Regulation of Coagulation in Orthopedic Surgery to Preven... | NCT00362232

NCT00362232

ID	Type	Description	Link
2006-002402-60	EudraCT Number

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Rivaroxaban 10 mg Once Daily (OD) ((Xarelto, BAY59-7939))	Experimental	Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.	Drug: Rivaroxaban (Xarelto, BAY59-7939) Drug: Placebo: syringes of Enoxaparin
Enoxaparin 30 mg twice a day (bid)	Active Comparator	Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.	Drug: Enoxaparin Drug: Placebo: tablet of Rivaroxaban

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rivaroxaban (Xarelto, BAY59-7939)	Drug	Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening.	Rivaroxaban 10 mg Once Daily (OD) ((Xarelto, BAY59-7939))

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Composite Endpoint of Total Venous Thrombo Embolism (VTE) i.e.: Any Deep Vein Thromboembolism (DVT) (Proximal and/or Distal), Non Fatal Pulmonary Embolism (PE), Death of All Causes Per Protocol Population	Blinded, adjudicated assessment of bilateral venography, clinical signs of deep vein thrombosis (DVT) and pulmonary embolism (PE), ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography	Up to 16 days after surgery
Composite Endpoint of Total VTE i.e.: Any DVT (Proximal and/or Distal), Non Fatal PE, Death of All Causes Per Modified Intent to Treat Population.	Blinded, adjudicated assessment of bilateral venography, clinical signs of deep vein thrombosis (DVT) and pulmonary embolism (PE), ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography	Up to 16 days after surgery

Secondary Outcomes

Measure	Description	Time Frame
Incidence of the Composite Endpoint Comprising Proximal DVT, Non-fatal PE and VTE- Related Death (Major VTE) Per Protocol Population of Major VTE	Blinded, adjudicated assessment of bilateral venography, clinical signs of deep vein thrombosis (DVT) and pulmonary embolism (PE), ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography

Eligibility Module

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		Birmingham	Alabama	35209	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19411100	Result	Turpie AG, Lassen MR, Davidson BL, Bauer KA, Gent M, Kwong LM, Cushner FD, Lotke PA, Berkowitz SD, Bandel TJ, Benson A, Misselwitz F, Fisher WD; RECORD4 Investigators. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty (RECORD4): a randomised trial. Lancet. 2009 May 16;373(9676):1673-80. doi: 10.1016/S0140-6736(09)60734-0. Epub 2009 May 4.

Label	URL
Click here and search for information of Bayer products for Europe	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)	Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
FG001	Enoxaparin 30 mg Twice a Day (Bid)

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)	Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
BG001	Enoxaparin 30 mg Twice a Day (Bid)	Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00064.4± 9.7 BG00164.7± 9.7 BG00264.5± 9.7

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0001007 BG001967 BG002

Race/Ethnicity, Customized

One subject in the rivaroxaban 10 mg OD treatment group was missing race.

Number

participants

Title

Denominators

Categories

White

Title	Measurements
	BG0001008 BG0011032 BG002

Weight

One subject in each treatment group was missing baseline weight.

Number

participants

Title

Denominators

Categories

=< 50 kg

Title	Measurements
	BG00022 BG00128 BG002

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

Composite Endpoint of Total Venous Thrombo Embolism (VTE) i.e.: Any Deep Vein Thromboembolism (DVT) (Proximal and/or Distal), Non Fatal Pulmonary Embolism (PE), Death of All Causes Per Protocol Population

Blinded, adjudicated assessment of bilateral venography, clinical signs of deep vein thrombosis (DVT) and pulmonary embolism (PE), ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography

The primary efficacy analysis was based on the per protocol (PP) population and included subjects who were valid for the modified intent to treat (MITT) population, had an adequate assessment of thromboembolism that, in case of a positive finding, was done not later than 36 hours after stop of study drug, and had no major protocol deviations.

Posted

Number

Percentage of participants

Up to 16 days after surgery

ID	Title	Description
OG000	Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)	Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
OG001	Enoxaparin 30 mg Twice a Day (Bid)	Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.

