Dabigatran Etexilate in Extended Venous Thromboembolism (... | NCT00168818

NCT00168818

ID	Type	Description	Link
2004-001988-21	EudraCT Number	EudraCT

Status Module

Description 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
dabigatran etexilate 75 mg	Experimental	daily dose 150 mg once daily, half a dose on the day of surgery	Drug: dabigatran etexilate
dabigatran etexilate 110 mg	Experimental	daily dose 220 mg once daily, half a dose on the day of surgery	Drug: dabigatran etexilate
enoxaparin	Active Comparator	40 mg once daily	Drug: enoxaparin

Name	Type	Description	Arm Group Labels	Other Names
dabigatran etexilate	Drug	daily dose 150 mg once daily, half a dose on the day of surgery	dabigatran etexilate 75 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 bilateral venography), symptomatic DVT (confirmed by venous compression 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.	First administration until 31-38 days

Secondary Outcomes

Measure	Description	Time Frame
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	First administration until 31-38 days
Proximal Deep Vein Thrombosis During Treatment Period

Eligibility Module

Name	Affiliation	Role
Boehringer Ingelheim	Boehringer Ingelheim	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
1160.48.06108 Canberra Hospital		Garren	Australian Capital Territory		Australia
1160.48.06106 St George Public Hospital

References Module

Citations

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.
22995531

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Dabigatran 220mg	Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
FG001	Dabigatran 150mg

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Dabigatran 220mg	Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
BG001	Dabigatran 150mg	Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
BG002	Enoxaparin	Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.
BG003	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
	BG00064.6± 10.4 BG00163.4± 11.1 BG00263.8± 10.8 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000636 BG001667 BG002

Body Mass Index N=(1146;1163;1151;3460)

Mean

Standard Deviation

kg/m^2

Title

Denominators

Categories

Title	Measurements
	BG00027.7± 4.6 BG00127.8± 4.6 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

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 bilateral venography), symptomatic DVT (confirmed by venous compression 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 (all patients who had surgery and were randomised, received treatment, had an evaluable venogram for distal and proximal Deep Vein Thrombosis, or symptomatic Deep Vein Thrombosis, Pulmonary Embolism, or had died)

Posted

Number

Participants

First administration until 31-38 days

ID	Title	Description
OG000	Dabigatran 220mg	Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
OG001	Dabigatran 150mg	Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
OG002	Enoxaparin	Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.

Units	Counts
Participants	OG000880 OG001874 OG002897

Title

Denominators

Categories

Title	Measurements
	OG00053 OG00175 OG00260

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 OG002	Risk difference versus Enoxaparin	Normal approximation	Normal approximation of independent binomial distribution without stratification	0.5648	p-value is for superiority testing	Risk Difference (Percentage)	-0.7				95	-2.9	1.6				Yes	Non-Inferiority or Equivalence	Non-inferiority Analysis with NI margin 7.7%. This results from the null-hypotheses of non-inferiority testing, where the rate difference has to be below 7.7%. Non-inferiority can only be shown with CI.

Secondary

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 (all patients who had surgery and were randomised, received treatment, had an evaluable venogram for proximal Deep Vein Thrombosis, or had confirmed symptomatic Deep Vein Thrombosis, Pulmonary Embolism, or had died by a Venous Thromboembolic Event-related death)

Posted

Number

Participants

First administration until 31-38 days

ID	Title	Description
OG000	Dabigatran 220mg	Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
OG001	Dabigatran 150mg	Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
OG002	Enoxaparin	Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.

Secondary

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 surgery and were randomised, received treatment, had an evaluable venogram for proximal Deep Vein Thrombosis, or had confirmed symptomatic Deep Vein Thrombosis)

Posted

Number

Participants

First administration until 31-38 days

ID	Title	Description
OG000	Dabigatran 220mg	Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
OG001	Dabigatran 150mg	Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
OG002	Enoxaparin	Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.

