Efficacy and Safety of Empagliflozin (BI 10773) With Metf... | NCT01167881

ID	Type	Description	Link
2009-016244-39	EudraCT Number	EudraCT

Name	Class
Eli Lilly and Company	INDUSTRY

Label	Type	Description	Intervention Names
BI 10773 dose plus metformin	Experimental	Patients receive one BI10773 tablet and one placebo Glimepiride capsule once daily	Drug: BI 10773 Drug: Placebo
Glimepiride 1-4 mg plus metformin	Active Comparator	Patients receive one glimepiride capsule and one placebo tablet Bi 10773 once daily.	Drug: Glimepiride Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
BI 10773	Drug	Medium dose once daily	BI 10773 dose plus metformin

Measure	Description	Time Frame
The Change From Baseline in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment.		Baseline and 104 weeks

Measure	Description	Time Frame
The Change in Body Weight From Baseline After 104 Weeks of Treatment.		baseline and 104 weeks
The Occurrence of Confirmed Hypoglycaemic Events During 104 Weeks of Treatment.		baseline and 104 weeks

Name	Affiliation	Role
Boehringer Ingelheim	Boehringer Ingelheim	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
1245.28.10005 Boehringer Ingelheim Investigational Site		Phoenix	Arizona		United States
1245.28.10012 Boehringer Ingelheim Investigational Site

PubMed Identifier	Type	Citation	Retractions
40020703	Derived	Dennis JM, Young KG, Cardoso P, Gudemann LM, McGovern AP, Farmer A, Holman RR, Sattar N, McKinley TJ, Pearson ER, Jones AG, Shields BM, Hattersley AT; MASTERMIND Consortium. A five-drug class model using routinely available clinical features to optimise prescribing in type 2 diabetes: a prediction model development and validation study. Lancet. 2025 Mar 1;405(10480):701-714. doi: 10.1016/S0140-6736(24)02617-5. Epub 2025 Feb 25.
38770818

ID	Title	Description
FG000	Empaglifozin 25 mg	Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily. Empagliflozin: 25 mg once daily Placebo: Placebo matching Glimepiride
FG001	Glimepiride

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

Secondary

The Change in Body Weight From Baseline After 104 Weeks of Treatment.

FAS (LOCF) - Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF); Values after start of antidiabetic rescue therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.

Posted

Mean

Standard Error

kilograms

baseline and 104 weeks

ID	Title	Description
OG000	Empaglifozin 25 mg	Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily. Empagliflozin: 25 mg once daily Placebo: Placebo matching Glimepiride
OG001	Glimepiride	Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily. Glimepiride: 1-4 mg once daily Placebo: Placebo matching Empagliflozin

Units	Counts
Participants	OG000765 OG001780

Title

Denominators

Categories

Title	Measurements
	OG000-3.11± 0.13 OG0011.33± 0.13

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	Testing Hierarchy for main analysis (104 weeks): Non-inferiority in HbA1c change from baseline at 104 weeks, Superiority in body weight change from baseline at 104 weeks, Superiority in occurrence of confirmed hypoglycaemic adverse events at 104 weeks, Superiority in HbA1c change from baseline at 104 weeks, Superiority in systolic blood pressure change from baseline at 104 weeks, Superiority in diastolic blood pressure change from baseline at 104 weeks.	ANCOVA	ANCOVA with treatment, geographical region, renal function at baseline as fixed effects and baseline weight, baseline HbA1c as linear covariates.	<0.0001	The superiority tests performed at 104 weeks and the superiority tests performed at 52 weeks both used a nominal significance level of 2.5% to maintain the overall significance level of 5%.	Mean Difference (Net)	-4.46	Standard Error of the Mean	0.18	2-Sided	97.5	-4.87

Primary

The Change From Baseline in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment.

Posted

Mean

Standard Error

percentage of HbA1c

Baseline and 104 weeks

ID	Title	Description
OG000	Empaglifozin 25 mg	Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily. Empagliflozin: 25 mg once daily Placebo: Placebo matching Glimepiride
OG001	Glimepiride	Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily. Glimepiride: 1-4 mg once daily Placebo: Placebo matching Empagliflozin

Units	Counts
Participants	OG000

Secondary

The Occurrence of Confirmed Hypoglycaemic Events During 104 Weeks of Treatment.

Treated set, all patients treated with at least one dose of randomised study drug.

Posted

Number

participants

baseline and 104 weeks

ID	Title	Description
OG000	Empaglifozin 25 mg	Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily. Empagliflozin: 25 mg once daily Placebo: Placebo matching Glimepiride
OG001	Glimepiride	Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily. Glimepiride: 1-4 mg once daily Placebo: Placebo matching Empagliflozin

Units	Counts
Participants	OG000

Secondary

The Change in Systolic Blood Pressure (SBP) From Baseline After 104 Weeks of Treatment.

