Cardiovascular Risk Reduction Study (Reduction in Recurre... | NCT01327846

NCT01327846

ID	Type	Description	Link
2010-022970-14	EudraCT Number

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Canakinumab Dose 50 mg	Experimental	Pivotal Phase: Blinded Canakinumab 50 mg quarterly subcutaneous + standard of care therapy. Extension Phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care therapy	Drug: Canakinumab Drug: Standard of care
Canakinumab Dose 150 mg	Experimental	Pivotal Phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care therapy	Drug: Canakinumab Drug: Standard of care
Canakinumab Dose 300 mg	Experimental	Pivotal Phase: Blinded Canakinumab 300 mg quarterly subcutaneous (with one additional dose at week 2) + standard of care therapy. Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care therapy	Drug: Canakinumab Drug: Standard of care
Placebo	Placebo Comparator	Pivotal Phase: Blinded matching placebo quarterly subcutaneous + standard of care therapy. Extension Phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care therapy	Drug: Placebo Drug: Standard of care

Name	Type	Description	Arm Group Labels	Other Names
Canakinumab	Drug		Canakinumab Dose 150 mg Canakinumab Dose 300 mg Canakinumab Dose 50 mg	ACZ885

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Analysis of Core Phase First CEC Confirmed Major Adverse Cardiovascular Events (MACE) and Its Components	Time to occurrence of CEC (Cardiovascular clinical events adjudication committee) confirmed MACE, which was a composite endpoint consisting of CEC confirmed CV death, CEC confirmed non-fatal MI,or CEC confirmed non-fatal stroke. Patients with the CEC adjudicated reason for death of "Unknown" were counted as CV (cardiovascular) death.	From randomization, to end of treatment plus 30 days, up to approximately 6 years
Substudy 1 (Core Phase): Change From Baseline in Carotid Plaque Burden in the Bifurcation Region of the Index Carotid Artery		24 months
Substudy 2 (Core Phase): Change From Baseline of the Insulin Secretion Rate (ISR) Relative to Glucose 0-30 Min Defined as Φ30 = AUCISR 0-30 / AUCGluc 0-30 Averaged Across the Year 3, 4, 5 Visits		From randomization up to approximately 6 years

Secondary Outcomes

Measure	Description	Time Frame
Patients With Core Phase CEC Confirmed CV Death, Non-fatal MI, Non-fatal Stroke, or Hospitalization for Unstable Angina Requiring Unplanned Revascularization	Occurrence of the composite cardiovascular endpoint consisting of cardiovascular death, non-fatal MI, non-fatal stroke or hospitalization for unstable angina requiring unplanned revascularization. MACE includes CV death, non-fatal MI and non-fatal stroke. CEC = Clinical Endpoints Committee

Eligibility Module

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Athens	Alabama	35611	United States
Novartis Investigative Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
42141513	Derived	Scheidegger C, Wandel S, Mutze T. Covariate Adjustment for the Win Odds: Application to Cardiovascular Outcomes Trials. Stat Med. 2026 May;45(10-12):e70602. doi: 10.1002/sim.70602.
37934948	Derived	Woo J, Lu D, Lewandowski A, Xu H, Serrano P, Healey M, Yates DP, Beste MT, Libby P, Ridker PM, Steensma DP. Effects of IL-1beta inhibition on anemia and clonal hematopoiesis in the randomized CANTOS trial. Blood Adv. 2023 Dec 26;7(24):7471-7484. doi: 10.1182/bloodadvances.2023011578.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Group I	Core phase: Blinded Canakinumab 300 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
FG001	Group II

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Sep 13, 2016	Nov 14, 2019

Arm/Group Information

ID	Title	Description
BG000	Group I	Core phase: Blinded Canakinumab 300 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
BG001	Group II	Core phase: Blinded Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
BG002	Group III	Core phase: Blinded Canakinumab 50 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
BG003	Group IV	Core phase: Blinded matching placebo quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
BG004	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Customized

FAS

Number

Participants

Title

Denominators

Categories

< 65

Title	Measurements
	BG0001424 BG0011428 BG0021350 BG003

Sex: Female, Male

FAS

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000606 BG001575 BG002

Race/Ethnicity, Customized

FAS

Number

Participants

Title

Denominators

Categories

Caucasian

Title	Measurements
	BG0001804 BG0011808 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

Analysis of Core Phase First CEC Confirmed Major Adverse Cardiovascular Events (MACE) and Its Components

Time to occurrence of CEC (Cardiovascular clinical events adjudication committee) confirmed MACE, which was a composite endpoint consisting of CEC confirmed CV death, CEC confirmed non-fatal MI,or CEC confirmed non-fatal stroke. Patients with the CEC adjudicated reason for death of "Unknown" were counted as CV (cardiovascular) death.

Full Analysis Set (FAS): All randomized patients except for those who were misrandomized or from sites with serious GCP violations

Posted

Number

Participants

From randomization, to end of treatment plus 30 days, up to approximately 6 years

ID	Title	Description
OG000	Group I	Core phase: Blinded Canakinumab 300 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
OG001	Group II	Core phase: Blinded Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
OG002	Group III	Core phase: Blinded Canakinumab 50 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
OG003	Group IV	Core phase: Blinded matching placebo quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy

Units	Counts
Participants	OG0002263 OG0012284 OG0022170 OG003

Title

Denominators

Categories

MACE

Title	Measurements
	OG000322 OG001320 OG002313 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG003	H11: The hazard rate of first adjudication committee confirmed MACE in the canakinumab 300 mg dose group is greater than or equal to the hazard rate of the placebo group	Log Rank		0.0648	1-sided adjusted for multiplicity using weighted Dunnett test. [significance level 0.0245]	Cox Proportional Hazard	0.86			2-Sided	95	0.75	0.99			MACE		Superiority	A HR < 1 favors Canakinumab

Primary

Substudy 1 (Core Phase): Change From Baseline in Carotid Plaque Burden in the Bifurcation Region of the Index Carotid Artery

Data from subjects were not collected as the substudy was terminated prior to data collection.

Posted

24 months

ID	Title	Description
OG000	Group I	Core phase: Blinded Canakinumab 300 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
OG001	Group II	Core phase: Blinded Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
OG002	Group III	Core phase: Blinded Canakinumab 50 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
OG003	Group IV	Core phase: Blinded matching placebo quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy

Primary

Substudy 2 (Core Phase): Change From Baseline of the Insulin Secretion Rate (ISR) Relative to Glucose 0-30 Min Defined as Φ30 = AUCISR 0-30 / AUCGluc 0-30 Averaged Across the Year 3, 4, 5 Visits

Data from subjects were not collected as the substudy was terminated prior to data collection.

Posted

From randomization up to approximately 6 years

ID	Title	Description
OG000	Group I	Core phase: Blinded Canakinumab 300 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
OG001	Group II	Core phase: Blinded Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
OG002	Group III	Core phase: Blinded Canakinumab 50 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
OG003	Group IV

Secondary

Patients With Core Phase CEC Confirmed CV Death, Non-fatal MI, Non-fatal Stroke, or Hospitalization for Unstable Angina Requiring Unplanned Revascularization

Occurrence of the composite cardiovascular endpoint consisting of cardiovascular death, non-fatal MI, non-fatal stroke or hospitalization for unstable angina requiring unplanned revascularization.

MACE includes CV death, non-fatal MI and non-fatal stroke. CEC = Clinical Endpoints Committee

FAS: All randomized patients except for those who were misrandomized or from sites with serious GCP violations

Posted

Number

Participants

From randomization, to end of treatment pus 30 days, up to approximately 6 years

ID	Title	Description
OG000	Group I	Core phase: Blinded Canakinumab 300 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
OG001	Group II	Core phase: Blinded Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
OG002	Group III	Core phase: Blinded Canakinumab 50 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy

Secondary

Patients With Core Phase New Onset Type 2 Diabetes Among Patients With Pre-diabetes at Randomization

Time to CEC confirmed new onset of type 2 diabetes among those with pre-diabetes at randomization (i.e. excluding those that are normoglycemic at baseline)

FAS: All randomized patients except for those who were misrandomized or from sites with serious GCP violations

Posted

Number

Participants

From randomization up to approximately 6 years

ID	Title	Description
OG000	Group I	Core phase: Blinded Canakinumab 300 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
OG001	Group II	Core phase: Blinded Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
OG002	Group III	Core phase: Blinded Canakinumab 50 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy

Secondary

Core Phase All-cause Mortality, Non-fatal MI, or Non-fatal Stroke

Occurrence of the composite endpoint consisting of all-cause mortality, non-fatal IM, or non-fatal stroke

FAS: All randomized patients except for those who were misrandomized or from sites with serious GCP violations

Posted

Number

Participants

From randomization, to end of treatment plus 30 days, up to approximately 6 years

ID	Title	Description
OG000	Group I	Core phase: Blinded Canakinumab 300 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
OG001	Group II	Core phase: Blinded Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
OG002	Group III	Core phase: Blinded Canakinumab 50 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy

Secondary

Core Phase All-cause Mortality

Number of participant deaths

FAS: All randomized patients except for those who were misrandomized or from sites with serious GCP violations

Posted

Number

Participants

From randomization, to end of treatment plus 30 days, up to approximately 6 years

ID	Title	Description
OG000	Group I	Core phase: Blinded Canakinumab 300 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
OG001	Group II	Core phase: Blinded Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
OG002	Group III	Core phase: Blinded Canakinumab 50 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
OG003	Group IV

Secondary

Summary of Adverse Events (Core Phase)

Summary of Adverse Events (AEs) and Serious Adverse Events (SAEs) occurring during the double-blind Core phase of the study. AEs/SAEs are any signs or symptoms that occur during the study treatment.

Safety set: All patients who received at least one dose of study treatment and had at least one post-baseline safety assessment

Posted

Number

Participants

From randomization, to end of treatment plus 30 days, up to approximately 6 years

ID	Title	Description
OG000	Group I	Core phase: Blinded Canakinumab 300 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
OG001	Group II	Core phase: Blinded Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
OG002	Group III	Core phase: Blinded Canakinumab 50 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy

Secondary

Summary of Adverse Events (Extension Phase)

Summary of Adverse Events (AEs) and Serious Adverse Events (SAEs) occurring during the Extension phase of the study. AEs/SAEs are any signs or symptoms that occur during the study treatment.

Extension Safety set: All patients who received at least one dose of study treatment during the Core Phase and who entered the Extension phase.