Secondary

Total Deep Vein Thrombosis During Treatment Period

Total Deep Vein Thrombosis as adjudicated by the VTE events committee

Full Analysis Set - tDVT (all patients who had surgery and were randomised, received treatment, had an evaluable venogram, or had confirmed symptomatic Deep Vein Thrombosis)

Posted

Number

Participants

First administration until 31-38 days

ID	Title	Description
OG000	Dabigatran 220mg	Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
OG001	Dabigatran 150mg	Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
OG002	Enoxaparin	Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.

Secondary

Symptomatic Deep Vein Thrombosis During Treatment Period

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

Full Analysis Set - op (all patients who are treated and operated)

Posted

Number

Participants

First administration until 31-38 days

ID	Title	Description
OG000	Dabigatran 220mg	Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
OG001	Dabigatran 150mg	Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
OG002	Enoxaparin	Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.

Secondary

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 are treated and operated)

Posted

Number

Participants

First administration until 31-38 days

ID	Title	Description
OG000	Dabigatran 220mg	Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
OG001	Dabigatran 150mg	Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
OG002	Enoxaparin	Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.

Secondary

Death During Treatment Period

All cause death, as adjudicated by the VTE events committee

Full Analysis Set - op (all patients who are treated and operated)

Posted

Number

Participants

First administration until 31-38 days

ID	Title	Description
OG000	Dabigatran 220mg	Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
OG001	Dabigatran 150mg	Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
OG002	Enoxaparin	Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.

Units	Counts

Secondary

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

end of treatment to day 91±7

ID	Title	Description
OG000	Dabigatran 220mg	Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
OG001	Dabigatran 150mg	Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
OG002	Enoxaparin	Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.

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 greater than or equal to 25 cm²
wound hematoma greater than or equal to 100 cm²
spontaneous nose bleed lasting longer than 5 min
macroscopic hematuria spontaneous or lasting longer than 24 hours if associated with an intervention
spontaneous rectal bleeding (more than a spot on toilet paper)
gingival bleeding lasting longer than 5 min
any other bleeding event considered clinically relevant by the investigator

Minor bleeding events were defined as all other bleeding events that did not fulfil the criteria from above.

Treated set

Posted

Number

Participants

First administration until 31-38 days

ID	Title	Description
OG000	Dabigatran 220mg	Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
OG001	Dabigatran 150mg	Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.

Secondary

Blood Transfusion

Blood transfusion for treated and operated patients on Day of surgery.

Posted

Number

participants

Day 1

ID	Title	Description
OG000	Dabigatran 220mg	Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
OG001	Dabigatran 150mg	Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
OG002	Enoxaparin	Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.

Units	Counts
Participants

Secondary

Volume of Blood Loss

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

Posted

Mean

Standard Deviation

Day 1

ID	Title	Description
OG000	Dabigatran 220mg	Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
OG001	Dabigatran 150mg	Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
OG002	Enoxaparin	Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.

Units	Counts
Participants

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	Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
OG001	Dabigatran 150mg	Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
OG002	Enoxaparin	Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Dabigatran 220mg	Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.	89	1,146	620	1,146
EG001	Dabigatran 150mg	Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.	91	1,163	642	1,163
EG002	Enoxaparin	Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.	82	1,154	648	1,154

