Cardiovascular Outcomes Study of Alogliptin in Patients W... | NCT00968708

NCT00968708

Secondary IDs

ID	Type	Description
U1111-1111-6825	Registry Identifier	WHO
2009-011222-34	Registry Identifier	EudraCT
JapicCTI-101246	Registry Identifier	JapicCTI
DOH-27-0310-3047	Registry Identifier	SANCTR
09/H0709/63	Registry Identifier	NRES
CTRI/2010/091/000046	Registry Identifier	CTRI
2009-011222-34	Registry Identifier	REPEC
2009-011222-34	Registry Identifier	OsSC
NMRR-09-872-4471	Registry Identifier	NMRR

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Experimental	Alogliptin placebo matching tablets, orally, once daily. Participants continued to receive standard of care for cardiovascular disease and diabetes according to regional guidelines.	Drug: Placebo
Alogliptin	Experimental	Alogliptin 25 mg, tablets, orally, once daily for participants with normal or mildly impaired renal function as defined by estimated glomerular filtration rate (eGFR) ≥ 60 mL/min). Alogliptin 12.5 mg, tablets, orally, once daily for participants with moderately impaired renal function (eGFR ≥30 and <60 mL/min). Alogliptin 6.25 mg, tablets, orally, once daily for participants with severely impaired renal function or end stage renal disease (eGFR <30 mL/min). Participants continued to receive standard of care for cardiovascular disease and diabetes according to regional guidelines.	Drug: Alogliptin

Name	Type	Description	Arm Group Labels	Other Names
Alogliptin	Drug	Alogliptin tablets	Alogliptin	Nesina®

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Primary Major Adverse Cardiac Events (MACE)	Primary Major Adverse Cardiac Events were defined as a composite of cardiovascular death, nonfatal myocardial infarction and nonfatal stroke; these events were adjudicated by an independent cardiovascular endpoints committee.	From randomization until the adjudication cut-off date of May 31 2013 (maximum time on study was 41 months).

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Secondary Major Adverse Cardiac Events (MACE)	Secondary MACE composite consisted of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or urgent revascularization due to unstable angina; these events were adjudicated by an independent cardiovascular endpoint committee.	From randomization until the adjudication cut-of date of May 31 2013 (maximum time on study was 41 months).

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Medical Director Clinical Science	Takeda	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34872085	Derived	Ferreira JP, Rossignol P, Bakris G, Mehta C, White WB, Zannad F. Blood and Urine Biomarkers Predicting Worsening Kidney Function in Patients with Type 2 Diabetes Post-Acute Coronary Syndrome: An Analysis from the EXAMINE Trial. Am J Nephrol. 2021;52(12):969-976. doi: 10.1159/000519436. Epub 2021 Dec 6.
32493335	Derived

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo	Alogliptin placebo matching tablets, orally, once daily. Participants continued to receive standard of care for cardiovascular disease and diabetes according to regional guidelines.
FG001	Alogliptin

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Alogliptin 25 mg, tablets, orally, once daily for participants with normal or mildly impaired renal function as defined by estimated glomerular filtration rate (eGFR) ≥ 60 mL/min). Alogliptin 12.5 mg, tablets, orally, once daily for participants with moderately impaired renal function (eGFR ≥30 and <60 mL/min). Alogliptin 6.25 mg, tablets, orally, once daily for participants with severely impaired renal function or end stage renal disease (eGFR <30 mL/min). Participants continued to receive standard of care for cardiovascular disease and diabetes according to regional guidelines.

Arm/Group Information

ID	Title	Description
BG000	Placebo	Alogliptin placebo matching tablets, orally, once daily.
BG001	Alogliptin	Alogliptin 25 mg, tablets, orally, once daily for participants with normal or mildly impaired renal function as defined by estimated glomerular filtration rate (eGFR) ≥ 60 mL/min). Alogliptin 12.5 mg, tablets, orally, once daily for participants with moderately impaired renal function (eGFR ≥30 and <60 mL/min). Alogliptin 6.25 mg, tablets, orally, once daily for participants with severely impaired renal function or end stage renal disease (eGFR <30 mL/min).
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00060.7± 9.88 BG00161.0± 9.96 BG00260.9± 9.92

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000856 BG001873 BG002

Race/Ethnicity, Customized

Number

participants

Title

Denominators

Categories

American Indian or Alaska Native

Title	Measurements
	BG00054 BG00156 BG002

Race/Ethnicity, Customized

Number

participants

Title

Denominators

Categories

Hispanic or Latino

Title	Measurements
	BG000764 BG001773 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

Argentina

Title	Measurements
	BG000136 BG001136 BG002

Body Mass Index

Mean

Standard Deviation

kg/m^2

Title

Denominators

Categories

Title	Measurements
	BG00029.53± 5.758 BG00129.42± 5.422 BG002

Duration of Type 2 Diabetes Mellitus

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG0009.18± 8.121 BG0019.13± 8.198 BG002

Smoking History

Number

participants

Title

Denominators

Categories

Never smoked

Title	Measurements
	BG0001144 BG0011158 BG002

Estimated Glomerular Filtration Rate (eGFR)

Calculated using the Modification of Diet in Renal Disease (MDRD) formula

Mean

Standard Deviation

mL/min/1.73 m^2

Title

Denominators

Categories

Title	Measurements
	BG00071.01± 21.541 BG00170.86± 21.297

Renal Impairment Category

Normal renal function: eGFR ≥90 mL/min/1.73 m^2; Mild renal impairment: eGFR ≥60 and <90 mL/min/1.73 m^2; Moderate renal impairment: eGFR ≥30 and <60 mL/min/1.73 m^2; Severe renal impairment: eGFR <30 mL/min/1.73 m^2; End-stage renal disease (ESRD): eGFR <15 mL/min/1.73 m^2

Number

participants

Title

Denominators

Categories

Normal Renal Function

Title	Measurements
	BG000440 BG001

Index Acute Coronary Syndrome (ACS) Event Type

Six participants in the placebo arm and 7 participants in the alogliptin arm are not included because they did not meet the ACS requirements for study inclusion.

Number

participants

Title

Denominators

Categories

Myocardial Infarction

Title	Measurements
	BG0002068 BG001

Time From Index ACS Event to Randomization

Six participants in the placebo arm and 7 participants in the alogliptin arm are not included because they did not meet the ACS requirements for study inclusion.

Mean

Standard Deviation

days

Title

Denominators

Categories

Title	Measurements
	BG00048.0± 21.95 BG001

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

Percentage of Participants With Primary Major Adverse Cardiac Events (MACE)

Primary Major Adverse Cardiac Events were defined as a composite of cardiovascular death, nonfatal myocardial infarction and nonfatal stroke; these events were adjudicated by an independent cardiovascular endpoints committee.

