Efficacy and Safety of BI 1356 in Combination With Metfor... | NCT00622284

ID	Type	Description	Link
2007-004585-40	EudraCT Number	EudraCT

Label	Type	Description	Intervention Names
BI 1356 5mg, once daily	Experimental	patient to receive a tablet containing 5mg BI 1356 plus one (two in US) inactive placebo capsule matching Glimepiride	Drug: Placebo identical to Glimepiride 1mg or 2mg or 3mg or 4 mg Drug: BI 1356
Glimepiride	Active Comparator	patient to receive 1mg or 2mg or 3mg (not in US) or 4mg Glimepiride capsule plus one inactive placebo tablet matching BI 1356 (plus one inactive placebo capsule in US)	Drug: Placebo identical to BI 1356 5mg Drug: Glimepiride

Name	Type	Description	Arm Group Labels	Other Names
Placebo identical to BI 1356 5mg	Drug	Placebo tablet once daily	Glimepiride

Measure	Description	Time Frame
HbA1c Change From Baseline at Week 52	This co-primary endpoint, change from baseline, reflects the Week 52 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications.	Baseline and week 52
HbA1c Change From Baseline at Week 104	This co-primary endpoint, change from baseline, reflects the Week 104 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications.	Baseline and week 104

Measure	Description	Time Frame
Body Weight Change From Baseline at Week 52	This key secondary endpoint, change from baseline, reflects the Week 52 body weight minus the baseline body weight. Means are treatment adjusted for baseline HbA1c, baseline weight and the number of previous antidiabetic-medications.	Baseline and week 52
Body Weight Change From Baseline at Week 104

Name	Affiliation	Role
Boehringer Ingelheim	Boehringer Ingelheim	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
1218.20.10033 Boehringer Ingelheim Investigational Site		Tempe	Arizona		United States
1218.20.10003 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.
23521323

Label	URL
Related Info	View source

ID	Title	Description
FG000	Linagliptin	Patients randomized to receive Linagliptin 5mg and metformin
FG001	Glimepiride	Patients randomized to receive Glimepiride 1-4mg and metformin

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

HbA1c Change From Baseline at Week 52

This co-primary endpoint, change from baseline, reflects the Week 52 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications.

The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement. Last observation carried forward (LOCF) was used as imputation rule.

Posted

Mean

Standard Error

Percent

Baseline and week 52

ID	Title	Description
OG000	Linagliptin	Patients randomized to receive Linagliptin 5mg and metformin
OG001	Glimepiride	Patients randomized to receive Glimepiride 1-4mg and metformin

Units	Counts
Participants	OG000764 OG001755

Title

Denominators

Categories

Title	Measurements
	OG000-0.36± 0.03 OG001-0.57± 0.03

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	Linagliptin versus Glimepiride	ANCOVA		0.0005	Due to multiple testing of the primary endpoints at weeks 52 and 104 a Bonferroni correction was applied and 97.5% confidence intervals produced. This 1-sided p-value for non-inferiority should be compared to the 1-sided threshold of 0.0125.	Least Squares Mean Difference	0.22	Standard Error of the Mean	0.04		97.5	0.13	0.31				Yes	Non-Inferiority or Equivalence	The null hypothesis of non-inferiority is rejected if the upper bound of the two-sided 97.5% confidence interval is less than 0.35%. Superiority testing was not part of the pre-specified Week 52 confirmatory analysis.

Primary

HbA1c Change From Baseline at Week 104

This co-primary endpoint, change from baseline, reflects the Week 104 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and the number of previous anti-diabetic medications.

Posted

Mean

Standard Error

Percent

Baseline and week 104

ID	Title	Description
OG000	Linagliptin	Patients randomized to receive Linagliptin 5mg and metformin
OG001	Glimepiride	Patients randomized to receive Glimepiride 1-4mg and metformin

Units	Counts
Participants	OG000

Secondary

Body Weight Change From Baseline at Week 52

This key secondary endpoint, change from baseline, reflects the Week 52 body weight minus the baseline body weight. Means are treatment adjusted for baseline HbA1c, baseline weight and the number of previous antidiabetic-medications.

This population includes the FAS further restricted to patients with a baseline body weight and one on-treatment body weight measurement. Last observation carried forward (LOCF) was used as imputation rule.