Posted

Number

Participants

From start of Extension phase, to end of treatment plus 30 days, up to approximately 2 years

ID	Title	Description
OG000	Group I	Core phase: Blinded Canakinumab 300 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
OG001	Group II	Core phase: Blinded Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
OG002	Group III	Core phase: Blinded Canakinumab 50 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy

Secondary

Substudy 1 (Core Phase): Change From Baseline of the Total Vessel Wall Area at Month 3 in the Bifurcation Region of the Index Carotid Artery

Data from subjects were not collected as the substudy was terminated prior to data collection.

Posted

3 months

ID	Title	Description
OG000	Group I	Core phase: Blinded Canakinumab 300 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
OG001	Group II	Core phase: Blinded Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
OG002	Group III	Core phase: Blinded Canakinumab 50 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
OG003	Group IV	Core phase: Blinded matching placebo quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy

Secondary

Substudy 1 (Core Phase): Mean Total Vessel Wall Area Across the Left and Right Carotid Artery at Month 3 and Month 24

Data from subjects were not collected as the substudy was terminated prior to data collection.

Posted

24 months

ID	Title	Description
OG000	Group I	Core phase: Blinded Canakinumab 300 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
OG001	Group II	Core phase: Blinded Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
OG002	Group III	Core phase: Blinded Canakinumab 50 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
OG003	Group IV	Core phase: Blinded matching placebo quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy

Secondary

Substudy 1 (Core Phase): Change From Baseline in Corresponding Total Vessel Wall Area in the Left and Right Carotid Arteries

Data from subjects were not collected as the substudy was terminated prior to data collection.

Posted

24 months

ID	Title	Description
OG000	Group I	Core phase: Blinded Canakinumab 300 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
OG001	Group II	Core phase: Blinded Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
OG002	Group III	Core phase: Blinded Canakinumab 50 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
OG003	Group IV	Core phase: Blinded matching placebo quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy

Secondary

Substudy 1 (Core Phase): The Existence of a Baseline Total Vessel Wall Area by Treatment Interaction as Well as the Consistency of the Treatment Effect Across Subgroups

Data from subjects were not collected as the substudy was terminated prior to data collection.

Posted

24 months

ID	Title	Description
OG000	Group I	Core phase: Blinded Canakinumab 300 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
OG001	Group II	Core phase: Blinded Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
OG002	Group III	Core phase: Blinded Canakinumab 50 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
OG003	Group IV	Core phase: Blinded matching placebo quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy

Secondary

Substudy 2 (Core Phase): Change From Baseline in Insulin Sensitivity Index

Data from subjects were not collected as the substudy was terminated prior to data collection.

Posted

From randomization up to approximately 6 years

ID	Title	Description
OG000	Group I	Core phase: Blinded Canakinumab 300 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
OG001	Group II	Core phase: Blinded Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
OG002	Group III	Core phase: Blinded Canakinumab 50 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
OG003	Group IV	Core phase: Blinded matching placebo quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy

Secondary

Substudy 2 (Core Phase): Change From Baseline in OGTT Stimulated Area Under Curve (AUC) 0-120 Min of Glucose Concentration, Insulin Concentration, Pro-insulin Concentration, and Insulin Concentration/Glucose Concentration Ratio

Data from subjects were not collected as the substudy was terminated prior to data collection.

Posted

From randomization up to approximately 6 years

ID	Title	Description
OG000	Group I	Core phase: Blinded Canakinumab 300 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
OG001	Group II	Core phase: Blinded Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
OG002	Group III	Core phase: Blinded Canakinumab 50 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
OG003	Group IV

Secondary

Substudy 2 (Core Phase): Change From Baseline in Fasting Pro-Insulin Concentration/Insulin Concentration Ratio

Data from subjects were not collected as the substudy was terminated prior to data collection.

Posted

From randomization up to approximately 6 years

ID	Title	Description
OG000	Group I	Core phase: Blinded Canakinumab 300 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
OG001	Group II	Core phase: Blinded Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
OG002	Group III	Core phase: Blinded Canakinumab 50 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
OG003	Group IV	Core phase: Blinded matching placebo quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy

Secondary

Substudy 2 (Core Phase): Change From Baseline in OGTT Stimulated Area Under the Curve (AUC) 0-120 Min of C-peptide Concentration

Data from subjects were not collected as the substudy was terminated prior to data collection.

Posted

From randomization up to approximately 6 years

ID	Title	Description
OG000	Group I	Core phase: Blinded Canakinumab 300 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
OG001	Group II	Core phase: Blinded Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
OG002	Group III	Core phase: Blinded Canakinumab 50 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy
OG003	Group IV	Core phase: Blinded matching placebo quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy

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	Group I	Core phase: Blinded Canakinumab 300 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy	239	2,263	759	2,263	1,271	2,263
EG001	Group II	Core phase: Blinded Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy	240	2,285	743	2,285	1,324	2,285
EG002	Group III	Core phase: Blinded Canakinumab 50 mg quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy	228	2,170	686	2,170	1,199	2,170
EG003	Group IV	Core phase: Blinded matching placebo quarterly subcutaneous + standard of care (SoC) therapy Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy	378	3,348	1,099	3,348	1,905	3,348
EG004	Group V	Extension phase: Switched to open-label Canakinumab 150 mg quarterly subcutaneous + standard of care (SoC) therapy.	211	5,777	1,216	5,777	1,497	5,777

