Rivaroxaban in Combination With Aspirin Alone or With Asp... | NCT00402597

ID	Type	Description	Link
39039039ACS2001

Name	Class
Bayer	INDUSTRY

Label	Type	Description	Intervention Names
001	Experimental	Rivaroxaban 1 rivaroxaban tablet twice daily for 6 months. Safety at each dose level will be confirmed before additional patients are randomized to the next higher dose level.	Drug: Rivaroxaban
002	Experimental	Rivaroxaban/Placebo 1 rivaroxaban tablet once daily (and 1 placebo tablet once daily) for 6 months. Safety at each dose level will be confirmed before additional patients are randomized to the next higher dose level.	Drug: Rivaroxaban/Placebo
003	Placebo Comparator	Placebo 1 placebo tablet twice daily for 6 months.	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Rivaroxaban/Placebo	Drug	1 rivaroxaban tablet once daily (and 1 placebo tablet once daily) for 6 months. Safety at each dose level will be confirmed before additional patients are randomized to the next higher dose level.

Measure	Description	Time Frame
Thrombolysis in Myocardial Infarction (TIMI) Clinically Significant Bleeding Events (Primary Safety)	The number of patients with a first occurrence of a TIMI clinically significant bleeding event that occurred from the time of randomization to the time of the last patient contact. TIMI clinically significant bleeding events included TIMI minor bleeding events, TIMI major bleeding events, or any bleeding that required medical attention.	Day 1 to Day 210
The Composite Endpoint of All Cause Death, Myocardial Infarction (MI) (Including Repeat MI), Stroke (Ischemic, Hemorrhagic or Unknown), or Severe Recurrent Ischemia Requiring Revascularization (Primary Efficacy)	The number of patients who died due to any cause or had a first occurrence of MI (including repeat MI) or stroke (ischemic, hemorrhagic or unknown) or severe recurrent ischemia requiring revascularization from the time of randomization to the last date of patient contact.	Day 1 to Day 210

Measure	Description	Time Frame
The Composite Endpoint of Death (All Cause), Myocardial Infarction (MI) (or Repeat MI), or Stroke	The number of patients who died due to any cause or had a first occurrence of MI (or repeat MI) or stroke from the time of randomization to the last date of patient contact.	Day 1 to Day 210
The Composite Endpoint of Cardiovascular Death, Myocardial Infarction (MI), or Stroke

Name	Affiliation	Role
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	Study Director

PubMed Identifier	Type	Citation	Retractions
19539361	Result	Mega JL, Braunwald E, Mohanavelu S, Burton P, Poulter R, Misselwitz F, Hricak V, Barnathan ES, Bordes P, Witkowski A, Markov V, Oppenheimer L, Gibson CM; ATLAS ACS-TIMI 46 study group. Rivaroxaban versus placebo in patients with acute coronary syndromes (ATLAS ACS-TIMI 46): a randomised, double-blind, phase II trial. Lancet. 2009 Jul 4;374(9683):29-38. doi: 10.1016/S0140-6736(09)60738-8. Epub 2009 Jun 17.
31535314

ID	Title	Description
FG000	Placebo	One placebo tablet twice daily for 6 months.
FG001	Riva 5 mg Total Daily Dose (TDD)	Rivaroxaban 5 mg (2.5 mg twice a day or 5 mg once daily)

ID	Title	Description
BG000	Placebo	One placebo tablet twice daily for 6 months.
BG001	Riva 5 mg Total Daily Dose (TDD)	Rivaroxaban 5 mg (2.5 mg twice a day or 5 mg once daily)
BG002	Riva 10 mg TDD	Rivaroxaban 10 mg (5 mg twice a day or 10 mg once daily) for 6 months.
BG003	Riva 15 mg TDD	Rivaroxaban 15 mg (7.5 mg twice a day or 15 mg once daily) for 6 months.
BG004	Riva 20 mg TDD	Rivaroxaban 20 mg (10 mg twice a day or 20 mg once daily) for 6 months.
BG005	Total	Total of all reporting groups

Units	Counts
Participants	BG0001153 BG001307 BG0021046 BG003353 BG004603 BG0053462

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Thrombolysis in Myocardial Infarction (TIMI) Clinically Significant Bleeding Events (Primary Safety)

The number of patients with a first occurrence of a TIMI clinically significant bleeding event that occurred from the time of randomization to the time of the last patient contact. TIMI clinically significant bleeding events included TIMI minor bleeding events, TIMI major bleeding events, or any bleeding that required medical attention.

The safety population consisted of all randomized patients who took at least 1 dose of study medication after randomization during the double-blind treatment period.

