Safety and Efficacy of Aliskiren on the Progression of At... | NCT00853827

ID	Type	Description	Link
2008-006447-40

Status Module

Name	Class
The Cleveland Clinic	OTHER

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Label	Type	Description	Intervention Names
1	Placebo Comparator		Drug: Placebo
2	Experimental	Aliskiren 300 mg	Drug: Aliskiren

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	Placebo	1
Aliskiren

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in Percent Atheroma Volume(PAV) After 104 Weeks of Treatment	Change from baseline in PAV for all matched slices of anatomically comparable segments of the target coronary artery were assessed by intravascular ultrasound (IVUS) evaluation after 104 weeks of treatment . calculation for change is the value at the later time point minus the value at the earlier time point, with positive numbers to represent increases and negative numbers to represent decreases	Baseline, 104 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change in Normalized Total Atheroma Volume (TAV) as Assessed by IVUS	Change from baseline in normalized total atheroma volume (TAV) (mm^3) for all matched slices of anatomically comparable segments of the target coronary artery were assess by IVUS after 104 weeks of treatment. calculation for change is the value at the later time point minus the value at the earlier time point, with positive numbers to represent increases and negative numbers to represent decreases

Eligibility Module

Contacts/Locations Module

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	36693	United States
Novartis Investigative Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26523993	Derived	Puri R, Nissen SE, Menon V, Shao M, Hsu A, Bakris GL, Kastelein JJ, Williams B, Armbrecht J, Brunel P, Kataoka Y, Nicholls SJ. Effects of aliskiren in diabetic and non-diabetic patients with coronary artery disease: Insights from AQUARIUS. Atherosclerosis. 2015 Dec;243(2):553-9. doi: 10.1016/j.atherosclerosis.2015.10.019. Epub 2015 Oct 20.
23999933

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Aliskiren	Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: Visit 2 to 3, single blind for 1 week: patients received aliskiren 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets aliskiren 150 mg (force titration)

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Aliskiren	Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: Visit 2 to 3, single blind for 1 week: patients received aliskiren 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets aliskiren 150 mg (force titration)
BG001	Placebo	Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: visit 2 to 3, single blind for 1 week: patients received 1 tablet aliskiren 150 mg, 1 tablet placebo 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets placebo 150 mg
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG000-0.33± 0.18 OG0010.11± 0.18

Secondary

Change in Normalized Total Atheroma Volume (TAV) as Assessed by IVUS

Change from baseline in normalized total atheroma volume (TAV) (mm^3) for all matched slices of anatomically comparable segments of the target coronary artery were assess by IVUS after 104 weeks of treatment. calculation for change is the value at the later time point minus the value at the earlier time point, with positive numbers to represent increases and negative numbers to represent decreases

Posted

Least Squares Mean

Standard Error

mm^3

Baseline, 104 weeks

ID	Title	Description
OG000	Aliskiren	Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: Visit 2 to 3, single blind for 1 week: patients received aliskiren 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets aliskiren 150 mg (force titration)
OG001	Placebo	Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: visit 2 to 3, single blind for 1 week: patients received 1 tablet aliskiren 150 mg, 1 tablet placebo 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets placebo 150 mg

Secondary

Patients That Demonstrated Evidence of Atheroma Regression

Atheroma regression is defined as change from baseline to endpoint in PAV <0 .

Full Analysis Set (FAS) - All randomized patients. Patients were analyzed according to the treatment that they were assigned at randomization

Posted

Number

Participants

Baseline to endpoint (104 weeks)

ID	Title	Description
OG000	Aliskiren	Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: Visit 2 to 3, single blind for 1 week: patients received aliskiren 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets aliskiren 150 mg (force titration)
OG001	Placebo	Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: visit 2 to 3, single blind for 1 week: patients received 1 tablet aliskiren 150 mg, 1 tablet placebo 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets placebo 150 mg

Units	Counts

Secondary

Number of Patients With Adverse Events, Serious Adverse Events, and Death

overall safety and tolerability of aliskiren 300 mg compared to placebo in patients with CAD and BP in the pre-hypertensive (high normal) range with or without treatment for hypertension following 104 weeks of treatment. Any Adverse Event was defined as occurrence of any symptom regardless of intensity grade, Serious Adverse Event (SAEs) assessed as medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in persistent or significant disability/incapacity.

