Six Months Efficacy and Safety of Aliskiren Therapy on To... | NCT00894387

ID	Type	Description	Link
2009-010236-18	EudraCT Number

Label	Type	Description	Intervention Names
Aliskiren	Experimental	Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.	Drug: Aliskiren
Placebo	Placebo Comparator	Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Aliskiren	Drug	Aliskiren 150 mg and Aliskiren 300 mg	Aliskiren	Aliskiren®,

Measure	Description	Time Frame
Time to Event Analysis: Number of Patients Experienced the First Confirmed Occurrence of Either Cardiovascular Death or Heart Failure (HF) Re-hospitalization Within 6 Months	Time to first confirmed occurrence of either cardiovascular death or heart failure re-hospitalization within 6 months of randomization was the primary efficacy variable. For the primary efficacy analysis, an event will be considered for the analysis if it occurs on or before Day 190 (189 days from randomization). The primary composite endpoint is the the composite of cardiovascular death or heart faliure re-hospitalization within 6 months.	6 months

Measure	Description	Time Frame
Time to Event Analysis: Number of Patients Experienced the First Confirmed Occurrence of Either Cardiovascular Death or Heart Failure (HF) Re-hospitalization Within 12 Months	Time to first confirmed occurrence of either cardiovascular death or heart failure re-hospitalization within 12 months of randomization was the key secondary efficacy variable. For the primary efficacy analysis, an event will be considered for the analysis if it occurs on or before Day 395 (394 days from randomization). The secondary composite endpoint is the the composite of cardiovascular death or heart faliure re-hospitalization within 12 months.

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director
Novartis	Novartis	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Investigative Site		Mobile	Alabama	36608	United States
Novartis Investigative Site

PubMed Identifier	Type	Citation	Retractions
29143416	Derived	Vaduganathan M, Cheema B, Cleveland E, Sankar K, Subacius H, Fonarow GC, Solomon SD, Lewis EF, Greene SJ, Maggioni AP, Bohm M, Zannad F, Butler J, Gheorghiade M. Plasma renin activity, response to aliskiren, and clinical outcomes in patients hospitalized for heart failure: the ASTRONAUT trial. Eur J Heart Fail. 2018 Apr;20(4):677-686. doi: 10.1002/ejhf.973. Epub 2017 Nov 16.
29044915

ID	Title	Description
FG000	Aliskiren	Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.
FG001	Placebo