Posted

Mean

Standard Error

Baseline and week 52

ID	Title	Description
OG000	Linagliptin	Patients randomized to receive Linagliptin 5mg and metformin
OG001	Glimepiride	Patients randomized to receive Glimepiride 1-4mg and metformin

Units	Counts
Participants	OG000

Secondary

Body Weight Change From Baseline at Week 104

This key secondary endpoint, change from baseline, reflects the Week 104 body weight minus the baseline body weight. Means are treatment adjusted for baseline HbA1c, baseline weight and the number of previous antidiabetic-medications.

Posted

Mean

Standard Error

Baseline and week 104

ID	Title	Description
OG000	Linagliptin	Patients randomized to receive Linagliptin 5mg and metformin
OG001	Glimepiride	Patients randomized to receive Glimepiride 1-4mg and metformin

Units	Counts
Participants	OG000

Secondary

Incidence of Hypoglycaemic Events up to 52 Weeks

A hypoglycaemic event is defined as patient showing clinical signs suggestive of low blood glucose confirmed by a home blood glucose monitoring (HBGM) of below 55 mg/dl (3.1 mmol/L)

The treated set consisted of all patients treated with at least one dose of study drug

Posted

Number

Patients

Week 52

ID	Title	Description
OG000	Linagliptin	Patients randomized to receive Linagliptin 5mg and metformin
OG001	Glimepiride	Patients randomized to receive Glimepiride 1-4mg and metformin

Units	Counts
Participants	OG000

Secondary

Incidence of Hypoglycaemic Events up to 104 Weeks

A hypoglycaemic event is defined as patient showing clinical signs suggestive of low blood glucose confirmed by a HBGM of below 55 mg/dl (3.1 mmol/L)

The treated set consisted of all patients treated with at least one dose of study drug

Posted

Number

Patients

Week 104

ID	Title	Description
OG000	Linagliptin	Patients randomized to receive Linagliptin 5mg and metformin
OG001	Glimepiride	Patients randomized to receive Glimepiride 1-4mg and metformin

Units	Counts
Participants	OG000

Secondary

Fasting Plasma Glucose (FPG) Change From Baseline at Week 52

This change from baseline reflects the Week 52 FPG minus the Baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and the number of previous anti-diabetic medications.

This population includes the FAS further restricted to patients with a baseline FPG and one on-treatment FPG measurement. Last observation carried forward (LOCF) was used as imputation rule.

Posted

Mean

Standard Error

mg/dL

Baseline and week 52

ID	Title	Description
OG000	Linagliptin	Patients randomized to receive Linagliptin 5mg and metformin
OG001	Glimepiride	Patients randomized to receive Glimepiride 1-4mg and metformin

Units	Counts
Participants	OG000

Secondary

Fasting Plasma Glucose (FPG) Change From Baseline at Week 104

This change from baseline reflects the Week 104 FPG minus the Baseline FPG. Means are treatment adjusted for baseline HbA1c, baseline FPG and number of previous anti-diabetic medications.

This population includes the FAS further restricted to patients with a baseline FPG and one on-treatment FPG measurement. Last observation carried forward (LOCF) was used as imputation rule.

Posted

Mean

Standard Error

mg/dL

Baseline and week 104

ID	Title	Description
OG000	Linagliptin	Patients randomized to receive Linagliptin 5mg and metformin
OG001	Glimepiride	Patients randomized to receive Glimepiride 1-4mg and metformin

Units	Counts
Participants	OG000

Secondary

Percentage of Patients With HbA1c <7.0% at Week 52

The percentage of patients with an HbA1c value below 7.0% at week 52, based upon patients with baseline HbA1c >= 7%. If a patient did not have an HbA1c value at week 52 they were considered a failure, so HbA1c >= 7.0%. The logistic regression is treatment adjusted for baseline HbA1c and number of previous anti-diabetic medications.

Full analysis set (FAS) patients with non-completers considered as failures (i.e., non-responders) (NCF) and with baseline HbA1c >=7.0%.

Posted

Number

Percentage of patients

Week 52

ID	Title	Description
OG000	Linagliptin	Patients randomized to receive Linagliptin 5mg and metformin
OG001	Glimepiride	Patients randomized to receive Glimepiride 1-4mg and metformin

Units	Counts
Participants	OG000

Secondary

Percentage of Patients With HbA1c <7.0% at Week 104

The percentage of patients with an HbA1c value below 7.0% at week 104, based upon patients with baseline HbA1c >= 7%. If a patient did not have an HbA1c value at week 104 they were considered a failure, so HbA1c >= 7.0%. The logistic regression is treatment adjusted for baseline HbA1c and number of previous anti-diabetic medications.

