Empagliflozin (BI 10773) in Type Two Diabetes (T2D) Patie... | NCT00881530

NCT00881530

ID	Type	Description	Link
2008-007938-21	EudraCT Number	EudraCT

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sitagliptin	Active Comparator	100 mg	Drug: Sitagliptin
Metformin	Active Comparator	2000 mg	Drug: Metformin
BI 10773 X mg	Experimental	lower dose	Drug: BI 10773
BI 10773 Y mg	Experimental	higher dose	Drug: BI 10773

Name	Type	Description	Arm Group Labels	Other Names
BI 10773	Drug	BI 10773 high dose once daily	BI 10773 Y mg
Metformin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hypoglycaemic Events	Investigator defined Hypoglycaemic events. For documentation of hypoglycemic events, the following criteria were taken into consideration: Asymptomatic hypoglycemia: the event was not accompanied by typical symptoms of hypoglycemia but with a measured plasma glucose of ≤70 mg/dL (≤3.9 mmol/L) Documented symptomatic hypoglycemia with glucose of ≥54 mg/dL and ≤70 mg/dL (≥3.0 mmol/L and ≤3.9 mmol/L) Documented symptomatic hypoglycemia with glucose of <54 mg/dL (<3.0 mmol/L): the event was accompanied by typical symptoms of hypoglycemia but in no need for external assistance Severe hypoglycemic episode: the event required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions	78 weeks plus 1 week of follow-up
Change From Baseline to Week 78 in Lipid Parameters	Change from baseline to week 78 in lipid parameters (Total cholesterol, High-density lipoprotein (HDL), Low-density lipoprotein (LDL) and Triglyceride)	Weeks 1 and 78
Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements	Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements. New abnormal findings or worsening of baseline conditions were reported as treatment related Adverse Events.	78 weeks plus 1 week of follow-up

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in HbA1c Over Time	Baseline source: before first intake of active treatment (preceding trial or Open label extension)	Weeks 1, 6, 18, 30, 42, 54, 66 and 78
Occurence of a Treat-to-target Response (HbA1c < 7.0%)

Eligibility Module

Name	Affiliation	Role
Boehringer Ingelheim	Boehringer Ingelheim	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
1245.24.101001 Boehringer Ingelheim Investigational Site		Mission Viejo	California		United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24186878	Derived	Ferrannini E, Berk A, Hantel S, Pinnetti S, Hach T, Woerle HJ, Broedl UC. Long-term safety and efficacy of empagliflozin, sitagliptin, and metformin: an active-controlled, parallel-group, randomized, 78-week open-label extension study in patients with type 2 diabetes. Diabetes Care. 2013 Dec;36(12):4015-21. doi: 10.2337/dc13-0663. Epub 2013 Nov 1.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Empagliflozin 10 mg	Patients receive 10 mg Empagliflozin in tablets once daily.
FG001	Empagliflozin 25 mg	Patients receive 25 mg Empagliflozin in tablets once daily.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Empagliflozin 10 mg	Patients receive 10 mg Empagliflozin in tablets once daily.
BG001	Empagliflozin 25 mg	Patients receive 25 mg Empagliflozin in tablets once daily.
BG002	Metformin	Patients receive between 1000 and 2000 mg Metformin daily as monotherapy. Patients on metformin as active comparator (from trial NCT00789035) were to take their medication according to the instruction of their investigator, continuing the maximum tolerated dose determined in the preceding trial.
BG003	Empagliflozin 10 mg + Metformin	Patients receive 10 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
BG004	Empagliflozin 25 mg + Metformin	Patients receive 25 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
BG005	Sitaglipin + Metformin	Patients receive 100 mg Sitagliptin once daily in tablets added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
BG006	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG0000.9 OG0011.8 OG0027.1 OG003

Primary

Change From Baseline to Week 78 in Lipid Parameters

Change from baseline to week 78 in lipid parameters (Total cholesterol, High-density lipoprotein (HDL), Low-density lipoprotein (LDL) and Triglyceride)

Treated set

Posted

Mean

Standard Deviation

mmol/L

Weeks 1 and 78

ID	Title	Description
OG000	Empagliflozin 10 mg	Patients receive 10 mg Empagliflozin in tablets once daily.
OG001	Empagliflozin 25 mg	Patients receive 25 mg Empagliflozin in tablets once daily.
OG002	Metformin	Patients receive between 1000 and 2000 mg Metformin daily as monotherapy. Patients on metformin as active comparator (from trial NCT00789035) were to take their medication according to the instruction of their investigator, continuing the maximum tolerated dose determined in the preceding trial.
OG003	Empagliflozin 10 mg + Metformin	Patients receive 10 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.

