Dabigatran Etexilate Compared With Enoxaparin in Preventi... | NCT00657150

NCT00657150

ID	Type	Description	Link
2007-002630-11	EudraCT Number	EudraCT

Status Module

Label	Type	Description	Intervention Names
Dabigatran etexilate	Experimental	220 mg once daily	Drug: Dabigatran etexilate
Enoxaparin	Active Comparator	40 mg once daily	Drug: Enoxaparin

Name	Type	Description	Arm Group Labels	Other Names
Enoxaparin	Drug	40 mg once daily	Enoxaparin
Dabigatran etexilate

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period	Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine venography), symptomatic DVT (confirmed by venous duplex, ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy). All of these components and all deaths were centrally adjudicated by the VTE events committee, which was not aware of the treatment allocation of the patients.	28-35 days

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period	Major Venous Thromboembolic Event (VTE) is defined as proximal DVT and PE, as adjudicated by the VTE events committee	28-35 days
Number of Participants With Proximal Deep Vein Thrombosis During Treatment Period

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Patients scheduled to undergo primary, unilateral, elective total hip arthroplasty.
Male or female 18 years of age or older.
Patients giving written informed consent for study participation.

Exclusion criteria:

Patients weighing less than 40 kg.
History of bleeding diathesis.
Patients who in the investigators judgement are perceived as having an excessive risk of bleeding, for example, constitutional or acquired coagulation disorders or because of anticipated need of quinidine, verapamil or other restricted medication during the treatment period (see Section 4.2.2).
Major surgery or trauma (e.g., hip fracture) within 3 months of enrolment.
Recent unstable cardiovascular disease (in the investigators opinion) such as uncontrolled hypertension, that is ongoing at the time of enrolment or history of myocardial infarction within 3 months of enrolment.
Any history of haemorrhagic stroke or any of the following intracranial pathologies: bleeding, neoplasm, Atriovenous (AV) malformation or aneurysm.
Ongoing treatment for Venous Thromboembolism (VTE).
Clinically relevant bleeding (gastrointestinal, pulmonary, intraocular or urogenital bleeding) within 6 months of enrolment.
Gastric or duodenal ulcer within one year of enrolment.
Liver disease expected to have any potential impact on survival (ie, hepatitis B or C, cirrhosis). This does not include Gilberts syndrome or hepatitis A with complete recovery.
Active liver disease or liver disease decreasing survival (e.g, acute hepatitis, chronic active hepatitis, cirrhosis) or Alanine Aminotransferase (ALT) >3 x ULN.
Known severe renal insufficiency (CrCl <30 ml/min). Note: CrCl should be calculated only if serum creatinine is elevated or renal insufficiency is suspected. See Appendix 10.1 for calculation.
Elevated creatinine that, in the investigators opinion, contraindicates venography.
Treatment with anticoagulants, clopidogrel, ticlopidine, abciximab, aspirin >162.5 mg/day or NSAID with t 1/2 >12 hours within 7 days prior to hip replacement surgery OR anticipated need while the patient is receiving study medication and prior to 24 hours after the last administration of any blinded study medication (COX-2 selective inhibitors are allowed).
Anticipated required use of intermittent pneumatic compression and electric stimulation of lower limb.
Pre-menopausal women (last menstruation within 1 year prior to signing informed consent) who:
- Are pregnant.
- Are nursing.
- Are of child-bearing potential and are NOT practicing acceptable methods of birth control, or do NOT plan to continue practicing an acceptable method throughout the study. Acceptable methods of birth control include intrauterine device; oral, implantable or injectable contraceptives and surgical sterility.
Known allergy to radio opaque contrast media.
History of thrombocytopenia, including heparin-induced thrombocytopenia, or a platelet count <100,000 cells/microliter at randomisation.
Allergy to heparins or dabigatran etexilate.
Active malignant disease or current cytostatic treatment. Patients should be disease free for at least 5 years.
Participation in a clinical trial within 30 days of randomisation.
Leg amputee.
Known alcohol or drug abuse which would interfere with completion of the study.
Contraindications to enoxaparin.
Previous participation in this study.

Name	Affiliation	Role
Boehringer Ingelheim	Boehringer Ingelheim	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
1160.64.01005 Boehringer Ingelheim Investigational Site		La Jolla	California		United States
1160.64.01010 Boehringer Ingelheim Investigational Site

PubMed Identifier	Type	Citation	Retractions
26578849	Derived	Eriksson BI, Dahl OE, Rosencher N, Clemens A, Hantel S, Feuring M, Kreuzer J, Huo M, Friedman RJ. Oral dabigatran etexilate versus enoxaparin for venous thromboembolism prevention after total hip arthroplasty: pooled analysis of two phase 3 randomized trials. Thromb J. 2015 Nov 17;13:36. doi: 10.1186/s12959-015-0067-8. eCollection 2015.
21225098

Results Section

Participant Flow Module

ID	Title	Description
FG000	Dabigatran 220mg	qd (once daily) oral
FG001	Enoxaparin	40mg qd (once daily) subcutaneous

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

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 Total Venous Thromboembolic Event and All-cause Mortality During Treatment Period

Total Venous Thromboembolic Event (VTE) includes both proximal and distal deep vein thrombosis (DVT) (detected by routine venography), symptomatic DVT (confirmed by venous duplex, ultrasound, venography or autopsy) and pulmonary embolism (PE) (confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy).

All of these components and all deaths were centrally adjudicated by the VTE events committee, which was not aware of the treatment allocation of the patients.

Full Analysis Set (randomised, had taken at least 1 dose of oral or subcutaneous trial medication, had undergone surgery, had evaluable negative venogram for both distal and proximal DVT in both legs or positive venography in any 1 segment of 1 or both legs, or confirmed symptomatic DVT, PE or death during the treatment period.)

Posted

Number

Participants

28-35 days

ID	Title	Description
OG000	Dabigatran 220mg	qd (once daily) oral
OG001	Enoxaparin	40mg qd (once daily) subcutaneous

Units	Counts
Participants	OG000792 OG001786

Title

Denominators

Categories

Title	Measurements
	OG00061 OG00169

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	Risk difference versus Enoxaparin	Normal approximation	Normal approximation of independent binomial distribution without stratification	< 0.0001	Superiority p-value = 0.4367	Risk Difference (Percentage)	-1.08				95	-3.79	1.64				Yes	Non-Inferiority or Equivalence	Non-inferiority Analysis with NI margin 7.7%

Secondary

Number of Participants With Major Venous Thromboembolic Event and Venous Thromboembolic Event-related Mortality During Treatment Period

Major Venous Thromboembolic Event (VTE) is defined as proximal DVT and PE, as adjudicated by the VTE events committee

Full Analysis Set-major (randomised, had taken at least 1 dose of oral or subcutaneous trial medication, had undergone surgery, had evaluable negative venogram for proximal DVT in both legs or a positive venogram for proximal DVT in either leg or confirmed symptomatic proximal DVT, PE or death related to VTE during the treatment period.)

Posted

Number

Participants

28-35 days

ID	Title	Description
OG000	Dabigatran 220mg	qd (once daily) oral
OG001	Enoxaparin	40mg qd (once daily) subcutaneous

Units	Counts
Participants	OG000

Secondary

Number of Participants With Proximal Deep Vein Thrombosis During Treatment Period

Proximal Deep Vein Thrombosis as adjudicated by the VTE events committee

Full Analysis Set - pDVT (all patients who had been randomised, had taken at least 1 dose of oral or subcutaneous trial medication, had undergone surgery (i.e. a date of surgery was reported), evaluable negative venogram for proximal DVT in both legs or positive venogram in either leg or confirmed symptomatic proximal DVT)

Posted

Number

Participants

28-35 days

ID	Title	Description
OG000	Dabigatran 220mg	qd (once daily) oral
OG001	Enoxaparin	40mg qd (once daily) subcutaneous

Units	Counts
Participants	OG000

Secondary

Number of Participants With Total Deep Vein Thrombosis During Treatment Period

Total Deep Vein Thrombosis as adjudicated by the VTE events committee

Full Analysis Set-tDVT (randomised, had taken at least 1 dose of oral or subcutaneous trial medication, had undergone surgery, evaluable negative venogram for both distal and proximal DVT in both legs or positive venography in any 1 segment of 1 or both legs, or confirmed symptomatic DVT.)