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abnormal clotting factor	Blood and lymphatic system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG0030 affected3,348 at risk EG004
Anaemia	Blood and lymphatic system disorders	MedDRA (21.1)	Systematic Assessment	EG00015 affected2,263 at risk EG00110 affected2,285 at risk EG0024 affected2,170 at risk EG003
Bone marrow oedema	Blood and lymphatic system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Coagulopathy	Blood and lymphatic system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA (21.1)	Systematic Assessment	EG0004 affected2,263 at risk EG0012 affected2,285 at risk EG0025 affected2,170 at risk EG003
Heparin-induced thrombocytopenia	Blood and lymphatic system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Hilar lymphadenopathy	Blood and lymphatic system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Histiocytosis haematophagic	Blood and lymphatic system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Hypochromic anaemia	Blood and lymphatic system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
Immune thrombocytopenic purpura	Blood and lymphatic system disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
Leukocytosis	Blood and lymphatic system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Leukopenia	Blood and lymphatic system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Lymphadenitis	Blood and lymphatic system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Lymphadenopathy mediastinal	Blood and lymphatic system disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Microcytic anaemia	Blood and lymphatic system disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
Monoclonal B-cell lymphocytosis	Blood and lymphatic system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Normochromic normocytic anaemia	Blood and lymphatic system disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Normocytic anaemia	Blood and lymphatic system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Pancytopenia	Blood and lymphatic system disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0012 affected2,285 at risk EG0020 affected2,170 at risk EG003
Polycythaemia	Blood and lymphatic system disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Splenic infarction	Blood and lymphatic system disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Splenomegaly	Blood and lymphatic system disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (21.1)	Systematic Assessment	EG0005 affected2,263 at risk EG0010 affected2,285 at risk EG0023 affected2,170 at risk EG003
Thrombocytopenic purpura	Blood and lymphatic system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Acute coronary syndrome	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0006 affected2,263 at risk EG0011 affected2,285 at risk EG0024 affected2,170 at risk EG003
Acute left ventricular failure	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0012 affected2,285 at risk EG0022 affected2,170 at risk EG003
Adams-Stokes syndrome	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Angina pectoris	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG00042 affected2,263 at risk EG00141 affected2,285 at risk EG00237 affected2,170 at risk EG003
Angina unstable	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG00039 affected2,263 at risk EG00134 affected2,285 at risk EG00237 affected2,170 at risk EG003
Aortic valve incompetence	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Aortic valve stenosis	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0003 affected2,263 at risk EG0012 affected2,285 at risk EG0022 affected2,170 at risk EG003
Arrhythmia	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0004 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Arrhythmia supraventricular	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Arteriospasm coronary	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0003 affected2,263 at risk EG0016 affected2,285 at risk EG0024 affected2,170 at risk EG003
Atrial flutter	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Atrial tachycardia	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Atrial thrombosis	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Atrioventricular block	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
Atrioventricular block complete	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0011 affected2,285 at risk EG0022 affected2,170 at risk EG003
Atrioventricular block first degree	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Atrioventricular block second degree	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0014 affected2,285 at risk EG0022 affected2,170 at risk EG003
Bradyarrhythmia	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Bradycardia	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0004 affected2,263 at risk EG0012 affected2,285 at risk EG0023 affected2,170 at risk EG003
Cardiac aneurysm	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Cardiac arrest	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0017 affected2,285 at risk EG0027 affected2,170 at risk EG003
Cardiac discomfort	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0005 affected2,263 at risk EG0014 affected2,285 at risk EG0027 affected2,170 at risk EG003
Cardiac failure acute	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0012 affected2,285 at risk EG0020 affected2,170 at risk EG003
Cardiac failure chronic	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0005 affected2,263 at risk EG0012 affected2,285 at risk EG0022 affected2,170 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0004 affected2,263 at risk EG0012 affected2,285 at risk EG0020 affected2,170 at risk EG003
Cardiac fibrillation	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Cardiac pseudoaneurysm	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Cardiac tamponade	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Cardiac ventricular thrombosis	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Cardio-respiratory arrest	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0012 affected2,285 at risk EG0023 affected2,170 at risk EG003
Cardiogenic shock	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0013 affected2,285 at risk EG0023 affected2,170 at risk EG003
Cardiomegaly	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Cardiomyopathy	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
Cardiopulmonary failure	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Conduction disorder	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Congestive cardiomyopathy	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Cor pulmonale	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0009 affected2,263 at risk EG00110 affected2,285 at risk EG0025 affected2,170 at risk EG003
Coronary artery insufficiency	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Coronary artery occlusion	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Coronary artery stenosis	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Hypertensive heart disease	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Intracardiac thrombus	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0003 affected2,263 at risk EG0015 affected2,285 at risk EG0022 affected2,170 at risk EG003
Left ventricular dysfunction	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Left ventricular failure	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Left ventricular hypertrophy	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
Microvascular coronary artery disease	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Mitral valve incompetence	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0005 affected2,263 at risk EG0013 affected2,285 at risk EG0020 affected2,170 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0004 affected2,263 at risk EG0012 affected2,285 at risk EG0025 affected2,170 at risk EG003
Myocardial ischaemia	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0006 affected2,263 at risk EG0013 affected2,285 at risk EG0025 affected2,170 at risk EG003
Nodal arrhythmia	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Palpitations	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0003 affected2,263 at risk EG0012 affected2,285 at risk EG0022 affected2,170 at risk EG003
Pericardial effusion	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Pericarditis	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Prinzmetal angina	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Pulseless electrical activity	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Right ventricular dysfunction	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Right ventricular failure	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Silent myocardial infarction	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Sinus arrest	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Sinus bradycardia	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0003 affected2,263 at risk EG0010 affected2,285 at risk EG0022 affected2,170 at risk EG003
Sinus node dysfunction	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0004 affected2,263 at risk EG0012 affected2,285 at risk EG0025 affected2,170 at risk EG003
Sinus tachycardia	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Stress cardiomyopathy	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Supraventricular tachycardia	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Tachyarrhythmia	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Tachycardia	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0003 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
Torsade de pointes	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Tricuspid valve incompetence	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Trifascicular block	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Ventricular arrhythmia	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Ventricular extrasystoles	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0022 affected2,170 at risk EG003
Ventricular fibrillation	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0004 affected2,263 at risk EG0019 affected2,285 at risk EG0023 affected2,170 at risk EG003
Ventricular tachyarrhythmia	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Ventricular tachycardia	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG00010 affected2,263 at risk EG0015 affected2,285 at risk EG0029 affected2,170 at risk EG003
Atrial septal defect	Congenital, familial and genetic disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Branchial cyst	Congenital, familial and genetic disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Cerebrovascular arteriovenous malformation	Congenital, familial and genetic disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Haemorrhagic arteriovenous malformation	Congenital, familial and genetic disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Hereditary haemochromatosis	Congenital, familial and genetic disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Hydrocele	Congenital, familial and genetic disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Nonketotic hyperglycinaemia	Congenital, familial and genetic disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Phimosis	Congenital, familial and genetic disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Pyloric stenosis	Congenital, familial and genetic disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Tracheo-oesophageal fistula	Congenital, familial and genetic disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Cerumen impaction	Ear and labyrinth disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Ear pain	Ear and labyrinth disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Hypoacusis	Ear and labyrinth disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0012 affected2,285 at risk EG0020 affected2,170 at risk EG003
Meniere's disease	Ear and labyrinth disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Otosclerosis	Ear and labyrinth disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Presbyacusis	Ear and labyrinth disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Sudden hearing loss	Ear and labyrinth disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Tympanic membrane perforation	Ear and labyrinth disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA (21.1)	Systematic Assessment	EG0003 affected2,263 at risk EG0015 affected2,285 at risk EG0024 affected2,170 at risk EG003
Vertigo positional	Ear and labyrinth disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0012 affected2,285 at risk EG0023 affected2,170 at risk EG003
Goitre	Endocrine disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Hyperparathyroidism primary	Endocrine disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Hyperthyroidism	Endocrine disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Hypopituitarism	Endocrine disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Hypothyroidism	Endocrine disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Inappropriate antidiuretic hormone secretion	Endocrine disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Primary hyperaldosteronism	Endocrine disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Toxic goitre	Endocrine disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Amaurosis fugax	Eye disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Angle closure glaucoma	Eye disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Blindness	Eye disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Blindness transient	Eye disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Blindness unilateral	Eye disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0012 affected2,285 at risk EG0020 affected2,170 at risk EG003
Cataract	Eye disorders	MedDRA (21.1)	Systematic Assessment	EG0004 affected2,263 at risk EG0018 affected2,285 at risk EG0025 affected2,170 at risk EG003
Cataract cortical	Eye disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Cataract diabetic	Eye disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Cataract nuclear	Eye disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Corneal degeneration	Eye disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Corneal infiltrates	Eye disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Dacryostenosis acquired	Eye disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Diabetic retinopathy	Eye disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Eye haemorrhage	Eye disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Eyelid ptosis	Eye disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Glaucoma	Eye disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Iridocyclitis	Eye disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Lens dislocation	Eye disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Macular degeneration	Eye disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Macular fibrosis	Eye disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Macular hole	Eye disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Macular oedema	Eye disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Neovascular age-related macular degeneration	Eye disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Ocular ischaemic syndrome	Eye disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Papilloedema	Eye disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Retinal artery thrombosis	Eye disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Retinal detachment	Eye disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0012 affected2,285 at risk EG0020 affected2,170 at risk EG003
Retinal haemorrhage	Eye disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Retinal vein occlusion	Eye disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Retinal vein thrombosis	Eye disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Vitreous haemorrhage	Eye disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Abdominal adhesions	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0022 affected2,170 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Abdominal hernia	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0003 affected2,263 at risk EG0011 affected2,285 at risk EG0022 affected2,170 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0007 affected2,263 at risk EG0014 affected2,285 at risk EG00210 affected2,170 at risk EG003
Abdominal pain lower	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0022 affected2,170 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0006 affected2,263 at risk EG0012 affected2,285 at risk EG0023 affected2,170 at risk EG003
Acute abdomen	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Alcoholic pancreatitis	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Anal fissure	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Anal haemorrhage	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
Anal skin tags	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Anal ulcer	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Anal ulcer haemorrhage	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Anorectal disorder	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Appendiceal mucocoele	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Appendix disorder	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0012 affected2,285 at risk EG0021 affected2,170 at risk EG003
Change of bowel habit	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Chronic gastritis	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0012 affected2,285 at risk EG0020 affected2,170 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0003 affected2,263 at risk EG0013 affected2,285 at risk EG0022 affected2,170 at risk EG003
Colitis ischaemic	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0011 affected2,285 at risk EG0022 affected2,170 at risk EG003
Colitis microscopic	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Colitis ulcerative	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Colonic fistula	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0004 affected2,263 at risk EG0012 affected2,285 at risk EG0021 affected2,170 at risk EG003
Crohn's disease	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0013 affected2,285 at risk EG0021 affected2,170 at risk EG003
Dental caries	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Diabetic gastroenteropathy	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0003 affected2,263 at risk EG0015 affected2,285 at risk EG0024 affected2,170 at risk EG003
Dieulafoy's vascular malformation	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Diverticulum	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Diverticulum intestinal	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Diverticulum intestinal haemorrhagic	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
Duodenal stenosis	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Duodenal ulcer	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Duodenal ulcer perforation	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Duodenitis	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Enteritis	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Enterocolitis	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0012 affected2,285 at risk EG0020 affected2,170 at risk EG003
Enterovesical fistula	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Epigastric discomfort	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Erosive duodenitis	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Erosive oesophagitis	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Faecaloma	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Faeces discoloured	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Food poisoning	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Gallstone ileus	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Gastric haemorrhage	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
Gastric ulcer	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0007 affected2,263 at risk EG0016 affected2,285 at risk EG0020 affected2,170 at risk EG003
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
Gastric ulcer perforation	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
Gastric volvulus	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0004 affected2,263 at risk EG0011 affected2,285 at risk EG0024 affected2,170 at risk EG003
Gastritis erosive	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Gastritis haemorrhagic	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Gastroduodenitis	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Gastrointestinal angiodysplasia	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Gastrointestinal erosion	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG00013 affected2,263 at risk EG00116 affected2,285 at risk EG00214 affected2,170 at risk EG003
Gastrointestinal necrosis	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Gastrointestinal pain	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Gastrointestinal perforation	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Gastrointestinal ulcer	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Gastrointestinal vascular malformation	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0015 affected2,285 at risk EG0021 affected2,170 at risk EG003