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0006 affected808 at risk EG0015 affected810 at risk
Haemorrhagic disorder	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Hilar lymphadenopathy	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Jaundice acholuric	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Splenic infarction	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA	Systematic Assessment	EG0003 affected808 at risk EG0013 affected810 at risk
Acute left ventricular failure	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0011 affected810 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA	Systematic Assessment	EG0009 affected808 at risk EG00115 affected810 at risk
Angina pectoris	Cardiac disorders	MedDRA	Systematic Assessment	EG0009 affected808 at risk EG00110 affected810 at risk
Angina unstable	Cardiac disorders	MedDRA	Systematic Assessment	EG0007 affected808 at risk EG0016 affected810 at risk
Aortic valve incompetence	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Arrhythmia	Cardiac disorders	MedDRA	Systematic Assessment	EG0003 affected808 at risk EG0013 affected810 at risk
Arrhythmia supraventricular	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Arteriospasm coronary	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Atrial fibrillation	Cardiac disorders	MedDRA	Systematic Assessment	EG00014 affected808 at risk EG00116 affected810 at risk
Atrial flutter	Cardiac disorders	MedDRA	Systematic Assessment	EG0003 affected808 at risk EG0012 affected810 at risk
Atrial tachycardia	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0011 affected810 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 affected808 at risk EG0011 affected810 at risk
Bradyarrhythmia	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Bradycardia	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0012 affected810 at risk
Cardiac arrest	Cardiac disorders	MedDRA	Systematic Assessment	EG00011 affected808 at risk EG00114 affected810 at risk
Cardiac failure	Cardiac disorders	MedDRA	Systematic Assessment	EG000147 affected808 at risk EG001155 affected810 at risk
Cardiac failure acute	Cardiac disorders	MedDRA	Systematic Assessment	EG00058 affected808 at risk EG00160 affected810 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA	Systematic Assessment	EG00050 affected808 at risk EG00162 affected810 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA	Systematic Assessment	EG00021 affected808 at risk EG00131 affected810 at risk
Cardiac tamponade	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA	Systematic Assessment	EG0007 affected808 at risk EG0013 affected810 at risk
Cardiogenic shock	Cardiac disorders	MedDRA	Systematic Assessment	EG0007 affected808 at risk EG0016 affected810 at risk
Cardiomyopathy	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 affected808 at risk EG0011 affected810 at risk
Cardiorenal syndrome	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Congestive cardiomyopathy	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 affected808 at risk EG0012 affected810 at risk
Coronary artery disease	Cardiac disorders	MedDRA	Systematic Assessment	EG0004 affected808 at risk EG0012 affected810 at risk
Heart valve incompetence	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Left ventricular dysfunction	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Low cardiac output syndrome	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Myocardial fibrosis	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Myocardial infarction	Cardiac disorders	MedDRA	Systematic Assessment	EG00011 affected808 at risk EG00111 affected810 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA	Systematic Assessment	EG0003 affected808 at risk EG0013 affected810 at risk
Palpitations	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 affected808 at risk EG0012 affected810 at risk
Pericardial effusion	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Pulseless electrical activity	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0012 affected810 at risk
Sick sinus syndrome	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0012 affected810 at risk
Tachyarrhythmia	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Tachycardia	Cardiac disorders	MedDRA	Systematic Assessment	EG0003 affected808 at risk EG0011 affected810 at risk
Ventricular arrhythmia	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 affected808 at risk EG0014 affected810 at risk
Ventricular dysfunction	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA	Systematic Assessment	EG0004 affected808 at risk EG0015 affected810 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA	Systematic Assessment	EG00010 affected808 at risk EG0016 affected810 at risk
Vertigo	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0004 affected808 at risk EG0012 affected810 at risk
Cataract	Eye disorders	MedDRA	Systematic Assessment	EG0003 affected808 at risk EG0010 affected810 at risk
Eye haemorrhage	Eye disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Glaucoma	Eye disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0011 affected810 at risk
Retinal detachment	Eye disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Retinal haemorrhage	Eye disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Retinal vein occlusion	Eye disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0003 affected808 at risk EG0014 affected810 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Ascites	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0014 affected810 at risk
Colonic polyp	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Constipation	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected808 at risk EG0010 affected810 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected808 at risk EG0013 affected810 at risk
Diverticular perforation	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Diverticulum intestinal	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected808 at risk EG0012 affected810 at risk
Enteritis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Gastritis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0015 affected810 at risk
Gingival bleeding	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0011 affected810 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Intestinal polyp	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0012 affected810 at risk
Nausea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0008 affected808 at risk EG0013 affected810 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0012 affected810 at risk
Small intestinal haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0012 affected810 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Tongue oedema	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Umbilical hernia, obstructive	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Vomiting	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0005 affected808 at risk EG0012 affected810 at risk
Asthenia	General disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0013 affected810 at risk
Cardiac death	General disorders	MedDRA	Systematic Assessment	EG0003 affected808 at risk EG0013 affected810 at risk
Chest discomfort	General disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Chest pain	General disorders	MedDRA	Systematic Assessment	EG0006 affected808 at risk EG0010 affected810 at risk
Death	General disorders	MedDRA	Systematic Assessment	EG00021 affected808 at risk EG00125 affected810 at risk