Full analysis set (all randomized participants)

Posted

Number

percentage of participants

From randomization until the adjudication cut-off date of May 31 2013 (maximum time on study was 41 months).

ID	Title	Description
OG000	Placebo	Alogliptin placebo matching tablets, orally, once daily.
OG001	Alogliptin	Alogliptin 25 mg, tablets, orally, once daily for participants with normal or mildly impaired renal function as defined by estimated glomerular filtration rate (eGFR) ≥ 60 mL/min). Alogliptin 12.5 mg, tablets, orally, once daily for participants with moderately impaired renal function (eGFR ≥30 and <60 mL/min). Alogliptin 6.25 mg, tablets, orally, once daily for participants with severely impaired renal function or end stage renal disease (eGFR <30 mL/min).

Units	Counts
Participants	OG0002679 OG0012701

Title

Denominators

Categories

Title	Measurements
	OG00011.8 OG00111.3

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Statistical analyses of the primary MACE composite endpoint was based on sequences of 1-sided repeated confidence intervals (CIs) to assess non-inferiority or statistical superiority with respect to the null hypotheses. Each sequence of repeated CIs was constructed using critical values from a 1-sided stopping boundary for a group sequential design (GSD), to preserve an overall false-rejection rate of 2.5%. Each sequence of 1-sided repeated CIs had a simultaneous coverage probability of 97.5%.	Cox proportional hazards		0.315		Hazard Ratio (HR)	0.962			1-Sided	97.5		1.160				Yes	Non-Inferiority or Equivalence

Secondary

Percentage of Participants With Secondary Major Adverse Cardiac Events (MACE)

Secondary MACE composite consisted of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or urgent revascularization due to unstable angina; these events were adjudicated by an independent cardiovascular endpoint committee.

Full analysis set

Posted

Number

percentage of participants

From randomization until the adjudication cut-of date of May 31 2013 (maximum time on study was 41 months).

ID	Title	Description
OG000	Placebo	Alogliptin placebo matching tablets, orally, once daily.
OG001	Alogliptin	Alogliptin 25 mg, tablets, orally, once daily for participants with normal or mildly impaired renal function as defined by estimated glomerular filtration rate (eGFR) ≥ 60 mL/min). Alogliptin 12.5 mg, tablets, orally, once daily for participants with moderately impaired renal function (eGFR ≥30 and <60 mL/min). Alogliptin 6.25 mg, tablets, orally, once daily for participants with severely impaired renal function or end stage renal disease (eGFR <30 mL/min).

Units	Counts
Participants

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	Placebo	Alogliptin placebo matching tablets, orally, once daily.			952	2,679	1,493	2,679
EG001	Alogliptin	Alogliptin 25 mg, tablets, orally, once daily for participants with normal or mildly impaired renal function as defined by estimated glomerular filtration rate (eGFR) ≥ 60 mL/min). Alogliptin 12.5 mg, tablets, orally, once daily for participants with moderately impaired renal function (eGFR ≥30 and <60 mL/min). Alogliptin 6.25 mg, tablets, orally, once daily for participants with severely impaired renal function or end stage renal disease (eGFR <30 mL/min).			907	2,701	1,523	2,701