Haematemesis	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0011 affected2,285 at risk EG0022 affected2,170 at risk EG003
Haematochezia	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0013 affected2,285 at risk EG0021 affected2,170 at risk EG003
Haemorrhagic necrotic pancreatitis	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Haemorrhoids	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0013 affected2,285 at risk EG0021 affected2,170 at risk EG003
Haemorrhoids thrombosed	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Hiatus hernia	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
Ileal ulcer	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Ileus	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0003 affected2,263 at risk EG0011 affected2,285 at risk EG0022 affected2,170 at risk EG003
Ileus paralytic	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Impaired gastric emptying	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Incarcerated inguinal hernia	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Incarcerated umbilical hernia	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Inflammatory bowel disease	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0008 affected2,263 at risk EG0015 affected2,285 at risk EG0027 affected2,170 at risk EG003
Inguinal hernia strangulated	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Intestinal fistula	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Intestinal haemorrhage	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
Intestinal infarction	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Intestinal ischaemia	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Intestinal mass	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Intestinal obstruction	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0011 affected2,285 at risk EG0023 affected2,170 at risk EG003
Intestinal perforation	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
Intestinal ulcer	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Irritable bowel syndrome	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Ischaemic enteritis	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Large intestinal obstruction	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Large intestinal stenosis	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Large intestine perforation	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0012 affected2,285 at risk EG0020 affected2,170 at risk EG003
Large intestine polyp	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0003 affected2,263 at risk EG0014 affected2,285 at risk EG0022 affected2,170 at risk EG003
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0014 affected2,285 at risk EG0021 affected2,170 at risk EG003
Mallory-Weiss syndrome	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Melaena	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Mesenteric artery stenosis	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Mesenteric artery thrombosis	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Mesenteric vascular insufficiency	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Mouth cyst	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Mouth ulceration	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Narcotic bowel syndrome	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0004 affected2,263 at risk EG0013 affected2,285 at risk EG0022 affected2,170 at risk EG003
Obstruction gastric	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Odynophagia	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Oesophageal obstruction	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Oesophageal perforation	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Oesophageal rupture	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Oesophageal stenosis	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
Oesophageal ulcer	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Oesophageal varices haemorrhage	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Oesophagitis	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Pancreatic cyst	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Pancreatic disorder	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Pancreatic duct dilatation	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Pancreatic mass	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Pancreatic pseudocyst	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0006 affected2,263 at risk EG0016 affected2,285 at risk EG0023 affected2,170 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0003 affected2,263 at risk EG0016 affected2,285 at risk EG0022 affected2,170 at risk EG003
Pancreatitis chronic	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0012 affected2,285 at risk EG0021 affected2,170 at risk EG003
Pancreatitis necrotising	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Peptic ulcer	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Peptic ulcer haemorrhage	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Peritoneal haemorrhage	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Pneumatosis intestinalis	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Pneumoperitoneum	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Proctalgia	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Proctitis	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Ranula	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Rectal haemorrhage	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0016 affected2,285 at risk EG0021 affected2,170 at risk EG003
Rectal lesion	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Rectal perforation	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Rectal polyp	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0012 affected2,285 at risk EG0020 affected2,170 at risk EG003
Retroperitoneal haematoma	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Retroperitoneal haemorrhage	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Salivary gland calculus	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Small intestinal haemorrhage	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0011 affected2,285 at risk EG0022 affected2,170 at risk EG003
Small intestinal perforation	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Small intestine ulcer	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Subileus	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
Thrombosis mesenteric vessel	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Umbilical hernia	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0014 affected2,285 at risk EG0022 affected2,170 at risk EG003
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0003 affected2,263 at risk EG0018 affected2,285 at risk EG0028 affected2,170 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0005 affected2,263 at risk EG0014 affected2,285 at risk EG0022 affected2,170 at risk EG003
Adverse drug reaction	General disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Asthenia	General disorders	MedDRA (21.1)	Systematic Assessment	EG0004 affected2,263 at risk EG0012 affected2,285 at risk EG0021 affected2,170 at risk EG003
Cardiac death	General disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Chest discomfort	General disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Chest pain	General disorders	MedDRA (21.1)	Systematic Assessment	EG0003 affected2,263 at risk EG00112 affected2,285 at risk EG0022 affected2,170 at risk EG003
Chills	General disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Complication associated with device	General disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Death	General disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Drowning	General disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Drug intolerance	General disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Exercise tolerance decreased	General disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Facial pain	General disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Fatigue	General disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0012 affected2,285 at risk EG0020 affected2,170 at risk EG003
Gait disturbance	General disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
General physical health deterioration	General disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Generalised oedema	General disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Hernia	General disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Heteroplasia	General disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Hyperplasia	General disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Hypothermia	General disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Impaired healing	General disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
Implant site irritation	General disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Incarcerated hernia	General disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Inflammation	General disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Influenza like illness	General disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Injection site reaction	General disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Ischaemic ulcer	General disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
Local swelling	General disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Malaise	General disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Mass	General disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Multiple organ dysfunction syndrome	General disorders	MedDRA (21.1)	Systematic Assessment	EG0003 affected2,263 at risk EG0012 affected2,285 at risk EG0020 affected2,170 at risk EG003
Necrosis	General disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA (21.1)	Systematic Assessment	EG00044 affected2,263 at risk EG00148 affected2,285 at risk EG00239 affected2,170 at risk EG003
Oedema peripheral	General disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Pacemaker syndrome	General disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Pain	General disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Polyp	General disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Pseudocyst	General disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Pyrexia	General disorders	MedDRA (21.1)	Systematic Assessment	EG0004 affected2,263 at risk EG0014 affected2,285 at risk EG0026 affected2,170 at risk EG003
Stent-graft endoleak	General disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Sudden cardiac death	General disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
Sudden death	General disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Surgical failure	General disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Systemic inflammatory response syndrome	General disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0023 affected2,170 at risk EG003
Vascular stent restenosis	General disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0012 affected2,285 at risk EG0021 affected2,170 at risk EG003
Vascular stent stenosis	General disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Vascular stent thrombosis	General disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Vessel puncture site haemorrhage	General disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Acute hepatic failure	Hepatobiliary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Alcoholic liver disease	Hepatobiliary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Autoimmune hepatitis	Hepatobiliary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Bile duct stenosis	Hepatobiliary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0012 affected2,285 at risk EG0020 affected2,170 at risk EG003
Bile duct stone	Hepatobiliary disorders	MedDRA (21.1)	Systematic Assessment	EG0004 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Biliary cirrhosis	Hepatobiliary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Biliary colic	Hepatobiliary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Biliary dilatation	Hepatobiliary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Biliary fistula	Hepatobiliary disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Cholangitis	Hepatobiliary disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0012 affected2,285 at risk EG0024 affected2,170 at risk EG003
Cholangitis acute	Hepatobiliary disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA (21.1)	Systematic Assessment	EG00011 affected2,263 at risk EG0014 affected2,285 at risk EG0028 affected2,170 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MedDRA (21.1)	Systematic Assessment	EG0005 affected2,263 at risk EG0017 affected2,285 at risk EG0024 affected2,170 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA (21.1)	Systematic Assessment	EG0008 affected2,263 at risk EG0018 affected2,285 at risk EG0028 affected2,170 at risk EG003
Cholestasis	Hepatobiliary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Drug-induced liver injury	Hepatobiliary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
Gallbladder polyp	Hepatobiliary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Haemorrhagic hepatic cyst	Hepatobiliary disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Hepatic congestion	Hepatobiliary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Hepatic failure	Hepatobiliary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Hepatic function abnormal	Hepatobiliary disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Hepatic steatosis	Hepatobiliary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Hepatic vein thrombosis	Hepatobiliary disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Hepatitis	Hepatobiliary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Hepatitis toxic	Hepatobiliary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Hepatomegaly	Hepatobiliary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Hepatorenal failure	Hepatobiliary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Hepatosplenomegaly	Hepatobiliary disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Hydrocholecystis	Hepatobiliary disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Ischaemic hepatitis	Hepatobiliary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Jaundice cholestatic	Hepatobiliary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Liver disorder	Hepatobiliary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Liver injury	Hepatobiliary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Non-alcoholic fatty liver	Hepatobiliary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Non-alcoholic steatohepatitis	Hepatobiliary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Portal vein thrombosis	Hepatobiliary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Steatohepatitis	Hepatobiliary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Allergy to arthropod sting	Immune system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Anaphylactic reaction	Immune system disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Anaphylactic shock	Immune system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Contrast media allergy	Immune system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Drug hypersensitivity	Immune system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0022 affected2,170 at risk EG003
Hypersensitivity	Immune system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Abdominal abscess	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Abdominal infection	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Abdominal sepsis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Abscess intestinal	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Abscess jaw	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Abscess limb	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0004 affected2,263 at risk EG0011 affected2,285 at risk EG0023 affected2,170 at risk EG003
Abscess neck	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Abscess oral	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Abscess soft tissue	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Acute hepatitis B	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Acute sinusitis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Anal abscess	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
Appendicitis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0003 affected2,263 at risk EG0014 affected2,285 at risk EG0026 affected2,170 at risk EG003
Appendicitis perforated	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Arthritis bacterial	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Arthritis infective	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Atypical pneumonia	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0012 affected2,285 at risk EG0020 affected2,170 at risk EG003
Bacteraemia	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0003 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
Bacterial disease carrier	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Bacterial pyelonephritis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Bacterial sepsis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0012 affected2,285 at risk EG0020 affected2,170 at risk EG003
Bacteroides infection	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Bartholin's abscess	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Beta haemolytic streptococcal infection	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Bone abscess	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Bronchitis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG00010 affected2,263 at risk EG0019 affected2,285 at risk EG0026 affected2,170 at risk EG003
Bronchitis bacterial	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Bursitis infective	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
Bursitis infective staphylococcal	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Campylobacter gastroenteritis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Campylobacter infection	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Candida infection	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Carbuncle	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Cellulitis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG00029 affected2,263 at risk EG00132 affected2,285 at risk EG00219 affected2,170 at risk EG003
Cellulitis gangrenous	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Cellulitis of male external genital organ	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Cellulitis staphylococcal	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Central nervous system infection	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Chikungunya virus infection	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Cholangitis infective	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Cholecystitis infective	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Chorioretinitis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Chronic sinusitis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Chronic tonsillitis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Clostridial infection	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Clostridium difficile colitis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0003 affected2,263 at risk EG0011 affected2,285 at risk EG0024 affected2,170 at risk EG003
Clostridium difficile infection	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0011 affected2,285 at risk EG0022 affected2,170 at risk EG003
Colonic abscess	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Conjunctivitis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Corona virus infection	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Creutzfeldt-Jakob disease	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Cystitis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0010 affected2,285 at risk EG0023 affected2,170 at risk EG003
Dengue fever	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Device related infection	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0022 affected2,170 at risk EG003
Device related sepsis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Diabetic foot infection	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Diabetic gangrene	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Diarrhoea infectious	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
Diverticulitis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0008 affected2,263 at risk EG0019 affected2,285 at risk EG0028 affected2,170 at risk EG003
Ear infection	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Empyema	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Endocarditis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0011 affected2,285 at risk EG0022 affected2,170 at risk EG003
Endocarditis bacterial	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Enteritis infectious	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0023 affected2,170 at risk EG003
Epididymitis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Epiglottitis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Erysipelas	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0006 affected2,263 at risk EG00112 affected2,285 at risk EG0026 affected2,170 at risk EG003
