Reduced-dosed Rivaroxaban in the Long-term Prevention of... | NCT02064439

ID	Type	Description	Link
2013-000619-26	EudraCT Number

Name	Class
Janssen Scientific Affairs, LLC	INDUSTRY

Label	Type	Description	Intervention Names
Arm 1	Experimental	Rivaroxaban 10 mg once daily for 12 months	Drug: BAY 59-7939
Arm 2	Experimental	Rivaroxaban 20 mg once daily for 12 months	Drug: BAY 59-7939
Arm 3	Active Comparator	ASA (Acetylsalicylic Acid) 100 mg once daily for 12 months	Drug: ASA

Name	Type	Description	Arm Group Labels	Other Names
BAY 59-7939	Drug	10 mg tablet once daily for 12 months	Arm 1
BAY 59-7939

Measure	Description	Time Frame
Number of Participants With the Composite of Fatal or Non-fatal Symptomatic Recurrent Venous Thromboembolism	The primary efficacy outcomes (i.e., recurrent venous thromboembolism [VTE] defined as composite of fatal or non-fatal symptomatic recurrent VTE, including unexplained death for which pulmonary embolism [PE] could not be ruled out) as confirmed by the central independent adjudication committee (CIAC) were considered up to the end of the individual intended duration of treatment. Incidence of the composite of the primary and secondary efficacy outcome and its components are based on the first occurrence to participant.	Up to 12 months, at least 6 months
Number of Participants With First Treatment-emergent Major Bleeding	The principal safety outcome was major bleeding which was defined according to the criteria of the International Society on Thrombosis and Hemostasis (ISTH) as clinically overt bleeding and associated with a fall in hemoglobin of 2 gram per deciliter (g/dL) or more, or leading to a transfusion of 2 or more units of packed red blood cells or whole blood, or occurring in a critical site, e.g. intracranial, intraspinal, intraocular, pericardial, intra articular, intramuscular with compartment syndrome, retroperitoneal, or contributing to death. Incidence of the composite of the primary and secondary efficacy outcome and its components are based on the first occurrence to participant.	Up to 12 months, at least 6 months

Measure	Description	Time Frame
Number of Participants With the Composite of the Primary Efficacy Outcome, Myocardial Infarction, Ischemic Stroke or Systemic Non-CNS Embolism	The secondary efficacy outcome is the composite of the primary efficacy outcome, myocardial infarction (MI), ischemic stroke or non-central nervous system (CNS) systemic embolism. Incidence of the composite of the primary and secondary efficacy outcome and its components are based on the first occurrence to participant.

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Beverly Hills	California	90211	United States

PubMed Identifier	Type	Citation	Retractions
25994838	Background	Weitz JI, Bauersachs R, Beyer-Westendorf J, Bounameaux H, Brighton TA, Cohen AT, Davidson BL, Holberg G, Kakkar A, Lensing AW, Prins M, Haskell L, van Bellen B, Verhamme P, Wells PS, Prandoni P; EINSTEIN CHOICE Investigators. Two doses of rivaroxaban versus aspirin for prevention of recurrent venous thromboembolism. Rationale for and design of the EINSTEIN CHOICE study. Thromb Haemost. 2015 Aug 31;114(3):645-50. doi: 10.1160/TH15-02-0131. Epub 2015 May 21.
40163217

ID	Title	Description
FG000	Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD	Participants were randomized, stratified by country and by index event, to receive rivaroxaban 10 mg tablet or matching placebo once daily (OD) with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized.

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

Number of Participants With the Composite of Fatal or Non-fatal Symptomatic Recurrent Venous Thromboembolism

The primary efficacy outcomes (i.e., recurrent venous thromboembolism [VTE] defined as composite of fatal or non-fatal symptomatic recurrent VTE, including unexplained death for which pulmonary embolism [PE] could not be ruled out) as confirmed by the central independent adjudication committee (CIAC) were considered up to the end of the individual intended duration of treatment.

Incidence of the composite of the primary and secondary efficacy outcome and its components are based on the first occurrence to participant.

Posted

Number

participants

Up to 12 months, at least 6 months

ID	Title	Description
OG000	Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD	Participants were randomized, stratified by country and by index event, to receive rivaroxaban 10 mg tablet or matching placebo once daily (OD) with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized.
OG001	Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD	Participants were randomized, stratified by country and by index event, to receive rivaroxaban 20 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized.
OG002	Acetylsalicylic (ASA) 100 mg, OD	Participants were randomized, stratified by country and by index event, to receive ASA 100 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized.