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Angina unstable	Cardiac disorders	MedDRA Version 16.0	Systematic Assessment	EG000142 affected2,679 at risk EG001117 affected2,701 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA Version 16.0	Systematic Assessment	EG000104 affected2,679 at risk EG001125 affected2,701 at risk
Angina pectoris	Cardiac disorders	MedDRA Version 16.0	Systematic Assessment	EG00083 affected2,679 at risk EG00186 affected2,701 at risk
Myocardial infarction	Cardiac disorders	MedDRA Version 16.0	Systematic Assessment	EG00054 affected2,679 at risk EG00166 affected2,701 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA Version 16.0	Systematic Assessment	EG00053 affected2,679 at risk EG00163 affected2,701 at risk
Cardiac failure	Cardiac disorders	MedDRA Version 16.0	Systematic Assessment	EG00056 affected2,679 at risk EG00145 affected2,701 at risk
Coronary artery disease	Cardiac disorders	MedDRA Version 16.0	Systematic Assessment	EG00034 affected2,679 at risk EG00135 affected2,701 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA Version 16.0	Systematic Assessment	EG00029 affected2,679 at risk EG00127 affected2,701 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA Version 16.0	Systematic Assessment	EG00019 affected2,679 at risk EG00120 affected2,701 at risk
Atrial fibrillation	Cardiac disorders	MedDRA Version 16.0	Systematic Assessment	EG00022 affected2,679 at risk EG00115 affected2,701 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA Version 16.0	Systematic Assessment	EG00017 affected2,679 at risk EG00120 affected2,701 at risk
Cardiac arrest	Cardiac disorders	MedDRA Version 16.0	Systematic Assessment	EG00011 affected2,679 at risk EG00114 affected2,701 at risk
Cardiogenic shock	Cardiac disorders	MedDRA Version 16.0	Systematic Assessment	EG0005 affected2,679 at risk EG00114 affected2,701 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA Version 16.0	Systematic Assessment	EG0009 affected2,679 at risk EG0016 affected2,701 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA Version 16.0	Systematic Assessment	EG00010 affected2,679 at risk EG0015 affected2,701 at risk
Cardiac failure acute	Cardiac disorders	MedDRA Version 16.0	Systematic Assessment	EG0008 affected2,679 at risk EG0016 affected2,701 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA Version 16.0	Systematic Assessment	EG0007 affected2,679 at risk EG0017 affected2,701 at risk
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA Version 16.0	Systematic Assessment	EG0004 affected2,679 at risk EG0019 affected2,701 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA Version 16.0	Systematic Assessment	EG0004 affected2,679 at risk EG0017 affected2,701 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA Version 16.0	Systematic Assessment	EG0006 affected2,679 at risk EG0015 affected2,701 at risk
Atrial flutter	Cardiac disorders	MedDRA Version 16.0	Systematic Assessment	EG0004 affected2,679 at risk EG0013 affected2,701 at risk
Bradycardia	Cardiac disorders	MedDRA Version 16.0	Systematic Assessment	EG0004 affected2,679 at risk EG0013 affected2,701 at risk
Arrhythmia	Cardiac disorders	MedDRA Version 16.0	Systematic Assessment	EG0004 affected2,679 at risk EG0012 affected2,701 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0016 affected2,701 at risk
Cardiomyopathy	Cardiac disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0014 affected2,701 at risk
Left ventricular failure	Cardiac disorders	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0013 affected2,701 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0013 affected2,701 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0011 affected2,701 at risk
Silent myocardial infarction	Cardiac disorders	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0011 affected2,701 at risk
Tachycardia	Cardiac disorders	MedDRA Version 16.0	Systematic Assessment	EG0003 affected2,679 at risk EG0010 affected2,701 at risk
Acute left ventricular failure	Cardiac disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0012 affected2,701 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0011 affected2,701 at risk
Atrial tachycardia	Cardiac disorders	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0010 affected2,701 at risk
Cardiac discomfort	Cardiac disorders	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0010 affected2,701 at risk
Cardiorenal syndrome	Cardiac disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0011 affected2,701 at risk
Coronary artery insufficiency	Cardiac disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0012 affected2,701 at risk
Left ventricular dysfunction	Cardiac disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0011 affected2,701 at risk
Postinfarction angina	Cardiac disorders	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0010 affected2,701 at risk
Right ventricular failure	Cardiac disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0011 affected2,701 at risk
Sick sinus syndrome	Cardiac disorders	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0010 affected2,701 at risk
Tricuspid valve incompetence	Cardiac disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0011 affected2,701 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0011 affected2,701 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Arteriospasm coronary	Cardiac disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Atrioventricular block	Cardiac disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Atrioventricular block second degree	Cardiac disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Bradyarrhythmia	Cardiac disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Cardiac asthma	Cardiac disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Cardiac valve disease	Cardiac disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Cardiovascular disorder	Cardiac disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Cardiovascular insufficiency	Cardiac disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Congestive cardiomyopathy	Cardiac disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Cor pulmonale chronic	Cardiac disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Coronary artery dissection	Cardiac disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Coronary artery thrombosis	Cardiac disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Intracardiac thrombus	Cardiac disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Nodal rhythm	Cardiac disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Palpitations	Cardiac disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Pulseless electrical activity	Cardiac disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Sinus bradycardia	Cardiac disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Trifascicular block	Cardiac disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Ventricular arrhythmia	Cardiac disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Ventricular dysfunction	Cardiac disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Ventricular dyskinesia	Cardiac disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Pneumonia	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG00044 affected2,679 at risk EG00149 affected2,701 at risk
Sepsis	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG00019 affected2,679 at risk EG00111 affected2,701 at risk
Bronchitis	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG00010 affected2,679 at risk EG00114 affected2,701 at risk
Urinary tract infection	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG00014 affected2,679 at risk EG00110 affected2,701 at risk
Cellulitis	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG00015 affected2,679 at risk EG0017 affected2,701 at risk
Gastroenteritis	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG00010 affected2,679 at risk EG0017 affected2,701 at risk
Septic shock	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0006 affected2,679 at risk EG00110 affected2,701 at risk
Postoperative wound infection	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0005 affected2,679 at risk EG0014 affected2,701 at risk
Gangrene	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0004 affected2,679 at risk EG0014 affected2,701 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0005 affected2,679 at risk EG0013 affected2,701 at risk
Abscess limb	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0006 affected2,679 at risk EG0011 affected2,701 at risk
Pyelonephritis	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0015 affected2,701 at risk
Diverticulitis	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0005 affected2,679 at risk EG0011 affected2,701 at risk
Erysipelas	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0003 affected2,679 at risk EG0013 affected2,701 at risk
Osteomyelitis	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0015 affected2,701 at risk
Cystitis	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0004 affected2,679 at risk EG0011 affected2,701 at risk
Localised infection	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0013 affected2,701 at risk
Pyelonephritis acute	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0004 affected2,679 at risk EG0011 affected2,701 at risk
Appendicitis	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0003 affected2,679 at risk EG0011 affected2,701 at risk
Bacteraemia	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0012 affected2,701 at risk
Bronchopneumonia	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0003 affected2,679 at risk EG0011 affected2,701 at risk
Endocarditis	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0012 affected2,701 at risk
Lobar pneumonia	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0003 affected2,679 at risk EG0011 affected2,701 at risk
Subcutaneous abscess	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0012 affected2,701 at risk
Wound infection	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0004 affected2,679 at risk EG0010 affected2,701 at risk
Arthritis bacterial	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0012 affected2,701 at risk
Gastroenteritis viral	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0011 affected2,701 at risk
Herpes zoster	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0011 affected2,701 at risk
Respiratory tract infection	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0011 affected2,701 at risk
Urosepsis	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0011 affected2,701 at risk
Viral infection	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0012 affected2,701 at risk
Appendicitis perforated	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0011 affected2,701 at risk
Atypical pneumonia	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0012 affected2,701 at risk
Carbuncle	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0012 affected2,701 at risk
Diarrhoea infectious	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0012 affected2,701 at risk
Intestinal gangrene	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0011 affected2,701 at risk