FAS (LOCF-H) - Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF); Values after start of antidiabetic rescue therapy or change of antihypertensive therapy were set to missing and last observation carried forward (LOCF) was used for imputation of missing values.

Posted

Mean

Standard Error

mmHg

baseline and 104 weeks

ID	Title	Description
OG000	Empaglifozin 25 mg	Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily. Empagliflozin: 25 mg once daily Placebo: Placebo matching Glimepiride
OG001	Glimepiride	Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily. Glimepiride: 1-4 mg once daily Placebo: Placebo matching Empagliflozin

Units	Counts
Participants	OG000

Secondary

The Change in Diastolic Blood Pressure (DBP) From Baseline After 104 Weeks of Treatment.

Posted

Mean

Standard Error

mmHg

baseline and 104 weeks

ID	Title	Description
OG000	Empaglifozin 25 mg	Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily. Empagliflozin: 25 mg once daily Placebo: Placebo matching Glimepiride
OG001	Glimepiride	Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily. Glimepiride: 1-4 mg once daily Placebo: Placebo matching Empagliflozin

Units	Counts
Participants	OG000

Secondary

The Change From Baseline in HbA1c After 52 Weeks of Treatment.

Posted

Mean

Standard Error

percentage of HbA1c

baseline and 52 weeks

ID	Title	Description
OG000	Empaglifozin 25 mg	Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily. Empagliflozin: 25 mg once daily Placebo: Placebo matching Glimepiride
OG001	Glimepiride	Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily. Glimepiride: 1-4 mg once daily Placebo: Placebo matching Empagliflozin

Units	Counts
Participants	OG000

Secondary

The Change in Body Weight From Baseline After 52 Weeks of Treatment.

Posted

Mean

Standard Error

kilograms

baseline and 52 weeks

ID	Title	Description
OG000	Empaglifozin 25 mg	Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily. Empagliflozin: 25 mg once daily Placebo: Placebo matching Glimepiride
OG001	Glimepiride	Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily. Glimepiride: 1-4 mg once daily Placebo: Placebo matching Empagliflozin

Units	Counts
Participants	OG000

Secondary

The Occurrence of Confirmed Hypoglycaemic Events During 52 Weeks of Treatment.

Treated set, all patients treated with at least one dose of randomised study drug.

Posted

Number

participants

baseline and 52 weeks

ID	Title	Description
OG000	Empaglifozin 25 mg	Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily. Empagliflozin: 25 mg once daily Placebo: Placebo matching Glimepiride
OG001	Glimepiride	Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily. Glimepiride: 1-4 mg once daily Placebo: Placebo matching Empagliflozin

Units	Counts
Participants	OG000

Secondary

The Change in Systolic Blood Pressure (SBP) From Baseline After 52 Weeks of Treatment.

Posted

Mean

Standard Error

mmHg

baseline and 52 weeks

ID	Title	Description
OG000	Empaglifozin 25 mg	Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily. Empagliflozin: 25 mg once daily Placebo: Placebo matching Glimepiride
OG001	Glimepiride	Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily. Glimepiride: 1-4 mg once daily Placebo: Placebo matching Empagliflozin

Units	Counts
Participants	OG000

Secondary

The Change in Diastolic Blood Pressure (DBP) From Baseline After 52 Weeks of Treatment.

Posted

Mean

Standard Error

mmHg

baseline and 52 weeks

ID	Title	Description
OG000	Empaglifozin 25 mg	Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily. Empagliflozin: 25 mg once daily Placebo: Placebo matching Glimepiride
OG001	Glimepiride	Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily. Glimepiride: 1-4 mg once daily Placebo: Placebo matching Empagliflozin