Escherichia sepsis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0022 affected2,170 at risk EG003
Escherichia urinary tract infection	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
External ear cellulitis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Folliculitis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Fungal skin infection	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Furuncle	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Gallbladder abscess	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Gallbladder empyema	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Gangrene	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0011 affected2,285 at risk EG0025 affected2,170 at risk EG003
Gastritis viral	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0006 affected2,263 at risk EG0015 affected2,285 at risk EG0026 affected2,170 at risk EG003
Gastroenteritis clostridial	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Gastroenteritis rotavirus	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Gastroenteritis salmonella	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Gastroenteritis viral	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0010 affected2,285 at risk EG0022 affected2,170 at risk EG003
Gastrointestinal bacterial infection	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Gastrointestinal infection	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Gastrointestinal viral infection	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Groin infection	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Haematoma infection	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Haemophilus infection	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Haemophilus sepsis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Haemorrhagic pneumonia	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Helicobacter infection	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Hepatic amoebiasis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Hepatitis viral	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Herpes ophthalmic	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Herpes zoster	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Human ehrlichiosis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Hypopyon	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Implant site abscess	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Implant site infection	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0022 affected2,170 at risk EG003
Incision site cellulitis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Incision site infection	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Infected bite	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Infected cyst	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Infected skin ulcer	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
Infection	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Infectious colitis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Infectious pleural effusion	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0003 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0005 affected2,263 at risk EG0010 affected2,285 at risk EG0022 affected2,170 at risk EG003
Infective spondylitis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Influenza	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0004 affected2,263 at risk EG0016 affected2,285 at risk EG0022 affected2,170 at risk EG003
Intervertebral discitis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Joint abscess	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Labyrinthitis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Leptospirosis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Liver abscess	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Localised infection	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0012 affected2,285 at risk EG0023 affected2,170 at risk EG003
Lower respiratory tract infection	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0003 affected2,263 at risk EG0012 affected2,285 at risk EG0024 affected2,170 at risk EG003
Lung abscess	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Lung infection	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0010 affected2,285 at risk EG0023 affected2,170 at risk EG003
Lyme disease	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Lymphangitis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Malaria	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Mastoiditis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Mediastinitis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Medical device site infection	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Meningitis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Meningitis bacterial	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Meningococcal sepsis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Mesenteric abscess	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Metapneumovirus infection	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Muscle abscess	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Mycobacterial infection	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Mycobacterium avium complex infection	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Necrotising fasciitis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0012 affected2,285 at risk EG0021 affected2,170 at risk EG003
Neutropenic sepsis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Oesophageal candidiasis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Orchitis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0022 affected2,170 at risk EG003
Osteomyelitis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0004 affected2,263 at risk EG0013 affected2,285 at risk EG0023 affected2,170 at risk EG003
Osteomyelitis bacterial	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Osteomyelitis blastomyces	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Otitis externa	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0022 affected2,170 at risk EG003
Otitis media	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Otitis media acute	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Otitis media chronic	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Pancreatic abscess	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Parainfluenzae virus infection	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Parametritis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Paronychia	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Parotitis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Pelvic abscess	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Perichondritis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Perineal abscess	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Periodontitis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Periorbital cellulitis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0022 affected2,170 at risk EG003
Perirectal abscess	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Peritoneal abscess	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Peritonitis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0011 affected2,285 at risk EG0023 affected2,170 at risk EG003
Pharyngeal abscess	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Pharyngitis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Pharyngitis streptococcal	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Pilonidal cyst	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Pneumococcal sepsis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Pneumonia	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG00067 affected2,263 at risk EG00160 affected2,285 at risk EG00253 affected2,170 at risk EG003
Pneumonia bacterial	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Pneumonia escherichia	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Pneumonia haemophilus	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Pneumonia klebsiella	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Pneumonia legionella	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
Pneumonia necrotising	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Pneumonia pneumococcal	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Pneumonia pseudomonal	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Pneumonia staphylococcal	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Post procedural cellulitis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Post procedural infection	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0012 affected2,285 at risk EG0020 affected2,170 at risk EG003
Post procedural sepsis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Postoperative abscess	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Postoperative wound infection	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0012 affected2,285 at risk EG0022 affected2,170 at risk EG003
Proctitis infectious	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Propionibacterium infection	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Pseudomembranous colitis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0022 affected2,170 at risk EG003
Pseudomonal bacteraemia	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Pseudomonas bronchitis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Pseudomonas infection	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Psoas abscess	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Pulmonary sepsis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0012 affected2,285 at risk EG0022 affected2,170 at risk EG003
Pulmonary tuberculosis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0012 affected2,285 at risk EG0021 affected2,170 at risk EG003
Pyelitis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0003 affected2,263 at risk EG0011 affected2,285 at risk EG0022 affected2,170 at risk EG003
Pyelonephritis acute	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0015 affected2,285 at risk EG0021 affected2,170 at risk EG003
Pyoderma	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Pyuria	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Renal abscess	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0017 affected2,285 at risk EG0020 affected2,170 at risk EG003
Respiratory tract infection viral	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Rhinitis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Rubella	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Salmonellosis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Scrotal abscess	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Scrub typhus	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Sepsis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG00019 affected2,263 at risk EG00125 affected2,285 at risk EG00215 affected2,170 at risk EG003
Sepsis syndrome	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Septic embolus	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Septic necrosis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Septic shock	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0006 affected2,263 at risk EG0018 affected2,285 at risk EG0026 affected2,170 at risk EG003
Sialoadenitis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Sinusitis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0003 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Sinusitis fungal	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Staphylococcal abscess	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Staphylococcal bacteraemia	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Staphylococcal infection	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0011 affected2,285 at risk EG0022 affected2,170 at risk EG003
Staphylococcal mediastinitis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Staphylococcal sepsis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Streptococcal bacteraemia	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Streptococcal sepsis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Subcutaneous abscess	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0004 affected2,263 at risk EG0013 affected2,285 at risk EG0022 affected2,170 at risk EG003
Subdiaphragmatic abscess	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Subdural empyema	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Testicular abscess	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Tetanus	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Tonsillitis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Tooth abscess	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Tracheobronchitis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Tuberculosis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0022 affected2,170 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG00013 affected2,263 at risk EG00111 affected2,285 at risk EG00210 affected2,170 at risk EG003
Urinary tract infection bacterial	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0003 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Urinary tract infection enterococcal	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Urinary tract infection fungal	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Urinary tract infection pseudomonal	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Urosepsis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0004 affected2,263 at risk EG0014 affected2,285 at risk EG0025 affected2,170 at risk EG003
Vestibular neuronitis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Viral cardiomyopathy	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Viral diarrhoea	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Viral infection	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Viral upper respiratory tract infection	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Vulval abscess	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
Wound infection	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0013 affected2,285 at risk EG0024 affected2,170 at risk EG003
Wound infection bacterial	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Wound infection staphylococcal	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Wound sepsis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Abdominal injury	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Accident	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Accidental overdose	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Acetabulum fracture	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Alcohol poisoning	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Anaemia postoperative	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Anastomotic leak	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Animal bite	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Ankle fracture	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0005 affected2,263 at risk EG0010 affected2,285 at risk EG0023 affected2,170 at risk EG003
Arterial injury	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Arthropod sting	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Asbestosis	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Bone contusion	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Brain contusion	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Cardiac function disturbance postoperative	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Central cord syndrome	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
Chest injury	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Closed globe injury	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Comminuted fracture	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Concussion	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0011 affected2,285 at risk EG0023 affected2,170 at risk EG003
Coronary artery restenosis	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Dural tear	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Epicondylitis	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Face injury	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0003 affected2,263 at risk EG0011 affected2,285 at risk EG0022 affected2,170 at risk EG003
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0003 affected2,263 at risk EG0015 affected2,285 at risk EG0022 affected2,170 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0013 affected2,285 at risk EG0022 affected2,170 at risk EG003
Foot fracture	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Forearm fracture	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Foreign body	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Fracture displacement	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Gallbladder injury	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Gastrointestinal stoma complication	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Gastrointestinal stoma necrosis	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Gun shot wound	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Hand fracture	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Head injury	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
Hip fracture	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0012 affected2,285 at risk EG0023 affected2,170 at risk EG003
Humerus fracture	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
Incision site haemorrhage	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Incision site pain	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Incisional hernia	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0012 affected2,285 at risk EG0021 affected2,170 at risk EG003
Incisional hernia, obstructive	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Injury	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Intentional overdose	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Intentional product misuse	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Jaw fracture	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Joint dislocation	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0004 affected2,263 at risk EG0010 affected2,285 at risk EG0023 affected2,170 at risk EG003
Joint injury	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Laceration	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
Ligament injury	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Ligament rupture	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0022 affected2,170 at risk EG003
Ligament sprain	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
Limb injury	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0012 affected2,285 at risk EG0022 affected2,170 at risk EG003
Limb traumatic amputation	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0012 affected2,285 at risk EG0021 affected2,170 at risk EG003
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Meniscus injury	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0013 affected2,285 at risk EG0025 affected2,170 at risk EG003
Multiple fractures	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Multiple injuries	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Muscle contusion	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Muscle rupture	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Muscle strain	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0012 affected2,285 at risk EG0020 affected2,170 at risk EG003
Musculoskeletal foreign body	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Nerve injury	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Overdose	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0011 affected2,285 at risk EG0022 affected2,170 at risk EG003
Patella fracture	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0011 affected2,285 at risk EG0022 affected2,170 at risk EG003
Peripheral artery restenosis	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Periprosthetic fracture	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
Perirenal haematoma	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Pneumoconiosis	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Pneumothorax traumatic	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Post procedural complication	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Post procedural discharge	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Post procedural fever	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0003 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Postoperative hernia	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Postoperative wound complication	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0022 affected2,170 at risk EG003
Procedural complication	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Procedural intestinal perforation	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Procedural pain	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Pubis fracture	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Radiation mucositis	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Radius fracture	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0004 affected2,263 at risk EG0013 affected2,285 at risk EG0023 affected2,170 at risk EG003