Mediastinitis	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0010 affected2,701 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0012 affected2,701 at risk
Wound infection staphylococcal	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0012 affected2,701 at risk
Abdominal sepsis	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Abdominal wall infection	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Acinetobacter bacteraemia	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Acute hepatitis B	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Acute sinusitis	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Anal abscess	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Bacterial diarrhoea	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Bacterial pyelonephritis	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Biliary tract infection	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Breast abscess	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Cystitis escherichia	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Dacryocanaliculitis	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Dengue fever	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Diabetic foot infection	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Diabetic gangrene	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Endocarditis bacterial	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Enterocolitis infectious	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Escherichia sepsis	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Extradural abscess	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Gas gangrene	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Gastritis viral	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Gastrointestinal infection	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Genital infection	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Groin abscess	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
HIV infection	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Haematoma infection	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Hepatitis B	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Incision site infection	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Infection	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Influenza	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Intervertebral discitis	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Korean haemorrhagic fever	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Liver abscess	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Malaria	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Meningitis	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Meningitis viral	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Orchitis	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Osteomyelitis acute	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Osteomyelitis chronic	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Periodontitis	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Pharyngitis streptococcal	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Pleural infection bacterial	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Pneumonia bacterial	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Pneumonia influenzal	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Pneumonia staphylococcal	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Pneumonia viral	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Post procedural cellulitis	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Pseudomembranous colitis	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Respiratory tract infection viral	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Scrotal abscess	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Scrub typhus	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Serratia infection	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Staphylococcal infection	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Staphylococcal skin infection	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Thrombophlebitis septic	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Tooth abscess	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Tuberculosis	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Urethritis	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Viraemia	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA Version 16.0	Systematic Assessment	EG00025 affected2,679 at risk EG00115 affected2,701 at risk
Ischaemic stroke	Nervous system disorders	MedDRA Version 16.0	Systematic Assessment	EG0007 affected2,679 at risk EG00115 affected2,701 at risk
Syncope	Nervous system disorders	MedDRA Version 16.0	Systematic Assessment	EG0009 affected2,679 at risk EG0019 affected2,701 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA Version 16.0	Systematic Assessment	EG0007 affected2,679 at risk EG0015 affected2,701 at risk
Convulsion	Nervous system disorders	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0017 affected2,701 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA Version 16.0	Systematic Assessment	EG0005 affected2,679 at risk EG0013 affected2,701 at risk
Cerebral infarction	Nervous system disorders	MedDRA Version 16.0	Systematic Assessment	EG0004 affected2,679 at risk EG0014 affected2,701 at risk
Epilepsy	Nervous system disorders	MedDRA Version 16.0	Systematic Assessment	EG0003 affected2,679 at risk EG0012 affected2,701 at risk
Haemorrhagic stroke	Nervous system disorders	MedDRA Version 16.0	Systematic Assessment	EG0004 affected2,679 at risk EG0010 affected2,701 at risk
Presyncope	Nervous system disorders	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0012 affected2,701 at risk
Sciatica	Nervous system disorders	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0012 affected2,701 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0011 affected2,701 at risk
Dizziness	Nervous system disorders	MedDRA Version 16.0	Systematic Assessment	EG0003 affected2,679 at risk EG0010 affected2,701 at risk
Hypoxic-ischaemic encephalopathy	Nervous system disorders	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0011 affected2,701 at risk
Lacunar infarction	Nervous system disorders	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0011 affected2,701 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0012 affected2,701 at risk
Carotid artery disease	Nervous system disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0012 affected2,701 at risk
Cauda equina syndrome	Nervous system disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0011 affected2,701 at risk
Cerebrovascular disorder	Nervous system disorders	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0010 affected2,701 at risk
Cervicobrachial syndrome	Nervous system disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0011 affected2,701 at risk
Coma	Nervous system disorders	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0010 affected2,701 at risk
Headache	Nervous system disorders	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0010 affected2,701 at risk
Hemiparesis	Nervous system disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0011 affected2,701 at risk
Hypoglycaemic seizure	Nervous system disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0012 affected2,701 at risk
Migraine	Nervous system disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0012 affected2,701 at risk
Neuralgia	Nervous system disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0011 affected2,701 at risk
Neuritis cranial	Nervous system disorders	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0010 affected2,701 at risk
Polyneuropathy	Nervous system disorders	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0010 affected2,701 at risk
Spinal claudication	Nervous system disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0011 affected2,701 at risk
VIIth nerve paralysis	Nervous system disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0012 affected2,701 at risk
Amyotrophic lateral sclerosis	Nervous system disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Ataxia	Nervous system disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Balance disorder	Nervous system disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Brain hypoxia	Nervous system disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Brain stem haemorrhage	Nervous system disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Brain stem stroke	Nervous system disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Carotid artery occlusion	Nervous system disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Carotid sinus syndrome	Nervous system disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Central pain syndrome	Nervous system disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Cerebellar infarction	Nervous system disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Cerebral arteriosclerosis	Nervous system disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Cerebrovascular insufficiency	Nervous system disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Cognitive disorder	Nervous system disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Diabetic ketoacidotic hyperglycaemic coma	Nervous system disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Diabetic neuropathy	Nervous system disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Embolic stroke	Nervous system disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Encephalopathy	Nervous system disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Grand mal convulsion	Nervous system disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Hypoaesthesia	Nervous system disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Hypoglycaemic coma	Nervous system disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Ischaemic cerebral infarction	Nervous system disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Lumbar radiculopathy	Nervous system disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Metabolic encephalopathy	Nervous system disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Multiple sclerosis	Nervous system disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Petit mal epilepsy	Nervous system disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Senile dementia	Nervous system disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Thrombotic cerebral infarction	Nervous system disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
VIth nerve paralysis	Nervous system disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Vascular dementia	Nervous system disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Vertebrobasilar insufficiency	Nervous system disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Renal failure acute	Renal and urinary disorders	MedDRA Version 16.0	Systematic Assessment	EG00036 affected2,679 at risk EG00143 affected2,701 at risk
Renal failure	Renal and urinary disorders	MedDRA Version 16.0	Systematic Assessment	EG00013 affected2,679 at risk EG00112 affected2,701 at risk
Renal failure chronic	Renal and urinary disorders	MedDRA Version 16.0	Systematic Assessment	EG00013 affected2,679 at risk EG0019 affected2,701 at risk
Renal impairment	Renal and urinary disorders	MedDRA Version 16.0	Systematic Assessment	EG0007 affected2,679 at risk EG0018 affected2,701 at risk
Haematuria	Renal and urinary disorders	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0015 affected2,701 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0014 affected2,701 at risk
Urinary retention	Renal and urinary disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0016 affected2,701 at risk
Calculus ureteric	Renal and urinary disorders	MedDRA Version 16.0	Systematic Assessment	EG0003 affected2,679 at risk EG0012 affected2,701 at risk
Azotaemia	Renal and urinary disorders	MedDRA Version 16.0	Systematic Assessment	EG0003 affected2,679 at risk EG0011 affected2,701 at risk
Renal colic	Renal and urinary disorders	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0012 affected2,701 at risk
Calculus urinary	Renal and urinary disorders	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0011 affected2,701 at risk
Diabetic nephropathy	Renal and urinary disorders	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0011 affected2,701 at risk
Acute prerenal failure	Renal and urinary disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0011 affected2,701 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0011 affected2,701 at risk
Nephropathy	Renal and urinary disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0011 affected2,701 at risk
Prerenal failure	Renal and urinary disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0012 affected2,701 at risk
Renal artery stenosis	Renal and urinary disorders	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0010 affected2,701 at risk
Renal tubular necrosis	Renal and urinary disorders	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0010 affected2,701 at risk
Urethral stenosis	Renal and urinary disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0011 affected2,701 at risk
Calculus bladder	Renal and urinary disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Cystitis haemorrhagic	Renal and urinary disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Incontinence	Renal and urinary disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Obstructive uropathy	Renal and urinary disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Renal embolism	Renal and urinary disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Renal injury	Renal and urinary disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Renal mass	Renal and urinary disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Ureteric obstruction	Renal and urinary disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Urinary tract obstruction	Renal and urinary disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.0	Systematic Assessment	EG00015 affected2,679 at risk EG00124 affected2,701 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.0	Systematic Assessment	EG00019 affected2,679 at risk EG00113 affected2,701 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.0	Systematic Assessment	EG00015 affected2,679 at risk EG00113 affected2,701 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0008 affected2,679 at risk EG0018 affected2,701 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0008 affected2,679 at risk EG0017 affected2,701 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0019 affected2,701 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0017 affected2,701 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0004 affected2,679 at risk EG0014 affected2,701 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0014 affected2,701 at risk
Pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0003 affected2,679 at risk EG0012 affected2,701 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0013 affected2,701 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0012 affected2,701 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0011 affected2,701 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0011 affected2,701 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0013 affected2,701 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0012 affected2,701 at risk
Bronchiectasis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0011 affected2,701 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0011 affected2,701 at risk
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0012 affected2,701 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0012 affected2,701 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0011 affected2,701 at risk
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0010 affected2,701 at risk
Asphyxia	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Bronchial hyperreactivity	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Bullous lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Chronic respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Hydrothorax	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Laryngeal oedema	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Pickwickian syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Pulmonary arterial hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Pulmonary sarcoidosis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Thoracic haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Tracheal stenosis	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Vocal cord polyp	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Non-cardiac chest pain	General disorders	MedDRA Version 16.0	Systematic Assessment	EG00054 affected2,679 at risk EG00140 affected2,701 at risk
Chest pain	General disorders	MedDRA Version 16.0	Systematic Assessment	EG0009 affected2,679 at risk EG0018 affected2,701 at risk
Sudden cardiac death	General disorders	MedDRA Version 16.0	Systematic Assessment	EG0008 affected2,679 at risk EG0018 affected2,701 at risk
Sudden death	General disorders	MedDRA Version 16.0	Systematic Assessment	EG0007 affected2,679 at risk EG0016 affected2,701 at risk
Death	General disorders	MedDRA Version 16.0	Systematic Assessment	EG0006 affected2,679 at risk EG0016 affected2,701 at risk
Pyrexia	General disorders	MedDRA Version 16.0	Systematic Assessment	EG0003 affected2,679 at risk EG0013 affected2,701 at risk
Multi-organ failure	General disorders	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0013 affected2,701 at risk
Chest discomfort	General disorders	MedDRA Version 16.0	Systematic Assessment	EG0003 affected2,679 at risk EG0011 affected2,701 at risk
Device occlusion	General disorders	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0012 affected2,701 at risk
Oedema peripheral	General disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0013 affected2,701 at risk
Asthenia	General disorders	MedDRA Version 16.0	Systematic Assessment	EG0003 affected2,679 at risk EG0010 affected2,701 at risk
Adverse drug reaction	General disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0012 affected2,701 at risk
General physical health deterioration	General disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0012 affected2,701 at risk
Cardiac death	General disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Device battery issue	General disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Device dislocation	General disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Device failure	General disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Hyperpyrexia	General disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Impaired healing	General disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Implant site pain	General disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Necrobiosis	General disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Oedema	General disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Pseudoangina	General disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG00010 affected2,679 at risk EG0019 affected2,701 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0008 affected2,679 at risk EG0018 affected2,701 at risk
Gastritis	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0007 affected2,679 at risk EG0013 affected2,701 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0004 affected2,679 at risk EG0016 affected2,701 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0004 affected2,679 at risk EG0016 affected2,701 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0003 affected2,679 at risk EG0016 affected2,701 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0004 affected2,679 at risk EG0012 affected2,701 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0004 affected2,679 at risk EG0012 affected2,701 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0003 affected2,679 at risk EG0012 affected2,701 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0003 affected2,679 at risk EG0012 affected2,701 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0014 affected2,701 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0012 affected2,701 at risk
Constipation	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0003 affected2,679 at risk EG0010 affected2,701 at risk
Diabetic gastroparesis	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0012 affected2,701 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0011 affected2,701 at risk
Impaired gastric emptying	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0013 affected2,701 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0012 affected2,701 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0012 affected2,701 at risk
Pancreatitis chronic	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0012 affected2,701 at risk
Pancreatitis relapsing	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0013 affected2,701 at risk
Peptic ulcer	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0011 affected2,701 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0012 affected2,701 at risk
Vomiting	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0011 affected2,701 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0011 affected2,701 at risk
Diverticulum intestinal haemorrhagic	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0011 affected2,701 at risk
Intestinal ischaemia	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0012 affected2,701 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0011 affected2,701 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0010 affected2,701 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0012 affected2,701 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Acute abdomen	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Colitis ulcerative	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Crohn's disease	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Dental caries	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Diverticulitis intestinal haemorrhagic	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Duodenitis	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Dysphagia	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Enteritis	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Erosive duodenitis	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Gastrointestinal angiodysplasia	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Gastrointestinal motility disorder	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Gastrointestinal ulcer haemorrhage	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Gingival bleeding	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Hernial eventration	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Inguinal hernia, obstructive	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Intestinal angina	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Intestinal infarction	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Irritable bowel syndrome	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Large intestinal obstruction	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Lip haematoma	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Mallory-Weiss syndrome	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Oesophageal obstruction	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Oesophageal pain	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Oesophageal spasm	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Pancreatic cyst	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Pancreatic enlargement	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Pancreatic mass	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Peptic ulcer haemorrhage	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Peritonitis sclerosing	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Retroperitoneal fibrosis	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Retroperitoneal haematoma	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Coronary artery restenosis	Injury, poisoning and procedural complications	MedDRA Version 16.0	Systematic Assessment	EG00017 affected2,679 at risk EG00119 affected2,701 at risk
Fall	Injury, poisoning and procedural complications	MedDRA Version 16.0	Systematic Assessment	EG0006 affected2,679 at risk EG0013 affected2,701 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA Version 16.0	Systematic Assessment	EG0008 affected2,679 at risk EG0011 affected2,701 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA Version 16.0	Systematic Assessment	EG0003 affected2,679 at risk EG0012 affected2,701 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA Version 16.0	Systematic Assessment	EG0003 affected2,679 at risk EG0012 affected2,701 at risk
Arterial restenosis	Injury, poisoning and procedural complications	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0013 affected2,701 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0011 affected2,701 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0012 affected2,701 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA Version 16.0	Systematic Assessment	EG0003 affected2,679 at risk EG0010 affected2,701 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0013 affected2,701 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0011 affected2,701 at risk
Traumatic haematoma	Injury, poisoning and procedural complications	MedDRA Version 16.0	Systematic Assessment	EG0003 affected2,679 at risk EG0010 affected2,701 at risk
Alcohol poisoning	Injury, poisoning and procedural complications	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0010 affected2,701 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0012 affected2,701 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0011 affected2,701 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0010 affected2,701 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0012 affected2,701 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0012 affected2,701 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0011 affected2,701 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0012 affected2,701 at risk
Postoperative wound complication	Injury, poisoning and procedural complications	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0012 affected2,701 at risk
Pubis fracture	Injury, poisoning and procedural complications	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0010 affected2,701 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0011 affected2,701 at risk
Vascular graft complication	Injury, poisoning and procedural complications	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0011 affected2,701 at risk
Vascular graft occlusion	Injury, poisoning and procedural complications	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0010 affected2,701 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0011 affected2,701 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0011 affected2,701 at risk
Accident	Injury, poisoning and procedural complications	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Anaemia postoperative	Injury, poisoning and procedural complications	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Arterial injury	Injury, poisoning and procedural complications	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Arteriovenous fistula occlusion	Injury, poisoning and procedural complications	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Arteriovenous fistula site complication	Injury, poisoning and procedural complications	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Chemical poisoning	Injury, poisoning and procedural complications	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Chest injury	Injury, poisoning and procedural complications	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Coronary artery reocclusion	Injury, poisoning and procedural complications	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Eyeball rupture	Injury, poisoning and procedural complications	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Fat embolism	Injury, poisoning and procedural complications	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Gun shot wound	Injury, poisoning and procedural complications	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Human bite	Injury, poisoning and procedural complications	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Inflammation of wound	Injury, poisoning and procedural complications	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Intentional overdose	Injury, poisoning and procedural complications	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Ligament injury	Injury, poisoning and procedural complications	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Multiple fractures	Injury, poisoning and procedural complications	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Muscle rupture	Injury, poisoning and procedural complications	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Open fracture	Injury, poisoning and procedural complications	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Patella fracture	Injury, poisoning and procedural complications	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Post procedural myocardial infarction	Injury, poisoning and procedural complications	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Postoperative thoracic procedure complication	Injury, poisoning and procedural complications	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Repetitive strain injury	Injury, poisoning and procedural complications	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Tobacco poisoning	Injury, poisoning and procedural complications	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Transfusion reaction	Injury, poisoning and procedural complications	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Traumatic intracranial haemorrhage	Injury, poisoning and procedural complications	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Ulna fracture	Injury, poisoning and procedural complications	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Wound necrosis	Injury, poisoning and procedural complications	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Hypertension	Vascular disorders	MedDRA Version 16.0	Systematic Assessment	EG00016 affected2,679 at risk EG0018 affected2,701 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA Version 16.0	Systematic Assessment	EG0009 affected2,679 at risk EG0019 affected2,701 at risk
Hypertensive crisis	Vascular disorders	MedDRA Version 16.0	Systematic Assessment	EG00010 affected2,679 at risk EG0015 affected2,701 at risk
Hypotension	Vascular disorders	MedDRA Version 16.0	Systematic Assessment	EG0007 affected2,679 at risk EG0016 affected2,701 at risk
Peripheral artery stenosis	Vascular disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0016 affected2,701 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA Version 16.0	Systematic Assessment	EG0004 affected2,679 at risk EG0013 affected2,701 at risk
Deep vein thrombosis	Vascular disorders	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0013 affected2,701 at risk
Hypertensive emergency	Vascular disorders	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0013 affected2,701 at risk
Aortic stenosis	Vascular disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0013 affected2,701 at risk
Malignant hypertension	Vascular disorders	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0012 affected2,701 at risk
Peripheral ischaemia	Vascular disorders	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0012 affected2,701 at risk
Hypovolaemic shock	Vascular disorders	MedDRA Version 16.0	Systematic Assessment	EG0003 affected2,679 at risk EG0010 affected2,701 at risk
Intermittent claudication	Vascular disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0013 affected2,701 at risk
Orthostatic hypotension	Vascular disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0013 affected2,701 at risk
Arterial occlusive disease	Vascular disorders	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0010 affected2,701 at risk
Circulatory collapse	Vascular disorders	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0010 affected2,701 at risk
Femoral artery occlusion	Vascular disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0011 affected2,701 at risk
Iliac artery occlusion	Vascular disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0011 affected2,701 at risk
Accelerated hypertension	Vascular disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Angiodysplasia	Vascular disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Angiopathy	Vascular disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Aortic aneurysm	Vascular disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Aortic occlusion	Vascular disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Aortic thrombosis	Vascular disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Arterial insufficiency	Vascular disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Arterial stenosis	Vascular disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Arteriosclerosis	Vascular disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Arteriovenous fistula	Vascular disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Femoral artery embolism	Vascular disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Haematoma	Vascular disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Peripheral artery aneurysm	Vascular disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Peripheral artery thrombosis	Vascular disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Peripheral embolism	Vascular disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Shock haemorrhagic	Vascular disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Subclavian artery stenosis	Vascular disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Thrombosis	Vascular disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Venous insufficiency	Vascular disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Venous occlusion	Vascular disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA Version 16.0	Systematic Assessment	EG00016 affected2,679 at risk EG00118 affected2,701 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA Version 16.0	Systematic Assessment	EG00014 affected2,679 at risk EG0015 affected2,701 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA Version 16.0	Systematic Assessment	EG00011 affected2,679 at risk EG0016 affected2,701 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA Version 16.0	Systematic Assessment	EG00011 affected2,679 at risk EG0015 affected2,701 at risk
Gout	Metabolism and nutrition disorders	MedDRA Version 16.0	Systematic Assessment	EG0004 affected2,679 at risk EG0013 affected2,701 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0015 affected2,701 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA Version 16.0	Systematic Assessment	EG0004 affected2,679 at risk EG0011 affected2,701 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0011 affected2,701 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0011 affected2,701 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0010 affected2,701 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0010 affected2,701 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0012 affected2,701 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0011 affected2,701 at risk
Obesity	Metabolism and nutrition disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0011 affected2,701 at risk
Diabetes complicating pregnancy	Metabolism and nutrition disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Hyperglycaemic hyperosmolar nonketotic syndrome	Metabolism and nutrition disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Hyperlipasaemia	Metabolism and nutrition disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Hyperosmolar state	Metabolism and nutrition disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Lactic acidosis	Metabolism and nutrition disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA Version 16.0	Systematic Assessment	EG00014 affected2,679 at risk EG00116 affected2,701 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0015 affected2,701 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA Version 16.0	Systematic Assessment	EG0003 affected2,679 at risk EG0013 affected2,701 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA Version 16.0	Systematic Assessment	EG0003 affected2,679 at risk EG0011 affected2,701 at risk
Intervertebral disc disorder	Musculoskeletal and connective tissue disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0012 affected2,701 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0010 affected2,701 at risk
Myopathy	Musculoskeletal and connective tissue disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0011 affected2,701 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0011 affected2,701 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Chondrocalcinosis pyrophosphate	Musculoskeletal and connective tissue disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Costochondritis	Musculoskeletal and connective tissue disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Fibromyalgia	Musculoskeletal and connective tissue disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Haemarthrosis	Musculoskeletal and connective tissue disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Muscle contracture	Musculoskeletal and connective tissue disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Muscle haemorrhage	Musculoskeletal and connective tissue disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Muscle twitching	Musculoskeletal and connective tissue disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Myositis	Musculoskeletal and connective tissue disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Neuropathic arthropathy	Musculoskeletal and connective tissue disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Psoriatic arthropathy	Musculoskeletal and connective tissue disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Tendon disorder	Musculoskeletal and connective tissue disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Torticollis	Musculoskeletal and connective tissue disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 16.0	Systematic Assessment	EG0004 affected2,679 at risk EG0014 affected2,701 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 16.0	Systematic Assessment	EG0003 affected2,679 at risk EG0014 affected2,701 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0013 affected2,701 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0012 affected2,701 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0012 affected2,701 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0012 affected2,701 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0013 affected2,701 at risk
Adenocarcinoma gastric	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0012 affected2,701 at risk
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0011 affected2,701 at risk
Lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0011 affected2,701 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0012 affected2,701 at risk
Oesophageal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0011 affected2,701 at risk
Renal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0011 affected2,701 at risk
Squamous cell carcinoma of lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0012 affected2,701 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0011 affected2,701 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Benign salivary gland neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Bladder papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Breast cancer stage III	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Colon adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Colon cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Colon cancer stage II	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Colon neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Colorectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Endometrial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Endometrial cancer stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Fibroadenoma of breast	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Follicular thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Gallbladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Hepatic cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Hepatocellular carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Lentigo maligna	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Lip neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Lip squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Metastases to lymph nodes	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Metastatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Non-Hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Osteoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Ovarian neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Rectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Rectal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Rectosigmoid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Signet-ring cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Spinal cord neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA Version 16.0	Systematic Assessment	EG0009 affected2,679 at risk EG0017 affected2,701 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0015 affected2,701 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0014 affected2,701 at risk
Cholecystitis chronic	Hepatobiliary disorders	MedDRA Version 16.0	Systematic Assessment	EG0003 affected2,679 at risk EG0010 affected2,701 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0010 affected2,701 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0010 affected2,701 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0012 affected2,701 at risk
Jaundice cholestatic	Hepatobiliary disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0012 affected2,701 at risk
Acute hepatic failure	Hepatobiliary disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Biliary colic	Hepatobiliary disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Biliary tract disorder	Hepatobiliary disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Cholangitis	Hepatobiliary disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Cholangitis acute	Hepatobiliary disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Hepatitis acute	Hepatobiliary disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Liver injury	Hepatobiliary disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Post cholecystectomy syndrome	Hepatobiliary disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA Version 16.0	Systematic Assessment	EG00017 affected2,679 at risk EG00116 affected2,701 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA Version 16.0	Systematic Assessment	EG0003 affected2,679 at risk EG0010 affected2,701 at risk
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Haemolytic anaemia	Blood and lymphatic system disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Lymphopenia	Blood and lymphatic system disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Microcytic anaemia	Blood and lymphatic system disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Haemoglobin decreased	Investigations	MedDRA Version 16.0	Systematic Assessment	EG0003 affected2,679 at risk EG0010 affected2,701 at risk
Lipase increased	Investigations	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0011 affected2,701 at risk
Amylase increased	Investigations	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0012 affected2,701 at risk
Blood glucose increased	Investigations	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0010 affected2,701 at risk
Cardiac enzymes increased	Investigations	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0010 affected2,701 at risk
Hepatic enzyme increased	Investigations	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0010 affected2,701 at risk