Full analysis set (FAS) patients with non-completers considered as failures (i.e., non-responders) (NCF) and with baseline HbA1c >=7.0%.

Posted

Number

Percentage of patients

Week 104

ID	Title	Description
OG000	Linagliptin	Patients randomized to receive Linagliptin 5mg and metformin
OG001	Glimepiride	Patients randomized to receive Glimepiride 1-4mg and metformin

Units	Counts
Participants	OG000

Secondary

Percentage of Patients With HbA1c <6.5% at Week 52

The percentage of patients with an HbA1c value below 6.5% at week 52, based upon patients with baseline HbA1c >= 6.5%. If a patient did not have an HbA1c value at week 52 they were considered a failure, so HbA1c >= 6.5%. The logistic regression is treatment adjusted for baseline HbA1c and number of previous anti-diabetic medications.

Full analysis set (FAS) patients with non-completers considered as failures (i.e., non-responders) (NCF) and with baseline HbA1c >=6.5%.

Posted

Number

Percentage of patients

Week 52

ID	Title	Description
OG000	Linagliptin	Patients randomized to receive Linagliptin 5mg and metformin
OG001	Glimepiride	Patients randomized to receive Glimepiride 1-4mg and metformin

Units	Counts
Participants	OG000

Secondary

Percentage of Patients With HbA1c <6.5% at Week 104

The percentage of patients with an HbA1c value below 6.5% at week 104, based upon patients with baseline HbA1c >= 6.5%. If a patient did not have an HbA1c value at week 104 they were considered a failure, so HbA1c >= 6.5%. The logistic regression is treatment adjusted for baseline HbA1c and number of previous anti-diabetic medications.

Full analysis set (FAS) patients with non-completers considered as failures (i.e., non-responders) (NCF) and with baseline HbA1c >=6.5%.

Posted

Number

Percentage of patients

Week 104

ID	Title	Description
OG000	Linagliptin	Patients randomized to receive Linagliptin 5mg and metformin
OG001	Glimepiride	Patients randomized to receive Glimepiride 1-4mg and metformin

Units	Counts
Participants	OG000

Secondary

Percentage of Patients With HbA1c Lowering by 0.5% at Week 104

Occurrence of relative efficacy response, defined as a lowering of 0.5% HbA1c at week 104

FAS (NCF)

Posted

Number

Percentage of patients

Week 104

ID	Title	Description
OG000	Linagliptin	Patients randomized to receive Linagliptin 5mg and metformin
OG001	Glimepiride	Patients randomized to receive Glimepiride 1-4mg and metformin

Units	Counts
Participants	OG000

Secondary

2 hr Postprandial Glucose (PPG) Change From Baseline at Week 104

This change from baseline reflects the Week 104 2 hr PPG minus the Baseline 2hr PPG. Means are treatment adjusted for baseline HbA1c, baseline 2hr PPG and number of previous anti-diabetic medications.

Patients in the FAS with a valid meal tolerance test (MTT) at baseline and at least one valid on-treatment MTT (MTT104).

Posted

Mean

Standard Error

mg/dL

Baseline and week 104

ID	Title	Description
OG000	Linagliptin	Patients randomized to receive Linagliptin 5mg and metformin
OG001	Glimepiride	Patients randomized to receive Glimepiride 1-4mg and metformin

Units	Counts
Participants	OG000

Secondary

HbA1c Change at Week 4

Difference of base percent value [Week x(%) - baseline (%)]

Posted

Mean

Standard Deviation

Percent

Baseline and week 4

ID	Title	Description
OG000	Linagliptin	Patients randomized to receive Linagliptin 5mg and metformin
OG001	Glimepiride	Patients randomized to receive Glimepiride 1-4mg and metformin

Units	Counts
Participants	OG000

Secondary

HbA1c Change at Week 8

Posted

Mean

Standard Deviation

Percent

Baseline and week 8

ID	Title	Description
OG000	Linagliptin	Patients randomized to receive Linagliptin 5mg and metformin
OG001	Glimepiride	Patients randomized to receive Glimepiride 1-4mg and metformin

Units	Counts
Participants	OG000

Secondary

HbA1c Change at Week 12

Posted

Mean

Standard Deviation

Percent

Baseline and week 12

ID	Title	Description
OG000	Linagliptin	Patients randomized to receive Linagliptin 5mg and metformin
OG001	Glimepiride	Patients randomized to receive Glimepiride 1-4mg and metformin

Units	Counts
Participants	OG000

Secondary

HbA1c Change at Week 16

Posted

Mean

Standard Deviation

Percent

Baseline and week 16

ID	Title	Description
OG000	Linagliptin	Patients randomized to receive Linagliptin 5mg and metformin
OG001	Glimepiride	Patients randomized to receive Glimepiride 1-4mg and metformin

Units	Counts
Participants	OG000

Secondary

HbA1c Change at Week 28

Posted

Mean

Standard Deviation

Percent

Baseline and week 28

ID	Title	Description
OG000	Linagliptin	Patients randomized to receive Linagliptin 5mg and metformin
OG001	Glimepiride	Patients randomized to receive Glimepiride 1-4mg and metformin

Units	Counts
Participants	OG000

Secondary

HbA1c Change at Week 40

Posted

Mean

Standard Deviation

Percent

Baseline and week 40

ID	Title	Description
OG000	Linagliptin	Patients randomized to receive Linagliptin 5mg and metformin
OG001	Glimepiride	Patients randomized to receive Glimepiride 1-4mg and metformin

Units	Counts
Participants	OG000

Secondary

HbA1c Change at Week 52

Posted

Mean

Standard Deviation

Percent

Baseline and week 52

ID	Title	Description
OG000	Linagliptin	Patients randomized to receive Linagliptin 5mg and metformin
OG001	Glimepiride	Patients randomized to receive Glimepiride 1-4mg and metformin

Units	Counts
Participants	OG000

Secondary

HbA1c Change at Week 65

Posted

Mean

Standard Deviation

Percent

Baseline and week 65

ID	Title	Description
OG000	Linagliptin	Patients randomized to receive Linagliptin 5mg and metformin
OG001	Glimepiride	Patients randomized to receive Glimepiride 1-4mg and metformin

Units	Counts
Participants	OG000

Secondary

HbA1c Change at Week 78

Posted

Mean

Standard Deviation

Percent

Baseline and week 78

ID	Title	Description
OG000	Linagliptin	Patients randomized to receive Linagliptin 5mg and metformin
OG001	Glimepiride	Patients randomized to receive Glimepiride 1-4mg and metformin

Units	Counts
Participants	OG000

Secondary

HbA1c Change at Week 91

Posted

Mean

Standard Deviation

Percent

Baseline and week 91

ID	Title	Description
OG000	Linagliptin	Patients randomized to receive Linagliptin 5mg and metformin
OG001	Glimepiride	Patients randomized to receive Glimepiride 1-4mg and metformin

Units	Counts
Participants	OG000

Secondary

HbA1c Change at Week 104

The Full Analysis Set (FAS) included all treated and randomized patients with a baseline and at least one on-treatment HbA1c measurement available during the first phase of the study. Last observation carried forward (LOCF) was used as imputation rule.

Posted

Mean

Standard Deviation

Percent

Baseline and week 104

ID	Title	Description
OG000	Linagliptin	Patients randomized to receive Linagliptin 5mg and metformin
OG001	Glimepiride	Patients randomized to receive Glimepiride 1-4mg and metformin

Units	Counts
Participants	OG000

Secondary

Change in Baseline Lipid Parameter Cholesterol at Week 104

This population includes the treated set (all patients treated with at least one dose of study drug), and non-missing laboratory data.

Posted

Mean

Standard Deviation

mg/dL

Baseline and week 104

ID	Title	Description
OG000	Linagliptin	Patients randomized to receive Linagliptin 5mg and metformin
OG001	Glimepiride	Patients randomized to receive Glimepiride 1-4mg and metformin

Units	Counts
Participants	OG000

Secondary

Change in Baseline Lipid Parameter HDL at Week 104

This population includes the treated set (all patients treated with at least one dose of study drug), and non-missing laboratory data.

Posted

Mean

Standard Deviation

mg/dl

Baseline and week 104

ID	Title	Description
OG000	Linagliptin	Patients randomized to receive Linagliptin 5mg and metformin
OG001	Glimepiride	Patients randomized to receive Glimepiride 1-4mg and metformin

Units	Counts
Participants	OG000

Secondary

Change in Baseline Lipid Parameter Low Density Lipoprotein (LDL) at Week 104

This population includes the treated set (all patients treated with at least one dose of study drug), and non-missing laboratory data.

Posted

Mean

Standard Deviation

mg/dL

Baseline and week 104

ID	Title	Description
OG000	Linagliptin	Patients randomized to receive Linagliptin 5mg and metformin
OG001	Glimepiride	Patients randomized to receive Glimepiride 1-4mg and metformin

Units	Counts
Participants	OG000

Secondary

Change in Baseline Lipid Parameter Triglyceride at Week 104

This population includes the treated set (all patients treated with at least one dose of study drug), and non-missing laboratory data.

Posted

Mean

Standard Deviation

mg/dL

Baseline and week 104

ID	Title	Description
OG000	Linagliptin	Patients randomized to receive Linagliptin 5mg and metformin
OG001	Glimepiride	Patients randomized to receive Glimepiride 1-4mg and metformin

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	13.1	Systematic Assessment	EG0003 affected776 at risk EG0011 affected775 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Lymphadenopathy	Blood and lymphatic system disorders	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Acute coronary syndrome	Cardiac disorders	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Acute myocardial infarction	Cardiac disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0014 affected775 at risk
Angina pectoris	Cardiac disorders	13.1	Systematic Assessment	EG0005 affected776 at risk EG0014 affected775 at risk
Angina unstable	Cardiac disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0011 affected775 at risk
Aortic valve disease	Cardiac disorders	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Aortic valve stenosis	Cardiac disorders	13.1	Systematic Assessment	EG0000 affected776 at risk EG0012 affected775 at risk
Arrhythmia	Cardiac disorders	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Arteriosclerosis coronary artery	Cardiac disorders	13.1	Systematic Assessment	EG0003 affected776 at risk EG0011 affected775 at risk
Arteriospasm coronary	Cardiac disorders	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Atrial fibrillation	Cardiac disorders	13.1	Systematic Assessment	EG0003 affected776 at risk EG0012 affected775 at risk
Atrial flutter	Cardiac disorders	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Atrioventricular block	Cardiac disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Bradyarrhythmia	Cardiac disorders	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Bradycardia	Cardiac disorders	13.1	Systematic Assessment	EG0002 affected776 at risk EG0010 affected775 at risk
Cardiac failure	Cardiac disorders	13.1	Systematic Assessment	EG0003 affected776 at risk EG0012 affected775 at risk
Cardio-respiratory arrest	Cardiac disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Congestive cardiomyopathy	Cardiac disorders	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Coronary artery disease	Cardiac disorders	13.1	Systematic Assessment	EG0005 affected776 at risk EG0016 affected775 at risk
Coronary artery stenosis	Cardiac disorders	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Ischaemic cardiomyopathy	Cardiac disorders	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Mitral valve disease mixed	Cardiac disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Myocardial infarction	Cardiac disorders	13.1	Systematic Assessment	EG0004 affected776 at risk EG0016 affected775 at risk
Pericarditis constrictive	Cardiac disorders	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Sinoatrial block	Cardiac disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Central nervous system dermoid tumour	Congenital, familial and genetic disorders	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Hydrocele	Congenital, familial and genetic disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0011 affected775 at risk
Hypoacusis	Ear and labyrinth disorders	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Vertigo	Ear and labyrinth disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0012 affected775 at risk
Goitre	Endocrine disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0012 affected775 at risk
Hyperthyroidism	Endocrine disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Cataract	Eye disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0011 affected775 at risk
Glaucoma	Eye disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0011 affected775 at risk
Optic disc haemorrhage	Eye disorders	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Optic neuropathy	Eye disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Retinal degeneration	Eye disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Retinal haemorrhage	Eye disorders	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Abdominal pain upper	Gastrointestinal disorders	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Anal prolapse	Gastrointestinal disorders	13.1	Systematic Assessment	EG0002 affected776 at risk EG0010 affected775 at risk
Colitis	Gastrointestinal disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Colonic polyp	Gastrointestinal disorders	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Colonic stenosis	Gastrointestinal disorders	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Constipation	Gastrointestinal disorders	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Diarrhoea	Gastrointestinal disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0011 affected775 at risk
Diverticulum intestinal	Gastrointestinal disorders	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Duodenal ulcer haemorrhage	Gastrointestinal disorders	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Gastric polyps	Gastrointestinal disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Gastritis	Gastrointestinal disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0011 affected775 at risk
Gastritis erosive	Gastrointestinal disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Haemorrhoids	Gastrointestinal disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Inguinal hernia	Gastrointestinal disorders	13.1	Systematic Assessment	EG0000 affected776 at risk EG0013 affected775 at risk
Intestinal obstruction	Gastrointestinal disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Lip swelling	Gastrointestinal disorders	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Oesophageal food impaction	Gastrointestinal disorders	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Rectal haemorrhage	Gastrointestinal disorders	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Rectal stenosis	Gastrointestinal disorders	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Umbilical hernia	Gastrointestinal disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Chest pain	General disorders	13.1	Systematic Assessment	EG0002 affected776 at risk EG0011 affected775 at risk
Drowning	General disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Fatigue	General disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Mass	General disorders	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Medical device complication	General disorders	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Non-cardiac chest pain	General disorders	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Sudden cardiac death	General disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0011 affected775 at risk