Road traffic accident	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0004 affected2,263 at risk EG0011 affected2,285 at risk EG0022 affected2,170 at risk EG003
Scapula fracture	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Scratch	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Seroma	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Skeletal injury	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Skin laceration	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Skull fracture	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Spinal column injury	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0012 affected2,285 at risk EG0020 affected2,170 at risk EG003
Spinal cord injury	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Spinal cord injury cervical	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Spinal fracture	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Splenic rupture	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Stab wound	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Sternal fracture	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Stress fracture	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Subarachnoid haemorrhage	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0012 affected2,285 at risk EG0021 affected2,170 at risk EG003
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0014 affected2,285 at risk EG0024 affected2,170 at risk EG003
Subdural haemorrhage	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
Tendon injury	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Tendon rupture	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0004 affected2,263 at risk EG0012 affected2,285 at risk EG0020 affected2,170 at risk EG003
Thermal burn	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Tibia fracture	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Tooth fracture	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0010 affected2,285 at risk EG0022 affected2,170 at risk EG003
Tracheal haemorrhage	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Traumatic amputation	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Traumatic arthritis	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Traumatic haematoma	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Traumatic haemothorax	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Traumatic intracranial haemorrhage	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Ulna fracture	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0011 affected2,285 at risk EG0022 affected2,170 at risk EG003
Urinary retention postoperative	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Vascular graft complication	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Vascular pseudoaneurysm ruptured	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
Wound secretion	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Wrist fracture	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0012 affected2,285 at risk EG0021 affected2,170 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Anticoagulation drug level above therapeutic	Investigations	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Blood creatine phosphokinase MB increased	Investigations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Blood creatine phosphokinase increased	Investigations	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Blood creatinine increased	Investigations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Blood glucose increased	Investigations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Blood magnesium decreased	Investigations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Blood pressure increased	Investigations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Blood urine present	Investigations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Body mass index decreased	Investigations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Central venous pressure increased	Investigations	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Chest X-ray abnormal	Investigations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Clostridium test positive	Investigations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Ejection fraction decreased	Investigations	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
Haemoglobin decreased	Investigations	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Hepatic enzyme increased	Investigations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Human metapneumovirus test positive	Investigations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Imaging procedure abnormal	Investigations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
International normalised ratio decreased	Investigations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
International normalised ratio increased	Investigations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Liver function test abnormal	Investigations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Liver function test increased	Investigations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
N-terminal prohormone brain natriuretic peptide increased	Investigations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Oxygen saturation decreased	Investigations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Platelet count decreased	Investigations	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Quality of life decreased	Investigations	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Scan myocardial perfusion abnormal	Investigations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Troponin T increased	Investigations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Troponin increased	Investigations	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Volume blood decreased	Investigations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Weight decreased	Investigations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Weight increased	Investigations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
White blood cell count increased	Investigations	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Acidosis	Metabolism and nutrition disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Cachexia	Metabolism and nutrition disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA (21.1)	Systematic Assessment	EG0005 affected2,263 at risk EG0016 affected2,285 at risk EG0026 affected2,170 at risk EG003
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA (21.1)	Systematic Assessment	EG0003 affected2,263 at risk EG00110 affected2,285 at risk EG0021 affected2,170 at risk EG003
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0011 affected2,285 at risk EG0027 affected2,170 at risk EG003
Diabetes with hyperosmolarity	Metabolism and nutrition disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Diabetic complication	Metabolism and nutrition disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0012 affected2,285 at risk EG0021 affected2,170 at risk EG003
Diabetic metabolic decompensation	Metabolism and nutrition disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
Fluid overload	Metabolism and nutrition disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Gout	Metabolism and nutrition disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Hyperammonaemia	Metabolism and nutrition disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Hyperchloraemia	Metabolism and nutrition disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (21.1)	Systematic Assessment	EG0003 affected2,263 at risk EG0014 affected2,285 at risk EG0023 affected2,170 at risk EG003
Hyperglycaemic hyperosmolar nonketotic syndrome	Metabolism and nutrition disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (21.1)	Systematic Assessment	EG0003 affected2,263 at risk EG0014 affected2,285 at risk EG0023 affected2,170 at risk EG003
Hypermagnesaemia	Metabolism and nutrition disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (21.1)	Systematic Assessment	EG0004 affected2,263 at risk EG0014 affected2,285 at risk EG0023 affected2,170 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0011 affected2,285 at risk EG0023 affected2,170 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0012 affected2,285 at risk EG0024 affected2,170 at risk EG003
Hypovolaemia	Metabolism and nutrition disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0022 affected2,170 at risk EG003
Insulin resistant diabetes	Metabolism and nutrition disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Insulin-requiring type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Ketoacidosis	Metabolism and nutrition disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Lactic acidosis	Metabolism and nutrition disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Malnutrition	Metabolism and nutrition disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0012 affected2,285 at risk EG0022 affected2,170 at risk EG003
Obesity	Metabolism and nutrition disorders	MedDRA (21.1)	Systematic Assessment	EG0005 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
Type 1 diabetes mellitus	Metabolism and nutrition disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA (21.1)	Systematic Assessment	EG0003 affected2,263 at risk EG0012 affected2,285 at risk EG0021 affected2,170 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0015 affected2,285 at risk EG0022 affected2,170 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Arthritis reactive	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Arthropathy	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0004 affected2,263 at risk EG0018 affected2,285 at risk EG0025 affected2,170 at risk EG003
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0022 affected2,170 at risk EG003
Cervical spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Chondromalacia	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Chondropathy	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Compartment syndrome	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Costochondritis	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Dactylitis	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Dupuytren's contracture	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Exostosis	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Fasciitis	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Finger deformity	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
Fracture malunion	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Gouty arthritis	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Gouty tophus	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Haemarthrosis	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0012 affected2,285 at risk EG0020 affected2,170 at risk EG003
Immunoglobulin G4 related disease	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Intervertebral disc calcification	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Intervertebral disc compression	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0011 affected2,285 at risk EG0022 affected2,170 at risk EG003
Intervertebral disc disorder	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Intervertebral disc displacement	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0004 affected2,263 at risk EG0012 affected2,285 at risk EG0026 affected2,170 at risk EG003
Jaw cyst	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Joint instability	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0014 affected2,285 at risk EG0021 affected2,170 at risk EG003
Meniscal degeneration	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Metatarsalgia	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Muscle atrophy	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Muscle haemorrhage	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Muscle swelling	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0003 affected2,263 at risk EG0013 affected2,285 at risk EG0025 affected2,170 at risk EG003
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0012 affected2,285 at risk EG0020 affected2,170 at risk EG003
Myofascial pain syndrome	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Neuropathic arthropathy	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
Osteitis	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG00019 affected2,263 at risk EG00121 affected2,285 at risk EG00218 affected2,170 at risk EG003
Osteochondrosis	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0012 affected2,285 at risk EG0020 affected2,170 at risk EG003
Osteolysis	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Osteoporosis	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Osteoporotic fracture	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0005 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Pathological fracture	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Polyarthritis	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Polymyalgia rheumatica	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0011 affected2,285 at risk EG0022 affected2,170 at risk EG003
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0023 affected2,170 at risk EG003
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0010 affected2,285 at risk EG0022 affected2,170 at risk EG003
Shoulder deformity	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Soft tissue mass	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0006 affected2,263 at risk EG0012 affected2,285 at risk EG0024 affected2,170 at risk EG003
Spinal deformity	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0012 affected2,285 at risk EG0021 affected2,170 at risk EG003
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0003 affected2,263 at risk EG0012 affected2,285 at risk EG0023 affected2,170 at risk EG003
Spondylitis	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0022 affected2,170 at risk EG003
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Synovitis	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Tenosynovitis	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0022 affected2,170 at risk EG003
Trigger finger	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Vertebral foraminal stenosis	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Vertebral wedging	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Abdominal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Acute leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0023 affected2,170 at risk EG003
Adenocarcinoma gastric	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0012 affected2,285 at risk EG0022 affected2,170 at risk EG003
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0003 affected2,263 at risk EG0011 affected2,285 at risk EG0022 affected2,170 at risk EG003
Adenocarcinoma pancreas	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Adenoma benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Adenosquamous cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Adrenal adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Adrenal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Angiolipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Angiosarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG00014 affected2,263 at risk EG00118 affected2,285 at risk EG00218 affected2,170 at risk EG003
Benign cardiac neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Benign gastric neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Benign lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Benign neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Benign neoplasm of bladder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Benign neoplasm of scrotum	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Benign neoplasm of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Benign salivary gland neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Benign small intestinal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Benign urinary tract neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Bile duct cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0005 affected2,263 at risk EG0015 affected2,285 at risk EG0023 affected2,170 at risk EG003
Bladder neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Bladder papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0003 affected2,263 at risk EG0012 affected2,285 at risk EG0022 affected2,170 at risk EG003
Bone cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Bone cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Bowen's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0003 affected2,263 at risk EG0011 affected2,285 at risk EG0022 affected2,170 at risk EG003
Brain neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Brain neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0012 affected2,285 at risk EG0020 affected2,170 at risk EG003
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0004 affected2,263 at risk EG0010 affected2,285 at risk EG0025 affected2,170 at risk EG003
Breast cancer female	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Breast cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Brenner tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Carcinoid tumour of the gastrointestinal tract	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Cervix carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Cholangiocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0012 affected2,285 at risk EG0021 affected2,170 at risk EG003
Chronic lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Clear cell renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
Colon adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0003 affected2,263 at risk EG0014 affected2,285 at risk EG0025 affected2,170 at risk EG003
Colon neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Colorectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Colorectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Diffuse large B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Diffuse large B-cell lymphoma stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Ductal adenocarcinoma of pancreas	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Endometrial adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Endometrial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Endometrial cancer stage III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Extranodal marginal zone B-cell lymphoma (MALT type)	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Fibroma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Fibrous histiocytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Gallbladder adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Gastric adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0005 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
Gastrointestinal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0022 affected2,170 at risk EG003
Gastrointestinal tract adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Glioblastoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Glioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Haemangioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Hepatic cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
Hepatic cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Hepatic cancer stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Hepatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Hepatocellular carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0012 affected2,285 at risk EG0021 affected2,170 at risk EG003
Hodgkin's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Hypergammaglobulinaemia benign monoclonal	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Inflammatory pseudotumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Intestinal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
Intraductal proliferative breast lesion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
Invasive breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Keratoacanthoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Large intestine benign neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Laryngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Laryngeal squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Lentigo maligna	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Lip and/or oral cavity cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0012 affected2,285 at risk EG0020 affected2,170 at risk EG003
Lip squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Liposarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0013 affected2,285 at risk EG0023 affected2,170 at risk EG003
Lung adenocarcinoma stage III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Lung adenocarcinoma stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0012 affected2,285 at risk EG0020 affected2,170 at risk EG003
Lung carcinoma cell type unspecified recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Lung carcinoma cell type unspecified stage III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0004 affected2,263 at risk EG0019 affected2,285 at risk EG0029 affected2,170 at risk EG003
Lung squamous cell carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0012 affected2,285 at risk EG0020 affected2,170 at risk EG003