Safety - All patients who received at least one dose of double-blind trial medication. Patients were analyzed according to the treatment that they received

Posted

Number

Number of patients

104 weeks

ID	Title	Description
OG000	Aliskiren	Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: Visit 2 to 3, single blind for 1 week: patients received aliskiren 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets aliskiren 150 mg (force titration)
OG001	Placebo	Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: visit 2 to 3, single blind for 1 week: patients received 1 tablet aliskiren 150 mg, 1 tablet placebo 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets placebo 150 mg

Arm/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 300 mg	Visit 2 to 3, single blind for 1 week: patients received aliskiren 150 mg. visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets aliskiren 150 mg (force titration)			76	305	186	305
EG001	Placebo	Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: visit 2 to 3, single blind for 1 week: patients received 1 tablet aliskiren 150 mg, 1 tablet placebo 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets placebo 150 mg			97	308	175	308

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 affected305 at risk EG0011 affected308 at risk
Spontaneous haematoma	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 affected305 at risk EG0010 affected308 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 affected305 at risk EG0010 affected308 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected305 at risk EG0013 affected308 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0012 affected308 at risk
Angina pectoris	Cardiac disorders	MedDRA	Systematic Assessment	EG0006 affected305 at risk EG00112 affected308 at risk
Angina unstable	Cardiac disorders	MedDRA	Systematic Assessment	EG0006 affected305 at risk EG0016 affected308 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected305 at risk EG0012 affected308 at risk
Atrial fibrillation	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 affected305 at risk EG0012 affected308 at risk
Atrial flutter	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0011 affected308 at risk
Cardiac arrest	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0011 affected308 at risk
Cardiac failure	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0011 affected308 at risk
Cardiac failure acute	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0011 affected308 at risk
Coronary artery disease	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 affected305 at risk EG0015 affected308 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected305 at risk EG0012 affected308 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 affected305 at risk EG0015 affected308 at risk
Myocardial infarction	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected305 at risk EG0012 affected308 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 affected305 at risk EG0012 affected308 at risk
Sick sinus syndrome	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0011 affected308 at risk
Tachycardia	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected305 at risk EG0011 affected308 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected305 at risk EG0010 affected308 at risk
Atrial septal defect	Congenital, familial and genetic disorders	MedDRA	Systematic Assessment	EG0001 affected305 at risk EG0010 affected308 at risk
Deafness	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0001 affected305 at risk EG0010 affected308 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA	Systematic Assessment	EG0001 affected305 at risk EG0010 affected308 at risk
Hyperparathyroidism	Endocrine disorders	MedDRA	Systematic Assessment	EG0001 affected305 at risk EG0010 affected308 at risk
Amaurosis fugax	Eye disorders	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0011 affected308 at risk
Cataract	Eye disorders	MedDRA	Systematic Assessment	EG0001 affected305 at risk EG0010 affected308 at risk
Retinal degeneration	Eye disorders	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0011 affected308 at risk
Visual impairment	Eye disorders	MedDRA	Systematic Assessment	EG0001 affected305 at risk EG0010 affected308 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0011 affected308 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected305 at risk EG0010 affected308 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected305 at risk EG0010 affected308 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected305 at risk EG0010 affected308 at risk
Enterocolitis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0011 affected308 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0011 affected308 at risk
Gastritis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0011 affected308 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected305 at risk EG0012 affected308 at risk
Gastrointestinal inflammation	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected305 at risk EG0010 affected308 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected305 at risk EG0010 affected308 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0011 affected308 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0011 affected308 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0011 affected308 at risk
Melaena	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected305 at risk EG0010 affected308 at risk
Nausea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected305 at risk EG0010 affected308 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected305 at risk EG0010 affected308 at risk
Peptic ulcer	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0011 affected308 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected305 at risk EG0010 affected308 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0011 affected308 at risk
Vomiting	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected305 at risk EG0010 affected308 at risk
Asthenia	General disorders	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0011 affected308 at risk
Catheter site haemorrhage	General disorders	MedDRA	Systematic Assessment	EG0001 affected305 at risk EG0010 affected308 at risk
Chest discomfort	General disorders	MedDRA	Systematic Assessment	EG0001 affected305 at risk EG0010 affected308 at risk
Chest pain	General disorders	MedDRA	Systematic Assessment	EG0001 affected305 at risk EG0012 affected308 at risk
Fatigue	General disorders	MedDRA	Systematic Assessment	EG0002 affected305 at risk EG0011 affected308 at risk
Multi-organ failure	General disorders	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0011 affected308 at risk
Non-cardiac chest pain	General disorders	MedDRA	Systematic Assessment	EG0004 affected305 at risk EG0014 affected308 at risk
Oedema peripheral	General disorders	MedDRA	Systematic Assessment	EG0002 affected305 at risk EG0010 affected308 at risk
Pyrexia	General disorders	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0011 affected308 at risk
Sudden cardiac death	General disorders	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0011 affected308 at risk