Units	Counts
Participants	OG0001127 OG0011107 OG0021131

Title

Denominators

Categories

Composite

Title	Measurements
	OG00013 OG00117 OG00250

Symptomatic recurrent Deep vein thrombosis (DVT)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG001 OG002	Statistical analysis was performed on the first occurrence of the composite outcome.	Wald test		0.0001	P-value and hazard ratio estimates based on stratified proportional hazards model, with stratification based index event (DVT or PE with or without DVT).	Hazard Ratio (HR)	0.34			2-Sided	95	0.20	0.59					Superiority or Other

Primary

Number of Participants With First Treatment-emergent Major Bleeding

The principal safety outcome was major bleeding which was defined according to the criteria of the International Society on Thrombosis and Hemostasis (ISTH) as clinically overt bleeding and associated with a fall in hemoglobin of 2 gram per deciliter (g/dL) or more, or leading to a transfusion of 2 or more units of packed red blood cells or whole blood, or occurring in a critical site, e.g. intracranial, intraspinal, intraocular, pericardial, intra articular, intramuscular with compartment syndrome, retroperitoneal, or contributing to death.

Incidence of the composite of the primary and secondary efficacy outcome and its components are based on the first occurrence to participant.

Posted

Number

participants

Up to 12 months, at least 6 months

ID	Title	Description
OG000	Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD	Participants were randomized, stratified by country and by index event, to receive rivaroxaban 10 mg tablet or matching placebo once daily (OD) with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized.
OG001	Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD	Participants were randomized, stratified by country and by index event, to receive rivaroxaban 20 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized.

Secondary

Number of Participants With the Composite of the Primary Efficacy Outcome, Myocardial Infarction, Ischemic Stroke or Systemic Non-CNS Embolism

The secondary efficacy outcome is the composite of the primary efficacy outcome, myocardial infarction (MI), ischemic stroke or non-central nervous system (CNS) systemic embolism. Incidence of the composite of the primary and secondary efficacy outcome and its components are based on the first occurrence to participant.

Posted

Number

participants

Up to 12 months, at least 6 months

ID	Title	Description
OG000	Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD	Participants were randomized, stratified by country and by index event, to receive rivaroxaban 10 mg tablet or matching placebo once daily (OD) with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized.
OG001	Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD	Participants were randomized, stratified by country and by index event, to receive rivaroxaban 20 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized.
OG002	Acetylsalicylic (ASA) 100 mg, OD

Secondary

Number of Participants With Non-major Bleeding Associated With Study Drug Interruption for > 14 Days

The secondary safety outcome was clinically relevant non-major (CRNM) bleeding, which was adjudicated by the CIAC using the ASA criteria: the bleeding was non-major and the bleeding was associated with a study medication interruption of more than 14 days.

Posted

Number

participants

Up to 12 months, at least 6 months

ID	Title	Description
OG000	Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD	Participants were randomized, stratified by country and by index event, to receive rivaroxaban 10 mg tablet or matching placebo once daily (OD) with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized.
OG001	Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD	Participants were randomized, stratified by country and by index event, to receive rivaroxaban 20 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized.
OG002	Acetylsalicylic (ASA) 100 mg, OD	Participants were randomized, stratified by country and by index event, to receive ASA 100 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0012 events2 affected1,107 at risk EG0020 events0 affected1,131 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0012 events2 affected1,107 at risk EG0020 events0 affected1,131 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0020 events0 affected1,131 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0020 events0 affected1,131 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected1,127 at risk EG0013 events3 affected1,107 at risk EG0021 events1 affected1,131 at risk
Atrial flutter	Cardiac disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0020 events0 affected1,131 at risk
Atrioventricular block second degree	Cardiac disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0020 events0 affected1,131 at risk
Bradycardia	Cardiac disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0020 events0 affected1,131 at risk
Cardiac failure	Cardiac disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0021 events1 affected1,131 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0020 events0 affected1,131 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0021 events1 affected1,131 at risk
Coronary artery disease	Cardiac disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0022 events2 affected1,131 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0020 events0 affected1,131 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0020 events0 affected1,131 at risk
Pericarditis	Cardiac disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0021 events1 affected1,131 at risk
Pericarditis constrictive	Cardiac disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0020 events0 affected1,131 at risk
Tachycardia	Cardiac disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0020 events0 affected1,131 at risk
Vertigo	Ear and labyrinth disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0021 events1 affected1,131 at risk
Vestibular disorder	Ear and labyrinth disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0020 events0 affected1,131 at risk
Sudden hearing loss	Ear and labyrinth disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0021 events1 affected1,131 at risk
Cushing's syndrome	Endocrine disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0021 events1 affected1,131 at risk
Corneal degeneration	Eye disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0020 events0 affected1,131 at risk
Ascites	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0020 events0 affected1,131 at risk
Diverticulum	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0020 events0 affected1,131 at risk
Diverticulum intestinal	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0020 events0 affected1,131 at risk
Gastritis	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0020 events0 affected1,131 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0020 events0 affected1,131 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected1,127 at risk EG0012 events2 affected1,107 at risk EG0020 events0 affected1,131 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0020 events0 affected1,131 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0021 events1 affected1,131 at risk
Pancreatitis relapsing	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0021 events1 affected1,131 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0021 events1 affected1,131 at risk
Subileus	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0020 events0 affected1,131 at risk
Hypertrophic anal papilla	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0020 events0 affected1,131 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0021 events1 affected1,131 at risk
Eosinophilic oesophagitis	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0020 events0 affected1,131 at risk
Colon dysplasia	Gastrointestinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0020 events0 affected1,131 at risk
Chest pain	General disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0021 events1 affected1,131 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0021 events1 affected1,131 at risk
Biliary colic	Hepatobiliary disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0021 events1 affected1,131 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0020 events0 affected1,131 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0022 events2 affected1,131 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA (19.1)	Non-systematic Assessment	EG0002 events1 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0020 events0 affected1,131 at risk
Overlap syndrome	Immune system disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0020 events0 affected1,131 at risk
Appendicitis	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0020 events0 affected1,131 at risk
Cellulitis	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected1,127 at risk EG0012 events2 affected1,107 at risk EG0021 events1 affected1,131 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0020 events0 affected1,131 at risk
Diarrhoea infectious	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0021 events1 affected1,131 at risk
Diverticulitis	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0020 events0 affected1,131 at risk
Erysipelas	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0002 events2 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0022 events2 affected1,131 at risk
Gastroenteritis	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0002 events2 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0021 events1 affected1,131 at risk
Influenza	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0020 events0 affected1,131 at risk
Nasopharyngitis	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0020 events0 affected1,131 at risk
Orchitis	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0020 events0 affected1,131 at risk
Peritonitis	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0020 events0 affected1,131 at risk
Plasmodium falciparum infection	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0020 events0 affected1,131 at risk
Pneumonia	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0002 events2 affected1,127 at risk EG0016 events5 affected1,107 at risk EG0023 events3 affected1,131 at risk
Pseudomembranous colitis	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0020 events0 affected1,131 at risk
Pyelitis	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0021 events1 affected1,131 at risk
Pyelonephritis acute	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0021 events1 affected1,131 at risk
Sepsis	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected1,127 at risk EG0013 events3 affected1,107 at risk EG0022 events2 affected1,131 at risk
Septic shock	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0020 events0 affected1,131 at risk
Urethral abscess	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0020 events0 affected1,131 at risk
Urinary tract infection	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0002 events2 affected1,127 at risk EG0016 events4 affected1,107 at risk EG0020 events0 affected1,131 at risk
Wound infection	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0020 events0 affected1,131 at risk
Urosepsis	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0020 events0 affected1,131 at risk
Abscess limb	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0020 events0 affected1,131 at risk
Arthritis bacterial	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0013 events2 affected1,107 at risk EG0020 events0 affected1,131 at risk
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0020 events0 affected1,131 at risk
Pseudomonal sepsis	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0020 events0 affected1,131 at risk
Pneumonia bacterial	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0020 events0 affected1,131 at risk
Lung infection	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0020 events0 affected1,131 at risk
Borrelia infection	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0020 events0 affected1,131 at risk
Post procedural infection	Infections and infestations	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0020 events0 affected1,131 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0020 events0 affected1,131 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0020 events0 affected1,131 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0023 events3 affected1,131 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0020 events0 affected1,131 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0023 events3 affected1,131 at risk
Fibula fracture	Injury, poisoning and procedural complications	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0020 events0 affected1,131 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0020 events0 affected1,131 at risk
Humerus fracture	Injury, poisoning and procedural complications	MedDRA (19.1)	Non-systematic Assessment	EG0002 events2 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0021 events1 affected1,131 at risk
Injury	Injury, poisoning and procedural complications	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0021 events1 affected1,131 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0020 events0 affected1,131 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0020 events0 affected1,131 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0020 events0 affected1,131 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0021 events1 affected1,131 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0021 events1 affected1,131 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0020 events0 affected1,131 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0020 events0 affected1,131 at risk
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0021 events1 affected1,131 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0021 events1 affected1,131 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0020 events0 affected1,131 at risk
Stomal hernia	Injury, poisoning and procedural complications	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0021 events1 affected1,131 at risk
Pubis fracture	Injury, poisoning and procedural complications	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0020 events0 affected1,131 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0021 events1 affected1,131 at risk
Cystoscopy	Investigations	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0020 events0 affected1,131 at risk
Haemoglobin decreased	Investigations	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0020 events0 affected1,131 at risk
White blood cell count decreased	Investigations	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0020 events0 affected1,131 at risk
B-lymphocyte count increased	Investigations	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0020 events0 affected1,131 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0020 events0 affected1,131 at risk
Obesity	Metabolism and nutrition disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0020 events0 affected1,131 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA (19.1)	Non-systematic Assessment	EG0002 events2 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0020 events0 affected1,131 at risk
Joint ankylosis	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0021 events1 affected1,131 at risk
Osteitis	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0022 events1 affected1,131 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0003 events3 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0026 events5 affected1,131 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0020 events0 affected1,131 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0020 events0 affected1,131 at risk
Spinal column stenosis	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0012 events2 affected1,107 at risk EG0021 events1 affected1,131 at risk
Mobility decreased	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0020 events0 affected1,131 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0021 events1 affected1,131 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0020 events0 affected1,131 at risk
Meniscal degeneration	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0020 events0 affected1,131 at risk
Spinal pain	Musculoskeletal and connective tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0012 events1 affected1,107 at risk EG0020 events0 affected1,131 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0020 events0 affected1,131 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0021 events1 affected1,131 at risk
Benign gastric neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0021 events1 affected1,131 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0020 events0 affected1,131 at risk
Bladder cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0021 events1 affected1,131 at risk
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0021 events1 affected1,131 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0021 events1 affected1,131 at risk
Cervix carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0021 events1 affected1,131 at risk
Cervix carcinoma recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0020 events0 affected1,131 at risk
Endometrial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0020 events0 affected1,131 at risk
Gastric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0020 events0 affected1,131 at risk
Leiomyosarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0021 events1 affected1,131 at risk
Lung carcinoma cell type unspecified stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0020 events0 affected1,131 at risk
Malignant melanoma stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0020 events0 affected1,131 at risk
Malignant melanoma stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0021 events1 affected1,131 at risk
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0020 events0 affected1,131 at risk
Metastases to lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0020 events0 affected1,131 at risk
Metastases to lymph nodes	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0020 events0 affected1,131 at risk
Oesophageal carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0020 events0 affected1,131 at risk
Oesophageal carcinoma stage 0	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0021 events1 affected1,131 at risk
Plasma cell myeloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0020 events0 affected1,131 at risk
Rectal cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0020 events0 affected1,131 at risk
Ureteric cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0020 events0 affected1,131 at risk
Uterine cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0021 events1 affected1,131 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0020 events0 affected1,131 at risk
Colon cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0020 events0 affected1,131 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Non-systematic Assessment	EG0003 events3 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0021 events1 affected1,131 at risk
Cervix warts	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0021 events1 affected1,131 at risk
Malignant glioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0020 events0 affected1,131 at risk
Ovarian cancer stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0021 events1 affected1,131 at risk
Axonal neuropathy	Nervous system disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0020 events0 affected1,131 at risk
Dizziness	Nervous system disorders	MedDRA (19.1)	Non-systematic Assessment	EG0002 events1 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0020 events0 affected1,131 at risk
Dyskinesia	Nervous system disorders	MedDRA (19.1)	Non-systematic Assessment	EG0002 events2 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0020 events0 affected1,131 at risk
Headache	Nervous system disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0020 events0 affected1,131 at risk
Migraine	Nervous system disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0021 events1 affected1,131 at risk
Presyncope	Nervous system disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0020 events0 affected1,131 at risk
Sciatica	Nervous system disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0021 events1 affected1,131 at risk
Seizure	Nervous system disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0020 events0 affected1,131 at risk
Syncope	Nervous system disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0022 events2 affected1,131 at risk
Facial paresis	Nervous system disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0021 events1 affected1,131 at risk
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0020 events0 affected1,131 at risk
Adjustment disorder with depressed mood	Psychiatric disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0020 events0 affected1,131 at risk
Alcohol abuse	Psychiatric disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0022 events1 affected1,131 at risk
Alcoholism	Psychiatric disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0022 events1 affected1,131 at risk
Anxiety	Psychiatric disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0020 events0 affected1,131 at risk
Depression	Psychiatric disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0022 events2 affected1,131 at risk
Paranoia	Psychiatric disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0021 events1 affected1,131 at risk
Suicide attempt	Psychiatric disorders	MedDRA (19.1)	Non-systematic Assessment	EG0003 events3 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0020 events0 affected1,131 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA (19.1)	Non-systematic Assessment	EG0002 events2 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0020 events0 affected1,131 at risk
Neurogenic bladder	Renal and urinary disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0020 events0 affected1,131 at risk
Renal colic	Renal and urinary disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0021 events1 affected1,131 at risk
Renal failure	Renal and urinary disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0020 events0 affected1,131 at risk
Urinary retention	Renal and urinary disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0021 events1 affected1,131 at risk
Tubulointerstitial nephritis	Renal and urinary disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0020 events0 affected1,131 at risk
Urethral stenosis	Renal and urinary disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0020 events0 affected1,131 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0022 events2 affected1,131 at risk
End stage renal disease	Renal and urinary disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0021 events1 affected1,131 at risk
Ureterolithiasis	Renal and urinary disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0020 events0 affected1,131 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0020 events0 affected1,131 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0021 events1 affected1,131 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0020 events0 affected1,131 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected1,127 at risk EG0014 events3 affected1,107 at risk EG0023 events3 affected1,131 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected1,127 at risk EG0014 events2 affected1,107 at risk EG0021 events1 affected1,131 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0020 events0 affected1,131 at risk
Nasal polyps	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0020 events0 affected1,131 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0012 events1 affected1,107 at risk EG0020 events0 affected1,131 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0021 events1 affected1,131 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0021 events1 affected1,131 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0020 events0 affected1,131 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0021 events1 affected1,131 at risk
Organising pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0021 events1 affected1,131 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0021 events1 affected1,131 at risk
Seborrhoea	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0021 events1 affected1,131 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0020 events0 affected1,131 at risk
Pruritus generalised	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0020 events0 affected1,131 at risk
Cutaneous lupus erythematosus	Skin and subcutaneous tissue disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0021 events1 affected1,131 at risk
Hysterectomy	Surgical and medical procedures	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0020 events0 affected1,131 at risk
Meningioma surgery	Surgical and medical procedures	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0020 events0 affected1,131 at risk
Aortic aneurysm	Vascular disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0021 events1 affected1,131 at risk
Aortic dissection	Vascular disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0020 events0 affected1,131 at risk
Aortic stenosis	Vascular disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0011 events1 affected1,107 at risk EG0020 events0 affected1,131 at risk
Hypertension	Vascular disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0021 events1 affected1,131 at risk
Hypertensive crisis	Vascular disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0021 events1 affected1,131 at risk
Thrombophlebitis	Vascular disorders	MedDRA (19.1)	Non-systematic Assessment	EG0000 events0 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0021 events1 affected1,131 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA (19.1)	Non-systematic Assessment	EG0001 events1 affected1,127 at risk EG0010 events0 affected1,107 at risk EG0020 events0 affected1,131 at risk

ID	Term
D011655	Pulmonary Embolism
D013923	Thromboembolism
D013927	Thrombosis
D020246	Venous Thrombosis
D054556	Venous Thromboembolism

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D004617	Embolism
D016769	Embolism and Thrombosis
D014652	Vascular Diseases
D002318	Cardiovascular 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
BG000	Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD	Participants were randomized, stratified by country and by index event, to receive rivaroxaban 10 mg tablet or matching placebo once daily (OD) with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized.
BG001	Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD	Participants were randomized, stratified by country and by index event, to receive rivaroxaban 20 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized.
BG002	Acetylsalicylic (ASA) 100 mg, OD	Participants were randomized, stratified by country and by index event, to receive ASA 100 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized.
BG003	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Rivaroxaban (Xarelto, BAY59-7939) 10 mg, OD	Participants were randomized, stratified by country and by index event, to receive rivaroxaban 10 mg tablet or matching placebo once daily (OD) with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized.	78	1,127	40	1,127
EG001	Rivaroxaban (Xarelto, BAY59-7939) 20 mg, OD	Participants were randomized, stratified by country and by index event, to receive rivaroxaban 20 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized.	82	1,107	35	1,107
EG002	Acetylsalicylic (ASA) 100 mg, OD	Participants were randomized, stratified by country and by index event, to receive ASA 100 mg tablet or matching placebo OD with food for 12, or 9 to less than 12, or 6 months depending on the date of randomization. Treatment of all participants stopped 6 months after the last participant was randomized.	79	1,131	38	1,131