Lymphoproliferative disorder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Malignant fibrous histiocytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Malignant mediastinal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0015 affected2,285 at risk EG0023 affected2,170 at risk EG003
Malignant melanoma in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0010 affected2,285 at risk EG0022 affected2,170 at risk EG003
Malignant neoplasm of pleura	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Malignant neoplasm of unknown primary site	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Malignant peritoneal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
Malignant pleural effusion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Mantle cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Medullary thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Meningioma benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Metastases to adrenals	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0022 affected2,170 at risk EG003
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0012 affected2,285 at risk EG0021 affected2,170 at risk EG003
Metastases to kidney	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0015 affected2,285 at risk EG0021 affected2,170 at risk EG003
Metastases to lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0012 affected2,285 at risk EG0025 affected2,170 at risk EG003
Metastases to lymph nodes	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0022 affected2,170 at risk EG003
Metastases to pelvis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Metastases to pleura	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Metastases to rectum	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Metastases to spine	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
Metastatic bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Metastatic malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Metastatic renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0012 affected2,285 at risk EG0020 affected2,170 at risk EG003
Metastatic squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Monoclonal gammopathy	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
Mucinous adenocarcinoma of appendix	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Mycosis fungoides	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Myelofibrosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Nasal cavity cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Neoplasm skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Neuroendocrine breast tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Neuroendocrine carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Non-Hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Non-Hodgkin's lymphoma refractory	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0011 affected2,285 at risk EG0023 affected2,170 at risk EG003
Non-small cell lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Non-small cell lung cancer stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Oesophageal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0012 affected2,285 at risk EG0021 affected2,170 at risk EG003
Oesophageal adenocarcinoma stage II	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Oesophageal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Oesophageal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0024 affected2,170 at risk EG003
Oesophageal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Oesophageal squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Oligodendroglioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Oropharyngeal squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Ovarian adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Ovarian cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Ovarian neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0014 affected2,285 at risk EG0023 affected2,170 at risk EG003
Pancreatic carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Papillary cystadenoma lymphomatosum	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Papillary renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Papillary thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
Parathyroid tumour benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Penile cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Phaeochromocytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Pharyngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Pituitary tumour benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Pleomorphic adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Polycythaemia vera	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG00012 affected2,263 at risk EG00110 affected2,285 at risk EG00210 affected2,170 at risk EG003
Prostate cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
Prostate cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Prostatic adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Rectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
Rectal adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0004 affected2,263 at risk EG0012 affected2,285 at risk EG0022 affected2,170 at risk EG003
Rectal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Rectosigmoid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0012 affected2,285 at risk EG0023 affected2,170 at risk EG003
Renal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0011 affected2,285 at risk EG0025 affected2,170 at risk EG003
Renal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Renal oncocytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
Rosai-Dorfman syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Salivary gland adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Salivary gland neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Seborrhoeic keratosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Skin cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Small cell lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Small intestine adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Small intestine carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Small intestine carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG00012 affected2,263 at risk EG0015 affected2,285 at risk EG0026 affected2,170 at risk EG003
Squamous cell carcinoma of lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0015 affected2,285 at risk EG0020 affected2,170 at risk EG003
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0003 affected2,263 at risk EG0012 affected2,285 at risk EG0021 affected2,170 at risk EG003
Squamous cell carcinoma of the hypopharynx	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Squamous cell carcinoma of the tongue	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Superficial spreading melanoma stage II	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Testis cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Throat cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Thyroid cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Thyroid neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Tongue neoplasm malignant stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Tonsil cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Transitional cell carcinoma urethra	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Tumour perforation	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Uterine cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0022 affected2,170 at risk EG003
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Amnesia	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Amyotrophic lateral sclerosis	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Aphasia	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Apraxia	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Ataxia	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Balance disorder	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Brain injury	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0013 affected2,285 at risk EG0020 affected2,170 at risk EG003
Brain oedema	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Carotid arteriosclerosis	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Carotid artery aneurysm	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Carotid artery disease	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Carotid artery occlusion	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
Carotid artery stenosis	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0003 affected2,263 at risk EG0010 affected2,285 at risk EG0022 affected2,170 at risk EG003
Carpal tunnel syndrome	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Cauda equina syndrome	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Cerebellar infarction	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Cerebellar stroke	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Cerebral arteriosclerosis	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Cerebral haemorrhage	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Cerebral infarction	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Cerebral ischaemia	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
Cervical myelopathy	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Cervical radiculopathy	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Cervicobrachial syndrome	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Cognitive disorder	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Coma	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Dementia	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Dementia Alzheimer's type	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Dementia with Lewy bodies	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Depressed level of consciousness	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Diabetic coma	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Diabetic neuropathy	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Diplegia	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Dizziness	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0006 affected2,263 at risk EG0012 affected2,285 at risk EG0023 affected2,170 at risk EG003
Dysaesthesia	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Dysarthria	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Dystonia	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Embolic stroke	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Encephalopathy	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Epilepsy	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0012 affected2,285 at risk EG0021 affected2,170 at risk EG003
Facial paralysis	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Focal dyscognitive seizures	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Generalised tonic-clonic seizure	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Guillain-Barre syndrome	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Haemorrhage intracranial	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Haemorrhagic stroke	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Haemorrhagic transformation stroke	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Headache	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0004 affected2,263 at risk EG0013 affected2,285 at risk EG0023 affected2,170 at risk EG003
Hemiparesis	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Hydrocephalus	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Hypersomnia	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Hypertensive encephalopathy	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Hypoaesthesia	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Hypoglycaemic coma	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Hypoglycaemic encephalopathy	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Hypoxic-ischaemic encephalopathy	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
IIIrd nerve paresis	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Intracranial aneurysm	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Intracranial pressure increased	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Ischaemic stroke	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Lacunar infarction	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Lacunar stroke	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Loss of consciousness	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0013 affected2,285 at risk EG0020 affected2,170 at risk EG003
Lumbar radiculopathy	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Lumbosacral radiculopathy	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Mental impairment	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Metabolic encephalopathy	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Migraine	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Mixed dementia	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Nerve compression	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Neuralgia	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Neuropathy peripheral	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Normal pressure hydrocephalus	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Optic neuritis	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Orthostatic intolerance	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Paralysis	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Paresis	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Partial seizures	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Peripheral nerve lesion	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Polyneuropathy	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Post herpetic neuralgia	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Post stroke seizure	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Presyncope	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0011 affected2,285 at risk EG0022 affected2,170 at risk EG003
Restless legs syndrome	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Sciatica	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0025 affected2,170 at risk EG003
Seizure	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0003 affected2,263 at risk EG0012 affected2,285 at risk EG0021 affected2,170 at risk EG003
Sensory disturbance	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Spinal claudication	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Spinal cord compression	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Spinal cord infarction	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Spondylitic myelopathy	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0012 affected2,285 at risk EG0020 affected2,170 at risk EG003
Status epilepticus	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Stupor	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Subdural hygroma	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Syncope	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG00015 affected2,263 at risk EG00117 affected2,285 at risk EG00216 affected2,170 at risk EG003
Tension headache	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Thalamic infarction	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Thrombotic cerebral infarction	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Tonic convulsion	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Toxic encephalopathy	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Transient global amnesia	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Trigeminal neuralgia	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Upper motor neurone lesion	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
VIth nerve paralysis	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Vascular dementia	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Vascular encephalopathy	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0012 affected2,285 at risk EG0020 affected2,170 at risk EG003
Vertebrobasilar insufficiency	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Device battery issue	Product Issues	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0010 affected2,285 at risk EG0022 affected2,170 at risk EG003
Device dislocation	Product Issues	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0022 affected2,170 at risk EG003
Device end of service	Product Issues	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
Device failure	Product Issues	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Device inappropriate shock delivery	Product Issues	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Device issue	Product Issues	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Device lead damage	Product Issues	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Device lead issue	Product Issues	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Device loosening	Product Issues	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Device malfunction	Product Issues	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0012 affected2,285 at risk EG0021 affected2,170 at risk EG003
Device occlusion	Product Issues	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Device signal detection issue	Product Issues	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Lead dislodgement	Product Issues	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Acute stress disorder	Psychiatric disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Adjustment disorder	Psychiatric disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Affective disorder	Psychiatric disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Alcoholic psychosis	Psychiatric disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Alcoholism	Psychiatric disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Anxiety	Psychiatric disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
Anxiety disorder	Psychiatric disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Anxiety disorder due to a general medical condition	Psychiatric disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Bipolar I disorder	Psychiatric disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Bipolar disorder	Psychiatric disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Burnout syndrome	Psychiatric disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Completed suicide	Psychiatric disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Confusional state	Psychiatric disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Conversion disorder	Psychiatric disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Delirium	Psychiatric disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0012 affected2,285 at risk EG0021 affected2,170 at risk EG003
Delirium tremens	Psychiatric disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Depression	Psychiatric disorders	MedDRA (21.1)	Systematic Assessment	EG0007 affected2,263 at risk EG0014 affected2,285 at risk EG0022 affected2,170 at risk EG003
Dissociative amnesia	Psychiatric disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Drug use disorder	Psychiatric disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Generalised anxiety disorder	Psychiatric disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Hallucination, visual	Psychiatric disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Head banging	Psychiatric disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Homicidal ideation	Psychiatric disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Insomnia	Psychiatric disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Intentional self-injury	Psychiatric disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Major depression	Psychiatric disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
Mental status changes	Psychiatric disorders	MedDRA (21.1)	Systematic Assessment	EG0004 affected2,263 at risk EG0010 affected2,285 at risk EG0022 affected2,170 at risk EG003
Panic attack	Psychiatric disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Personality change	Psychiatric disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Psychotic disorder	Psychiatric disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0012 affected2,285 at risk EG0020 affected2,170 at risk EG003
Psychotic disorder due to a general medical condition	Psychiatric disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Restlessness	Psychiatric disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Schizophrenia	Psychiatric disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0022 affected2,170 at risk EG003
Somnambulism	Psychiatric disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Suicidal ideation	Psychiatric disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Suicide attempt	Psychiatric disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
Acute kidney injury	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG00020 affected2,263 at risk EG00130 affected2,285 at risk EG00216 affected2,170 at risk EG003
Acute prerenal failure	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Anuria	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Azotaemia	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Calculus bladder	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Calculus urethral	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Calculus urinary	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Chronic kidney disease	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0004 affected2,263 at risk EG0015 affected2,285 at risk EG0024 affected2,170 at risk EG003