Posted

Number

Patients

Day 1 to Day 210

ID	Title	Description
OG000	Placebo	One Placebo tablet twice daily for 6 months.
OG001	Riva 5 mg Total Daily Dose (TDD)	Rivaroxaban 5 mg (2.5 mg twice a day or 5 mg once daily) for 6 months.
OG002	Riva 10 mg TDD	Rivaroxaban 10 mg (5 mg twice a day or 10 mg once daily) for 6 months.
OG003	Riva 15 mg TDD	Rivaroxaban 15 mg (7.5 mg twice a day or 15 mg once daily) for 6 months.
OG004	Riva 20 mg TDD	Rivaroxaban 20 mg (10 mg twice a day or 20 mg once daily) for 6 months.

Units	Counts
Participants	OG0001153 OG001307 OG0021046 OG003

Title

Denominators

Categories

Title	Measurements
	OG00036 OG00117 OG002109 OG003

Primary

The Composite Endpoint of All Cause Death, Myocardial Infarction (MI) (Including Repeat MI), Stroke (Ischemic, Hemorrhagic or Unknown), or Severe Recurrent Ischemia Requiring Revascularization (Primary Efficacy)

The number of patients who died due to any cause or had a first occurrence of MI (including repeat MI) or stroke (ischemic, hemorrhagic or unknown) or severe recurrent ischemia requiring revascularization from the time of randomization to the last date of patient contact.

The intent-to-treat (ITT) population consisted of all patients who were randomized to treatment, regardless of study drug intake.

Posted

Number

Patients

Day 1 to Day 210

ID	Title	Description
OG000	Placebo	One Placebo tablet twice daily for 6 months.
OG001	Riva 5 mg Total Daily Dose (TDD)	Rivaroxaban 5 mg (2.5 mg twice a day or 5 mg once daily) for 6 months.
OG002	Riva 10 mg TDD	Rivaroxaban 10 mg (5 mg twice a day or 10 mg once daily) for 6 months.
OG003	Riva 15 mg TDD

Secondary

The Composite Endpoint of Death (All Cause), Myocardial Infarction (MI) (or Repeat MI), or Stroke

The number of patients who died due to any cause or had a first occurrence of MI (or repeat MI) or stroke from the time of randomization to the last date of patient contact.

The ITT population consisted of all patients who were randomized to treatment, regardliess of study drug intake.

Posted

Number

Patients

Day 1 to Day 210

ID	Title	Description
OG000	Placebo	One Placebo tablet twice daily for 6 months.
OG001	Riva 5 mg Total Daily Dose (TDD)	Rivaroxaban 5 mg (2.5 mg twice a day or 5 mg once daily) for 6 months.
OG002	Riva 10 mg TDD	Rivaroxaban 10 mg (5 mg twice a day or 10 mg once daily) for 6 months.
OG003	Riva 15 mg TDD	Rivaroxaban 15 mg (7.5 mg twice a day or 15 mg once daily) for 6 months.
OG004

Secondary

The Composite Endpoint of Cardiovascular Death, Myocardial Infarction (MI), or Stroke

The number of patients with the composite endpoint of cardiovascular death or MI or stroke that occurred from the time of randomization to the last date of patient contact.

The ITT population consisted of all patients who were randomized to treatment regardless of study drug intake.

Posted

Number

Patients

Day 1 to Day 210

ID	Title	Description
OG000	Placebo	One Placebo tablet twice daily for 6 months.
OG001	Riva 5 mg Total Daily Dose (TDD)	Rivaroxaban 5 mg (2.5 mg twice a day or 5 mg once daily) for 6 months.
OG002	Riva 10 mg TDD	Rivaroxaban 10 mg (5 mg twice a day or 10 mg once daily) for 6 months.
OG003	Riva 15 mg TDD	Rivaroxaban 15 mg (7.5 mg twice a day or 15 mg once daily) for 6 months.
OG004

Secondary

The Number of Deaths (All Cause)

The number of patients who died due to any cause from the time of randomization to the last date of patient contact.

The ITT population consisted of all patients who were randomized to treatment, regardless of study drug intake.

Posted

Number

Patients

Day 1 to Day 210

ID	Title	Description
OG000	Placebo	One Placebo tablet twice daily for 6 months.
OG001	Riva 5 mg Total Daily Dose (TDD)	Rivaroxaban 5 mg (2.5 mg twice a day or 5 mg once daily) for 6 months.
OG002	Riva 10 mg TDD	Rivaroxaban 10 mg (5 mg twice a day or 10 mg once daily) for 6 months.
OG003	Riva 15 mg TDD	Rivaroxaban 15 mg (7.5 mg twice a day or 15 mg once daily) for 6 months.
OG004	Riva 20 mg TDD

Secondary

The Composite Endpoint of Death (All Cause), MI (or reMI), Stroke, Severe Recurrent Ischemia Requiring Revascularization, or Thrombolysis in Myocardial Infarction (TIMI) (Major or Minor Bleeding) to Assess the Net Clinical Benefit

The number of patients who died due to any cause or had a first occurrence of MI (or repeat MI), or stroke, or severe recurrent ischemia requiring revascularization, or TIMI (major or minor bleeding) from the time of randomization to the last date of patient contact to assess the net clinical benefit of rivaroxaban.