Sudden death	General disorders	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0011 affected308 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 affected305 at risk EG0011 affected308 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 affected305 at risk EG0010 affected308 at risk
Hydrocholecystis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0011 affected308 at risk
Abscess intestinal	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0011 affected308 at risk
Cellulitis	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected305 at risk EG0010 affected308 at risk
Diverticulitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0012 affected308 at risk
Enterocolitis infectious	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected305 at risk EG0010 affected308 at risk
Gastroenteritis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0012 affected308 at risk
Liver abscess	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0011 affected308 at risk
Lobar pneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected305 at risk EG0010 affected308 at risk
Meningitis aseptic	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected305 at risk EG0010 affected308 at risk
Osteomyelitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0011 affected308 at risk
Pneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG0002 affected305 at risk EG0013 affected308 at risk
Pneumonia bacterial	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0011 affected308 at risk
Pneumonia klebsiella	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0011 affected308 at risk
Pyelonephritis acute	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected305 at risk EG0010 affected308 at risk
Sepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected305 at risk EG0012 affected308 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0011 affected308 at risk
Sweat gland infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0011 affected308 at risk
Urinary tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0011 affected308 at risk
Arterial restenosis	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 affected305 at risk EG0011 affected308 at risk
Coronary artery restenosis	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected305 at risk EG0014 affected308 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected305 at risk EG0010 affected308 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0011 affected308 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0011 affected308 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected305 at risk EG0010 affected308 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0011 affected308 at risk
Ligament rupture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0011 affected308 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 affected305 at risk EG0011 affected308 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0011 affected308 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0011 affected308 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected305 at risk EG0010 affected308 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0011 affected308 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0011 affected308 at risk
Electrocardiogram ST segment depression	Investigations	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0012 affected308 at risk
Electrocardiogram T wave inversion	Investigations	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0011 affected308 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected305 at risk EG0010 affected308 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0002 affected305 at risk EG0011 affected308 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0011 affected308 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0011 affected308 at risk
Haemarthrosis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected305 at risk EG0010 affected308 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0011 affected308 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0011 affected308 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected305 at risk EG0010 affected308 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected305 at risk EG0011 affected308 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0011 affected308 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0011 affected308 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0002 affected305 at risk EG0010 affected308 at risk
Bladder papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected305 at risk EG0010 affected308 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected305 at risk EG0010 affected308 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0011 affected308 at risk
Mesothelioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected305 at risk EG0010 affected308 at risk
Pancreatic carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0011 affected308 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0002 affected305 at risk EG0010 affected308 at risk
Prostatic adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0011 affected308 at risk
Rectal adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 affected305 at risk EG0010 affected308 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0011 affected308 at risk
Cerebral ischaemia	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected305 at risk EG0010 affected308 at risk
Cerebral microangiopathy	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected305 at risk EG0010 affected308 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected305 at risk EG0012 affected308 at risk
Convulsion	Nervous system disorders	MedDRA	Systematic Assessment	EG0002 affected305 at risk EG0010 affected308 at risk
Headache	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 affected305 at risk EG0012 affected308 at risk
Ischaemic stroke	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0011 affected308 at risk
Paraesthesia	Nervous system disorders	MedDRA	Systematic Assessment	EG0002 affected305 at risk EG0010 affected308 at risk
Syncope	Nervous system disorders	MedDRA	Systematic Assessment	EG0003 affected305 at risk EG0011 affected308 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0011 affected308 at risk
Vertebrobasilar insufficiency	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0011 affected308 at risk
Conversion disorder	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0011 affected308 at risk
Depression	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 affected305 at risk EG0011 affected308 at risk
Depression suicidal	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 affected305 at risk EG0010 affected308 at risk
Suicidal ideation	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 affected305 at risk EG0010 affected308 at risk
Suicide attempt	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 affected305 at risk EG0010 affected308 at risk
Haematuria	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0012 affected308 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected305 at risk EG0010 affected308 at risk
Renal failure	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected305 at risk EG0010 affected308 at risk