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Gastroenteritis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0004 affected765 at risk EG0010 affected780 at risk
Cellulitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0003 affected765 at risk EG0010 affected780 at risk
Diverticulitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0003 affected765 at risk EG0010 affected780 at risk
Viral infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0003 affected765 at risk EG0010 affected780 at risk
Bronchitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0012 affected780 at risk
Erysipelas	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0012 affected780 at risk
Post procedural infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0012 affected780 at risk
Sepsis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0012 affected780 at risk
Abscess limb	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0011 affected780 at risk
Appendicitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0011 affected780 at risk
Bacteraemia	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Cystitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Cystitis escherichia	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Dengue fever	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Diarrhoea infectious	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0011 affected780 at risk
Escherichia bacteraemia	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Febrile infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Gastroenteritis salmonella	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Hepatitis E	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Infectious mononucleosis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Kidney infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Liver abscess	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Lobar pneumonia	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Localised infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Lung infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Nasopharyngitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Osteomyelitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Pelvic abscess	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Peritonitis bacterial	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Pneumonia legionella	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Pyelonephritis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Pyelonephritis acute	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0011 affected780 at risk
Salmonellosis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Septic shock	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Sialoadenitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Tuberculosis gastrointestinal	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Urosepsis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0002 affected765 at risk EG0016 affected780 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0002 affected765 at risk EG0014 affected780 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0002 affected765 at risk EG0010 affected780 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0002 affected765 at risk EG0011 affected780 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0002 affected765 at risk EG0010 affected780 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0012 affected780 at risk
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Adenocarcinoma pancreas	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Endometrial adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Glioblastoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Hepatic cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Invasive lobular breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Laryngeal squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Lung adenocarcinoma stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Malignant melanoma in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Malignant peritoneal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Melanoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Metastatic ocular melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Nasal neoplasm benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Non-small cell lung cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Paranasal sinus benign neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Renal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0011 affected780 at risk
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Uterine cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0012 affected780 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0013 affected780 at risk
Goitre	Endocrine disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0011 affected780 at risk
Pituitary-dependent Cushing's syndrome	Endocrine disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Obesity	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0012 affected780 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Gout	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Adjustment disorder	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Completed suicide	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Delusional disorder, unspecified type	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Depression	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Mental disorder	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Suicide attempt	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0008 affected765 at risk EG0012 affected780 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0012 affected780 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0012 affected780 at risk
Dizziness	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected765 at risk EG0010 affected780 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected765 at risk EG0012 affected780 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected765 at risk EG0012 affected780 at risk
Brain stem infarction	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Cerebral infarction	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Cerebrovascular disorder	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Diabetic coma	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Headache	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Lacunar infarction	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Myasthenia gravis	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Myelopathy	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Optic neuritis	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Paraesthesia	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Partial seizures	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Radicular pain	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Seizure	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Syncope	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0011 affected780 at risk
Thalamic infarction	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Trigeminal neuralgia	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Retinal detachment	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0013 affected780 at risk
Cataract	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0012 affected780 at risk
Diabetic retinopathy	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Endocrine ophthalmopathy	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Open angle glaucoma	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Retinal neovascularisation	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Vitreous haemorrhage	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Otosclerosis	Ear and labyrinth disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Coronary artery disease	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected765 at risk EG0018 affected780 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0017 affected780 at risk
Angina unstable	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0004 affected765 at risk EG0014 affected780 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0004 affected765 at risk EG0012 affected780 at risk
Myocardial infarction	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0013 affected780 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0013 affected780 at risk
Angina pectoris	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0012 affected780 at risk
Cardiac failure	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected765 at risk EG0011 affected780 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0012 affected780 at risk
Palpitations	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected765 at risk EG0010 affected780 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Arrhythmia	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Cardiac disorder	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Cardiac tamponade	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Tachycardia	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Ventricle rupture	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Hypertension	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0011 affected780 at risk
Hypertensive emergency	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0011 affected780 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Peripheral artery stenosis	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Thrombophlebitis	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Varicose vein	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected765 at risk EG0011 affected780 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected765 at risk EG0011 affected780 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected765 at risk EG0010 affected780 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Lung consolidation	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Nasal obstruction	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Paranasal cyst	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0004 affected765 at risk EG0010 affected780 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected765 at risk EG0010 affected780 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected765 at risk EG0012 affected780 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected765 at risk EG0010 affected780 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0012 affected780 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0012 affected780 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected765 at risk EG0011 affected780 at risk
Vomiting	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected765 at risk EG0010 affected780 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0011 affected780 at risk
Anorectal varices	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Anorectal varices haemorrhage	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Colitis	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Crohn's disease	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Diverticulum intestinal	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Enterocolitis haemorrhagic	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Gastritis	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0011 affected780 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0011 affected780 at risk
Impaired gastric emptying	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Incarcerated inguinal hernia	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Oesophageal varices haemorrhage	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Proctitis haemorrhagic	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Rectal polyp	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Volvulus	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0004 affected765 at risk EG0015 affected780 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0012 affected780 at risk
Cholangitis	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Cholangitis acute	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0011 affected780 at risk
Cholecystitis chronic	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Drug-induced liver injury	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0011 affected780 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Hepatitis acute	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Liver disorder	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Non-alcoholic steatohepatitis	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Portal hypertension	Hepatobiliary disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0011 affected780 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0004 affected765 at risk EG0014 affected780 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected765 at risk EG0011 affected780 at risk
Foot deformity	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected765 at risk EG0010 affected780 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0012 affected780 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected765 at risk EG0012 affected780 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0011 affected780 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Cervical spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Chondrocalcinosis pyrophosphate	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Intervertebral disc disorder	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Muscle twitching	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Synovitis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0012 affected780 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0012 affected780 at risk
Renal failure	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0012 affected780 at risk
Bladder prolapse	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Calculus ureteric	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0011 affected780 at risk
Haematuria	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Renal cyst	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Urinary tract obstruction	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 18.0	Systematic Assessment	EG0004 affected765 at risk EG0013 affected780 at risk
Menorrhagia	Reproductive system and breast disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected765 at risk EG0010 affected780 at risk
Balanoposthitis	Reproductive system and breast disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Dysfunctional uterine bleeding	Reproductive system and breast disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Endometrial hyperplasia	Reproductive system and breast disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Metrorrhagia	Reproductive system and breast disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Prostatism	Reproductive system and breast disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Uterine prolapse	Reproductive system and breast disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0011 affected780 at risk
Vaginal prolapse	Reproductive system and breast disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Phimosis	Congenital, familial and genetic disorders	MedDRA 18.0	Systematic Assessment	EG0002 affected765 at risk EG0010 affected780 at risk
Chest pain	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0015 affected780 at risk
Non-cardiac chest pain	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0012 affected780 at risk
Cyst	General disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Hernia	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Multi-organ failure	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Pain	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Pyrexia	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0011 affected780 at risk
Sudden death	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Liver function test abnormal	Investigations	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0008 affected765 at risk EG0011 affected780 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0003 affected765 at risk EG0011 affected780 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0002 affected765 at risk EG0010 affected780 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0002 affected765 at risk EG0011 affected780 at risk
Incisional hernia	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0012 affected780 at risk
Meniscus injury	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0012 affected780 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0012 affected780 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0012 affected780 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0002 affected765 at risk EG0010 affected780 at risk
Traumatic fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0002 affected765 at risk EG0011 affected780 at risk
Burns third degree	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Comminuted fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Foreign body	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Jaw fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Ligament sprain	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Muscle rupture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Post procedural constipation	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Procedural headache	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Soft tissue injury	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Arrhythmia prophylaxis	Surgical and medical procedures	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Cholecystectomy	Surgical and medical procedures	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Hip arthroplasty	Surgical and medical procedures	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Hysterectomy	Surgical and medical procedures	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0011 affected780 at risk
Knee arthroplasty	Surgical and medical procedures	MedDRA 18.0	Systematic Assessment	EG0000 affected765 at risk EG0011 affected780 at risk
Omentectomy	Surgical and medical procedures	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk
Oophorectomy bilateral	Surgical and medical procedures	MedDRA 18.0	Systematic Assessment	EG0001 affected765 at risk EG0010 affected780 at risk