The ITT population consisted of all patients who were randomized to treatment, regardless of study drug intake.

Posted

Number

Patients

Day 1 to Day 210

ID	Title	Description
OG000	Placebo	One Placebo tablet twice daily for 6 months.
OG001	Riva 5 mg Total Daily Dose (TDD)	Rivaroxaban 5 mg (2.5 mg twice a day or 5 mg once daily) for 6 months.
OG002	Riva 10 mg TDD	Rivaroxaban 10 mg (5 mg twice a day or 10 mg once daily) for 6 months.
OG003	Riva 15 mg TDD

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MEDDRA 11.1	Non-systematic Assessment	EG0001 affected1,153 at risk EG0010 affected307 at risk EG0023 affected1,046 at risk EG0030 affected353 at risk EG0041 affected603 at risk
Haemorrhagic Anaemia	Blood and lymphatic system disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Iron Deficiency Anaemia	Blood and lymphatic system disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Normochromic Normocytic Anaemia	Blood and lymphatic system disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Thrombocythaemia	Blood and lymphatic system disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0011 affected307 at risk EG0021 affected1,046 at risk EG003
Acute Coronary Syndrome	Cardiac disorders	MEDDRA 11.1	Non-systematic Assessment	EG0003 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Acute Myocardial Infarction	Cardiac disorders	MEDDRA 11.1	Non-systematic Assessment	EG00028 affected1,153 at risk EG0016 affected307 at risk EG00213 affected1,046 at risk EG003
Angina Pectoris	Cardiac disorders	MEDDRA 11.1	Non-systematic Assessment	EG00022 affected1,153 at risk EG0014 affected307 at risk EG00216 affected1,046 at risk EG003
Angina Unstable	Cardiac disorders	MEDDRA 11.1	Non-systematic Assessment	EG00042 affected1,153 at risk EG00112 affected307 at risk EG00223 affected1,046 at risk EG003
Arteriosclerosis Coronary Artery	Cardiac disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Arteriospasm Coronary	Cardiac disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Atrial Fibrillation	Cardiac disorders	MEDDRA 11.1	Non-systematic Assessment	EG0007 affected1,153 at risk EG0015 affected307 at risk EG0026 affected1,046 at risk EG003
Atrial Flutter	Cardiac disorders	MEDDRA 11.1	Non-systematic Assessment	EG0001 affected1,153 at risk EG0010 affected307 at risk EG0023 affected1,046 at risk EG003
Atrioventricular Block Second Degree	Cardiac disorders	MEDDRA 11.1	Non-systematic Assessment	EG0001 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Bradycardia	Cardiac disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0011 affected307 at risk EG0022 affected1,046 at risk EG003
Cardiac Arrest	Cardiac disorders	MEDDRA 11.1	Non-systematic Assessment	EG0002 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Cardiac Failure	Cardiac disorders	MEDDRA 11.1	Non-systematic Assessment	EG0006 affected1,153 at risk EG0011 affected307 at risk EG0026 affected1,046 at risk EG003
Cardiac Failure Acute	Cardiac disorders	MEDDRA 11.1	Non-systematic Assessment	EG0001 affected1,153 at risk EG0011 affected307 at risk EG0020 affected1,046 at risk EG003
Cardiac Failure Congestive	Cardiac disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0013 affected307 at risk EG0021 affected1,046 at risk EG003
Cardio-Respiratory Arrest	Cardiac disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0011 affected307 at risk EG0020 affected1,046 at risk EG003
Cardiogenic Shock	Cardiac disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0011 affected307 at risk EG0020 affected1,046 at risk EG003
Cardiomyopathy	Cardiac disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0011 affected307 at risk EG0020 affected1,046 at risk EG003
Coronary Artery Disease	Cardiac disorders	MEDDRA 11.1	Non-systematic Assessment	EG0005 affected1,153 at risk EG0010 affected307 at risk EG0023 affected1,046 at risk EG003
Coronary Artery Insufficiency	Cardiac disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0011 affected307 at risk EG0020 affected1,046 at risk EG003
Coronary Artery Occlusion	Cardiac disorders	MEDDRA 11.1	Non-systematic Assessment	EG0001 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Coronary Artery Stenosis	Cardiac disorders	MEDDRA 11.1	Non-systematic Assessment	EG0001 affected1,153 at risk EG0011 affected307 at risk EG0020 affected1,046 at risk EG003
Dressler's Syndrome	Cardiac disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Intracardiac Thrombus	Cardiac disorders	MEDDRA 11.1	Non-systematic Assessment	EG0001 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Left Ventricular Dysfunction	Cardiac disorders	MEDDRA 11.1	Non-systematic Assessment	EG0001 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Left Ventricular Failure	Cardiac disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Myocardial Infarction	Cardiac disorders	MEDDRA 11.1	Non-systematic Assessment	EG0005 affected1,153 at risk EG0013 affected307 at risk EG0026 affected1,046 at risk EG003
Myocardial Ischaemia	Cardiac disorders	MEDDRA 11.1	Non-systematic Assessment	EG0006 affected1,153 at risk EG0011 affected307 at risk EG00212 affected1,046 at risk EG003
Palpitations	Cardiac disorders	MEDDRA 11.1	Non-systematic Assessment	EG0001 affected1,153 at risk EG0010 affected307 at risk EG0023 affected1,046 at risk EG003
Parasystole	Cardiac disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0011 affected307 at risk EG0020 affected1,046 at risk EG003
Pericardial Effusion	Cardiac disorders	MEDDRA 11.1	Non-systematic Assessment	EG0002 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Pericarditis	Cardiac disorders	MEDDRA 11.1	Non-systematic Assessment	EG0001 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Postinfarction Angina	Cardiac disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0011 affected307 at risk EG0020 affected1,046 at risk EG003