Device breakage	General disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Device lead issue	General disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Device malfunction	General disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0014 affected810 at risk
Drug intolerance	General disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Fatigue	General disorders	MedDRA	Systematic Assessment	EG0002 affected808 at risk EG0014 affected810 at risk
General physical health deterioration	General disorders	MedDRA	Systematic Assessment	EG0002 affected808 at risk EG0013 affected810 at risk
Generalised oedema	General disorders	MedDRA	Systematic Assessment	EG0002 affected808 at risk EG0012 affected810 at risk
Implant site haematoma	General disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Medical device complication	General disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Metaplasia	General disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Multi-organ failure	General disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0013 affected810 at risk
Necrosis	General disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Non-cardiac chest pain	General disorders	MedDRA	Systematic Assessment	EG0007 affected808 at risk EG0011 affected810 at risk
Oedema peripheral	General disorders	MedDRA	Systematic Assessment	EG0003 affected808 at risk EG0016 affected810 at risk
Pain	General disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Pyrexia	General disorders	MedDRA	Systematic Assessment	EG0002 affected808 at risk EG0012 affected810 at risk
Soft tissue inflammation	General disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Stent malfunction	General disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Sudden cardiac death	General disorders	MedDRA	Systematic Assessment	EG0005 affected808 at risk EG0017 affected810 at risk
Sudden death	General disorders	MedDRA	Systematic Assessment	EG0009 affected808 at risk EG0015 affected810 at risk
Acute hepatic failure	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0002 affected808 at risk EG0011 affected810 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0012 affected810 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Hepatic cyst	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Hepatitis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Hepatitis cholestatic	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Hepatomegaly	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0011 affected810 at risk
Hepatorenal syndrome	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Ischaemic hepatitis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Heart transplant rejection	Immune system disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Abscess limb	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Anal abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Appendicitis	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected808 at risk EG0010 affected810 at risk
Arthritis infective	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Bacteraemia	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0011 affected810 at risk
Bronchiolitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Bronchitis	Infections and infestations	MedDRA	Systematic Assessment	EG0006 affected808 at risk EG0016 affected810 at risk
Bronchitis bacterial	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Bronchopneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG0003 affected808 at risk EG0014 affected810 at risk
Cellulitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0013 affected810 at risk
Citrobacter sepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Device related infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0014 affected810 at risk
Endocarditis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0013 affected810 at risk
Erysipelas	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected808 at risk EG0011 affected810 at risk
Gangrene	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected808 at risk EG0013 affected810 at risk
Gastroenteritis	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected808 at risk EG0013 affected810 at risk
Gastroenteritis norovirus	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0011 affected810 at risk
Gastrointestinal viral infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Hepatitis B	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0011 affected810 at risk
Influenza	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Liver abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Lobar pneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0012 affected810 at risk
Localised infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0003 affected808 at risk EG0012 affected810 at risk
Lung infection pseudomonal	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Orchitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Osteomyelitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0012 affected810 at risk
Osteomyelitis acute	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Paronychia	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Peritonitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Pneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG00025 affected808 at risk EG00127 affected810 at risk
Pneumonia legionella	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Postoperative wound infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0012 affected810 at risk
Pseudomembranous colitis	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected808 at risk EG0010 affected810 at risk
Pseudomonas bronchitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Pulmonary sepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0011 affected810 at risk
Respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0003 affected808 at risk EG0012 affected810 at risk
Sepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0008 affected808 at risk EG0015 affected810 at risk
Septic shock	Infections and infestations	MedDRA	Systematic Assessment	EG0005 affected808 at risk EG0015 affected810 at risk
Skin infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0012 affected810 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0011 affected810 at risk
Subacute endocarditis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0014 affected810 at risk
Urinary tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0004 affected808 at risk EG0015 affected810 at risk
Urosepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Viral infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Wound infection pseudomonas	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Accidental overdose	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Brain herniation	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Dermatitis artefacta	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Electric shock	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Extradural haematoma	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Facial bones fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Fall	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0013 affected810 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0004 affected808 at risk EG0011 affected810 at risk
Foot fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Hand fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0012 affected810 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 affected808 at risk EG0011 affected810 at risk
In-stent arterial restenosis	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Optic nerve injury	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0011 affected810 at risk
Pneumothorax traumatic	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Pubis fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Splenic rupture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Subcutaneous haematoma	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0011 affected810 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 affected808 at risk EG0010 affected810 at risk
Thermal burn	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Tongue injury	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 affected808 at risk EG0011 affected810 at risk
Traumatic haematoma	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Vascular graft occlusion	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0012 affected810 at risk
Vascular graft thrombosis	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Wound necrosis	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Activated partial thromboplastin time prolonged	Investigations	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Anticoagulation drug level above therapeutic	Investigations	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0011 affected810 at risk
Blood creatinine increased	Investigations	MedDRA	Systematic Assessment	EG0003 affected808 at risk EG0011 affected810 at risk
Blood osmolarity decreased	Investigations	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Blood potassium increased	Investigations	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Coagulation test abnormal	Investigations	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Ejection fraction decreased	Investigations	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Haemoglobin decreased	Investigations	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
International normalised ratio increased	Investigations	MedDRA	Systematic Assessment	EG0002 affected808 at risk EG0011 affected810 at risk
Renal function test abnormal	Investigations	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Transaminases increased	Investigations	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Urine output decreased	Investigations	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0013 affected810 at risk
Weight increased	Investigations	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0013 affected810 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0003 affected808 at risk EG0014 affected810 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0013 affected810 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0003 affected808 at risk EG0013 affected810 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Failure to thrive	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Fluid intake reduced	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0011 affected810 at risk
Gout	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0002 affected808 at risk EG0013 affected810 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0002 affected808 at risk EG0013 affected810 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG00012 affected808 at risk EG00112 affected810 at risk
Hyperosmolar state	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Hypervolaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Hypocholesterolaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0007 affected808 at risk EG0012 affected810 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0006 affected808 at risk EG0016 affected810 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0004 affected808 at risk EG0015 affected810 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0012 affected810 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Costochondritis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Fasciitis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0011 affected810 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Joint effusion	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Muscle haemorrhage	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0002 affected808 at risk EG0012 affected810 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0002 affected808 at risk EG0011 affected810 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Soft tissue necrosis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0011 affected810 at risk
Benign bone neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Bladder neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Bronchial carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Choroid melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Chronic lymphocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0011 affected810 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0002 affected808 at risk EG0011 affected810 at risk
Colorectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Hepatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Hepatobiliary neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Liposarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Lung squamous cell carcinoma stage unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Multiple myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Non-small cell lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Oesophageal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Ovarian cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0013 affected810 at risk
Prostate cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Renal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0011 affected810 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Anterior spinal artery syndrome	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Aphasia	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Burning sensation	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Cerebellar infarction	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0011 affected810 at risk
Cerebral haematoma	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Cerebral infarction	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0011 affected810 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA	Systematic Assessment	EG0009 affected808 at risk EG00115 affected810 at risk
Coma	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Convulsion	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Diabetic hyperglycaemic coma	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Diabetic neuropathy	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Dizziness	Nervous system disorders	MedDRA	Systematic Assessment	EG0004 affected808 at risk EG0010 affected810 at risk
Dysarthria	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Embolic stroke	Nervous system disorders	MedDRA	Systematic Assessment	EG0002 affected808 at risk EG0010 affected810 at risk
Epilepsy	Nervous system disorders	MedDRA	Systematic Assessment	EG0002 affected808 at risk EG0010 affected810 at risk
Haemorrhagic stroke	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Hemiparesis	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0013 affected810 at risk
Hypokinesia	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0011 affected810 at risk
Intracranial haematoma	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Ischaemic stroke	Nervous system disorders	MedDRA	Systematic Assessment	EG0005 affected808 at risk EG0019 affected810 at risk
Loss of consciousness	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Metabolic encephalopathy	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Myasthenia gravis	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Myasthenia gravis crisis	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Presyncope	Nervous system disorders	MedDRA	Systematic Assessment	EG0003 affected808 at risk EG0014 affected810 at risk
Sensory disturbance	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0011 affected810 at risk
Somnolence	Nervous system disorders	MedDRA	Systematic Assessment	EG0002 affected808 at risk EG0011 affected810 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0012 affected810 at risk
Syncope	Nervous system disorders	MedDRA	Systematic Assessment	EG00011 affected808 at risk EG00113 affected810 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0013 affected810 at risk
Trigeminal neuralgia	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Unresponsive to stimuli	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Uraemic encephalopathy	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Vertebrobasilar insufficiency	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Abnormal behaviour	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Alcohol abuse	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Anxiety	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Confusional state	Psychiatric disorders	MedDRA	Systematic Assessment	EG0002 affected808 at risk EG0010 affected810 at risk
Depression	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0011 affected810 at risk
Depression suicidal	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Disorientation	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Insomnia	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Mental status changes	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Restlessness	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0011 affected810 at risk
Screaming	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Suicidal ideation	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Acute prerenal failure	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0011 affected810 at risk
Anuria	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Bladder tamponade	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Haematuria	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Nephropathy	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Obstructive uropathy	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Polyuria	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Renal artery stenosis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Renal artery thrombosis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Renal failure	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0006 affected808 at risk EG0018 affected810 at risk
Renal failure acute	Renal and urinary disorders	MedDRA	Systematic Assessment	EG00020 affected808 at risk EG00112 affected810 at risk
Renal failure chronic	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0013 affected810 at risk
Renal impairment	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0005 affected808 at risk EG0014 affected810 at risk
Urinary retention	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0002 affected808 at risk EG0010 affected810 at risk
Menorrhagia	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Scrotal oedema	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0007 affected808 at risk EG0014 affected810 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0002 affected808 at risk EG0011 affected810 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Bronchiectasis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Bronchitis chronic	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG00013 affected808 at risk EG0015 affected810 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0002 affected808 at risk EG0012 affected810 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG00020 affected808 at risk EG00118 affected810 at risk
Dyspnoea at rest	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Dyspnoea paroxysmal nocturnal	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0012 affected810 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0013 affected810 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Obstructive airways disorder	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0002 affected808 at risk EG0012 affected810 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Pulmonary artery thrombosis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0012 affected810 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0005 affected808 at risk EG0015 affected810 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0004 affected808 at risk EG0018 affected810 at risk
Rales	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0006 affected808 at risk EG0015 affected810 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0012 affected810 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0002 affected808 at risk EG0010 affected810 at risk
Skin exfoliation	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Skin necrosis	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0011 affected810 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Skin ulcer haemorrhage	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Swelling face	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Gastric bypass	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Circulatory collapse	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0012 affected810 at risk
Deep vein thrombosis	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0011 affected810 at risk
Extremity necrosis	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Haematoma	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0011 affected810 at risk
Hypertension	Vascular disorders	MedDRA	Systematic Assessment	EG0002 affected808 at risk EG0013 affected810 at risk
Hypertensive crisis	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0013 affected810 at risk
Hypertensive emergency	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0012 affected810 at risk
Hypotension	Vascular disorders	MedDRA	Systematic Assessment	EG00024 affected808 at risk EG00116 affected810 at risk
Intra-abdominal haematoma	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk
Orthostatic hypotension	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0012 affected810 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA	Systematic Assessment	EG0004 affected808 at risk EG0012 affected810 at risk
Peripheral ischaemia	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA	Systematic Assessment	EG0002 affected808 at risk EG0011 affected810 at risk
Phlebitis	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected808 at risk EG0010 affected810 at risk
Venous haemorrhage	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected808 at risk EG0011 affected810 at risk

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

ID	Title	Description
BG000	Aliskiren	Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.
BG001	Placebo	Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
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	Aliskiren	Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.			421	808	367	808
EG001	Placebo	Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.			435	810	333	810