Secondary

Change From Baseline in HbA1c Over Time

Baseline source: before first intake of active treatment (preceding trial or Open label extension)

Treated set

Posted

Mean

Standard Deviation

percentage of HbA1c

Weeks 1, 6, 18, 30, 42, 54, 66 and 78

ID	Title	Description
OG000	Empagliflozin 10 mg	Patients receive 10 mg Empagliflozin in tablets once daily.
OG001	Empagliflozin 25 mg	Patients receive 25 mg Empagliflozin in tablets once daily.
OG002	Metformin	Patients receive between 1000 and 2000 mg Metformin daily as monotherapy. Patients on metformin as active comparator (from trial NCT00789035) were to take their medication according to the instruction of their investigator, continuing the maximum tolerated dose determined in the preceding trial.
OG003	Empagliflozin 10 mg + Metformin	Patients receive 10 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.

Secondary

Occurence of a Treat-to-target Response (HbA1c < 7.0%)

Occurence of a treat-to-target response, defined as HbA1c < 7.0% over time

Treated set

Posted

Number

percentage of participants

Weeks 1, 6, 18, 30, 42, 54, 66 and 78

ID	Title	Description
OG000	Empagliflozin 10 mg	Patients receive 10 mg Empagliflozin in tablets once daily.
OG001	Empagliflozin 25 mg	Patients receive 25 mg Empagliflozin in tablets once daily.
OG002	Metformin	Patients receive between 1000 and 2000 mg Metformin daily as monotherapy. Patients on metformin as active comparator (from trial NCT00789035) were to take their medication according to the instruction of their investigator, continuing the maximum tolerated dose determined in the preceding trial.
OG003	Empagliflozin 10 mg + Metformin	Patients receive 10 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.

Secondary

Occurrence of a Treat-to-target Response (HbA1c < 6.5%)

Occurrence of a Treat-to-target Response, defined as HbA1c < 6.5% over time

Treated set

Posted

Number

percentage of participants

Weeks 1, 6, 18, 30, 42, 54, 66 and 78

ID	Title	Description
OG000	Empagliflozin 10 mg	Patients receive 10 mg Empagliflozin in tablets once daily.
OG001	Empagliflozin 25 mg	Patients receive 25 mg Empagliflozin in tablets once daily.
OG002	Metformin	Patients receive between 1000 and 2000 mg Metformin daily as monotherapy. Patients on metformin as active comparator (from trial NCT00789035) were to take their medication according to the instruction of their investigator, continuing the maximum tolerated dose determined in the preceding trial.
OG003	Empagliflozin 10 mg + Metformin	Patients receive 10 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.

Secondary

Occurrence of a Relative Efficacy Response

Occurrence of a Relative Efficacy Response (HbA1c Lowered by at least >=0.5% over time)

Treated set

Posted

Number

percentage of participants

Weeks 1, 6, 18, 30, 42, 54, 66 and 78

ID	Title	Description
OG000	Empagliflozin 10 mg	Patients receive 10 mg Empagliflozin in tablets once daily.
OG001	Empagliflozin 25 mg	Patients receive 25 mg Empagliflozin in tablets once daily.
OG002	Metformin	Patients receive between 1000 and 2000 mg Metformin daily as monotherapy. Patients on metformin as active comparator (from trial NCT00789035) were to take their medication according to the instruction of their investigator, continuing the maximum tolerated dose determined in the preceding trial.
OG003	Empagliflozin 10 mg + Metformin	Patients receive 10 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.

Secondary

Change From Baseline in Fasting Plasma Glucose (FPG) Over Time

Baseline source: before first intake of active treatment (preceding trial or Open label extension)

Treated set

Posted

Mean

Standard Deviation

mg/dL

Weeks 1, 6, 18, 30, 42, 54, 66 and 78

ID	Title	Description
OG000	Empagliflozin 10 mg	Patients receive 10 mg Empagliflozin in tablets once daily.
OG001	Empagliflozin 25 mg	Patients receive 25 mg Empagliflozin in tablets once daily.
OG002	Metformin	Patients receive between 1000 and 2000 mg Metformin daily as monotherapy. Patients on metformin as active comparator (from trial NCT00789035) were to take their medication according to the instruction of their investigator, continuing the maximum tolerated dose determined in the preceding trial.
OG003	Empagliflozin 10 mg + Metformin	Patients receive 10 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.