Cholangitis	Hepatobiliary disorders	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Cholecystitis	Hepatobiliary disorders	13.1	Systematic Assessment	EG0002 affected776 at risk EG0012 affected775 at risk
Cholelithiasis	Hepatobiliary disorders	13.1	Systematic Assessment	EG0003 affected776 at risk EG0013 affected775 at risk
Gallbladder polyp	Hepatobiliary disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Hepatic steatosis	Hepatobiliary disorders	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Allergy to arthropod bite	Immune system disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Anaphylactic reaction	Immune system disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Sarcoidosis	Immune system disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Abdominal infection	Infections and infestations	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Abscess intestinal	Infections and infestations	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Abscess limb	Infections and infestations	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Appendicitis	Infections and infestations	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Arthritis bacterial	Infections and infestations	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Arthritis infective	Infections and infestations	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Balanitis candida	Infections and infestations	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Bronchitis	Infections and infestations	13.1	Systematic Assessment	EG0002 affected776 at risk EG0011 affected775 at risk
Chronic sinusitis	Infections and infestations	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Cystitis	Infections and infestations	13.1	Systematic Assessment	EG0001 affected776 at risk EG0011 affected775 at risk
Diverticulitis	Infections and infestations	13.1	Systematic Assessment	EG0000 affected776 at risk EG0013 affected775 at risk
Erysipelas	Infections and infestations	13.1	Systematic Assessment	EG0002 affected776 at risk EG0012 affected775 at risk
Escherichia sepsis	Infections and infestations	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Gangrene	Infections and infestations	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Gastroenteritis	Infections and infestations	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Klebsiella sepsis	Infections and infestations	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Localised infection	Infections and infestations	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Lung infection	Infections and infestations	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Malaria	Infections and infestations	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Mastitis	Infections and infestations	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Osteomyelitis	Infections and infestations	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Otitis media chronic	Infections and infestations	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Peritonsillar abscess	Infections and infestations	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Pneumonia	Infections and infestations	13.1	Systematic Assessment	EG0005 affected776 at risk EG0014 affected775 at risk
Pulmonary tuberculosis	Infections and infestations	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Pyelonephritis	Infections and infestations	13.1	Systematic Assessment	EG0001 affected776 at risk EG0011 affected775 at risk
Sepsis	Infections and infestations	13.1	Systematic Assessment	EG0001 affected776 at risk EG0012 affected775 at risk
Sinusitis	Infections and infestations	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Skin infection	Infections and infestations	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Soft tissue infection	Infections and infestations	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Subcutaneous abscess	Infections and infestations	13.1	Systematic Assessment	EG0000 affected776 at risk EG0013 affected775 at risk
Tonsillitis	Infections and infestations	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Urinary tract infection	Infections and infestations	13.1	Systematic Assessment	EG0001 affected776 at risk EG0011 affected775 at risk
Accident	Injury, poisoning and procedural complications	13.1	Systematic Assessment	EG0002 affected776 at risk EG0010 affected775 at risk
Ankle fracture	Injury, poisoning and procedural complications	13.1	Systematic Assessment	EG0002 affected776 at risk EG0012 affected775 at risk
Arthropod bite	Injury, poisoning and procedural complications	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Avulsion fracture	Injury, poisoning and procedural complications	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Concussion	Injury, poisoning and procedural complications	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Contusion	Injury, poisoning and procedural complications	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Fall	Injury, poisoning and procedural complications	13.1	Systematic Assessment	EG0003 affected776 at risk EG0012 affected775 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Femoral nerve injury	Injury, poisoning and procedural complications	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Fibula fracture	Injury, poisoning and procedural complications	13.1	Systematic Assessment	EG0002 affected776 at risk EG0010 affected775 at risk
Foot fracture	Injury, poisoning and procedural complications	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Humerus fracture	Injury, poisoning and procedural complications	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Joint sprain	Injury, poisoning and procedural complications	13.1	Systematic Assessment	EG0003 affected776 at risk EG0010 affected775 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Meniscus lesion	Injury, poisoning and procedural complications	13.1	Systematic Assessment	EG0000 affected776 at risk EG0012 affected775 at risk
Post procedural complication	Injury, poisoning and procedural complications	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Post procedural discharge	Injury, poisoning and procedural complications	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Road traffic accident	Injury, poisoning and procedural complications	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Suture related complication	Injury, poisoning and procedural complications	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Tendon rupture	Injury, poisoning and procedural complications	13.1	Systematic Assessment	EG0000 affected776 at risk EG0012 affected775 at risk