Sick Sinus Syndrome	Cardiac disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Sinus Bradycardia	Cardiac disorders	MEDDRA 11.1	Non-systematic Assessment	EG0001 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Ventricular Arrhythmia	Cardiac disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Ventricular Dysfunction	Cardiac disorders	MEDDRA 11.1	Non-systematic Assessment	EG0001 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Ventricular Extrasystoles	Cardiac disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0011 affected307 at risk EG0020 affected1,046 at risk EG003
Ventricular Fibrillation	Cardiac disorders	MEDDRA 11.1	Non-systematic Assessment	EG0001 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Ventricular Tachycardia	Cardiac disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0011 affected307 at risk EG0022 affected1,046 at risk EG003
Endocardial Fibroelastosis	Congenital, familial and genetic disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Vertigo	Ear and labyrinth disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Hyperthyroidism	Endocrine disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Thyroid Disorder	Endocrine disorders	MEDDRA 11.1	Non-systematic Assessment	EG0001 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Conjunctival Haemorrhage	Eye disorders	MEDDRA 11.1	Non-systematic Assessment	EG0001 affected1,153 at risk EG0011 affected307 at risk EG0020 affected1,046 at risk EG003
Eye Haemorrhage	Eye disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Retinal Artery Thrombosis	Eye disorders	MEDDRA 11.1	Non-systematic Assessment	EG0001 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Vitreous Haemorrhage	Eye disorders	MEDDRA 11.1	Non-systematic Assessment	EG0001 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Abdominal Pain	Gastrointestinal disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Abdominal Pain Upper	Gastrointestinal disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Anal Fissure	Gastrointestinal disorders	MEDDRA 11.1	Non-systematic Assessment	EG0001 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Colitis Ischaemic	Gastrointestinal disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Dry Mouth	Gastrointestinal disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Duodenal Ulcer	Gastrointestinal disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0011 affected307 at risk EG0020 affected1,046 at risk EG003
Gastric Ulcer Haemorrhage	Gastrointestinal disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Gastritis	Gastrointestinal disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Gastrointestinal Haemorrhage	Gastrointestinal disorders	MEDDRA 11.1	Non-systematic Assessment	EG0002 affected1,153 at risk EG0011 affected307 at risk EG00210 affected1,046 at risk EG003
Gastrooesophageal Reflux Disease	Gastrointestinal disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Gingival Bleeding	Gastrointestinal disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Haematemesis	Gastrointestinal disorders	MEDDRA 11.1	Non-systematic Assessment	EG0001 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Haemorrhoidal Haemorrhage	Gastrointestinal disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Inguinal Hernia	Gastrointestinal disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Intestinal Haemorrhage	Gastrointestinal disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Lower Gastrointestinal Haemorrhage	Gastrointestinal disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Melaena	Gastrointestinal disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Nausea	Gastrointestinal disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Oesophageal Haemorrhage	Gastrointestinal disorders	MEDDRA 11.1	Non-systematic Assessment	EG0001 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Pancreatitis	Gastrointestinal disorders	MEDDRA 11.1	Non-systematic Assessment	EG0001 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Pancreatitis Acute	Gastrointestinal disorders	MEDDRA 11.1	Non-systematic Assessment	EG0001 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Peptic Ulcer	Gastrointestinal disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Peptic Ulcer Haemorrhage	Gastrointestinal disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Rectal Haemorrhage	Gastrointestinal disorders	MEDDRA 11.1	Non-systematic Assessment	EG0001 affected1,153 at risk EG0011 affected307 at risk EG0020 affected1,046 at risk EG003
Retroperitoneal Haematoma	Gastrointestinal disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Small Intestinal Haemorrhage	Gastrointestinal disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Upper Gastrointestinal Haemorrhage	Gastrointestinal disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Vomiting	Gastrointestinal disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Asthenia	General disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Catheter Site Haemorrhage	General disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Chest Discomfort	General disorders	MEDDRA 11.1	Non-systematic Assessment	EG0001 affected1,153 at risk EG0011 affected307 at risk EG0022 affected1,046 at risk EG003
Chest Pain	General disorders	MEDDRA 11.1	Non-systematic Assessment	EG00024 affected1,153 at risk EG0019 affected307 at risk EG00217 affected1,046 at risk EG003
Death	General disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0011 affected307 at risk EG0020 affected1,046 at risk EG003
Injection Site Phlebitis	General disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0011 affected307 at risk EG0020 affected1,046 at risk EG003
Non-Cardiac Chest Pain	General disorders	MEDDRA 11.1	Non-systematic Assessment	EG00011 affected1,153 at risk EG0014 affected307 at risk EG00213 affected1,046 at risk EG003
Puncture Site Haemorrhage	General disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0022 affected1,046 at risk EG003