Primary

Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements

Clinical Relevant Abnormalities for Physical Examination, Vital Signs, ECG and Laboratory Measurements. New abnormal findings or worsening of baseline conditions were reported as treatment related Adverse Events.

Treated set

Posted

Number

percentage of participants

78 weeks plus 1 week of follow-up

ID	Title	Description
OG000	Empagliflozin 10 mg	Patients receive 10 mg Empagliflozin in tablets once daily.
OG001	Empagliflozin 25 mg	Patients receive 25 mg Empagliflozin in tablets once daily.
OG002	Metformin	Patients receive between 1000 and 2000 mg Metformin daily as monotherapy. Patients on metformin as active comparator (from trial NCT00789035) were to take their medication according to the instruction of their investigator, continuing the maximum tolerated dose determined in the preceding trial.
OG003	Empagliflozin 10 mg + Metformin

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Empagliflozin 10 mg	Patients receive 10 mg Empagliflozin in tablets once daily.	10	106	34	106
EG001	Empagliflozin 25 mg	Patients receive 25 mg Empagliflozin in tablets once daily.	7	109	46	109
EG002	Metformin	Patients receive between 1000 and 2000 mg Metformin daily as monotherapy. Patients on metformin as active comparator (from trial NCT00789035) were to take their medication according to the instruction of their investigator, continuing the maximum tolerated dose determined in the preceding trial.	3	56	27	56
EG003	Empagliflozin 10 mg + Metformin	Patients receive 10 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.	10	166	74	166
EG004	Empagliflozin 25 mg + Metformin	Patients receive 25 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.	13	166	79	166
EG005	Sitaglipin + Metformin	Patients receive 100 mg Sitagliptin once daily in tablets added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.	9	56	26	56

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cellulitis	Infections and infestations	MEDDRA 14.0	Systematic Assessment	EG0000 affected106 at risk EG0011 affected109 at risk EG0020 affected56 at risk EG0030 affected166 at risk EG0040 affected166 at risk EG0050 affected56 at risk
Anal abscess	Infections and infestations	MEDDRA 14.0	Systematic Assessment	EG0000 affected106 at risk EG0010 affected109 at risk EG0020 affected56 at risk EG003
Gastroenteritis	Infections and infestations	MEDDRA 14.0	Systematic Assessment	EG0000 affected106 at risk EG0010 affected109 at risk EG0020 affected56 at risk EG003
Post procedural infection	Infections and infestations	MEDDRA 14.0	Systematic Assessment	EG0000 affected106 at risk EG0010 affected109 at risk EG0020 affected56 at risk EG003
Pneumonia	Infections and infestations	MEDDRA 14.0	Systematic Assessment	EG0000 affected106 at risk EG0010 affected109 at risk EG0020 affected56 at risk EG003
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDDRA 14.0	Systematic Assessment	EG0000 affected106 at risk EG0010 affected109 at risk EG0021 affected56 at risk EG003
Cervix carcinoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDDRA 14.0	Systematic Assessment	EG0000 affected106 at risk EG0010 affected109 at risk EG0020 affected56 at risk EG003
Refractory cytopenia with multilineage dysplasia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDDRA 14.0	Systematic Assessment	EG0000 affected106 at risk EG0010 affected109 at risk EG0020 affected56 at risk EG003
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDDRA 14.0	Systematic Assessment	EG0000 affected106 at risk EG0010 affected109 at risk EG0020 affected56 at risk EG003
Bile duct cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDDRA 14.0	Systematic Assessment	EG0001 affected106 at risk EG0010 affected109 at risk EG0020 affected56 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDDRA 14.0	Systematic Assessment	EG0000 affected106 at risk EG0010 affected109 at risk EG0020 affected56 at risk EG003
Chronic lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDDRA 14.0	Systematic Assessment	EG0000 affected106 at risk EG0010 affected109 at risk EG0020 affected56 at risk EG003
Anaemia	Blood and lymphatic system disorders	MEDDRA 14.0	Systematic Assessment	EG0000 affected106 at risk EG0010 affected109 at risk EG0020 affected56 at risk EG003
Goitre	Endocrine disorders	MEDDRA 14.0	Systematic Assessment	EG0000 affected106 at risk EG0010 affected109 at risk EG0020 affected56 at risk EG003
Thyroid cyst	Endocrine disorders	MEDDRA 14.0	Systematic Assessment	EG0000 affected106 at risk EG0010 affected109 at risk EG0020 affected56 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MEDDRA 14.0	Systematic Assessment	EG0000 affected106 at risk EG0010 affected109 at risk EG0020 affected56 at risk EG003
Cerebral infarction	Nervous system disorders	MEDDRA 14.0	Systematic Assessment	EG0000 affected106 at risk EG0010 affected109 at risk EG0020 affected56 at risk EG003
Aphasia	Nervous system disorders	MEDDRA 14.0	Systematic Assessment	EG0000 affected106 at risk EG0010 affected109 at risk EG0020 affected56 at risk EG003
Hemiplegia	Nervous system disorders	MEDDRA 14.0	Systematic Assessment	EG0000 affected106 at risk EG0010 affected109 at risk EG0020 affected56 at risk EG003
Ischaemic stroke	Nervous system disorders	MEDDRA 14.0	Systematic Assessment	EG0000 affected106 at risk EG0010 affected109 at risk EG0020 affected56 at risk EG003
Transient ischaemic attack	Nervous system disorders	MEDDRA 14.0	Systematic Assessment	EG0000 affected106 at risk EG0010 affected109 at risk EG0020 affected56 at risk EG003
Cerebrovascular accident	Nervous system disorders	MEDDRA 14.0	Systematic Assessment	EG0001 affected106 at risk EG0010 affected109 at risk EG0020 affected56 at risk EG003
Carotid artery stenosis	Nervous system disorders	MEDDRA 14.0	Systematic Assessment	EG0000 affected106 at risk EG0010 affected109 at risk EG0020 affected56 at risk EG003
Visual acuity reduced	Eye disorders	MEDDRA 14.0	Systematic Assessment	EG0001 affected106 at risk EG0010 affected109 at risk EG0020 affected56 at risk EG003
Vertigo	Ear and labyrinth disorders	MEDDRA 14.0	Systematic Assessment	EG0000 affected106 at risk EG0011 affected109 at risk EG0020 affected56 at risk EG003
Angina pectoris	Cardiac disorders	MEDDRA 14.0	Systematic Assessment	EG0000 affected106 at risk EG0010 affected109 at risk EG0020 affected56 at risk EG003
Angina unstable	Cardiac disorders	MEDDRA 14.0	Systematic Assessment	EG0000 affected106 at risk EG0010 affected109 at risk EG0020 affected56 at risk EG003
Atrial fibrillation	Cardiac disorders	MEDDRA 14.0	Systematic Assessment	EG0000 affected106 at risk EG0011 affected109 at risk EG0020 affected56 at risk EG003
Myocardial infarction	Cardiac disorders	MEDDRA 14.0	Systematic Assessment	EG0000 affected106 at risk EG0011 affected109 at risk EG0020 affected56 at risk EG003
Palpitations	Cardiac disorders	MEDDRA 14.0	Systematic Assessment	EG0000 affected106 at risk EG0011 affected109 at risk EG0020 affected56 at risk EG003
Coronary artery disease	Cardiac disorders	MEDDRA 14.0	Systematic Assessment	EG0000 affected106 at risk EG0010 affected109 at risk EG0020 affected56 at risk EG003
Myocardial ischaemia	Cardiac disorders	MEDDRA 14.0	Systematic Assessment	EG0000 affected106 at risk EG0010 affected109 at risk EG0020 affected56 at risk EG003
Hypertension	Vascular disorders	MEDDRA 14.0	Systematic Assessment	EG0001 affected106 at risk EG0010 affected109 at risk EG0020 affected56 at risk EG003
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MEDDRA 14.0	Systematic Assessment	EG0000 affected106 at risk EG0010 affected109 at risk EG0020 affected56 at risk EG003
Colonic polyp	Gastrointestinal disorders	MEDDRA 14.0	Systematic Assessment	EG0000 affected106 at risk EG0010 affected109 at risk EG0020 affected56 at risk EG003
Abdominal hernia	Gastrointestinal disorders	MEDDRA 14.0	Systematic Assessment	EG0001 affected106 at risk EG0010 affected109 at risk EG0020 affected56 at risk EG003
Anal fistula	Gastrointestinal disorders	MEDDRA 14.0	Systematic Assessment	EG0001 affected106 at risk EG0010 affected109 at risk EG0020 affected56 at risk EG003
Gingival cyst	Gastrointestinal disorders	MEDDRA 14.0	Systematic Assessment	EG0001 affected106 at risk EG0010 affected109 at risk EG0020 affected56 at risk EG003
Inguinal hernia	Gastrointestinal disorders	MEDDRA 14.0	Systematic Assessment	EG0001 affected106 at risk EG0010 affected109 at risk EG0020 affected56 at risk EG003
Lumbar hernia	Gastrointestinal disorders	MEDDRA 14.0	Systematic Assessment	EG0000 affected106 at risk EG0010 affected109 at risk EG0020 affected56 at risk EG003
Cholecystitis acute	Hepatobiliary disorders	MEDDRA 14.0	Systematic Assessment	EG0000 affected106 at risk EG0010 affected109 at risk EG0020 affected56 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MEDDRA 14.0	Systematic Assessment	EG0001 affected106 at risk EG0010 affected109 at risk EG0020 affected56 at risk EG003
Bile duct obstruction	Hepatobiliary disorders	MEDDRA 14.0	Systematic Assessment	EG0001 affected106 at risk EG0010 affected109 at risk EG0020 affected56 at risk EG003
Cholecystitis	Hepatobiliary disorders	MEDDRA 14.0	Systematic Assessment	EG0000 affected106 at risk EG0010 affected109 at risk EG0020 affected56 at risk EG003
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MEDDRA 14.0	Systematic Assessment	EG0000 affected106 at risk EG0010 affected109 at risk EG0020 affected56 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MEDDRA 14.0	Systematic Assessment	EG0000 affected106 at risk EG0010 affected109 at risk EG0020 affected56 at risk EG003
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MEDDRA 14.0	Systematic Assessment	EG0000 affected106 at risk EG0010 affected109 at risk EG0020 affected56 at risk EG003
Urinary retention	Renal and urinary disorders	MEDDRA 14.0	Systematic Assessment	EG0000 affected106 at risk EG0011 affected109 at risk EG0020 affected56 at risk EG003
Benign prostatic hyperplasia	Reproductive system and breast disorders	MEDDRA 14.0	Systematic Assessment	EG0002 affected106 at risk EG0011 affected109 at risk EG0020 affected56 at risk EG003
Death	General disorders	MEDDRA 14.0	Systematic Assessment	EG0000 affected106 at risk EG0010 affected109 at risk EG0021 affected56 at risk EG003
Non-cardiac chest pain	General disorders	MEDDRA 14.0	Systematic Assessment	EG0000 affected106 at risk EG0010 affected109 at risk EG0020 affected56 at risk EG003
Pyrexia	General disorders	MEDDRA 14.0	Systematic Assessment	EG0000 affected106 at risk EG0010 affected109 at risk EG0020 affected56 at risk EG003
Traumatic fracture	Injury, poisoning and procedural complications	MEDDRA 14.0	Systematic Assessment	EG0000 affected106 at risk EG0010 affected109 at risk EG0021 affected56 at risk EG003
Fall	Injury, poisoning and procedural complications	MEDDRA 14.0	Systematic Assessment	EG0000 affected106 at risk EG0011 affected109 at risk EG0020 affected56 at risk EG003
Fibula fracture	Injury, poisoning and procedural complications	MEDDRA 14.0	Systematic Assessment	EG0000 affected106 at risk EG0011 affected109 at risk EG0020 affected56 at risk EG003
Ligament rupture	Injury, poisoning and procedural complications	MEDDRA 14.0	Systematic Assessment	EG0001 affected106 at risk EG0010 affected109 at risk EG0020 affected56 at risk EG003
Post procedural haematuria	Injury, poisoning and procedural complications	MEDDRA 14.0	Systematic Assessment	EG0000 affected106 at risk EG0011 affected109 at risk EG0020 affected56 at risk EG003
Vascular graft occlusion	Injury, poisoning and procedural complications	MEDDRA 14.0	Systematic Assessment	EG0000 affected106 at risk EG0011 affected109 at risk EG0020 affected56 at risk EG003
Wrist fracture	Injury, poisoning and procedural complications	MEDDRA 14.0	Systematic Assessment	EG0001 affected106 at risk EG0010 affected109 at risk EG0020 affected56 at risk EG003
Concussion	Injury, poisoning and procedural complications	MEDDRA 14.0	Systematic Assessment	EG0000 affected106 at risk EG0010 affected109 at risk EG0020 affected56 at risk EG003
Burns second degree	Injury, poisoning and procedural complications	MEDDRA 14.0	Systematic Assessment	EG0000 affected106 at risk EG0010 affected109 at risk EG0020 affected56 at risk EG003
Meniscus lesion	Injury, poisoning and procedural complications	MEDDRA 14.0	Systematic Assessment	EG0000 affected106 at risk EG0010 affected109 at risk EG0020 affected56 at risk EG003
Post procedural haematoma	Injury, poisoning and procedural complications	MEDDRA 14.0	Systematic Assessment	EG0000 affected106 at risk EG0010 affected109 at risk EG0020 affected56 at risk EG003
Hysterectomy	Surgical and medical procedures	MEDDRA 14.0	Systematic Assessment	EG0000 affected106 at risk EG0010 affected109 at risk EG0020 affected56 at risk EG003
Abortion induced	Surgical and medical procedures	MEDDRA 14.0	Systematic Assessment	EG0000 affected106 at risk EG0010 affected109 at risk EG0020 affected56 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nasopharyngitis	Infections and infestations	MEDDRA 14.0	Systematic Assessment	EG00010 affected106 at risk EG0018 affected109 at risk EG0029 affected56 at risk EG00312 affected166 at risk EG00415 affected166 at risk EG0055 affected56 at risk
Urinary tract infection	Infections and infestations	MEDDRA 14.0	Systematic Assessment	EG0003 affected106 at risk EG0014 affected109 at risk EG0021 affected56 at risk EG003
Bronchitis	Infections and infestations	MEDDRA 14.0	Systematic Assessment	EG0002 affected106 at risk EG0013 affected109 at risk EG0022 affected56 at risk EG003
Upper respiratory tract infection	Infections and infestations	MEDDRA 14.0	Systematic Assessment	EG0005 affected106 at risk EG0018 affected109 at risk EG0021 affected56 at risk EG003
Viral infection	Infections and infestations	MEDDRA 14.0	Systematic Assessment	EG0000 affected106 at risk EG0017 affected109 at risk EG0021 affected56 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MEDDRA 14.0	Systematic Assessment	EG00012 affected106 at risk EG00116 affected109 at risk EG0028 affected56 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MEDDRA 14.0	Systematic Assessment	EG0001 affected106 at risk EG0012 affected109 at risk EG0024 affected56 at risk EG003
Headache	Nervous system disorders	MEDDRA 14.0	Systematic Assessment	EG0001 affected106 at risk EG0017 affected109 at risk EG0024 affected56 at risk EG003
Hypertension	Vascular disorders	MEDDRA 14.0	Systematic Assessment	EG0004 affected106 at risk EG0013 affected109 at risk EG0024 affected56 at risk EG003
Nausea	Gastrointestinal disorders	MEDDRA 14.0	Systematic Assessment	EG0002 affected106 at risk EG0012 affected109 at risk EG0023 affected56 at risk EG003
Diarrhoea	Gastrointestinal disorders	MEDDRA 14.0	Systematic Assessment	EG0002 affected106 at risk EG0013 affected109 at risk EG0023 affected56 at risk EG003
Benign prostatic hyperplasia	Reproductive system and breast disorders	MEDDRA 14.0	Systematic Assessment	EG0001 affected106 at risk EG0013 affected109 at risk EG0020 affected56 at risk EG003
Chest pain	General disorders	MEDDRA 14.0	Systematic Assessment	EG0002 affected106 at risk EG0010 affected109 at risk EG0023 affected56 at risk EG003
Fatigue	General disorders	MEDDRA 14.0	Systematic Assessment	EG0000 affected106 at risk EG0011 affected109 at risk EG0021 affected56 at risk EG003

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

ID	Term
D001645	Biguanides
D006146	Guanidines
D000578	Amidines
D009930	Organic Chemicals
D014230	Triazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D011719	Pyrazines

ID	Term
C570240	empagliflozin
D008687	Metformin
D000068900	Sitagliptin Phosphate