Ulna fracture	Injury, poisoning and procedural complications	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Upper limb fracture	Injury, poisoning and procedural complications	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Alanine aminotransferase increased	Investigations	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Aspartate aminotransferase increased	Investigations	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Blood alkaline phosphatase increased	Investigations	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Gamma-glutamyltransferase increased	Investigations	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Dehydration	Metabolism and nutrition disorders	13.1	Systematic Assessment	EG0002 affected776 at risk EG0011 affected775 at risk
Gout	Metabolism and nutrition disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Hyperglycaemia	Metabolism and nutrition disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0011 affected775 at risk
Hypoglycaemia	Metabolism and nutrition disorders	13.1	Systematic Assessment	EG0000 affected776 at risk EG0013 affected775 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	13.1	Systematic Assessment	EG0003 affected776 at risk EG0012 affected775 at risk
Arthritis	Musculoskeletal and connective tissue disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0011 affected775 at risk
Back pain	Musculoskeletal and connective tissue disorders	13.1	Systematic Assessment	EG0003 affected776 at risk EG0010 affected775 at risk
Chondropathy	Musculoskeletal and connective tissue disorders	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Foot deformity	Musculoskeletal and connective tissue disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0012 affected775 at risk
Intervertebral disc disorder	Musculoskeletal and connective tissue disorders	13.1	Systematic Assessment	EG0000 affected776 at risk EG0013 affected775 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0011 affected775 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	13.1	Systematic Assessment	EG0005 affected776 at risk EG0016 affected775 at risk
Periarthritis	Musculoskeletal and connective tissue disorders	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Pseudarthrosis	Musculoskeletal and connective tissue disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Spinal disorder	Musculoskeletal and connective tissue disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Benign muscle neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	13.1	Systematic Assessment	EG0003 affected776 at risk EG0012 affected775 at risk
Breast cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Breast cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	13.1	Systematic Assessment	EG0002 affected776 at risk EG0010 affected775 at risk
Carcinoid tumour pulmonary	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Cholesteatoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	13.1	Systematic Assessment	EG0001 affected776 at risk EG0012 affected775 at risk
Endometrial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Gastrointestinal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Laryngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Metastases to abdominal cavity	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	13.1	Systematic Assessment	EG0001 affected776 at risk EG0011 affected775 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	13.1	Systematic Assessment	EG0002 affected776 at risk EG0010 affected775 at risk
Metastases to lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Metastases to lymph nodes	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Metastases to pleura	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Metastatic bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Osteoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Ovarian cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	13.1	Systematic Assessment	EG0001 affected776 at risk EG0011 affected775 at risk
Pancreatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	13.1	Systematic Assessment	EG0006 affected776 at risk EG0013 affected775 at risk
Prostatic adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	13.1	Systematic Assessment	EG0001 affected776 at risk EG0011 affected775 at risk
Small cell lung cancer stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	13.1	Systematic Assessment	EG0000 affected776 at risk EG0012 affected775 at risk
Vulval cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Agnosia	Nervous system disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Amnesia	Nervous system disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Carotid artery stenosis	Nervous system disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Cerebral haemorrhage	Nervous system disorders	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Cerebral infarction	Nervous system disorders	13.1	Systematic Assessment	EG0000 affected776 at risk EG0014 affected775 at risk
Cerebral ischaemia	Nervous system disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Cerebrovascular accident	Nervous system disorders	13.1	Systematic Assessment	EG0002 affected776 at risk EG0016 affected775 at risk
Cubital tunnel syndrome	Nervous system disorders	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Diabetic neuropathy	Nervous system disorders	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Dizziness	Nervous system disorders	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Guillain-Barre syndrome	Nervous system disorders	13.1	Systematic Assessment	EG0000 affected776 at risk EG0012 affected775 at risk
Hepatic encephalopathy	Nervous system disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Hydrocephalus	Nervous system disorders	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Hypoaesthesia	Nervous system disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Ischaemic stroke	Nervous system disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Monoparesis	Nervous system disorders	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Myelopathy	Nervous system disorders	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Nerve compression	Nervous system disorders	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Parkinson's disease	Nervous system disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Sciatica	Nervous system disorders	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Syncope	Nervous system disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0011 affected775 at risk
Transient global amnesia	Nervous system disorders	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Transient ischaemic attack	Nervous system disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0015 affected775 at risk
VIIth nerve paralysis	Nervous system disorders	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Confusional state	Psychiatric disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0011 affected775 at risk
Delirium tremens	Psychiatric disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Depression	Psychiatric disorders	13.1	Systematic Assessment	EG0002 affected776 at risk EG0012 affected775 at risk
Paranoia	Psychiatric disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Acute prerenal failure	Renal and urinary disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Calculus ureteric	Renal and urinary disorders	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Calculus urinary	Renal and urinary disorders	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Haematuria	Renal and urinary disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0011 affected775 at risk
Hydronephrosis	Renal and urinary disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0011 affected775 at risk
Hypertonic bladder	Renal and urinary disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Nephrolithiasis	Renal and urinary disorders	13.1	Systematic Assessment	EG0002 affected776 at risk EG0013 affected775 at risk
Renal colic	Renal and urinary disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0014 affected775 at risk
Renal failure	Renal and urinary disorders	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Renal failure acute	Renal and urinary disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0012 affected775 at risk
Stress urinary incontinence	Renal and urinary disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Ureteric stenosis	Renal and urinary disorders	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Urinary incontinence	Renal and urinary disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Urinary retention	Renal and urinary disorders	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Cystocele	Reproductive system and breast disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Endometrial hyperplasia	Reproductive system and breast disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0011 affected775 at risk
Endometriosis	Reproductive system and breast disorders	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Haemorrhagic ovarian cyst	Reproductive system and breast disorders	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Menorrhagia	Reproductive system and breast disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Ovarian mass	Reproductive system and breast disorders	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Pelvic pain	Reproductive system and breast disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Penile curvature	Reproductive system and breast disorders	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Postmenopausal haemorrhage	Reproductive system and breast disorders	13.1	Systematic Assessment	EG0002 affected776 at risk EG0010 affected775 at risk
Prostatism	Reproductive system and breast disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Prostatomegaly	Reproductive system and breast disorders	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Urogenital prolapse	Reproductive system and breast disorders	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Vaginal cyst	Reproductive system and breast disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Vaginal discharge	Reproductive system and breast disorders	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	13.1	Systematic Assessment	EG0003 affected776 at risk EG0010 affected775 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	13.1	Systematic Assessment	EG0000 affected776 at risk EG0012 affected775 at risk
Hydrothorax	Respiratory, thoracic and mediastinal disorders	13.1	Systematic Assessment	EG0000 affected776 at risk EG0012 affected775 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Nasal septum deviation	Respiratory, thoracic and mediastinal disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Nasal turbinate hypertrophy	Respiratory, thoracic and mediastinal disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Diabetic ulcer	Skin and subcutaneous tissue disorders	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Hypertrophic scar	Skin and subcutaneous tissue disorders	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Pemphigoid	Skin and subcutaneous tissue disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0011 affected775 at risk
Coronary artery bypass	Surgical and medical procedures	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Hip arthroplasty	Surgical and medical procedures	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Aortic aneurysm	Vascular disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Arterial occlusive disease	Vascular disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Arterial stenosis	Vascular disorders	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Blood pressure inadequately controlled	Vascular disorders	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Deep vein thrombosis	Vascular disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0011 affected775 at risk
Hypertensive crisis	Vascular disorders	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk
Hypotension	Vascular disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Peripheral arterial occlusive disease	Vascular disorders	13.1	Systematic Assessment	EG0002 affected776 at risk EG0012 affected775 at risk
Peripheral embolism	Vascular disorders	13.1	Systematic Assessment	EG0001 affected776 at risk EG0010 affected775 at risk
Peripheral vascular disorder	Vascular disorders	13.1	Systematic Assessment	EG0000 affected776 at risk EG0011 affected775 at risk

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

ID	Term
D011687	Purines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds
D011799	Quinazolines

ID	Title	Description
BG000	Linagliptin	Patients randomized to receive Linagliptin 5mg and metformin
BG001	Glimepiride	Patients randomized to receive Glimepiride 1-4mg and metformin
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	Linagliptin	Patients randomized to receive Linagliptin 5mg and metformin			135	776	438	776
EG001	Glimepiride	Patients randomized to receive Glimepiride 1-4mg and metformin			162	775	526	775