Posted

Number

Participants

28-35 days

ID	Title	Description
OG000	Dabigatran 220mg	qd (once daily) oral
OG001	Enoxaparin	40mg qd (once daily) subcutaneous

Units	Counts
Participants	OG000

Secondary

Number of Participants With Symptomatic Deep Vein Thrombosis During Treatment Period

Symptomatic Deep Vein Thrombosis, confirmed by venous duplex, ultrasound, venography or autopsy, and as adjudicated by the VTE events committee

Full Analysis Set - op (all patients who had been randomised, had taken at least 1 dose of oral or subcutaneous trial medication or had undergone surgery (i.e. a date of surgery was reported)

Posted

Number

Participants

28-35 days

ID	Title	Description
OG000	Dabigatran 220mg	qd (once daily) oral
OG001	Enoxaparin	40mg qd (once daily) subcutaneous

Units	Counts
Participants	OG000

Secondary

Number of Participants With Pulmonary Embolism During Treatment Period

Pulmonary embolism confirmed by pulmonary V-Q scintigraphy, chest x-ray, pulmonary angiography, spiral CT or autopsy, and as adjudicated by the VTE events committee

Full Analysis Set - op (all patients who had been randomised, had taken at least 1 dose of oral or subcutaneous trial medication or had undergone surgery (i.e. a date of surgery was reported)

Posted

Number

Participants

28-35 days

ID	Title	Description
OG000	Dabigatran 220mg	qd (once daily) oral
OG001	Enoxaparin	40mg qd (once daily) subcutaneous

Units	Counts
Participants	OG000

Secondary

Number of Participants Who Died During Treatment Period

All cause death, as adjudicated by the VTE events committee

Full Analysis Set - op (all patients who had been randomised, had taken at least 1 dose of oral or subcutaneous trial medication or had undergone surgery (i.e. a date of surgery was reported)

Posted

Number

Participants

28-35 days

ID	Title	Description
OG000	Dabigatran 220mg	qd (once daily) oral
OG001	Enoxaparin	40mg qd (once daily) subcutaneous

Units	Counts
Participants	OG000

Secondary

Number of Participants With Total Venous Thromboembolic Event (VTE) and All-cause Mortality During the Follow-up Period

Patients with any data available during follow-up

Posted

Number

Participants

3 months

ID	Title	Description
OG000	Dabigatran 220mg	qd (once daily) oral
OG001	Enoxaparin	40mg qd (once daily) subcutaneous

Units	Counts
Participants	OG000

Secondary

Number of Participants With Bleeding Events (Defined According to Modified McMaster Criteria) During Treatment Period

Major bleeding events were defined as

fatal
clinically overt associated with loss of haemoglobin >=20g/L in excess of what was expected
clinically overt leading to the transfusion of >=2 units packed cells or whole blood in excess of what was expected
symptomatic retroperitoneal, intracranial, intraocular or intraspinal
requiring treatment cessation
leading to re-operation

Clinically-relevant was defined as

spontaneous skin hematoma >=25 cm²
wound hematoma >=100 cm²
spontaneous nose bleed >5 min
macroscopic hematuria spontaneous or >24 hours if associated with an intervention
spontaneous rectal bleeding
gingival bleeding >5 min
any other bleeding event considered clinically relevant by the investigator

Any bleeding events were defined as major, clinically-relevant and minor bleeding events. Minor bleeding events were defined as all other bleeding events that did not fulfil the criteria from above.

All patients who had been randomised, had taken at least 1 dose of oral or subcutaneous trial medication.

Posted

Number

Participants

28-35 days

ID	Title	Description
OG000	Dabigatran 220mg	qd (once daily) oral
OG001	Enoxaparin	40mg qd (once daily) subcutaneous

Secondary

Blood Transfusion

Number of treated and operated patients with required blood transfusion on day of surgery.

Treated and operated patients

Posted

Number

participants

Day 1

ID	Title	Description
OG000	Dabigatran 220mg	qd (once daily) oral
OG001	Enoxaparin	40mg qd (once daily) subcutaneous

Units	Counts
Participants	OG000

Secondary

Volume of Blood Loss

Volume of blood loss for treated and operated patients during surgery.

Treated and operated patients

Posted

Mean

Standard Deviation

Day 1

ID	Title	Description
OG000	Dabigatran 220mg	qd (once daily) oral
OG001	Enoxaparin	40mg qd (once daily) subcutaneous

Units	Counts
Participants	OG000

Secondary

Laboratory Analyses

Frequency of patients with possible clinically significant abnormalities.

Treated patients

Posted

Number

participants

First administration to end of study

ID	Title	Description
OG000	Dabigatran 220mg	qd (once daily) oral
OG001	Enoxaparin	40mg qd (once daily) subcutaneous

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected1,010 at risk EG0010 affected1,003 at risk
Disseminated intravascular coagulation	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected1,010 at risk EG0010 affected1,003 at risk
Thrombocytosis	Blood and lymphatic system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected1,010 at risk EG0010 affected1,003 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected1,010 at risk EG0011 affected1,003 at risk
Cardiac arrest	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected1,010 at risk EG0010 affected1,003 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected1,010 at risk EG0011 affected1,003 at risk
Myocardial infarction	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected1,010 at risk EG0011 affected1,003 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected1,010 at risk EG0010 affected1,003 at risk
Retinal artery occlusion	Eye disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected1,010 at risk EG0011 affected1,003 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected1,010 at risk EG0011 affected1,003 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected1,010 at risk EG0010 affected1,003 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected1,010 at risk EG0011 affected1,003 at risk
Anal haemorrhage	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected1,010 at risk EG0011 affected1,003 at risk
Constipation	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected1,010 at risk EG0012 affected1,003 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected1,010 at risk EG0011 affected1,003 at risk
Ileus	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected1,010 at risk EG0011 affected1,003 at risk
Ileus paralytic	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected1,010 at risk EG0011 affected1,003 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected1,010 at risk EG0011 affected1,003 at risk
Intestinal perforation	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected1,010 at risk EG0010 affected1,003 at risk
Melaena	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected1,010 at risk EG0011 affected1,003 at risk
Nausea	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected1,010 at risk EG0012 affected1,003 at risk
Oesophageal perforation	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected1,010 at risk EG0011 affected1,003 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected1,010 at risk EG0011 affected1,003 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected1,010 at risk EG0010 affected1,003 at risk
Vomiting	Gastrointestinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected1,010 at risk EG0012 affected1,003 at risk
Asthenia	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected1,010 at risk EG0010 affected1,003 at risk
Hyperthermia	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected1,010 at risk EG0011 affected1,003 at risk
Impaired healing	General disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected1,010 at risk EG0011 affected1,003 at risk
Inflammation	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected1,010 at risk EG0011 affected1,003 at risk
Multi-organ failure	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected1,010 at risk EG0010 affected1,003 at risk
Oedema peripheral	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected1,010 at risk EG0011 affected1,003 at risk
Pyrexia	General disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected1,010 at risk EG0010 affected1,003 at risk
Secretion discharge	General disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected1,010 at risk EG0010 affected1,003 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected1,010 at risk EG0010 affected1,003 at risk
Abscess neck	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected1,010 at risk EG0011 affected1,003 at risk
Arthritis infective	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected1,010 at risk EG0012 affected1,003 at risk
Diverticulitis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected1,010 at risk EG0011 affected1,003 at risk
Haematoma infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected1,010 at risk EG0010 affected1,003 at risk
Hepatitis A	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected1,010 at risk EG0010 affected1,003 at risk
Injection site abscess	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected1,010 at risk EG0011 affected1,003 at risk
Oesophageal candidiasis	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected1,010 at risk EG0010 affected1,003 at risk
Post procedural infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected1,010 at risk EG0010 affected1,003 at risk
Postoperative wound infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0001 affected1,010 at risk EG0011 affected1,003 at risk
Urinary tract infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0000 affected1,010 at risk EG0012 affected1,003 at risk
Wound infection	Infections and infestations	MedDRA 12.1	Systematic Assessment	EG0002 affected1,010 at risk EG0010 affected1,003 at risk
Abdominal injury	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0001 affected1,010 at risk EG0010 affected1,003 at risk
Avulsion fracture	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0001 affected1,010 at risk EG0010 affected1,003 at risk
Brain contusion	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0001 affected1,010 at risk EG0010 affected1,003 at risk
Device dislocation	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0001 affected1,010 at risk EG0010 affected1,003 at risk
Dislocation of joint prosthesis	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0002 affected1,010 at risk EG0010 affected1,003 at risk
Fat embolism	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0001 affected1,010 at risk EG0010 affected1,003 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0002 affected1,010 at risk EG0013 affected1,003 at risk
Fracture	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 affected1,010 at risk EG0011 affected1,003 at risk
Genital injury	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0001 affected1,010 at risk EG0010 affected1,003 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 affected1,010 at risk EG0011 affected1,003 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0004 affected1,010 at risk EG0013 affected1,003 at risk
Oesophageal injury	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 affected1,010 at risk EG0011 affected1,003 at risk
Operative haemorrhage	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0002 affected1,010 at risk EG0010 affected1,003 at risk
Periprosthetic fracture	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 affected1,010 at risk EG0012 affected1,003 at risk
Post procedural discharge	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0001 affected1,010 at risk EG0010 affected1,003 at risk
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 affected1,010 at risk EG0011 affected1,003 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0002 affected1,010 at risk EG0010 affected1,003 at risk
Procedural hypotension	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 affected1,010 at risk EG0011 affected1,003 at risk
Seroma	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 affected1,010 at risk EG0011 affected1,003 at risk
Traumatic haematoma	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0001 affected1,010 at risk EG0011 affected1,003 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0000 affected1,010 at risk EG0011 affected1,003 at risk
Wound haemorrhage	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0001 affected1,010 at risk EG0011 affected1,003 at risk
Wound secretion	Injury, poisoning and procedural complications	MedDRA 12.1	Systematic Assessment	EG0003 affected1,010 at risk EG0011 affected1,003 at risk
C-reactive protein increased	Investigations	MedDRA 12.1	Systematic Assessment	EG0001 affected1,010 at risk EG0010 affected1,003 at risk
Haemoglobin decreased	Investigations	MedDRA 12.1	Systematic Assessment	EG0001 affected1,010 at risk EG0010 affected1,003 at risk
Hepatic enzyme increased	Investigations	MedDRA 12.1	Systematic Assessment	EG0000 affected1,010 at risk EG0011 affected1,003 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected1,010 at risk EG0011 affected1,003 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected1,010 at risk EG0011 affected1,003 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected1,010 at risk EG0012 affected1,003 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected1,010 at risk EG0010 affected1,003 at risk
Haemarthrosis	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected1,010 at risk EG0010 affected1,003 at risk
Joint effusion	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected1,010 at risk EG0011 affected1,003 at risk
Mobility decreased	Musculoskeletal and connective tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected1,010 at risk EG0011 affected1,003 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected1,010 at risk EG0011 affected1,003 at risk
Central nervous system lesion	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected1,010 at risk EG0011 affected1,003 at risk
Epilepsy	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected1,010 at risk EG0010 affected1,003 at risk
Monoparesis	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected1,010 at risk EG0011 affected1,003 at risk
Somnolence	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected1,010 at risk EG0010 affected1,003 at risk
Syncope	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected1,010 at risk EG0011 affected1,003 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 12.1	Systematic Assessment	EG0002 affected1,010 at risk EG0010 affected1,003 at risk
Anuria	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected1,010 at risk EG0010 affected1,003 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected1,010 at risk EG0014 affected1,003 at risk
Renal impairment	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected1,010 at risk EG0011 affected1,003 at risk
Urethral stenosis	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected1,010 at risk EG0011 affected1,003 at risk
Urinary retention	Renal and urinary disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected1,010 at risk EG0010 affected1,003 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected1,010 at risk EG0011 affected1,003 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected1,010 at risk EG0011 affected1,003 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected1,010 at risk EG0012 affected1,003 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected1,010 at risk EG0010 affected1,003 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected1,010 at risk EG0011 affected1,003 at risk
Hip arthroplasty	Surgical and medical procedures	MedDRA 12.1	Systematic Assessment	EG0001 affected1,010 at risk EG0010 affected1,003 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0004 affected1,010 at risk EG00110 affected1,003 at risk
Haemorrhage	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected1,010 at risk EG0010 affected1,003 at risk
Shock haemorrhagic	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0001 affected1,010 at risk EG0010 affected1,003 at risk
Thrombophlebitis superficial	Vascular disorders	MedDRA 12.1	Systematic Assessment	EG0000 affected1,010 at risk EG0011 affected1,003 at risk

ID	Term
D013923	Thromboembolism
D016769	Embolism and Thrombosis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Term
D006495	Heparin, Low-Molecular-Weight
D006493	Heparin
D006025	Glycosaminoglycans
D011134	Polysaccharides
D002241	Carbohydrates
D011725	Pyridines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D001562	Benzimidazoles
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

ID	Title	Description
BG000	Dabigatran 220mg	qd (once daily) oral
BG001	Enoxaparin	40mg qd (once daily) subcutaneous
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Dabigatran 220mg	qd (once daily) oral			57	1,010	389	1,010
EG001	Enoxaparin	40mg qd (once daily) subcutaneous			59	1,003	389	1,003