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute myocardial infarction	Cardiac disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected1,146 at risk EG0012 affected1,163 at risk EG0020 affected1,154 at risk
Acute right ventricular failure	Cardiac disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected1,146 at risk EG0011 affected1,163 at risk EG0020 affected1,154 at risk
Angina pectoris	Cardiac disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected1,146 at risk EG0011 affected1,163 at risk EG0021 affected1,154 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected1,146 at risk EG0011 affected1,163 at risk EG0023 affected1,154 at risk
Atrial flutter	Cardiac disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected1,146 at risk EG0010 affected1,163 at risk EG0020 affected1,154 at risk
Bradycardia	Cardiac disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected1,146 at risk EG0011 affected1,163 at risk EG0020 affected1,154 at risk
Cardiac arrest	Cardiac disorders	MedDRA (9.1)	Systematic Assessment	EG0002 affected1,146 at risk EG0011 affected1,163 at risk EG0021 affected1,154 at risk
Cardiac failure	Cardiac disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected1,146 at risk EG0010 affected1,163 at risk EG0020 affected1,154 at risk
Cardiopulmonary failure	Cardiac disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected1,146 at risk EG0011 affected1,163 at risk EG0020 affected1,154 at risk
Coronary artery disease	Cardiac disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected1,146 at risk EG0010 affected1,163 at risk EG0020 affected1,154 at risk
Myocardial infarction	Cardiac disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected1,146 at risk EG0013 affected1,163 at risk EG0025 affected1,154 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected1,146 at risk EG0010 affected1,163 at risk EG0021 affected1,154 at risk
Vertigo	Ear and labyrinth disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected1,146 at risk EG0011 affected1,163 at risk EG0021 affected1,154 at risk
Angle closure glaucoma	Eye disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected1,146 at risk EG0011 affected1,163 at risk EG0020 affected1,154 at risk
Diplopia	Eye disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected1,146 at risk EG0010 affected1,163 at risk EG0020 affected1,154 at risk
Constipation	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected1,146 at risk EG0010 affected1,163 at risk EG0021 affected1,154 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected1,146 at risk EG0010 affected1,163 at risk EG0021 affected1,154 at risk
Diarrhoea haemorrhagic	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected1,146 at risk EG0011 affected1,163 at risk EG0020 affected1,154 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected1,146 at risk EG0010 affected1,163 at risk EG0020 affected1,154 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected1,146 at risk EG0011 affected1,163 at risk EG0020 affected1,154 at risk
Gastritis haemorrhagic	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected1,146 at risk EG0011 affected1,163 at risk EG0020 affected1,154 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected1,146 at risk EG0010 affected1,163 at risk EG0021 affected1,154 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected1,146 at risk EG0011 affected1,163 at risk EG0020 affected1,154 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected1,146 at risk EG0010 affected1,163 at risk EG0020 affected1,154 at risk
Ileus paralytic	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected1,146 at risk EG0011 affected1,163 at risk EG0021 affected1,154 at risk
Intestinal ischaemia	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected1,146 at risk EG0011 affected1,163 at risk EG0020 affected1,154 at risk
Intra-abdominal haemorrhage	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected1,146 at risk EG0010 affected1,163 at risk EG0020 affected1,154 at risk
Melaena	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected1,146 at risk EG0011 affected1,163 at risk EG0020 affected1,154 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected1,146 at risk EG0010 affected1,163 at risk EG0020 affected1,154 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected1,146 at risk EG0010 affected1,163 at risk EG0022 affected1,154 at risk
Small intestinal perforation	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected1,146 at risk EG0010 affected1,163 at risk EG0020 affected1,154 at risk