Diabetic nephropathy	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
End stage renal disease	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Focal segmental glomerulosclerosis	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Glomerulonephritis membranous	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0005 affected2,263 at risk EG0016 affected2,285 at risk EG0023 affected2,170 at risk EG003
Hydronephrosis	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0013 affected2,285 at risk EG0021 affected2,170 at risk EG003
Hypertensive nephropathy	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Lower urinary tract symptoms	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0003 affected2,263 at risk EG0012 affected2,285 at risk EG0024 affected2,170 at risk EG003
Nephrotic syndrome	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Obstructive uropathy	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Pollakiuria	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Polyuria	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Prerenal failure	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Renal artery stenosis	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Renal artery thrombosis	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
Renal colic	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0012 affected2,285 at risk EG0020 affected2,170 at risk EG003
Renal cyst	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0007 affected2,263 at risk EG00110 affected2,285 at risk EG00211 affected2,170 at risk EG003
Renal haematoma	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Renal impairment	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0014 affected2,285 at risk EG0023 affected2,170 at risk EG003
Renal injury	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Renal mass	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Renal tubular necrosis	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Stress urinary incontinence	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Tubulointerstitial nephritis	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Ureteric obstruction	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Ureteric stenosis	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Ureterolithiasis	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0011 affected2,285 at risk EG0022 affected2,170 at risk EG003
Urethral obstruction	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Urinary bladder haemorrhage	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Urinary bladder polyp	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Urinary incontinence	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0004 affected2,263 at risk EG0014 affected2,285 at risk EG0023 affected2,170 at risk EG003
Urinary tract obstruction	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
Vesicocutaneous fistula	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Balanoposthitis	Reproductive system and breast disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA (21.1)	Systematic Assessment	EG0005 affected2,263 at risk EG0016 affected2,285 at risk EG0025 affected2,170 at risk EG003
Cystocele	Reproductive system and breast disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Dysmenorrhoea	Reproductive system and breast disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Endometrial hyperplasia	Reproductive system and breast disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Epididymal cyst	Reproductive system and breast disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Erectile dysfunction	Reproductive system and breast disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Female genital tract fistula	Reproductive system and breast disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Genital atrophy	Reproductive system and breast disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Genital prolapse	Reproductive system and breast disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Menorrhagia	Reproductive system and breast disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Ovarian cyst	Reproductive system and breast disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Pelvic pain	Reproductive system and breast disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Postmenopausal haemorrhage	Reproductive system and breast disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Prostatic haemorrhage	Reproductive system and breast disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Prostatic mass	Reproductive system and breast disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Prostatism	Reproductive system and breast disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
Prostatitis	Reproductive system and breast disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0010 affected2,285 at risk EG0022 affected2,170 at risk EG003
Prostatomegaly	Reproductive system and breast disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0012 affected2,285 at risk EG0021 affected2,170 at risk EG003
Rectocele	Reproductive system and breast disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Spermatocele	Reproductive system and breast disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Uterine cervix stenosis	Reproductive system and breast disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Uterine prolapse	Reproductive system and breast disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Varicocele	Reproductive system and breast disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Varicose veins pelvic	Reproductive system and breast disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0013 affected2,285 at risk EG0024 affected2,170 at risk EG003
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG00010 affected2,263 at risk EG0017 affected2,285 at risk EG00211 affected2,170 at risk EG003
Alveolitis	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Alveolitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Asphyxia	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0007 affected2,263 at risk EG0012 affected2,285 at risk EG0020 affected2,170 at risk EG003
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0003 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Bronchial hyperreactivity	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Bronchial obstruction	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Bronchiectasis	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Bronchitis chronic	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Cheyne-Stokes respiration	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG00028 affected2,263 at risk EG00121 affected2,285 at risk EG00216 affected2,170 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG00014 affected2,263 at risk EG0018 affected2,285 at risk EG00210 affected2,170 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
Dyspnoea paroxysmal nocturnal	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Emphysema	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0003 affected2,263 at risk EG0012 affected2,285 at risk EG0022 affected2,170 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Hydrothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Hypopnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0003 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
Idiopathic interstitial pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Idiopathic pneumonia syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Idiopathic pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0003 affected2,263 at risk EG0011 affected2,285 at risk EG0022 affected2,170 at risk EG003
Laryngeal oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Laryngospasm	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Lung consolidation	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Lung hernia	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Nasal obstruction	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Nasal polyps	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
Nasal turbinate hypertrophy	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Obstructive airways disorder	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Organising pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Pickwickian syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Pleural adhesion	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0008 affected2,263 at risk EG0015 affected2,285 at risk EG0024 affected2,170 at risk EG003
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0013 affected2,285 at risk EG0020 affected2,170 at risk EG003
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Pneumomediastinum	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0014 affected2,285 at risk EG0020 affected2,170 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0005 affected2,263 at risk EG0012 affected2,285 at risk EG0020 affected2,170 at risk EG003
Pneumothorax spontaneous	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Pulmonary alveolar haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Pulmonary arterial hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0012 affected2,285 at risk EG0020 affected2,170 at risk EG003
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0003 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Pulmonary haematoma	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0013 affected2,285 at risk EG0020 affected2,170 at risk EG003
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0012 affected2,285 at risk EG0021 affected2,170 at risk EG003
Pulmonary microemboli	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0004 affected2,263 at risk EG0014 affected2,285 at risk EG0021 affected2,170 at risk EG003
Pulmonary sarcoidosis	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Respiratory alkalosis	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0012 affected2,285 at risk EG0020 affected2,170 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG00012 affected2,263 at risk EG00111 affected2,285 at risk EG0029 affected2,170 at risk EG003
Respiratory tract inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Respiratory tract irritation	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Sinus polyp	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0012 affected2,285 at risk EG0020 affected2,170 at risk EG003
Status asthmaticus	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Vocal cord leukoplakia	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Acne	Skin and subcutaneous tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Actinic keratosis	Skin and subcutaneous tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Angioedema	Skin and subcutaneous tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0012 affected2,285 at risk EG0020 affected2,170 at risk EG003
Blister	Skin and subcutaneous tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Brow ptosis	Skin and subcutaneous tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
Dermatitis allergic	Skin and subcutaneous tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0016 affected2,285 at risk EG0021 affected2,170 at risk EG003
Eczema	Skin and subcutaneous tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0012 affected2,285 at risk EG0020 affected2,170 at risk EG003
Hyperkeratosis	Skin and subcutaneous tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Hypersensitivity vasculitis	Skin and subcutaneous tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Neurodermatitis	Skin and subcutaneous tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Prurigo	Skin and subcutaneous tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Pruritus allergic	Skin and subcutaneous tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0022 affected2,170 at risk EG003
Rhinophyma	Skin and subcutaneous tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0015 affected2,285 at risk EG0025 affected2,170 at risk EG003
Stasis dermatitis	Skin and subcutaneous tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Stevens-Johnson syndrome	Skin and subcutaneous tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Subcutaneous emphysema	Skin and subcutaneous tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Homicide	Social circumstances	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Accelerated hypertension	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Aneurysm ruptured	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Angiodysplasia	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Aortic aneurysm	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0008 affected2,263 at risk EG0014 affected2,285 at risk EG0026 affected2,170 at risk EG003
Aortic aneurysm rupture	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Aortic dissection	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Aortic stenosis	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0022 affected2,170 at risk EG003
Aortitis	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Arterial haemorrhage	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Arterial insufficiency	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Arteriosclerosis	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Arteriovenous fistula	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Arteritis	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Brachiocephalic artery stenosis	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Circulatory collapse	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0003 affected2,263 at risk EG0011 affected2,285 at risk EG0023 affected2,170 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Embolism	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Embolism arterial	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Embolism venous	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Essential hypertension	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Extremity necrosis	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
Femoral artery aneurysm	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Femoral artery embolism	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Haematoma	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0013 affected2,285 at risk EG0021 affected2,170 at risk EG003
Haemodynamic instability	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Haemorrhage	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Hypertension	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG00010 affected2,263 at risk EG0018 affected2,285 at risk EG0028 affected2,170 at risk EG003
Hypertensive crisis	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0007 affected2,263 at risk EG0015 affected2,285 at risk EG0022 affected2,170 at risk EG003
Hypertensive emergency	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0012 affected2,285 at risk EG0021 affected2,170 at risk EG003
Hypotension	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0008 affected2,263 at risk EG0015 affected2,285 at risk EG0024 affected2,170 at risk EG003
Hypovolaemic shock	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Intermittent claudication	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Internal haemorrhage	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Ischaemic limb pain	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Lymphatic fistula	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Lymphorrhoea	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Malignant hypertension	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Orthostatic hypertension	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Orthostatic hypotension	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0013 affected2,285 at risk EG0021 affected2,170 at risk EG003
Pallor	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Peripheral arterial occlusive disease	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0003 affected2,263 at risk EG0014 affected2,285 at risk EG0022 affected2,170 at risk EG003
Peripheral artery aneurysm	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Peripheral artery occlusion	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0013 affected2,285 at risk EG0022 affected2,170 at risk EG003
Peripheral artery stenosis	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0012 affected2,285 at risk EG0021 affected2,170 at risk EG003
Peripheral artery thrombosis	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0012 affected2,285 at risk EG0021 affected2,170 at risk EG003
Peripheral embolism	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Peripheral ischaemia	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Peripheral vascular disorder	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0013 affected2,285 at risk EG0022 affected2,170 at risk EG003
Peripheral venous disease	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Shock	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Shock haemorrhagic	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Temporal arteritis	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0021 affected2,170 at risk EG003
Thrombophlebitis	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0020 affected2,170 at risk EG003
Thrombophlebitis superficial	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Thrombosis	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Varicose ulceration	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Varicose vein	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0011 affected2,285 at risk EG0021 affected2,170 at risk EG003
Vascular insufficiency	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003
Venous thrombosis limb	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected2,263 at risk EG0010 affected2,285 at risk EG0020 affected2,170 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Angina pectoris	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG000142 affected2,263 at risk EG001164 affected2,285 at risk EG002129 affected2,170 at risk EG003228 affected3,348 at risk EG004115 affected5,777 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG000138 affected2,263 at risk EG001146 affected2,285 at risk EG002137 affected2,170 at risk EG003
Fatigue	General disorders	MedDRA (21.1)	Systematic Assessment	EG000113 affected2,263 at risk EG00199 affected2,285 at risk EG00284 affected2,170 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA (21.1)	Systematic Assessment	EG000142 affected2,263 at risk EG001143 affected2,285 at risk EG002111 affected2,170 at risk EG003
Oedema peripheral	General disorders	MedDRA (21.1)	Systematic Assessment	EG000136 affected2,263 at risk EG001142 affected2,285 at risk EG002134 affected2,170 at risk EG003
Bronchitis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG000131 affected2,263 at risk EG001162 affected2,285 at risk EG002114 affected2,170 at risk EG003
Influenza	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG000141 affected2,263 at risk EG001145 affected2,285 at risk EG002118 affected2,170 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG000153 affected2,263 at risk EG001156 affected2,285 at risk EG002134 affected2,170 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG000126 affected2,263 at risk EG001129 affected2,285 at risk EG00293 affected2,170 at risk EG003
Viral upper respiratory tract infection	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG000264 affected2,263 at risk EG001297 affected2,285 at risk EG002263 affected2,170 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG000165 affected2,263 at risk EG001181 affected2,285 at risk EG002144 affected2,170 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG000169 affected2,263 at risk EG001177 affected2,285 at risk EG002157 affected2,170 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG000145 affected2,263 at risk EG001145 affected2,285 at risk EG00298 affected2,170 at risk EG003
Dizziness	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG000114 affected2,263 at risk EG001126 affected2,285 at risk EG002132 affected2,170 at risk EG003
Headache	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG000133 affected2,263 at risk EG001111 affected2,285 at risk EG002120 affected2,170 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG000151 affected2,263 at risk EG001152 affected2,285 at risk EG002121 affected2,170 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG000126 affected2,263 at risk EG001123 affected2,285 at risk EG002110 affected2,170 at risk EG003
Hypertension	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG000198 affected2,263 at risk EG001216 affected2,285 at risk EG002208 affected2,170 at risk EG003

ID	Term
D050197	Atherosclerosis
D009203	Myocardial Infarction
D020521	Stroke

ID	Term
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D017202	Myocardial Ischemia
D006331	Heart Diseases
D007238	Infarction
D007511	Ischemia
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009336	Necrosis
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

ID	Term
D019984	Quality Indicators, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration
D017530	Health Care Quality, Access, and Evaluation