Puncture Site Reaction	General disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Pyrexia	General disorders	MEDDRA 11.1	Non-systematic Assessment	EG0001 affected1,153 at risk EG0011 affected307 at risk EG0020 affected1,046 at risk EG003
Sudden Cardiac Death	General disorders	MEDDRA 11.1	Non-systematic Assessment	EG0003 affected1,153 at risk EG0011 affected307 at risk EG0021 affected1,046 at risk EG003
Sudden Death	General disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0022 affected1,046 at risk EG003
Vessel Puncture Site Haemorrhage	General disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Cholecystitis	Hepatobiliary disorders	MEDDRA 11.1	Non-systematic Assessment	EG0002 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Cholecystitis Acute	Hepatobiliary disorders	MEDDRA 11.1	Non-systematic Assessment	EG0001 affected1,153 at risk EG0011 affected307 at risk EG0021 affected1,046 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MEDDRA 11.1	Non-systematic Assessment	EG0001 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Anaphylactic Shock	Immune system disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0011 affected307 at risk EG0020 affected1,046 at risk EG003
Abscess Limb	Infections and infestations	MEDDRA 11.1	Non-systematic Assessment	EG0001 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Acarodermatitis	Infections and infestations	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Anal Abscess	Infections and infestations	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Bronchitis	Infections and infestations	MEDDRA 11.1	Non-systematic Assessment	EG0001 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Bronchopneumonia	Infections and infestations	MEDDRA 11.1	Non-systematic Assessment	EG0001 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Cellulitis	Infections and infestations	MEDDRA 11.1	Non-systematic Assessment	EG0002 affected1,153 at risk EG0011 affected307 at risk EG0021 affected1,046 at risk EG003
Cellulitis Orbital	Infections and infestations	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Cellulitis Pharyngeal	Infections and infestations	MEDDRA 11.1	Non-systematic Assessment	EG0001 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Device Related Infection	Infections and infestations	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0011 affected307 at risk EG0020 affected1,046 at risk EG003
Erysipelas	Infections and infestations	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Gangrene	Infections and infestations	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Gastroenteritis	Infections and infestations	MEDDRA 11.1	Non-systematic Assessment	EG0002 affected1,153 at risk EG0010 affected307 at risk EG0022 affected1,046 at risk EG003
Gastrointestinal Infection	Infections and infestations	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Gingival Abscess	Infections and infestations	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Implant Site Infection	Infections and infestations	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Lobar Pneumonia	Infections and infestations	MEDDRA 11.1	Non-systematic Assessment	EG0001 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Orchitis	Infections and infestations	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Pneumonia	Infections and infestations	MEDDRA 11.1	Non-systematic Assessment	EG0003 affected1,153 at risk EG0011 affected307 at risk EG0021 affected1,046 at risk EG003
Post Procedural Infection	Infections and infestations	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Pyelonephritis	Infections and infestations	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Sepsis	Infections and infestations	MEDDRA 11.1	Non-systematic Assessment	EG0001 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Staphylococcal Sepsis	Infections and infestations	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Urinary Tract Infection	Infections and infestations	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Viral Infection	Infections and infestations	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Wound Infection	Infections and infestations	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Ankle Fracture	Injury, poisoning and procedural complications	MEDDRA 11.1	Non-systematic Assessment	EG0001 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Concussion	Injury, poisoning and procedural complications	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Contusion	Injury, poisoning and procedural complications	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Coronary Artery Restenosis	Injury, poisoning and procedural complications	MEDDRA 11.1	Non-systematic Assessment	EG0002 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Facial Bones Fracture	Injury, poisoning and procedural complications	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Fall	Injury, poisoning and procedural complications	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Head Injury	Injury, poisoning and procedural complications	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Implantable Defibrillator Malfunction	Injury, poisoning and procedural complications	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
In-Stent Coronary Artery Restenosis	Injury, poisoning and procedural complications	MEDDRA 11.1	Non-systematic Assessment	EG0004 affected1,153 at risk EG0011 affected307 at risk EG0020 affected1,046 at risk EG003
Multiple Injuries	Injury, poisoning and procedural complications	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Post Procedural Haematoma	Injury, poisoning and procedural complications	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0011 affected307 at risk EG0020 affected1,046 at risk EG003
Radius Fracture	Injury, poisoning and procedural complications	MEDDRA 11.1	Non-systematic Assessment	EG0001 affected1,153 at risk EG0011 affected307 at risk EG0020 affected1,046 at risk EG003
Rib Fracture	Injury, poisoning and procedural complications	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Road Traffic Accident	Injury, poisoning and procedural complications	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0011 affected307 at risk EG0021 affected1,046 at risk EG003
Skull Fracture	Injury, poisoning and procedural complications	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Subdural Haematoma	Injury, poisoning and procedural complications	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0023 affected1,046 at risk EG003
Thrombosis in Device	Injury, poisoning and procedural complications	MEDDRA 11.1	Non-systematic Assessment	EG0003 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Traumatic Haematoma	Injury, poisoning and procedural complications	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Upper Limb Fracture	Injury, poisoning and procedural complications	MEDDRA 11.1	Non-systematic Assessment	EG0001 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Vascular Pseudoaneurysm	Injury, poisoning and procedural complications	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0025 affected1,046 at risk EG003
Vascular Pseudoaneurysm Ruptured	Injury, poisoning and procedural complications	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Alanine Aminotransferase Increased	Investigations	MEDDRA 11.1	Non-systematic Assessment	EG0002 affected1,153 at risk EG0012 affected307 at risk EG0021 affected1,046 at risk EG003
Angiogram	Investigations	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Arteriogram Coronary	Investigations	MEDDRA 11.1	Non-systematic Assessment	EG0006 affected1,153 at risk EG0010 affected307 at risk EG0023 affected1,046 at risk EG003
Aspartate Aminotransferase Increased	Investigations	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0012 affected307 at risk EG0020 affected1,046 at risk EG003
Blood Alkaline Phosphatase Increased	Investigations	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Blood Bilirubin Increased	Investigations	MEDDRA 11.1	Non-systematic Assessment	EG0001 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Blood Pressure Increased	Investigations	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
C-Reactive Protein Increased	Investigations	MEDDRA 11.1	Non-systematic Assessment	EG0001 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Chest X-Ray Abnormal	Investigations	MEDDRA 11.1	Non-systematic Assessment	EG0001 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Ejection Fraction Decreased	Investigations	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Gamma-Glutamyltransferase Increased	Investigations	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0011 affected307 at risk EG0020 affected1,046 at risk EG003
Haemoglobin Decreased	Investigations	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Hepatic Enzyme Increased	Investigations	MEDDRA 11.1	Non-systematic Assessment	EG0001 affected1,153 at risk EG0011 affected307 at risk EG0020 affected1,046 at risk EG003
Liver Function Test Abnormal	Investigations	MEDDRA 11.1	Non-systematic Assessment	EG0002 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Occult Blood	Investigations	MEDDRA 11.1	Non-systematic Assessment	EG0001 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Dehydration	Metabolism and nutrition disorders	MEDDRA 11.1	Non-systematic Assessment	EG0002 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Diabetes Mellitus	Metabolism and nutrition disorders	MEDDRA 11.1	Non-systematic Assessment	EG0001 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MEDDRA 11.1	Non-systematic Assessment	EG0001 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0011 affected307 at risk EG0020 affected1,046 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MEDDRA 11.1	Non-systematic Assessment	EG0002 affected1,153 at risk EG0011 affected307 at risk EG0020 affected1,046 at risk EG003
Arthritis Reactive	Musculoskeletal and connective tissue disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0011 affected307 at risk EG0020 affected1,046 at risk EG003
Back Disorder	Musculoskeletal and connective tissue disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0011 affected307 at risk EG0020 affected1,046 at risk EG003
Back Pain	Musculoskeletal and connective tissue disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Haemarthrosis	Musculoskeletal and connective tissue disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0011 affected307 at risk EG0021 affected1,046 at risk EG003
Musculoskeletal Chest Pain	Musculoskeletal and connective tissue disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MEDDRA 11.1	Non-systematic Assessment	EG0001 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MEDDRA 11.1	Non-systematic Assessment	EG0001 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Pain in Extremity	Musculoskeletal and connective tissue disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Spondyloarthropathy	Musculoskeletal and connective tissue disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Breast Cancer in Situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Colon Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Colon Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Gastric Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0011 affected307 at risk EG0020 affected1,046 at risk EG003
Lung Neoplasm Malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Myelodysplastic Syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0011 affected307 at risk EG0020 affected1,046 at risk EG003
Ovarian Granulosa-Theca Cell Tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Ovarian Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Rectal Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Brain Oedema	Nervous system disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Carotid Artery Stenosis	Nervous system disorders	MEDDRA 11.1	Non-systematic Assessment	EG0001 affected1,153 at risk EG0011 affected307 at risk EG0020 affected1,046 at risk EG003
Carpal Tunnel Syndrome	Nervous system disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Cerebral Infarction	Nervous system disorders	MEDDRA 11.1	Non-systematic Assessment	EG0001 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Cerebrovascular Accident	Nervous system disorders	MEDDRA 11.1	Non-systematic Assessment	EG0001 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Haemorrhage Intracranial	Nervous system disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Haemorrhagic Stroke	Nervous system disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Headache	Nervous system disorders	MEDDRA 11.1	Non-systematic Assessment	EG0001 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Ischaemic Cerebral Infarction	Nervous system disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0011 affected307 at risk EG0021 affected1,046 at risk EG003
Ischaemic Stroke	Nervous system disorders	MEDDRA 11.1	Non-systematic Assessment	EG0002 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Lethargy	Nervous system disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Motor Neurone Disease	Nervous system disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Presyncope	Nervous system disorders	MEDDRA 11.1	Non-systematic Assessment	EG0002 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Progressive Supranuclear Palsy	Nervous system disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0011 affected307 at risk EG0020 affected1,046 at risk EG003
Somnolence	Nervous system disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Subarachnoid Haemorrhage	Nervous system disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Syncope	Nervous system disorders	MEDDRA 11.1	Non-systematic Assessment	EG0002 affected1,153 at risk EG0011 affected307 at risk EG0022 affected1,046 at risk EG003
Vascular Encephalopathy	Nervous system disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Vertebrobasilar Insufficiency	Nervous system disorders	MEDDRA 11.1	Non-systematic Assessment	EG0001 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Acute Psychosis	Psychiatric disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Alcohol Withdrawal Syndrome	Psychiatric disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Anxiety	Psychiatric disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Depression	Psychiatric disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0011 affected307 at risk EG0020 affected1,046 at risk EG003
Drug Dependence	Psychiatric disorders	MEDDRA 11.1	Non-systematic Assessment	EG0001 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Major Depression	Psychiatric disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0022 affected1,046 at risk EG003
Mental Status Changes	Psychiatric disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Calculus Ureteric	Renal and urinary disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Calculus Urinary	Renal and urinary disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Cystitis Haemorrhagic	Renal and urinary disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Haematuria	Renal and urinary disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Renal Colic	Renal and urinary disorders	MEDDRA 11.1	Non-systematic Assessment	EG0001 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Renal Failure Acute	Renal and urinary disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Renal Haemorrhage	Renal and urinary disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Renal Impairment	Renal and urinary disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Benign Prostatic Hyperplasia	Reproductive system and breast disorders	MEDDRA 11.1	Non-systematic Assessment	EG0001 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Menometrorrhagia	Reproductive system and breast disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Menorrhagia	Reproductive system and breast disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Metrorrhagia	Reproductive system and breast disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0011 affected307 at risk EG0020 affected1,046 at risk EG003
Vaginal Haemorrhage	Reproductive system and breast disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Acute Pulmonary Oedema	Respiratory, thoracic and mediastinal disorders	MEDDRA 11.1	Non-systematic Assessment	EG0001 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Acute Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MEDDRA 11.1	Non-systematic Assessment	EG0001 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Bronchopneumopathy	Respiratory, thoracic and mediastinal disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Chronic Obstructive Pulmonary Disease	Respiratory, thoracic and mediastinal disorders	MEDDRA 11.1	Non-systematic Assessment	EG0003 affected1,153 at risk EG0011 affected307 at risk EG0022 affected1,046 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MEDDRA 11.1	Non-systematic Assessment	EG0001 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MEDDRA 11.1	Non-systematic Assessment	EG0002 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Dyspnoea Exertional	Respiratory, thoracic and mediastinal disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MEDDRA 11.1	Non-systematic Assessment	EG0002 affected1,153 at risk EG0010 affected307 at risk EG0024 affected1,046 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Haemothorax	Respiratory, thoracic and mediastinal disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0011 affected307 at risk EG0020 affected1,046 at risk EG003
Hyperventilation	Respiratory, thoracic and mediastinal disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Productive Cough	Respiratory, thoracic and mediastinal disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0011 affected307 at risk EG0020 affected1,046 at risk EG003
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	MEDDRA 11.1	Non-systematic Assessment	EG0004 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Pulmonary Oedema	Respiratory, thoracic and mediastinal disorders	MEDDRA 11.1	Non-systematic Assessment	EG0004 affected1,153 at risk EG0013 affected307 at risk EG0022 affected1,046 at risk EG003
Rales	Respiratory, thoracic and mediastinal disorders	MEDDRA 11.1	Non-systematic Assessment	EG0001 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Respiratory Distress	Respiratory, thoracic and mediastinal disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0011 affected307 at risk EG0020 affected1,046 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MEDDRA 11.1	Non-systematic Assessment	EG0001 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Rash Papular	Skin and subcutaneous tissue disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Skin Ulcer	Skin and subcutaneous tissue disorders	MEDDRA 11.1	Non-systematic Assessment	EG0001 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Angioplasty	Surgical and medical procedures	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Catheterisation Cardiac	Surgical and medical procedures	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Coronary Arterial Stent Insertion	Surgical and medical procedures	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Coronary Artery Bypass	Surgical and medical procedures	MEDDRA 11.1	Non-systematic Assessment	EG0003 affected1,153 at risk EG0012 affected307 at risk EG0022 affected1,046 at risk EG003
Coronary Revascularisation	Surgical and medical procedures	MEDDRA 11.1	Non-systematic Assessment	EG0001 affected1,153 at risk EG0010 affected307 at risk EG0024 affected1,046 at risk EG003
Elective Procedure	Surgical and medical procedures	MEDDRA 11.1	Non-systematic Assessment	EG0002 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Elective Surgery	Surgical and medical procedures	MEDDRA 11.1	Non-systematic Assessment	EG0001 affected1,153 at risk EG0011 affected307 at risk EG0020 affected1,046 at risk EG003
Implantable Defibrillator Insertion	Surgical and medical procedures	MEDDRA 11.1	Non-systematic Assessment	EG0001 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Percutaneous Coronary Intervention	Surgical and medical procedures	MEDDRA 11.1	Non-systematic Assessment	EG0005 affected1,153 at risk EG0011 affected307 at risk EG0026 affected1,046 at risk EG003
Surgery	Surgical and medical procedures	MEDDRA 11.1	Non-systematic Assessment	EG0001 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Aortic Aneurysm	Vascular disorders	MEDDRA 11.1	Non-systematic Assessment	EG0001 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Aortic Arteriosclerosis	Vascular disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Aortic Stenosis	Vascular disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Arteriosclerosis	Vascular disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0011 affected307 at risk EG0020 affected1,046 at risk EG003
Arteriovenous Fistula	Vascular disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Femoral Arterial Stenosis	Vascular disorders	MEDDRA 11.1	Non-systematic Assessment	EG0001 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Femoral Artery Occlusion	Vascular disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Haematoma	Vascular disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Hypertension	Vascular disorders	MEDDRA 11.1	Non-systematic Assessment	EG0002 affected1,153 at risk EG0010 affected307 at risk EG0025 affected1,046 at risk EG003
Hypertensive Crisis	Vascular disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Iliac Artery Occlusion	Vascular disorders	MEDDRA 11.1	Non-systematic Assessment	EG0001 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Intermittent Claudication	Vascular disorders	MEDDRA 11.1	Non-systematic Assessment	EG0001 affected1,153 at risk EG0011 affected307 at risk EG0020 affected1,046 at risk EG003
Ischaemia	Vascular disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0021 affected1,046 at risk EG003
Neovascularisation	Vascular disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0011 affected307 at risk EG0020 affected1,046 at risk EG003
Orthostatic Hypotension	Vascular disorders	MEDDRA 11.1	Non-systematic Assessment	EG0001 affected1,153 at risk EG0011 affected307 at risk EG0020 affected1,046 at risk EG003
Peripheral Arterial Occlusive Disease	Vascular disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003
Phlebitis	Vascular disorders	MEDDRA 11.1	Non-systematic Assessment	EG0000 affected1,153 at risk EG0011 affected307 at risk EG0020 affected1,046 at risk EG003
Thrombosis	Vascular disorders	MEDDRA 11.1	Non-systematic Assessment	EG0001 affected1,153 at risk EG0010 affected307 at risk EG0020 affected1,046 at risk EG003

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

ID	Term
D013876	Thiophenes
D013457	Sulfur Compounds
D009930	Organic Chemicals
D009025	Morpholines
D010078	Oxazines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	One placebo tablet twice daily for 6 months.	247	1,153	223	1,153
EG001	Riva 5 mg Total Daily Dose (TDD)	Rivaroxaban 5 mg (2.5 mg twice a day or 5 mg once daily) for 6 months.	74	307	67	307
EG002	Riva 10 mg TDD	Rivaroxaban 10 mg (5 mg twice a day or 10 mg once daily) for 6 months.	208	1,046	293	1,046
EG003	Riva 15 mg TDD	Rivaroxaban 15 mg (7.5 mg twice a day or 15 mg once daily) for 6 months.	72	353	108	353
EG004	Riva 20 mg TDD	Rivaroxaban 20 mg (10 mg twice a day or 20 mg once daily) for 6 months.	128	603	148	603