TRIGEMINAL NEURALGIA	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
SQUAMOUS CELL CARCINOMA OF HEAD AND NECK	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
SPINAL EPIDURAL HAEMORRHAGE	Nervous system disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
ABORTION SPONTANEOUS	Pregnancy, puerperium and perinatal conditions	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
DEVICE DISLOCATION	Product Issues	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
DEVICE FAILURE	Product Issues	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
DEVICE OCCLUSION	Product Issues	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
ADJUSTMENT DISORDER	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
AGGRESSION	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
AGITATION	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
ALCOHOL ABUSE	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
ANXIETY	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
BIPOLAR II DISORDER	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
COMPLETED SUICIDE	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
CONFUSIONAL STATE	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
DELIRIUM	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
DEPRESSION	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0023 events3 affected2,601 at risk EG003
MAJOR DEPRESSION	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
MANIA	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
MENTAL STATUS CHANGES	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
PANIC ATTACK	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
PERSONALITY DISORDER	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
POST-TRAUMATIC STRESS DISORDER	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
PSYCHOTIC DISORDER	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
SUICIDAL IDEATION	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
SUICIDE ATTEMPT	Psychiatric disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
ACUTE KIDNEY INJURY	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,601 at risk EG0010 events0 affected2,603 at risk EG00231 events31 affected2,601 at risk EG003
CALCULUS BLADDER	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
CALCULUS URINARY	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
CHRONIC KIDNEY DISEASE	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0025 events5 affected2,601 at risk EG003
DYSURIA	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
END STAGE RENAL DISEASE	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
HAEMATURIA	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
HYDRONEPHROSIS	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0023 events3 affected2,601 at risk EG003
NEPHROLITHIASIS	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0026 events5 affected2,601 at risk EG003
OBSTRUCTIVE NEPHROPATHY	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
POLYURIA	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
RENAL ARTERY STENOSIS	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
RENAL COLIC	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
RENAL FAILURE	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
RENAL HAEMATOMA	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
RENAL HAEMORRHAGE	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
RENAL TUBULAR NECROSIS	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
URETERIC OBSTRUCTION	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
URETEROLITHIASIS	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0024 events4 affected2,601 at risk EG003
URETHRAL OBSTRUCTION	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
URINARY BLADDER HERNIATION	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
URINARY RETENTION	Renal and urinary disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0029 events9 affected2,601 at risk EG003
BENIGN PROSTATIC HYPERPLASIA	Reproductive system and breast disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0024 events4 affected2,601 at risk EG003
ERECTILE DYSFUNCTION	Reproductive system and breast disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
PRIAPISM	Reproductive system and breast disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
PROSTATOMEGALY	Reproductive system and breast disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
ACUTE PULMONARY OEDEMA	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
ACUTE RESPIRATORY DISTRESS SYNDROME	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
ACUTE RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG00239 events36 affected2,601 at risk EG003
ASPIRATION	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
ASTHMA	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
ATELECTASIS	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
BRONCHIAL HYPERREACTIVITY	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
BRONCHIECTASIS	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
BRONCHITIS CHRONIC	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
CHRONIC OBSTRUCTIVE PULMONARY DISEASE	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,601 at risk EG0010 events0 affected2,603 at risk EG00216 events13 affected2,601 at risk EG003
CHRONIC RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
COUGH	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0028 events8 affected2,601 at risk EG003
DYSPNOEA EXERTIONAL	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
EPISTAXIS	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
HYPERCAPNIA	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0023 events3 affected2,601 at risk EG003
HYPOXIA	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG00213 events12 affected2,601 at risk EG003
INTERSTITIAL LUNG DISEASE	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
LUNG CONSOLIDATION	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
LUNG INFILTRATION	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
OBSTRUCTIVE SLEEP APNOEA SYNDROME	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
PHARYNGEAL OEDEMA	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
PLEURAL EFFUSION	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0024 events4 affected2,601 at risk EG003
PLEURITIC PAIN	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0011 events1 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
PNEUMOMEDIASTINUM	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
PNEUMONITIS	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
PNEUMOTHORAX	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
PULMONARY CONGESTION	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
PULMONARY EMBOLISM	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG00217 events17 affected2,601 at risk EG003
PULMONARY FIBROSIS	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
PULMONARY FISTULA	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
PULMONARY HYPERTENSION	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
PULMONARY MASS	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
PULMONARY OEDEMA	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
RESPIRATORY ARREST	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
RESPIRATORY DISTRESS	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0028 events8 affected2,601 at risk EG003
TRACHEAL CALCIFICATION	Respiratory, thoracic and mediastinal disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
ANGIOEDEMA	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
DECUBITUS ULCER	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
DIABETIC FOOT	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0023 events3 affected2,601 at risk EG003
DIABETIC ULCER	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
DIABETIC WOUND	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
SKIN LESION	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
SKIN ULCER	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0011 events1 affected2,603 at risk EG0024 events4 affected2,601 at risk EG003
URTICARIA	Skin and subcutaneous tissue disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
IMMOBILE	Social circumstances	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
AMPUTATION	Surgical and medical procedures	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
ANGIOPLASTY	Surgical and medical procedures	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
CARDIAC PACEMAKER REPLACEMENT	Surgical and medical procedures	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
HIP ARTHROPLASTY	Surgical and medical procedures	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
KNEE ARTHROPLASTY	Surgical and medical procedures	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
LEG AMPUTATION	Surgical and medical procedures	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
SPINAL FUSION SURGERY	Surgical and medical procedures	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
STENT PLACEMENT	Surgical and medical procedures	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
TOE AMPUTATION	Surgical and medical procedures	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
AORTIC ANEURYSM	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
AORTIC STENOSIS	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0024 events4 affected2,601 at risk EG003
ARTERIAL HAEMORRHAGE	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
ARTERIAL THROMBOSIS	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
ARTERIOSCLEROSIS	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
DEEP VEIN THROMBOSIS	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0029 events8 affected2,601 at risk EG003
HAEMATOMA	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
HYPERTENSION	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0024 events4 affected2,601 at risk EG003
HYPERTENSIVE CRISIS	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
HYPERTENSIVE EMERGENCY	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
HYPERTENSIVE URGENCY	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
HYPOTENSION	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0001 events1 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0025 events5 affected2,601 at risk EG003
ILIAC ARTERY STENOSIS	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
INTERMITTENT CLAUDICATION	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0023 events3 affected2,601 at risk EG003
MALIGNANT HYPERTENSION	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
ORTHOSTATIC HYPOTENSION	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0024 events4 affected2,601 at risk EG003
PERIPHERAL ARTERIAL OCCLUSIVE DISEASE	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0028 events5 affected2,601 at risk EG003
PERIPHERAL ARTERY ANEURYSM	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
PERIPHERAL ARTERY OCCLUSION	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
PERIPHERAL ARTERY STENOSIS	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
PERIPHERAL ARTERY THROMBOSIS	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
PERIPHERAL ISCHAEMIA	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
PERIPHERAL VASCULAR DISORDER	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0025 events5 affected2,601 at risk EG003
PERIPHERAL VENOUS DISEASE	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
SHOCK HAEMORRHAGIC	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
SUBCLAVIAN VEIN THROMBOSIS	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0021 events1 affected2,601 at risk EG003
THROMBOSIS	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0022 events2 affected2,601 at risk EG003
VASCULAR COMPRESSION	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
VASCULAR STENOSIS	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003
VENOUS THROMBOSIS LIMB	Vascular disorders	MedDRA 25.0	Systematic Assessment	EG0000 events0 affected2,601 at risk EG0010 events0 affected2,603 at risk EG0020 events0 affected2,601 at risk EG003

ID	Term
D007006	Hypogonadism
D002318	Cardiovascular Diseases
D004194	Disease

ID	Term
D006058	Gonadal Disorders
D004700	Endocrine System Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D000737	Androstenols
D000736	Androstenes
D000731	Androstanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D045165	Testosterone Congeners
D012739	Gonadal Steroid Hormones
D042341	Gonadal Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists