VERIFY:A Study to Compare Combination Regimen With Vildag... | NCT01528254

ID	Type	Description	Link
2011-003712-23	EudraCT Number

Label	Type	Description	Intervention Names
Vilda 50mg bid + metformin	Active Comparator	Metformin + vildagliptin	Drug: vildagliptin Drug: Metformin
Placebo + metformin	Experimental	Metformin + Placebo of vildagliptin	Drug: Placebo of vildagliptin Drug: Metformin

Name	Type	Description	Arm Group Labels	Other Names
Placebo of vildagliptin	Drug		Placebo + metformin	Placebo
vildagliptin

Measure	Description	Time Frame
Time to Initial Treatment Failure	Treatment failure was defined as two consecutive scheduled visits with HbA1c >= 7.0% (starting from 13 weeks after randomization) and the time to treatment failure was the number of days from randomization to the second of the consecutive scheduled visits. Participants who discontinued the study for any reason during Period 1 were censored at the date of discontinuation. Participants who remained under the threshold (or whose measurement above the threshold was not confirmed at next scheduled visit) were censored at the date of last study visit.	Visit 4 (Week 13) up to End of Study (Study Drug Discontinuation or Premature Subject Discontinuation)

Measure	Description	Time Frame
Rate of Loss in Glycemic Control During Period 1	The rate of loss in glycemic control was estimated using the slope of HbA1c over time (years). HbA1c data collected from Week 26 up to and including the end of Period 1 visit was included in the analysis. Baseline HbA1c was the sample obtained on day 1, or the sample obtained at an earlier visit (scheduled or unscheduled) which was closest to Day 1, if the Day 1 measurement was missing. End of Period 1 was defined as the final post-baseline assessment obtained at any visit within Period 1 (scheduled or unscheduled), up to the last scheduled visit.

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		CABA	Buenos Aires	C1056ABJ	Argentina
Novartis Investigative Site

PubMed Identifier	Type	Citation	Retractions
36170017	Derived	Tsotra F, Kappel M, Peristeris P, Bader G, Levi E, Lister N, Malhotra A, Ostwald DA. The societal impact of early intensified treatment in patients with type 2 diabetes mellitus. J Comp Eff Res. 2022 Nov;11(16):1185-1199. doi: 10.2217/cer-2022-0110. Epub 2022 Sep 28.
34130731	Derived	Vencio S, Manosalva JP, Mathieu C, Proot P, Lozno HY, Paldanius PM. Exploring early combination strategy in Latin American patients with newly diagnosed type 2 diabetes: a sub-analysis of the VERIFY study. Diabetol Metab Syndr. 2021 Jun 15;13(1):68. doi: 10.1186/s13098-021-00686-9.

ID	Title	Description
FG000	Vilda 50mg Bid + Metformin	vildagliptin (Vilda 50mg bid) + Metformin
FG001	Placebo + Metformin	Placebo of vildagliptin (Vilda 50mg bid) + Metformin

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
SAP	No	Yes	No	Statistical Analysis Plan	Dec 17, 2019	Mar 30, 2020

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Cytopenia	Blood and lymphatic system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Hypochromic anaemia	Blood and lymphatic system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Lymphadenopathy mediastinal	Blood and lymphatic system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0013 affected1,001 at risk EG0023 affected1,999 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0003 affected998 at risk EG0014 affected1,001 at risk EG0027 affected1,999 at risk
Angina pectoris	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected998 at risk EG0014 affected1,001 at risk EG0026 affected1,999 at risk
Angina unstable	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected998 at risk EG0011 affected1,001 at risk EG0023 affected1,999 at risk
Aortic valve incompetence	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Arrhythmia	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0006 affected998 at risk EG0015 affected1,001 at risk EG00211 affected1,999 at risk
Atrial flutter	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Atrioventricular block second degree	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Bundle branch block left	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Cardiac arrest	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0011 affected1,001 at risk EG0022 affected1,999 at risk
Cardiac failure	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0003 affected998 at risk EG0014 affected1,001 at risk EG0027 affected1,999 at risk
Cardiac failure acute	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected998 at risk EG0011 affected1,001 at risk EG0023 affected1,999 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Cardiogenic shock	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Conduction disorder	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0012 affected1,001 at risk EG0022 affected1,999 at risk
Coronary artery disease	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0013 affected1,001 at risk EG0024 affected1,999 at risk
Coronary artery insufficiency	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0013 affected1,001 at risk EG0024 affected1,999 at risk
Mitral valve disease	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Myocardial infarction	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0003 affected998 at risk EG0017 affected1,001 at risk EG00210 affected1,999 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected998 at risk EG0013 affected1,001 at risk EG0025 affected1,999 at risk
Sinus node dysfunction	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Sinus tachycardia	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Supraventricular extrasystoles	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0012 affected1,001 at risk EG0022 affected1,999 at risk
Ventricular hypokinesia	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Congenital intestinal malformation	Congenital, familial and genetic disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Heart disease congenital	Congenital, familial and genetic disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Acute vestibular syndrome	Ear and labyrinth disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Deafness neurosensory	Ear and labyrinth disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Vertigo	Ear and labyrinth disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Goitre	Endocrine disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0011 affected1,001 at risk EG0022 affected1,999 at risk
Hypoparathyroidism	Endocrine disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Diplopia	Eye disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Vitreous haemorrhage	Eye disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0012 affected1,001 at risk EG0022 affected1,999 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Anal fissure	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Anal haemorrhage	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Ascites	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Colitis	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Food poisoning	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0011 affected1,001 at risk EG0022 affected1,999 at risk
Gastric disorder	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Gastric mucosal lesion	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Gastritis	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Gastrointestinal erosion	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Gastrointestinal fistula	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected998 at risk EG0010 affected1,001 at risk EG0022 affected1,999 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Ileus	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0017 affected1,001 at risk EG0027 affected1,999 at risk
Lumbar hernia	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0012 affected1,001 at risk EG0022 affected1,999 at risk
Rectal prolapse	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Retroperitoneal fibrosis	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0014 affected1,001 at risk EG0025 affected1,999 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0012 affected1,001 at risk EG0023 affected1,999 at risk
Varices oesophageal	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Vomiting	Gastrointestinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Chest pain	General disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Death	General disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected998 at risk EG0010 affected1,001 at risk EG0022 affected1,999 at risk
Granuloma	General disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Inflammation	General disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Non-cardiac chest pain	General disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Oedema peripheral	General disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Peripheral swelling	General disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Pyrexia	General disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected998 at risk EG0010 affected1,001 at risk EG0022 affected1,999 at risk
Stent-graft endoleak	General disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Sudden death	General disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Biliary colic	Hepatobiliary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Cholangitis	Hepatobiliary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA (21.1)	Systematic Assessment	EG0004 affected998 at risk EG0012 affected1,001 at risk EG0026 affected1,999 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA (21.1)	Systematic Assessment	EG0003 affected998 at risk EG0011 affected1,001 at risk EG0024 affected1,999 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected998 at risk EG0015 affected1,001 at risk EG0027 affected1,999 at risk
Cholestasis	Hepatobiliary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Hepatic cyst	Hepatobiliary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Hepatic steatosis	Hepatobiliary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Hepatitis toxic	Hepatobiliary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Hepatorenal syndrome	Hepatobiliary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Hydrocholecystis	Hepatobiliary disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Jaundice cholestatic	Hepatobiliary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Liver disorder	Hepatobiliary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Anaphylactic reaction	Immune system disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected998 at risk EG0010 affected1,001 at risk EG0022 affected1,999 at risk
Abscess limb	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Acute sinusitis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Anal abscess	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0011 affected1,001 at risk EG0022 affected1,999 at risk
Appendicitis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0002 affected998 at risk EG0012 affected1,001 at risk EG0024 affected1,999 at risk
Bartholin's abscess	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Bone tuberculosis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Bronchitis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Cervicitis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Dengue fever	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0002 affected998 at risk EG0011 affected1,001 at risk EG0023 affected1,999 at risk
Diarrhoea infectious	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Diverticulitis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0011 affected1,001 at risk EG0022 affected1,999 at risk
Epididymitis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Gastroenteritis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Gastroenteritis viral	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Hepatic echinococciasis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Hepatitis viral	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Herpes zoster	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0011 affected1,001 at risk EG0022 affected1,999 at risk
Infection	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Lung infection	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Mastoiditis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Meningitis pneumococcal	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Otitis media chronic	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Pancreas infection	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Pneumonia	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG00014 affected998 at risk EG0015 affected1,001 at risk EG00219 affected1,999 at risk
Pyelonephritis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Pyelonephritis acute	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Pyelonephritis chronic	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Rectal abscess	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0011 affected1,001 at risk EG0022 affected1,999 at risk
Sepsis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0011 affected1,001 at risk EG0022 affected1,999 at risk
Subcutaneous abscess	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Tooth abscess	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Urinary tract infection	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0002 affected998 at risk EG0013 affected1,001 at risk EG0025 affected1,999 at risk
Urinary tract infection bacterial	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Viral infection	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Viral myelitis	Infections and infestations	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0012 affected1,001 at risk EG0022 affected1,999 at risk
Burns first degree	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Face injury	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Forearm fracture	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Gun shot wound	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0011 affected1,001 at risk EG0022 affected1,999 at risk
Heat stroke	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Ligament rupture	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0002 affected998 at risk EG0011 affected1,001 at risk EG0023 affected1,999 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Meniscus injury	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0014 affected1,001 at risk EG0025 affected1,999 at risk
Multiple injuries	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0003 affected998 at risk EG0010 affected1,001 at risk EG0023 affected1,999 at risk
Muscle rupture	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0012 affected1,001 at risk EG0023 affected1,999 at risk
Post procedural fistula	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0013 affected1,001 at risk EG0023 affected1,999 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Skin abrasion	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Skull fracture	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Tooth fracture	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Traumatic arthrosis	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Ulna fracture	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Alanine aminotransferase increased	Investigations	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Aspartate aminotransferase increased	Investigations	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Blood lactate dehydrogenase increased	Investigations	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
HIV test positive	Investigations	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Transaminases increased	Investigations	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0012 affected1,001 at risk EG0022 affected1,999 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected998 at risk EG0011 affected1,001 at risk EG0023 affected1,999 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0012 affected1,001 at risk EG0022 affected1,999 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Exostosis	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Gouty tophus	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0003 affected998 at risk EG0012 affected1,001 at risk EG0025 affected1,999 at risk
Joint contracture	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Joint range of motion decreased	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected998 at risk EG0015 affected1,001 at risk EG0027 affected1,999 at risk
Osteochondrosis	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0012 affected1,001 at risk EG0023 affected1,999 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Periarthritis	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Pseudarthrosis	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Scleroderma	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0003 affected998 at risk EG0011 affected1,001 at risk EG0024 affected1,999 at risk
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0011 affected1,001 at risk EG0022 affected1,999 at risk
Tendonitis	Musculoskeletal and connective tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Adenocarcinoma gastric	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Adenoma benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0011 affected1,001 at risk EG0022 affected1,999 at risk
Brain neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0003 affected998 at risk EG0011 affected1,001 at risk EG0024 affected1,999 at risk
Breast cancer female	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Choroid melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Chronic lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Chronic myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Cystadenocarcinoma ovary	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Endometrial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Gallbladder neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Haemangioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Hepatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Intestinal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0012 affected1,001 at risk EG0023 affected1,999 at risk
Kaposi's sarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0002 affected998 at risk EG0010 affected1,001 at risk EG0022 affected1,999 at risk
Malignant splenic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0012 affected1,001 at risk EG0022 affected1,999 at risk
Metastases to central nervous system	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Metastases to lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Metastases to lymph nodes	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Neuroendocrine tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Oligoastrocytoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Ovarian adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Ovarian cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Ovarian epithelial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Ovarian neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0003 affected998 at risk EG0012 affected1,001 at risk EG0025 affected1,999 at risk
Parathyroid tumour benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0006 affected998 at risk EG0010 affected1,001 at risk EG0026 affected1,999 at risk
Prostatic adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Rectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0011 affected1,001 at risk EG0022 affected1,999 at risk
Rectosigmoid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Refractory cytopenia with multilineage dysplasia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Renal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Skin cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Skin papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Small cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Superficial spreading melanoma stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Tongue neoplasm malignant stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Undifferentiated sarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (21.1)	Systematic Assessment	EG0002 affected998 at risk EG0011 affected1,001 at risk EG0023 affected1,999 at risk
Brain oedema	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Cerebral haemorrhage	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected998 at risk EG0011 affected1,001 at risk EG0023 affected1,999 at risk
Cerebral infarction	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0012 affected1,001 at risk EG0023 affected1,999 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0014 affected1,001 at risk EG0024 affected1,999 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected998 at risk EG0012 affected1,001 at risk EG0024 affected1,999 at risk
Cerebrovascular disorder	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Coma	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Demyelination	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Haemorrhagic stroke	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Headache	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Hemiparesis	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Intracranial pressure increased	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Ischaemic stroke	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected998 at risk EG0015 affected1,001 at risk EG0027 affected1,999 at risk
Loss of consciousness	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Lumbar radiculopathy	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Monoparesis	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Paraesthesia	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0012 affected1,001 at risk EG0022 affected1,999 at risk
Radiculopathy	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected998 at risk EG0010 affected1,001 at risk EG0022 affected1,999 at risk
Sciatica	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0003 affected998 at risk EG0011 affected1,001 at risk EG0024 affected1,999 at risk
Seizure	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0011 affected1,001 at risk EG0022 affected1,999 at risk
Syncope	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0012 affected1,001 at risk EG0022 affected1,999 at risk
Thrombotic cerebral infarction	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Vertebrobasilar insufficiency	Nervous system disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Abortion missed	Pregnancy, puerperium and perinatal conditions	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0012 affected1,001 at risk EG0022 affected1,999 at risk
Abortion threatened	Pregnancy, puerperium and perinatal conditions	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Pregnancy with contraceptive device	Pregnancy, puerperium and perinatal conditions	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Depression	Psychiatric disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Eating disorder	Psychiatric disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Bladder tamponade	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Calculus bladder	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0011 affected1,001 at risk EG0022 affected1,999 at risk
Diabetic nephropathy	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Dysuria	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Haematuria	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0012 affected1,001 at risk EG0023 affected1,999 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0003 affected998 at risk EG0012 affected1,001 at risk EG0025 affected1,999 at risk
Renal colic	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0012 affected1,001 at risk EG0023 affected1,999 at risk
Renal failure	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0013 affected1,001 at risk EG0023 affected1,999 at risk
Renal impairment	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Stag horn calculus	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Ureterolithiasis	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0011 affected1,001 at risk EG0022 affected1,999 at risk
Urethral stenosis	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Urinary retention	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Urinary tract obstruction	Renal and urinary disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected998 at risk EG0010 affected1,001 at risk EG0022 affected1,999 at risk
Cervical cyst	Reproductive system and breast disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Dysfunctional uterine bleeding	Reproductive system and breast disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Endometrial hyperplasia	Reproductive system and breast disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Endometrial thickening	Reproductive system and breast disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Endometriosis	Reproductive system and breast disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Genital ulceration	Reproductive system and breast disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Metrorrhagia	Reproductive system and breast disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0014 affected1,001 at risk EG0025 affected1,999 at risk
Ovarian fibrosis	Reproductive system and breast disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Prostatomegaly	Reproductive system and breast disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Uterine polyp	Reproductive system and breast disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0012 affected1,001 at risk EG0023 affected1,999 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0012 affected1,001 at risk EG0022 affected1,999 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected998 at risk EG0013 affected1,001 at risk EG0025 affected1,999 at risk
Chronic respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Laryngeal cyst	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Angioedema	Skin and subcutaneous tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Skin ulcer haemorrhage	Skin and subcutaneous tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Aortic aneurysm	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected998 at risk EG0010 affected1,001 at risk EG0022 affected1,999 at risk
Aortic dissection	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Aortic stenosis	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected998 at risk EG0010 affected1,001 at risk EG0022 affected1,999 at risk
Deep vein thrombosis	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected998 at risk EG0010 affected1,001 at risk EG0022 affected1,999 at risk
Haematoma	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Hypertension	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected998 at risk EG0014 affected1,001 at risk EG0026 affected1,999 at risk
Hypertensive crisis	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Pelvic venous thrombosis	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0011 affected1,001 at risk EG0021 affected1,999 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0000 affected998 at risk EG0012 affected1,001 at risk EG0022 affected1,999 at risk
Peripheral artery stenosis	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Peripheral venous disease	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0001 affected998 at risk EG0010 affected1,001 at risk EG0021 affected1,999 at risk
Varicose vein	Vascular disorders	MedDRA (21.1)	Systematic Assessment	EG0002 affected998 at risk EG0011 affected1,001 at risk EG0023 affected1,999 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
D000077597	Vildagliptin
C475520	1-(((3-hydroxy-1-adamantyl)amino)acetyl)-2-cyanopyrrolidine
D008687	Metformin

ID	Term
D009570	Nitriles
D009930	Organic Chemicals
D011759	Pyrrolidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D001645	Biguanides
D006146	Guanidines
D000578	Amidines

ID	Title	Description
BG000	Vilda 50mg Bid + Metformin	vildagliptin (Vilda 50mg bid) + Metformin
BG001	Placebo + Metformin	Placebo of vildagliptin (Vilda 50mg bid) + 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	Vilda 50mg Bid + Metformin	vildagliptin (Vilda 50mg bid) + Metformin	13	998	166	998	582	998
EG001	Placebo + Metformin	Placebo of vildagliptin (Vilda 50mg bid) + Metformin	9	1,001	183	1,001	566	1,001
EG002	Total	Total	22	1,999	349	1,999	1,148	1,999