Vomiting	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected1,146 at risk EG0011 affected1,163 at risk EG0020 affected1,154 at risk
Chest pain	General disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected1,146 at risk EG0011 affected1,163 at risk EG0021 affected1,154 at risk
Drug ineffective	General disorders	MedDRA (9.1)	Systematic Assessment	EG0002 affected1,146 at risk EG0011 affected1,163 at risk EG0020 affected1,154 at risk
Feeling hot and cold	General disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected1,146 at risk EG0010 affected1,163 at risk EG0021 affected1,154 at risk
Impaired healing	General disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected1,146 at risk EG0014 affected1,163 at risk EG0020 affected1,154 at risk
Inflammation of wound	General disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected1,146 at risk EG0010 affected1,163 at risk EG0020 affected1,154 at risk
Malaise	General disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected1,146 at risk EG0010 affected1,163 at risk EG0020 affected1,154 at risk
Oedema peripheral	General disorders	MedDRA (9.1)	Systematic Assessment	EG0003 affected1,146 at risk EG0012 affected1,163 at risk EG0020 affected1,154 at risk
Pyrexia	General disorders	MedDRA (9.1)	Systematic Assessment	EG0002 affected1,146 at risk EG0011 affected1,163 at risk EG0020 affected1,154 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected1,146 at risk EG0010 affected1,163 at risk EG0021 affected1,154 at risk
Wound necrosis	General disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected1,146 at risk EG0010 affected1,163 at risk EG0020 affected1,154 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected1,146 at risk EG0010 affected1,163 at risk EG0020 affected1,154 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected1,146 at risk EG0010 affected1,163 at risk EG0020 affected1,154 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA (9.1)	Systematic Assessment	EG0002 affected1,146 at risk EG0010 affected1,163 at risk EG0021 affected1,154 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected1,146 at risk EG0011 affected1,163 at risk EG0020 affected1,154 at risk
Anaphylactic shock	Immune system disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected1,146 at risk EG0010 affected1,163 at risk EG0021 affected1,154 at risk
Drug hypersensitivity	Immune system disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected1,146 at risk EG0010 affected1,163 at risk EG0020 affected1,154 at risk
Hypersensitivity	Immune system disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected1,146 at risk EG0010 affected1,163 at risk EG0021 affected1,154 at risk
Arthritis infective	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0000 affected1,146 at risk EG0010 affected1,163 at risk EG0022 affected1,154 at risk
Bronchopneumonia	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0001 affected1,146 at risk EG0010 affected1,163 at risk EG0020 affected1,154 at risk
Device related infection	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0000 affected1,146 at risk EG0011 affected1,163 at risk EG0020 affected1,154 at risk
Erysipelas	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0001 affected1,146 at risk EG0010 affected1,163 at risk EG0020 affected1,154 at risk
Oesophageal candidiasis	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0001 affected1,146 at risk EG0010 affected1,163 at risk EG0020 affected1,154 at risk
Perineal abscess	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0000 affected1,146 at risk EG0011 affected1,163 at risk EG0020 affected1,154 at risk
Pneumonia	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0001 affected1,146 at risk EG0012 affected1,163 at risk EG0021 affected1,154 at risk
Postoperative infection	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0001 affected1,146 at risk EG0010 affected1,163 at risk EG0021 affected1,154 at risk
Postoperative wound infection	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0004 affected1,146 at risk EG0012 affected1,163 at risk EG0021 affected1,154 at risk
Pyelonephritis	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0000 affected1,146 at risk EG0010 affected1,163 at risk EG0021 affected1,154 at risk
Sepsis	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0000 affected1,146 at risk EG0012 affected1,163 at risk EG0020 affected1,154 at risk
Urinary tract infection	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0003 affected1,146 at risk EG0010 affected1,163 at risk EG0022 affected1,154 at risk
Wound abscess	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0001 affected1,146 at risk EG0010 affected1,163 at risk EG0020 affected1,154 at risk
Wound infection	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0007 affected1,146 at risk EG0013 affected1,163 at risk EG0027 affected1,154 at risk
Wound infection staphylococcal	Infections and infestations	MedDRA (9.1)	Systematic Assessment	EG0000 affected1,146 at risk EG0010 affected1,163 at risk EG0021 affected1,154 at risk
Arterial injury	Injury, poisoning and procedural complications	MedDRA (9.1)	Systematic Assessment	EG0000 affected1,146 at risk EG0010 affected1,163 at risk EG0021 affected1,154 at risk
Bone fissure	Injury, poisoning and procedural complications	MedDRA (9.1)	Systematic Assessment	EG0001 affected1,146 at risk EG0010 affected1,163 at risk EG0020 affected1,154 at risk
Contrast media reaction	Injury, poisoning and procedural complications	MedDRA (9.1)	Systematic Assessment	EG0000 affected1,146 at risk EG0010 affected1,163 at risk EG0021 affected1,154 at risk
Device breakage	Injury, poisoning and procedural complications	MedDRA (9.1)	Systematic Assessment	EG0001 affected1,146 at risk EG0010 affected1,163 at risk EG0022 affected1,154 at risk
Dislocation of joint prosthesis	Injury, poisoning and procedural complications	MedDRA (9.1)	Systematic Assessment	EG0003 affected1,146 at risk EG0016 affected1,163 at risk EG0026 affected1,154 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (9.1)	Systematic Assessment	EG0001 affected1,146 at risk EG0010 affected1,163 at risk EG0020 affected1,154 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA (9.1)	Systematic Assessment	EG0000 affected1,146 at risk EG0011 affected1,163 at risk EG0020 affected1,154 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA (9.1)	Systematic Assessment	EG0001 affected1,146 at risk EG0011 affected1,163 at risk EG0022 affected1,154 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA (9.1)	Systematic Assessment	EG0001 affected1,146 at risk EG0010 affected1,163 at risk EG0020 affected1,154 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA (9.1)	Systematic Assessment	EG0005 affected1,146 at risk EG0014 affected1,163 at risk EG0024 affected1,154 at risk
Joint dislocation postoperative	Injury, poisoning and procedural complications	MedDRA (9.1)	Systematic Assessment	EG0000 affected1,146 at risk EG0010 affected1,163 at risk EG0022 affected1,154 at risk
Meniscus lesion	Injury, poisoning and procedural complications	MedDRA (9.1)	Systematic Assessment	EG0000 affected1,146 at risk EG0011 affected1,163 at risk EG0020 affected1,154 at risk
Operative haemorrhage	Injury, poisoning and procedural complications	MedDRA (9.1)	Systematic Assessment	EG0002 affected1,146 at risk EG0010 affected1,163 at risk EG0023 affected1,154 at risk
Post procedural discharge	Injury, poisoning and procedural complications	MedDRA (9.1)	Systematic Assessment	EG0001 affected1,146 at risk EG0011 affected1,163 at risk EG0020 affected1,154 at risk
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA (9.1)	Systematic Assessment	EG0001 affected1,146 at risk EG0010 affected1,163 at risk EG0022 affected1,154 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA (9.1)	Systematic Assessment	EG0000 affected1,146 at risk EG0012 affected1,163 at risk EG0021 affected1,154 at risk
Postoperative thrombosis	Injury, poisoning and procedural complications	MedDRA (9.1)	Systematic Assessment	EG0000 affected1,146 at risk EG0010 affected1,163 at risk EG0021 affected1,154 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA (9.1)	Systematic Assessment	EG0001 affected1,146 at risk EG0011 affected1,163 at risk EG0021 affected1,154 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA (9.1)	Systematic Assessment	EG0000 affected1,146 at risk EG0011 affected1,163 at risk EG0020 affected1,154 at risk
Seroma	Injury, poisoning and procedural complications	MedDRA (9.1)	Systematic Assessment	EG0001 affected1,146 at risk EG0010 affected1,163 at risk EG0020 affected1,154 at risk
Stress fracture	Injury, poisoning and procedural complications	MedDRA (9.1)	Systematic Assessment	EG0001 affected1,146 at risk EG0010 affected1,163 at risk EG0020 affected1,154 at risk
Traumatic haematoma	Injury, poisoning and procedural complications	MedDRA (9.1)	Systematic Assessment	EG0000 affected1,146 at risk EG0010 affected1,163 at risk EG0022 affected1,154 at risk
Wound complication	Injury, poisoning and procedural complications	MedDRA (9.1)	Systematic Assessment	EG0000 affected1,146 at risk EG0010 affected1,163 at risk EG0022 affected1,154 at risk
Wound secretion	Injury, poisoning and procedural complications	MedDRA (9.1)	Systematic Assessment	EG0008 affected1,146 at risk EG0018 affected1,163 at risk EG0023 affected1,154 at risk
Haemoglobin decreased	Investigations	MedDRA (9.1)	Systematic Assessment	EG0001 affected1,146 at risk EG0010 affected1,163 at risk EG0020 affected1,154 at risk
Liver function test abnormal	Investigations	MedDRA (9.1)	Systematic Assessment	EG0000 affected1,146 at risk EG0011 affected1,163 at risk EG0022 affected1,154 at risk
Oxygen saturation decreased	Investigations	MedDRA (9.1)	Systematic Assessment	EG0000 affected1,146 at risk EG0011 affected1,163 at risk EG0020 affected1,154 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected1,146 at risk EG0010 affected1,163 at risk EG0020 affected1,154 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected1,146 at risk EG0011 affected1,163 at risk EG0020 affected1,154 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected1,146 at risk EG0010 affected1,163 at risk EG0020 affected1,154 at risk
Haemarthrosis	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Systematic Assessment	EG0002 affected1,146 at risk EG0013 affected1,163 at risk EG0020 affected1,154 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected1,146 at risk EG0010 affected1,163 at risk EG0021 affected1,154 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected1,146 at risk EG0011 affected1,163 at risk EG0020 affected1,154 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected1,146 at risk EG0010 affected1,163 at risk EG0021 affected1,154 at risk
Langerhans' cell granulomatosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (9.1)	Systematic Assessment	EG0000 affected1,146 at risk EG0010 affected1,163 at risk EG0021 affected1,154 at risk
Ovarian cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (9.1)	Systematic Assessment	EG0000 affected1,146 at risk EG0011 affected1,163 at risk EG0020 affected1,154 at risk
Cerebral infarction	Nervous system disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected1,146 at risk EG0011 affected1,163 at risk EG0020 affected1,154 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected1,146 at risk EG0012 affected1,163 at risk EG0020 affected1,154 at risk
Dizziness	Nervous system disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected1,146 at risk EG0010 affected1,163 at risk EG0021 affected1,154 at risk
Headache	Nervous system disorders	MedDRA (9.1)	Systematic Assessment	EG0002 affected1,146 at risk EG0010 affected1,163 at risk EG0021 affected1,154 at risk
Ischaemic stroke	Nervous system disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected1,146 at risk EG0012 affected1,163 at risk EG0021 affected1,154 at risk
Syncope	Nervous system disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected1,146 at risk EG0010 affected1,163 at risk EG0020 affected1,154 at risk
Delirium	Psychiatric disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected1,146 at risk EG0011 affected1,163 at risk EG0020 affected1,154 at risk
Neurogenic bladder	Renal and urinary disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected1,146 at risk EG0010 affected1,163 at risk EG0020 affected1,154 at risk
Renal failure acute	Renal and urinary disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected1,146 at risk EG0011 affected1,163 at risk EG0020 affected1,154 at risk
Urethral stenosis	Renal and urinary disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected1,146 at risk EG0010 affected1,163 at risk EG0021 affected1,154 at risk
Urinary retention	Renal and urinary disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected1,146 at risk EG0010 affected1,163 at risk EG0020 affected1,154 at risk
Prostatism	Reproductive system and breast disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected1,146 at risk EG0010 affected1,163 at risk EG0020 affected1,154 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected1,146 at risk EG0011 affected1,163 at risk EG0020 affected1,154 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected1,146 at risk EG0010 affected1,163 at risk EG0021 affected1,154 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected1,146 at risk EG0010 affected1,163 at risk EG0020 affected1,154 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (9.1)	Systematic Assessment	EG0005 affected1,146 at risk EG0012 affected1,163 at risk EG0022 affected1,154 at risk