Units	Counts
Participants	OG000864 OG001878

Title

Denominators

Categories

Title	Measurements
	OG0006.71 OG0019.34

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
OG000 OG001	Null hypothesis: rivaroxaban is inferior to the comparator, ie, the incidence of the primary efficacy endpoint in the rivaroxaban group is larger by more than 4% (absolute) compared to the comparator group.	Mantel Haenszel	weighted treatment differences	<0.001		Risk Difference (RD)	-2.71				95	-5.25	-0.17			Mantel-Haenszel weighted difference to Enoxaparin	Yes	Non-Inferiority or Equivalence	P-values were calculated based on the Mantel-Haenszel weighted estimator (one-sided).

Primary

Composite Endpoint of Total VTE i.e.: Any DVT (Proximal and/or Distal), Non Fatal PE, Death of All Causes Per Modified Intent to Treat Population.

A subject was considered valid for the MITT analysis if the subject was valid for the safety analysis, had undergone the appropriate surgery, and had an adequate assessment of thromboembolism

Posted

Number

Percentage of participants

Up to 16 days after surgery

ID	Title	Description
OG000	Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)	Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
OG001	Enoxaparin 30 mg Twice a Day (Bid)	Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.

Secondary

Incidence of the Composite Endpoint Comprising Proximal DVT, Non-fatal PE and VTE- Related Death (Major VTE) Per Protocol Population of Major VTE

The PP population included subjects who were valid for the modified intent to treat (MITT) population, had an adequate assessment of thromboembolism that, in case of a positive finding, was done not later than 36 hours after stop of study drug, and had no major protocol deviations.

Posted

Number

percentage of participants

Up to 16 days after surgery

ID	Title	Description
OG000	Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)	Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
OG001	Enoxaparin 30 mg Twice a Day (Bid)	Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.

Secondary

Incidence of the Composite Endpoint Comprising Proximal DVT, Non-fatal PE and VTE- Related Death (Major VTE) Per Modified Intent to Treat Population of Major VTE.

A subject was considered valid for the MITT analysis if the subject was valid for the safety analysis, had undergone the appropriate surgery, and had an adequate assessment of thromboembolism

Posted

Number

percentage of participants

Up to 16 days after surgery

ID	Title	Description
OG000	Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)	Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
OG001	Enoxaparin 30 mg Twice a Day (Bid)	Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.

Secondary

Incidence of Symptomatic VTE (DVT, PE) Per Protocol Population.

Blinded, adjudicated assessment of bilateral venography, clinical signs of DVT and PE, ultrasound, clinical chemistry and coagulation factors, autopsy report, electrocardiogram (ECG), pulmonary angiography, perfusion/ventilation lung scintigraphy, chest radiography, computed tomography

Posted

Number

percentage of participants

Up to 16 days after surgery

ID	Title	Description
OG000	Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)	Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
OG001	Enoxaparin 30 mg Twice a Day (Bid)	Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.

Secondary

Incidence of Symptomatic VTE (DVT, PE) Per Modified Intent to Treat Population.

A subject was considered valid for the MITT analysis if the subject was valid for the safety analysis, had undergone the appropriate surgery, and had an adequate assessment of thromboembolism

Posted

Number

percentage of participants

Up to 16 days after surgery

ID	Title	Description
OG000	Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)	Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
OG001	Enoxaparin 30 mg Twice a Day (Bid)	Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.

Units	Counts

Secondary

Incidence of DVT (Proximal, Distal) Per Protocol Population.

Posted

Number

percentage of participants

Up to 16 days after surgery

ID	Title	Description
OG000	Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)	Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
OG001	Enoxaparin 30 mg Twice a Day (Bid)	Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.

Secondary

Incidence of DVT (Proximal, Distal) Per Modified Intent to Treat Population.

A subject was considered valid for the MITT analysis if the subject was valid for the safety analysis, had undergone the appropriate surgery, and had an adequate assessment of thromboembolism

Posted

Number

percentage of participants

Up to 16 days after surgery

ID	Title	Description
OG000	Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)	Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
OG001	Enoxaparin 30 mg Twice a Day (Bid)	Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.

Units	Counts

Secondary

Incidence of Symptomatic VTE During Follow-up Per Protocol Population.

Posted

Number

percentage of participants

Up to 47 days after surgery

ID	Title	Description
OG000	Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)	Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
OG001	Enoxaparin 30 mg Twice a Day (Bid)	Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.

Secondary

Incidence of Symptomatic VTE During Follow-up Per Modified Intent to Treat Population.

A subject was considered valid for the MITT analysis if the subject was valid for the safety analysis, had undergone the appropriate surgery, and had an adequate assessment of thromboembolism

Posted

Number

percentage of participants

Up to 47 days after surgery

ID	Title	Description
OG000	Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)	Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
OG001	Enoxaparin 30 mg Twice a Day (Bid)	Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.

Units	Counts

Secondary

The Composite Endpoint Comprising Major VTE and Treatment-emergent Major Bleeding Per Subjects Valid for Analysis of Net Clinical Benefit

The net clinical benefit population comprised all subjects either valid for MITT analysis of major VTE or who showed treatment-emergent major bleeding.

Posted

Number

percentage of participants

Up to 47 days after surgery

ID	Title	Description
OG000	Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)	Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
OG001	Enoxaparin 30 mg Twice a Day (Bid)	Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.

Secondary

Incidence of the Composite Endpoint That Results From the Primary Endpoint by Substituting VTE Related Death for All Death Per Protocol Population.

Posted

Number

percentage of participants

Up to 16 days after surgery

ID	Title	Description
OG000	Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)	Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
OG001	Enoxaparin 30 mg Twice a Day (Bid)	Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.

Secondary

Incidence of the Composite Endpoint That Results From the Primary Endpoint by Substituting VTE Related Death for All Death Per Modified Intent to Treat Population.

A subject was considered valid for the MITT analysis if the subject was valid for the safety analysis, had undergone the appropriate surgery, and had an adequate assessment of thromboembolism

Posted

Number

percentage of participants

Up to 16 days after surgery

ID	Title	Description
OG000	Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)	Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
OG001	Enoxaparin 30 mg Twice a Day (Bid)	Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.

Secondary

Incidence of the Composite Endpoint That Results From Major VTE by Substituting All Cause Mortality for VTE-related Death Per Protocol of Major VTE Population.

Posted

Number

percentage of participants

Up to 16 days after surgery

ID	Title	Description
OG000	Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)	Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
OG001	Enoxaparin 30 mg Twice a Day (Bid)	Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.

Secondary

Incidence of the Composite Endpoint That Results From Major VTE by Substituting All Cause Mortality for VTE-related Death Per Modified Intent to Treat of Major VTE Population.

A subject was considered valid for the MITT analysis if the subject was valid for the safety analysis, had undergone the appropriate surgery, and had an adequate assessment of thromboembolism

Posted

Number

percentage of participants

Up to 16 days after surgery

ID	Title	Description
OG000	Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)	Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
OG001	Enoxaparin 30 mg Twice a Day (Bid)	Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.

Secondary

Treatment-emergent Major Bleedings Per Safety Population.

Blinded, adjudicated assessments of all available information (eg, anesthesia and surgery reports, laboratory results, number of transfusions, autopsy report)

The safety population comprised those subjects who received at least 1 dose of study drug.

Posted

Number

percentage of participants

from start of double-blind study medication to last dose of double-blind study medication plus two days. The average duration of double-blind treatment was 12 days in each treatment group (safety population).

ID	Title	Description
OG000	Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)	Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
OG001	Enoxaparin 30 mg Twice a Day (Bid)	Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)	Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.			106	1,526	1,167	1,526
EG001	Enoxaparin 30 mg Twice a Day (Bid)	Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.			131	1,508	1,152	1,508

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 affected1,526 at risk EG0013 affected1,508 at risk
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0010 affected1,508 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected1,526 at risk EG0011 affected1,508 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected1,526 at risk EG0011 affected1,508 at risk
Thrombocythaemia	Blood and lymphatic system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0010 affected1,508 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0010 affected1,508 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0011 affected1,508 at risk
Angina pectoris	Cardiac disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 affected1,526 at risk EG0011 affected1,508 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected1,526 at risk EG0014 affected1,508 at risk
Atrial tachycardia	Cardiac disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected1,526 at risk EG0011 affected1,508 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0010 affected1,508 at risk
Bundle branch block left	Cardiac disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0010 affected1,508 at risk
Cardiac arrest	Cardiac disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0012 affected1,508 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 affected1,526 at risk EG0012 affected1,508 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0010 affected1,508 at risk
Myocardial infarction	Cardiac disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0016 affected1,508 at risk
Adrenal haemorrhage	Endocrine disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0010 affected1,508 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0004 affected1,526 at risk EG0010 affected1,508 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected1,526 at risk EG0011 affected1,508 at risk
Colitis	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected1,526 at risk EG0011 affected1,508 at risk
Constipation	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected1,526 at risk EG0011 affected1,508 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected1,526 at risk EG0011 affected1,508 at risk
Duodenitis haemorrhagic	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0010 affected1,508 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected1,526 at risk EG0012 affected1,508 at risk
Gastritis	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0010 affected1,508 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0010 affected1,508 at risk
Gastroduodenal haemorrhage	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0010 affected1,508 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0011 affected1,508 at risk
Haematemesis	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected1,526 at risk EG0011 affected1,508 at risk
Haematochezia	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0010 affected1,508 at risk
Intestinal haemorrhage	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected1,526 at risk EG0011 affected1,508 at risk
Nausea	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0004 affected1,526 at risk EG0013 affected1,508 at risk
Oesophageal stenosis	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0010 affected1,508 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0010 affected1,508 at risk
Vomiting	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0004 affected1,526 at risk EG0013 affected1,508 at risk
Chest pain	General disorders	MedDRA (10.0)	Non-systematic Assessment	EG0003 affected1,526 at risk EG0016 affected1,508 at risk
Death	General disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0010 affected1,508 at risk
Generalised oedema	General disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected1,526 at risk EG0011 affected1,508 at risk
Non-cardiac chest pain	General disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected1,526 at risk EG0011 affected1,508 at risk
Oedema	General disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0011 affected1,508 at risk
Oedema peripheral	General disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0014 affected1,508 at risk
Pyrexia	General disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0012 affected1,508 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected1,526 at risk EG0011 affected1,508 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected1,526 at risk EG0012 affected1,508 at risk
Hepatitis	Hepatobiliary disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected1,526 at risk EG0011 affected1,508 at risk
Contrast media allergy	Immune system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected1,526 at risk EG0011 affected1,508 at risk
Drug hypersensitivity	Immune system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0010 affected1,508 at risk
Appendicitis	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0010 affected1,508 at risk
Arthritis infective	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0003 affected1,526 at risk EG0019 affected1,508 at risk
Cellulitis	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0004 affected1,526 at risk EG0014 affected1,508 at risk
Device related infection	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected1,526 at risk EG0011 affected1,508 at risk
Diverticulitis	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0003 affected1,526 at risk EG0010 affected1,508 at risk
Endocarditis bacterial	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0010 affected1,508 at risk
Gastroenteritis	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0011 affected1,508 at risk
Pneumonia	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0016 affected1,508 at risk
Post procedural infection	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected1,526 at risk EG0013 affected1,508 at risk
Postoperative wound infection	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0011 affected1,508 at risk
Sepsis	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0003 affected1,526 at risk EG0011 affected1,508 at risk
Septic shock	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected1,526 at risk EG0011 affected1,508 at risk
Staphylococcal infection	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected1,526 at risk EG0011 affected1,508 at risk
Urinary tract infection	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0002 affected1,526 at risk EG0011 affected1,508 at risk
Wound infection	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG0002 affected1,526 at risk EG0011 affected1,508 at risk
Allergic transfusion reaction	Injury, poisoning and procedural complications	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected1,526 at risk EG0011 affected1,508 at risk
Anaemia postoperative	Injury, poisoning and procedural complications	MedDRA (10.0)	Non-systematic Assessment	EG0002 affected1,526 at risk EG0012 affected1,508 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected1,526 at risk EG0011 affected1,508 at risk
Device malfunction	Injury, poisoning and procedural complications	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected1,526 at risk EG0011 affected1,508 at risk
Incision site haemorrhage	Injury, poisoning and procedural complications	MedDRA (10.0)	Non-systematic Assessment	EG0002 affected1,526 at risk EG0010 affected1,508 at risk
Operative haemorrhage	Injury, poisoning and procedural complications	MedDRA (10.0)	Non-systematic Assessment	EG0002 affected1,526 at risk EG0013 affected1,508 at risk
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0010 affected1,508 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected1,526 at risk EG0011 affected1,508 at risk
Post procedural swelling	Injury, poisoning and procedural complications	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected1,526 at risk EG0011 affected1,508 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0011 affected1,508 at risk
Subdural haemorrhage	Injury, poisoning and procedural complications	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected1,526 at risk EG0011 affected1,508 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0010 affected1,508 at risk
Thoracic vertebral fracture	Injury, poisoning and procedural complications	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected1,526 at risk EG0011 affected1,508 at risk
Transfusion reaction	Injury, poisoning and procedural complications	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0010 affected1,508 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0011 affected1,508 at risk
Alanine aminotransferase increased	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected1,526 at risk EG0013 affected1,508 at risk
Aspartate aminotransferase increased	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected1,526 at risk EG0011 affected1,508 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected1,526 at risk EG0011 affected1,508 at risk
Blood bilirubin increased	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected1,526 at risk EG0012 affected1,508 at risk
Blood creatinine increased	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0010 affected1,508 at risk
Body temperature increased	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0011 affected1,508 at risk
Clostridium difficile toxin test positive	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0010 affected1,508 at risk
Coagulation factor increased	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected1,526 at risk EG0011 affected1,508 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected1,526 at risk EG0011 affected1,508 at risk
Haematocrit decreased	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected1,526 at risk EG0011 affected1,508 at risk
Haemoglobin decreased	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0010 affected1,508 at risk
Hepatic enzyme increased	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected1,526 at risk EG0012 affected1,508 at risk
International normalised ratio increased	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected1,526 at risk EG0011 affected1,508 at risk
Liver function test abnormal	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG0002 affected1,526 at risk EG0010 affected1,508 at risk
Occult blood positive	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected1,526 at risk EG0011 affected1,508 at risk
Oxygen saturation decreased	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected1,526 at risk EG0011 affected1,508 at risk
Platelet count decreased	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0011 affected1,508 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0010 affected1,508 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0010 affected1,508 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0010 affected1,508 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0011 affected1,508 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0011 affected1,508 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected1,526 at risk EG0011 affected1,508 at risk
Fluctuance	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0010 affected1,508 at risk
Haemarthrosis	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0010 affected1,508 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected1,526 at risk EG0011 affected1,508 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0010 affected1,508 at risk
Musculoskeletal stiffness	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected1,526 at risk EG0011 affected1,508 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0012 affected1,508 at risk
Soft tissue haemorrhage	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected1,526 at risk EG0011 affected1,508 at risk
Metastatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected1,526 at risk EG0011 affected1,508 at risk
Cerebral infarction	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0010 affected1,508 at risk
Cerebrovascular insufficiency	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0010 affected1,508 at risk
Coma	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected1,526 at risk EG0011 affected1,508 at risk
Convulsion	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0010 affected1,508 at risk
Embolic stroke	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0010 affected1,508 at risk
Encephalopathy	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0012 affected1,508 at risk
Haemorrhagic stroke	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0010 affected1,508 at risk
Ischaemic stroke	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0011 affected1,508 at risk
Peroneal nerve palsy	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0010 affected1,508 at risk
Somnolence	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0010 affected1,508 at risk
Speech disorder	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0010 affected1,508 at risk
Confusional state	Psychiatric disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0011 affected1,508 at risk
Delirium	Psychiatric disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 affected1,526 at risk EG0010 affected1,508 at risk
Delirium tremens	Psychiatric disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected1,526 at risk EG0011 affected1,508 at risk
Depression	Psychiatric disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0010 affected1,508 at risk
Mental status changes	Psychiatric disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0010 affected1,508 at risk
Panic attack	Psychiatric disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected1,526 at risk EG0011 affected1,508 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected1,526 at risk EG0011 affected1,508 at risk
Obstructive uropathy	Renal and urinary disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0010 affected1,508 at risk
Renal failure acute	Renal and urinary disorders	MedDRA (10.0)	Non-systematic Assessment	EG0005 affected1,526 at risk EG0014 affected1,508 at risk
Renal failure chronic	Renal and urinary disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected1,526 at risk EG0011 affected1,508 at risk
Renal impairment	Renal and urinary disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0010 affected1,508 at risk
Urethral caruncle	Renal and urinary disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0010 affected1,508 at risk
Urinary retention	Renal and urinary disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0010 affected1,508 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected1,526 at risk EG0011 affected1,508 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0010 affected1,508 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0014 affected1,508 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0010 affected1,508 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0012 affected1,508 at risk
Idiopathic pulmonary fibrosis	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0010 affected1,508 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0011 affected1,508 at risk
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0011 affected1,508 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0009 affected1,526 at risk EG00111 affected1,508 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected1,526 at risk EG0011 affected1,508 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0012 affected1,508 at risk
Respiratory depression	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 affected1,526 at risk EG0010 affected1,508 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0010 affected1,508 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0002 affected1,526 at risk EG0011 affected1,508 at risk
Blister	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected1,526 at risk EG0011 affected1,508 at risk
Arterial thrombosis limb	Vascular disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected1,526 at risk EG0011 affected1,508 at risk
Deep vein thrombosis	Vascular disorders	MedDRA (10.0)	Non-systematic Assessment	EG00013 affected1,526 at risk EG00122 affected1,508 at risk
Embolism venous	Vascular disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected1,526 at risk EG0011 affected1,508 at risk
Haematoma	Vascular disorders	MedDRA (10.0)	Non-systematic Assessment	EG0003 affected1,526 at risk EG0013 affected1,508 at risk
Haemorrhage	Vascular disorders	MedDRA (10.0)	Non-systematic Assessment	EG0003 affected1,526 at risk EG0010 affected1,508 at risk
Hypertensive crisis	Vascular disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0010 affected1,508 at risk
Hypotension	Vascular disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected1,526 at risk EG0011 affected1,508 at risk
Hypovolaemic shock	Vascular disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected1,526 at risk EG0011 affected1,508 at risk
Thrombophlebitis superficial	Vascular disorders	MedDRA (10.0)	Non-systematic Assessment	EG0001 affected1,526 at risk EG0010 affected1,508 at risk
Wound haemorrhage	Vascular disorders	MedDRA (10.0)	Non-systematic Assessment	EG0000 affected1,526 at risk EG0011 affected1,508 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (10.0)	Non-systematic Assessment	EG00057 affected1,526 at risk EG00151 affected1,508 at risk
Thrombocythaemia	Blood and lymphatic system disorders	MedDRA (10.0)	Non-systematic Assessment	EG00033 affected1,526 at risk EG00135 affected1,508 at risk
Bradycardia	Cardiac disorders	MedDRA (10.0)	Non-systematic Assessment	EG00015 affected1,526 at risk EG00116 affected1,508 at risk
Tachycardia	Cardiac disorders	MedDRA (10.0)	Non-systematic Assessment	EG00096 affected1,526 at risk EG00195 affected1,508 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG00021 affected1,526 at risk EG00113 affected1,508 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG00016 affected1,526 at risk EG00116 affected1,508 at risk
Constipation	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG000258 affected1,526 at risk EG001266 affected1,508 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG00061 affected1,526 at risk EG00155 affected1,508 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG00042 affected1,526 at risk EG00146 affected1,508 at risk
Hyperchlorhydria	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG0009 affected1,526 at risk EG00117 affected1,508 at risk
Nausea	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG000272 affected1,526 at risk EG001282 affected1,508 at risk
Vomiting	Gastrointestinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG000157 affected1,526 at risk EG001131 affected1,508 at risk
Asthenia	General disorders	MedDRA (10.0)	Non-systematic Assessment	EG00077 affected1,526 at risk EG00184 affected1,508 at risk
Chest pain	General disorders	MedDRA (10.0)	Non-systematic Assessment	EG00016 affected1,526 at risk EG00124 affected1,508 at risk
Chills	General disorders	MedDRA (10.0)	Non-systematic Assessment	EG00028 affected1,526 at risk EG00133 affected1,508 at risk
Fatigue	General disorders	MedDRA (10.0)	Non-systematic Assessment	EG00079 affected1,526 at risk EG00179 affected1,508 at risk
Oedema	General disorders	MedDRA (10.0)	Non-systematic Assessment	EG00043 affected1,526 at risk EG00138 affected1,508 at risk
Oedema peripheral	General disorders	MedDRA (10.0)	Non-systematic Assessment	EG000235 affected1,526 at risk EG001256 affected1,508 at risk
Pain	General disorders	MedDRA (10.0)	Non-systematic Assessment	EG00019 affected1,526 at risk EG00125 affected1,508 at risk
Pyrexia	General disorders	MedDRA (10.0)	Non-systematic Assessment	EG000320 affected1,526 at risk EG001310 affected1,508 at risk
Urinary tract infection	Infections and infestations	MedDRA (10.0)	Non-systematic Assessment	EG00040 affected1,526 at risk EG00139 affected1,508 at risk
Anaemia postoperative	Injury, poisoning and procedural complications	MedDRA (10.0)	Non-systematic Assessment	EG000178 affected1,526 at risk EG001187 affected1,508 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA (10.0)	Non-systematic Assessment	EG00027 affected1,526 at risk EG00131 affected1,508 at risk
Post procedural swelling	Injury, poisoning and procedural complications	MedDRA (10.0)	Non-systematic Assessment	EG00016 affected1,526 at risk EG00111 affected1,508 at risk
Procedural nausea	Injury, poisoning and procedural complications	MedDRA (10.0)	Non-systematic Assessment	EG00026 affected1,526 at risk EG00122 affected1,508 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA (10.0)	Non-systematic Assessment	EG000172 affected1,526 at risk EG001186 affected1,508 at risk
Wound secretion	Injury, poisoning and procedural complications	MedDRA (10.0)	Non-systematic Assessment	EG00019 affected1,526 at risk EG00115 affected1,508 at risk
Alanine aminotransferase increased	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG00024 affected1,526 at risk EG00145 affected1,508 at risk
Aspartate aminotransferase increased	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG00022 affected1,526 at risk EG00128 affected1,508 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG00014 affected1,526 at risk EG00121 affected1,508 at risk
Blood creatinine increased	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG00017 affected1,526 at risk EG00118 affected1,508 at risk
Blood lactate dehydrogenase increased	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG00033 affected1,526 at risk EG00129 affected1,508 at risk
Blood potassium decreased	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG00019 affected1,526 at risk EG00124 affected1,508 at risk
Body temperature increased	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG00063 affected1,526 at risk EG00181 affected1,508 at risk
Breath sounds abnormal	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG00022 affected1,526 at risk EG00122 affected1,508 at risk
Gamma-glutamyltransferase increased	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG00040 affected1,526 at risk EG00152 affected1,508 at risk
Haemoglobin decreased	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG00044 affected1,526 at risk EG00133 affected1,508 at risk
Lipase increased	Investigations	MedDRA (10.0)	Non-systematic Assessment	EG00016 affected1,526 at risk EG00117 affected1,508 at risk
Anorexia	Metabolism and nutrition disorders	MedDRA (10.0)	Non-systematic Assessment	EG00018 affected1,526 at risk EG00128 affected1,508 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA (10.0)	Non-systematic Assessment	EG00016 affected1,526 at risk EG00119 affected1,508 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (10.0)	Non-systematic Assessment	EG00041 affected1,526 at risk EG00153 affected1,508 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG00047 affected1,526 at risk EG00167 affected1,508 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG00016 affected1,526 at risk EG00121 affected1,508 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG00035 affected1,526 at risk EG00139 affected1,508 at risk
Joint warmth	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG00021 affected1,526 at risk EG00118 affected1,508 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG00096 affected1,526 at risk EG00188 affected1,508 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG000131 affected1,526 at risk EG001119 affected1,508 at risk
Dizziness	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG000111 affected1,526 at risk EG001102 affected1,508 at risk
Headache	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG00049 affected1,526 at risk EG00146 affected1,508 at risk
Hypoaesthesia	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG00030 affected1,526 at risk EG00138 affected1,508 at risk
Lethargy	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG00016 affected1,526 at risk EG00113 affected1,508 at risk
Somnolence	Nervous system disorders	MedDRA (10.0)	Non-systematic Assessment	EG00064 affected1,526 at risk EG00158 affected1,508 at risk
Anxiety	Psychiatric disorders	MedDRA (10.0)	Non-systematic Assessment	EG00044 affected1,526 at risk EG00139 affected1,508 at risk
Confusional state	Psychiatric disorders	MedDRA (10.0)	Non-systematic Assessment	EG00038 affected1,526 at risk EG00135 affected1,508 at risk
Insomnia	Psychiatric disorders	MedDRA (10.0)	Non-systematic Assessment	EG000163 affected1,526 at risk EG001168 affected1,508 at risk
Dysuria	Renal and urinary disorders	MedDRA (10.0)	Non-systematic Assessment	EG00019 affected1,526 at risk EG00112 affected1,508 at risk
Pollakiuria	Renal and urinary disorders	MedDRA (10.0)	Non-systematic Assessment	EG00020 affected1,526 at risk EG00111 affected1,508 at risk
Urinary retention	Renal and urinary disorders	MedDRA (10.0)	Non-systematic Assessment	EG00072 affected1,526 at risk EG00165 affected1,508 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG00033 affected1,526 at risk EG00139 affected1,508 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG00047 affected1,526 at risk EG00136 affected1,508 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG00027 affected1,526 at risk EG00119 affected1,508 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG00026 affected1,526 at risk EG00126 affected1,508 at risk
Pharyngolaryngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG00022 affected1,526 at risk EG00126 affected1,508 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Non-systematic Assessment	EG00015 affected1,526 at risk EG00121 affected1,508 at risk
Blister	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG00037 affected1,526 at risk EG00125 affected1,508 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG00028 affected1,526 at risk EG00131 affected1,508 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG00079 affected1,526 at risk EG00175 affected1,508 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG00018 affected1,526 at risk EG00124 affected1,508 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG000128 affected1,526 at risk EG001123 affected1,508 at risk
Pruritus generalised	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG00020 affected1,526 at risk EG00114 affected1,508 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (10.0)	Non-systematic Assessment	EG00036 affected1,526 at risk EG00140 affected1,508 at risk
Deep vein thrombosis	Vascular disorders	MedDRA (10.0)	Non-systematic Assessment	EG00052 affected1,526 at risk EG00168 affected1,508 at risk
Hypertension	Vascular disorders	MedDRA (10.0)	Non-systematic Assessment	EG00034 affected1,526 at risk EG00121 affected1,508 at risk
Hypotension	Vascular disorders	MedDRA (10.0)	Non-systematic Assessment	EG000100 affected1,526 at risk EG001102 affected1,508 at risk
Thrombosis	Vascular disorders	MedDRA (10.0)	Non-systematic Assessment	EG00025 affected1,526 at risk EG00122 affected1,508 at risk

ID	Term
D013923	Thromboembolism
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
D006495	Heparin, Low-Molecular-Weight
D006493	Heparin
D006025	Glycosaminoglycans
D011134	Polysaccharides
D002241	Carbohydrates