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

ID	Title	Description
BG000	Empaglifozin 25 mg	Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily. Empagliflozin: 25 mg once daily Placebo: Placebo matching Glimepiride
BG001	Glimepiride	Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily. Glimepiride: 1-4 mg once daily Placebo: Placebo matching Empagliflozin
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Empa 25mg	Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily. Empagliflozin: 25 mg once daily Placebo: Placebo matching Glimepiride			161	765	580	765
EG001	Glimepiride	Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily. Glimepiride: 1-4 mg once daily Placebo: Placebo matching Empagliflozin			153	780	637	780

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Urinary tract infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG000137 affected765 at risk EG001121 affected780 at risk
Nasopharyngitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG00090 affected765 at risk EG001106 affected780 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG000103 affected765 at risk EG00197 affected780 at risk
Influenza	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG00071 affected765 at risk EG00173 affected780 at risk
Bronchitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG00034 affected765 at risk EG00164 affected780 at risk
Gastroenteritis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG00038 affected765 at risk EG00147 affected780 at risk
Pharyngitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG00042 affected765 at risk EG00144 affected780 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG00041 affected765 at risk EG001228 affected780 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG000152 affected765 at risk EG001227 affected780 at risk
Dyslipidaemia	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG00051 affected765 at risk EG00148 affected780 at risk
Headache	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG00059 affected765 at risk EG00168 affected780 at risk
Dizziness	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG00062 affected765 at risk EG00167 affected780 at risk
Hypertension	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG00055 affected765 at risk EG001105 affected780 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG00053 affected765 at risk EG00162 affected780 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG00062 affected765 at risk EG00167 affected780 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG00093 affected765 at risk EG00190 affected780 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG00070 affected765 at risk EG00186 affected780 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG00051 affected765 at risk EG00150 affected780 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG00043 affected765 at risk EG00143 affected780 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG00023 affected765 at risk EG00141 affected780 at risk