Pulmonary infarction	Respiratory, thoracic and mediastinal disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected1,146 at risk EG0010 affected1,163 at risk EG0021 affected1,154 at risk
Respiratory depression	Respiratory, thoracic and mediastinal disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected1,146 at risk EG0011 affected1,163 at risk EG0020 affected1,154 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected1,146 at risk EG0011 affected1,163 at risk EG0020 affected1,154 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected1,146 at risk EG0010 affected1,163 at risk EG0020 affected1,154 at risk
Immobile	Social circumstances	MedDRA (9.1)	Systematic Assessment	EG0001 affected1,146 at risk EG0010 affected1,163 at risk EG0020 affected1,154 at risk
Immobilisation prolonged	Social circumstances	MedDRA (9.1)	Systematic Assessment	EG0001 affected1,146 at risk EG0010 affected1,163 at risk EG0020 affected1,154 at risk
Air embolism	Vascular disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected1,146 at risk EG0011 affected1,163 at risk EG0020 affected1,154 at risk
Arterial rupture	Vascular disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected1,146 at risk EG0010 affected1,163 at risk EG0020 affected1,154 at risk
Circulatory collapse	Vascular disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected1,146 at risk EG0010 affected1,163 at risk EG0020 affected1,154 at risk
Deep vein thrombosis	Vascular disorders	MedDRA (9.1)	Systematic Assessment	EG0006 affected1,146 at risk EG00113 affected1,163 at risk EG0029 affected1,154 at risk
Haematoma	Vascular disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected1,146 at risk EG0010 affected1,163 at risk EG0021 affected1,154 at risk
Haemorrhage	Vascular disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected1,146 at risk EG0010 affected1,163 at risk EG0020 affected1,154 at risk
Hypotension	Vascular disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected1,146 at risk EG0011 affected1,163 at risk EG0022 affected1,154 at risk
Peripheral embolism	Vascular disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected1,146 at risk EG0010 affected1,163 at risk EG0020 affected1,154 at risk
Phlebitis	Vascular disorders	MedDRA (9.1)	Systematic Assessment	EG0000 affected1,146 at risk EG0011 affected1,163 at risk EG0020 affected1,154 at risk
Thrombophlebitis	Vascular disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected1,146 at risk EG0010 affected1,163 at risk EG0020 affected1,154 at risk
Venous thrombosis	Vascular disorders	MedDRA (9.1)	Systematic Assessment	EG0001 affected1,146 at risk EG0011 affected1,163 at risk EG0020 affected1,154 at risk
Wound haemorrhage	Vascular disorders	MedDRA (9.1)	Systematic Assessment	EG0002 affected1,146 at risk EG0013 affected1,163 at risk EG0023 affected1,154 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Constipation	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG000146 affected1,146 at risk EG001140 affected1,163 at risk EG002149 affected1,154 at risk
Nausea	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG000238 affected1,146 at risk EG001258 affected1,163 at risk EG002289 affected1,154 at risk
Vomiting	Gastrointestinal disorders	MedDRA (9.1)	Systematic Assessment	EG000193 affected1,146 at risk EG001185 affected1,163 at risk EG002191 affected1,154 at risk
Oedema peripheral	General disorders	MedDRA (9.1)	Systematic Assessment	EG00062 affected1,146 at risk EG00179 affected1,163 at risk EG00256 affected1,154 at risk
Pyrexia	General disorders	MedDRA (9.1)	Systematic Assessment	EG000121 affected1,146 at risk EG001140 affected1,163 at risk EG002162 affected1,154 at risk
Wound secretion	Injury, poisoning and procedural complications	MedDRA (9.1)	Systematic Assessment	EG00094 affected1,146 at risk EG00188 affected1,163 at risk EG00260 affected1,154 at risk
Insomnia	Psychiatric disorders	MedDRA (9.1)	Systematic Assessment	EG00077 affected1,146 at risk EG00188 affected1,163 at risk EG00280 affected1,154 at risk
Hypotension	Vascular disorders	MedDRA (9.1)	Systematic Assessment	EG00081 affected1,146 at risk EG00176 affected1,163 at risk EG00281 affected1,154 at risk

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

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