Alanine aminotransferase increased	Investigations	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Aspartate aminotransferase increased	Investigations	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Blood creatinine increased	Investigations	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Blood potassium increased	Investigations	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Electrocardiogram ST segment depression	Investigations	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Heart rate irregular	Investigations	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
International normalised ratio increased	Investigations	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Liver function test abnormal	Investigations	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Neutrophil count decreased	Investigations	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Oxygen saturation decreased	Investigations	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Pancreatic enzymes increased	Investigations	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Transaminases increased	Investigations	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Troponin increased	Investigations	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA Version 16.0	Systematic Assessment	EG0004 affected2,679 at risk EG0017 affected2,701 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0014 affected2,701 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0011 affected2,701 at risk
Skin necrosis	Skin and subcutaneous tissue disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0012 affected2,701 at risk
Cutaneous lupus erythematosus	Skin and subcutaneous tissue disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Drug eruption	Skin and subcutaneous tissue disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Dry gangrene	Skin and subcutaneous tissue disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Erythema nodosum	Skin and subcutaneous tissue disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Cataract	Eye disorders	MedDRA Version 16.0	Systematic Assessment	EG0006 affected2,679 at risk EG0015 affected2,701 at risk
Diabetic retinopathy	Eye disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0011 affected2,701 at risk
Vitreous haemorrhage	Eye disorders	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0010 affected2,701 at risk
Amaurosis	Eye disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Cataract subcapsular	Eye disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Dacryostenosis acquired	Eye disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Open angle glaucoma	Eye disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Retinal detachment	Eye disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Retinopathy	Eye disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Major depression	Psychiatric disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0012 affected2,701 at risk
Anxiety disorder	Psychiatric disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0011 affected2,701 at risk
Completed suicide	Psychiatric disorders	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0010 affected2,701 at risk
Stress	Psychiatric disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0011 affected2,701 at risk
Abnormal behaviour	Psychiatric disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Agoraphobia	Psychiatric disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Alcohol abuse	Psychiatric disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Bipolar disorder	Psychiatric disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Confusional state	Psychiatric disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Depression	Psychiatric disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Mental status changes	Psychiatric disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Mood altered	Psychiatric disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Schizophrenia, paranoid type	Psychiatric disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA Version 16.0	Systematic Assessment	EG0006 affected2,679 at risk EG0011 affected2,701 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0011 affected2,701 at risk
Gynaecomastia	Reproductive system and breast disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Menorrhagia	Reproductive system and breast disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Prostatism	Reproductive system and breast disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Scrotal mass	Reproductive system and breast disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Uterine prolapse	Reproductive system and breast disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Vertigo	Ear and labyrinth disorders	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0013 affected2,701 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA Version 16.0	Systematic Assessment	EG0002 affected2,679 at risk EG0013 affected2,701 at risk
Anaphylactic reaction	Immune system disorders	MedDRA Version 16.0	Systematic Assessment	EG0003 affected2,679 at risk EG0011 affected2,701 at risk
Congenital megaureter	Congenital, familial and genetic disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Pyloric stenosis	Congenital, familial and genetic disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Goitre	Endocrine disorders	MedDRA Version 16.0	Systematic Assessment	EG0000 affected2,679 at risk EG0011 affected2,701 at risk
Hyperthyroidism	Endocrine disorders	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Hospitalisation	Surgical and medical procedures	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Implantable defibrillator insertion	Surgical and medical procedures	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA Version 16.0	Systematic Assessment	EG0001 affected2,679 at risk EG0010 affected2,701 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA Version 16.0	Systematic Assessment	EG00096 affected2,679 at risk EG001130 affected2,701 at risk
Angina pectoris	Cardiac disorders	MedDRA Version 16.0	Systematic Assessment	EG000133 affected2,679 at risk EG001122 affected2,701 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG00099 affected2,679 at risk EG001122 affected2,701 at risk
Constipation	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG00066 affected2,679 at risk EG00170 affected2,701 at risk
Nausea	Gastrointestinal disorders	MedDRA Version 16.0	Systematic Assessment	EG00053 affected2,679 at risk EG00156 affected2,701 at risk
Oedema peripheral	General disorders	MedDRA Version 16.0	Systematic Assessment	EG000104 affected2,679 at risk EG001101 affected2,701 at risk
Nasopharyngitis	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG000120 affected2,679 at risk EG001112 affected2,701 at risk
Urinary tract infection	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG00094 affected2,679 at risk EG001102 affected2,701 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG00085 affected2,679 at risk EG00179 affected2,701 at risk
Bronchitis	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG00068 affected2,679 at risk EG00181 affected2,701 at risk
Influenza	Infections and infestations	MedDRA Version 16.0	Systematic Assessment	EG00054 affected2,679 at risk EG00164 affected2,701 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA Version 16.0	Systematic Assessment	EG000116 affected2,679 at risk EG001140 affected2,701 at risk
Glomerular filtration rate decreased	Investigations	MedDRA Version 16.0	Systematic Assessment	EG000116 affected2,679 at risk EG001132 affected2,701 at risk
Lipase increased	Investigations	MedDRA Version 16.0	Systematic Assessment	EG00083 affected2,679 at risk EG00181 affected2,701 at risk
Blood creatinine increased	Investigations	MedDRA Version 16.0	Systematic Assessment	EG00072 affected2,679 at risk EG00191 affected2,701 at risk
Creatinine renal clearance decreased	Investigations	MedDRA Version 16.0	Systematic Assessment	EG00047 affected2,679 at risk EG00159 affected2,701 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA Version 16.0	Systematic Assessment	EG000159 affected2,679 at risk EG001167 affected2,701 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA Version 16.0	Systematic Assessment	EG00099 affected2,679 at risk EG00194 affected2,701 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA Version 16.0	Systematic Assessment	EG00070 affected2,679 at risk EG00181 affected2,701 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	MedDRA Version 16.0	Systematic Assessment	EG00071 affected2,679 at risk EG00155 affected2,701 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA Version 16.0	Systematic Assessment	EG00070 affected2,679 at risk EG00152 affected2,701 at risk
Dyslipidaemia	Metabolism and nutrition disorders	MedDRA Version 16.0	Systematic Assessment	EG00049 affected2,679 at risk EG00156 affected2,701 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA Version 16.0	Systematic Assessment	EG00084 affected2,679 at risk EG00179 affected2,701 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA Version 16.0	Systematic Assessment	EG00064 affected2,679 at risk EG00168 affected2,701 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA Version 16.0	Systematic Assessment	EG00060 affected2,679 at risk EG00154 affected2,701 at risk
Dizziness	Nervous system disorders	MedDRA Version 16.0	Systematic Assessment	EG00068 affected2,679 at risk EG00181 affected2,701 at risk
Headache	Nervous system disorders	MedDRA Version 16.0	Systematic Assessment	EG00072 affected2,679 at risk EG00169 affected2,701 at risk
Renal impairment	Renal and urinary disorders	MedDRA Version 16.0	Systematic Assessment	EG000174 affected2,679 at risk EG001203 affected2,701 at risk
Proteinuria	Renal and urinary disorders	MedDRA Version 16.0	Systematic Assessment	EG000107 affected2,679 at risk EG001103 affected2,701 at risk
Diabetic nephropathy	Renal and urinary disorders	MedDRA Version 16.0	Systematic Assessment	EG00068 affected2,679 at risk EG00162 affected2,701 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.0	Systematic Assessment	EG00099 affected2,679 at risk EG00198 affected2,701 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA Version 16.0	Systematic Assessment	EG00074 affected2,679 at risk EG00170 affected2,701 at risk
Hypertension	Vascular disorders	MedDRA Version 16.0	Systematic Assessment	EG000198 affected2,679 at risk EG001193 affected2,701 at risk

Ancestor Terms

ID	Term
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular 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

If after accrual of 550 participants with MACE events, the upper bound of a 1-sided repeated CI for the hazard ratio (alogliptin to placebo) was <1.0, superiority of alogliptin to placebo for the primary MACE composite would be concluded. If the upper bound of the 1-sided repeated CI for the hazard ratio of the primary MACE composite was <1.3 but ≥1.0 then non-inferiority but not superiority of alogliptin to placebo was to be concluded.

Facility	Status	City	State	ZIP	Country	Contacts
		Birmingham	Alabama		United States

ID	Term
D003924	Diabetes Mellitus, Type 2
D054058	Acute Coronary Syndrome
D003920	Diabetes Mellitus
D009203	Myocardial Infarction
D020521	Stroke
D008659	Metabolic Diseases
D044882	Glucose Metabolism Disorders