Renal failure acute	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected305 at risk EG0011 affected308 at risk
Urethral stenosis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected305 at risk EG0010 affected308 at risk
Urinary retention	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0011 affected308 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0011 affected308 at risk
Uterine haemorrhage	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0001 affected305 at risk EG0010 affected308 at risk
Uterine polyp	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0011 affected308 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected305 at risk EG0010 affected308 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0002 affected305 at risk EG0010 affected308 at risk
Diaphragmatic disorder	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0011 affected308 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected305 at risk EG0011 affected308 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0011 affected308 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected305 at risk EG0010 affected308 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected305 at risk EG0010 affected308 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0011 affected308 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0002 affected305 at risk EG0010 affected308 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0011 affected308 at risk
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0011 affected308 at risk
Dermal cyst	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0011 affected308 at risk
Diabetic ulcer	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0011 affected308 at risk
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 affected305 at risk EG0010 affected308 at risk
Aortic aneurysm	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0011 affected308 at risk
Aortic stenosis	Vascular disorders	MedDRA	Systematic Assessment	EG0003 affected305 at risk EG0010 affected308 at risk
Arterial stenosis	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0011 affected308 at risk
Arteriosclerosis	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected305 at risk EG0010 affected308 at risk
Hypertensive crisis	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0011 affected308 at risk
Hypotension	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected305 at risk EG0010 affected308 at risk
Hypovolaemic shock	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0011 affected308 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0011 affected308 at risk
Peripheral artery aneurysm	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0011 affected308 at risk
Peripheral embolism	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected305 at risk EG0011 affected308 at risk
Reperfusion injury	Vascular disorders	MedDRA	Systematic Assessment	EG0001 affected305 at risk EG0010 affected308 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Angina pectoris	Cardiac disorders	MedDRA	Systematic Assessment	EG00021 affected305 at risk EG00124 affected308 at risk
Palpitations	Cardiac disorders	MedDRA	Systematic Assessment	EG0004 affected305 at risk EG0018 affected308 at risk
Constipation	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0008 affected305 at risk EG00110 affected308 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00020 affected305 at risk EG00115 affected308 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0005 affected305 at risk EG0018 affected308 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0009 affected305 at risk EG0015 affected308 at risk
Nausea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG00015 affected305 at risk EG00113 affected308 at risk
Asthenia	General disorders	MedDRA	Systematic Assessment	EG0007 affected305 at risk EG0018 affected308 at risk
Chest pain	General disorders	MedDRA	Systematic Assessment	EG0005 affected305 at risk EG0019 affected308 at risk
Fatigue	General disorders	MedDRA	Systematic Assessment	EG00032 affected305 at risk EG00121 affected308 at risk
Non-cardiac chest pain	General disorders	MedDRA	Systematic Assessment	EG00023 affected305 at risk EG00121 affected308 at risk
Oedema peripheral	General disorders	MedDRA	Systematic Assessment	EG00019 affected305 at risk EG00118 affected308 at risk
Bronchitis	Infections and infestations	MedDRA	Systematic Assessment	EG00010 affected305 at risk EG00114 affected308 at risk
Influenza	Infections and infestations	MedDRA	Systematic Assessment	EG00016 affected305 at risk EG00110 affected308 at risk
Nasopharyngitis	Infections and infestations	MedDRA	Systematic Assessment	EG00023 affected305 at risk EG00113 affected308 at risk
Sinusitis	Infections and infestations	MedDRA	Systematic Assessment	EG0006 affected305 at risk EG00110 affected308 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0007 affected305 at risk EG0018 affected308 at risk
Urinary tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0008 affected305 at risk EG00110 affected308 at risk
Fall	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0007 affected305 at risk EG0016 affected308 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00016 affected305 at risk EG0019 affected308 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00021 affected305 at risk EG00113 affected308 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0003 affected305 at risk EG0019 affected308 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0008 affected305 at risk EG00114 affected308 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00010 affected305 at risk EG0017 affected308 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG00014 affected305 at risk EG00115 affected308 at risk
Dizziness	Nervous system disorders	MedDRA	Systematic Assessment	EG00035 affected305 at risk EG00128 affected308 at risk
Headache	Nervous system disorders	MedDRA	Systematic Assessment	EG00018 affected305 at risk EG00122 affected308 at risk
Hypoaesthesia	Nervous system disorders	MedDRA	Systematic Assessment	EG0009 affected305 at risk EG0017 affected308 at risk
Syncope	Nervous system disorders	MedDRA	Systematic Assessment	EG0009 affected305 at risk EG0014 affected308 at risk
Anxiety	Psychiatric disorders	MedDRA	Systematic Assessment	EG0003 affected305 at risk EG0019 affected308 at risk
Depression	Psychiatric disorders	MedDRA	Systematic Assessment	EG0006 affected305 at risk EG00112 affected308 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0003 affected305 at risk EG0019 affected308 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG00014 affected305 at risk EG00112 affected308 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG00012 affected305 at risk EG00117 affected308 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0009 affected305 at risk EG0011 affected308 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0007 affected305 at risk EG0014 affected308 at risk
Hypertension	Vascular disorders	MedDRA	Systematic Assessment	EG00016 affected305 at risk EG00122 affected308 at risk
Hypotension	Vascular disorders	MedDRA	Systematic Assessment	EG00021 affected305 at risk EG00112 affected308 at risk

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases