Comparison of Efficacy and Safety of TachoSil® Versus Sur... | NCT01500135

NCT01500135

ID	Type	Description	Link
U1111-1163-1653	Registry Identifier	WHO

Status Module

Sponsor/Collaborators Module

Name	Class
Baxter Healthcare Corporation	INDUSTRY

Oversight Module

Description Module

Conditions 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
TachoSil®	Experimental	TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.	Drug: TachoSil®
Surgicel® Original	Active Comparator	Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.	Drug: Surgicel® Original

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TachoSil®	Drug	TachoSil® is a sterile, ready-to-use, absorbable patch for intra-operative topical application. It consists of an equine collagen patch coated with fibrin glue components: human fibrinogen and human thrombin.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Intra-operative Hemostasis at the Evaluation Site Within 3 Minutes After Application of the Randomized Treatment	After application of Investigational Medicinal Product (IMP) light pressure was applied to the IMP with e.g. gauze pads. The first assessment of hemostasis was at minute 3: the pressure was carefully relieved, and the area was observed for visual bleeding at the site of the IMP. If no bleeding was visible, hemostasis was obtained and recorded.	Within 3 minutes

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Intra-operative Hemostasis at the Evaluation Site Within 5 Minutes After Application of the Randomized Treatment	After application of Investigational Medicinal Product (IMP) light pressure was applied to the IMP with e.g. gauze pads. If hemostasis was not obtained at minute 3, pressure was immediately reapplied. Hemostasis was re-assessed at minutes 4 and 5.	Within 5 minutes

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Medical Director Clinical Science	Takeda	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Nycomed Investigational Site		Birmingham	Alabama		United States

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	TachoSil®	TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Full Analysis Set included all randomized participants.

Arm/Group Information

ID	Title	Description
BG000	TachoSil®	TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
BG001	Surgicel® Original	Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
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
	OG00026.0(17.7 to 35.7) OG00118.0(8.6 to 31.4)

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		Regression, Logistic		0.276	Logistic regression model with treatment, type of surgery (Peripheral Arterial Disease, Arterio Venous Graft) and current use of Clopidogrel or other similar anti-platelet drugs (yes/no) as covariates.	Odds Ratio (OR)	1.62	Standard Error of the Mean	0.72	2-Sided	95	0.68	3.88				No	Superiority or Other

Secondary

Percentage of Participants With Intra-operative Hemostasis at the Evaluation Site Within 5 Minutes After Application of the Randomized Treatment

After application of Investigational Medicinal Product (IMP) light pressure was applied to the IMP with e.g. gauze pads. If hemostasis was not obtained at minute 3, pressure was immediately reapplied. Hemostasis was re-assessed at minutes 4 and 5.

FAS included all randomized participants. The endpoint for one participant on TachoSil® was missing; it was assumed that hemostasis was not reached within 5 minutes.

Posted

Number

95% Confidence Interval

percentage of participants

Within 5 minutes

ID	Title	Description
OG000	TachoSil®	TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
OG001	Surgicel® Original	Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.

Secondary

Time to Intra-operative Hemostasis Within 10 Minutes at the Evaluation Site After Application of the Randomized Treatment

After application of Investigational Medicinal Product (IMP) light pressure was applied to the IMP with e.g. gauze pads. Hemostasis was assessed at 3, 4, and 5 minutes. If hemostasis was not obtained after 5 minutes a second application of IMP was applied with 3 minutes of light pressure and hemostasis was re-assessed at 8, 9 and 10 minutes.

FAS included all randomized participants. Participants who did not achieve hemostasis by 10 minutes were censored.

Posted

Median

95% Confidence Interval

minutes

Within 10 minutes

ID	Title	Description
OG000	TachoSil®	TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
OG001	Surgicel® Original	Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.

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	TachoSil®	TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.			49	99	52	99
EG001	Surgicel® Original	Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.			19	50	28	50

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment		EG0000 affected99 at risk EG0011 affected50 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 18.0	Systematic Assessment		EG0004 affected99 at risk EG0013 affected50 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 18.0	Systematic Assessment		EG0003 affected99 at risk EG0011 affected50 at risk
Cardiomyopathy	Cardiac disorders	MedDRA 18.0	Systematic Assessment	One treatment-emergent death occurred during treatment with TachoSil® and is not related.	EG0002 affected99 at risk EG0010 affected50 at risk
Angina unstable	Cardiac disorders	MedDRA 18.0	Systematic Assessment		EG0001 affected99 at risk EG0010 affected50 at risk
Cardiac arrest	Cardiac disorders	MedDRA 18.0	Systematic Assessment	One treatment-emergent death occurred during treatment with Surgicel® Original and is not related.	EG0001 affected99 at risk EG0011 affected50 at risk
Cor pulmonale	Cardiac disorders	MedDRA 18.0	Systematic Assessment		EG0001 affected99 at risk EG0010 affected50 at risk
Myocardial infarction	Cardiac disorders	MedDRA 18.0	Systematic Assessment	One treatment-emergent death occurred during treatment with TachoSil® is not related.	EG0001 affected99 at risk EG0010 affected50 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 18.0	Systematic Assessment		EG0000 affected99 at risk EG0011 affected50 at risk
Bradycardia	Cardiac disorders	MedDRA 18.0	Systematic Assessment		EG0000 affected99 at risk EG0011 affected50 at risk
Cardiogenic shock	Cardiac disorders	MedDRA 18.0	Systematic Assessment		EG0000 affected99 at risk EG0011 affected50 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 18.0	Systematic Assessment		EG0000 affected99 at risk EG0012 affected50 at risk
Constipation	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment		EG0001 affected99 at risk EG0010 affected50 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment		EG0001 affected99 at risk EG0010 affected50 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment		EG0001 affected99 at risk EG0010 affected50 at risk
Gastrointestinal ulcer haemorrhage	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment		EG0001 affected99 at risk EG0010 affected50 at risk
Intestinal mass	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment		EG0001 affected99 at risk EG0010 affected50 at risk
Nausea	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment		EG0001 affected99 at risk EG0010 affected50 at risk
Oesophagitis	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment		EG0001 affected99 at risk EG0010 affected50 at risk
Pancreatic mass	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment		EG0001 affected99 at risk EG0010 affected50 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment		EG0001 affected99 at risk EG0010 affected50 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment		EG0001 affected99 at risk EG0011 affected50 at risk
Gastrointestinal necrosis	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment		EG0000 affected99 at risk EG0011 affected50 at risk
Large intestine perforation	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment		EG0000 affected99 at risk EG0011 affected50 at risk
Impaired healing	General disorders	MedDRA 18.0	Systematic Assessment		EG0001 affected99 at risk EG0010 affected50 at risk
Multi-organ failure	General disorders	MedDRA 18.0	Systematic Assessment	One treatment-emergent death occurred during treatment with Surgicel® Original and is not related.	EG0000 affected99 at risk EG0011 affected50 at risk
Pain	General disorders	MedDRA 18.0	Systematic Assessment		EG0000 affected99 at risk EG0011 affected50 at risk
Pneumonia	Infections and infestations	MedDRA 18.0	Systematic Assessment		EG0006 affected99 at risk EG0010 affected50 at risk
Wound infection	Infections and infestations	MedDRA 18.0	Systematic Assessment		EG0005 affected99 at risk EG0010 affected50 at risk
Sepsis	Infections and infestations	MedDRA 18.0	Systematic Assessment	One treatment-emergent death occurred during treatment with TachoSil® and one treatment-emergent death occurred during treatment with Surgicel® Original and are not related.	EG0004 affected99 at risk EG0011 affected50 at risk
Cellulitis	Infections and infestations	MedDRA 18.0	Systematic Assessment		EG0002 affected99 at risk EG0010 affected50 at risk
Groin infection	Infections and infestations	MedDRA 18.0	Systematic Assessment		EG0002 affected99 at risk EG0010 affected50 at risk
Osteomyelitis	Infections and infestations	MedDRA 18.0	Systematic Assessment		EG0002 affected99 at risk EG0010 affected50 at risk
Abscess limb	Infections and infestations	MedDRA 18.0	Systematic Assessment		EG0001 affected99 at risk EG0010 affected50 at risk
Arteriovenous graft site infection	Infections and infestations	MedDRA 18.0	Systematic Assessment		EG0001 affected99 at risk EG0010 affected50 at risk
Arthritis bacterial	Infections and infestations	MedDRA 18.0	Systematic Assessment		EG0001 affected99 at risk EG0010 affected50 at risk
Bacteraemia	Infections and infestations	MedDRA 18.0	Systematic Assessment		EG0001 affected99 at risk EG0010 affected50 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 18.0	Systematic Assessment		EG0001 affected99 at risk EG0010 affected50 at risk
Epstein-Barr virus infection	Infections and infestations	MedDRA 18.0	Systematic Assessment		EG0001 affected99 at risk EG0010 affected50 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 18.0	Systematic Assessment		EG0001 affected99 at risk EG0010 affected50 at risk
Groin abscess	Infections and infestations	MedDRA 18.0	Systematic Assessment		EG0001 affected99 at risk EG0010 affected50 at risk
Peritonitis	Infections and infestations	MedDRA 18.0	Systematic Assessment		EG0001 affected99 at risk EG0010 affected50 at risk
Urinary tract infection	Infections and infestations	MedDRA 18.0	Systematic Assessment		EG0001 affected99 at risk EG0010 affected50 at risk
Gangrene	Infections and infestations	MedDRA 18.0	Systematic Assessment		EG0000 affected99 at risk EG0012 affected50 at risk
Haematoma infection	Infections and infestations	MedDRA 18.0	Systematic Assessment		EG0000 affected99 at risk EG0011 affected50 at risk
Postoperative wound infection	Infections and infestations	MedDRA 18.0	Systematic Assessment		EG0000 affected99 at risk EG0012 affected50 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA 18.0	Systematic Assessment		EG0000 affected99 at risk EG0011 affected50 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment		EG0005 affected99 at risk EG0011 affected50 at risk
Vascular graft thrombosis	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment		EG0004 affected99 at risk EG0012 affected50 at risk
Vascular graft occlusion	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment		EG0003 affected99 at risk EG0012 affected50 at risk
Arteriovenous fistula occlusion	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment		EG0001 affected99 at risk EG0010 affected50 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment		EG0001 affected99 at risk EG0010 affected50 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment		EG0001 affected99 at risk EG0010 affected50 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment		EG0001 affected99 at risk EG0010 affected50 at risk
Incision site complication	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment		EG0001 affected99 at risk EG0010 affected50 at risk
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment		EG0001 affected99 at risk EG0010 affected50 at risk
Seroma	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment		EG0001 affected99 at risk EG0010 affected50 at risk
Traumatic haemothorax	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment		EG0001 affected99 at risk EG0010 affected50 at risk
Vascular graft complication	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment		EG0001 affected99 at risk EG0010 affected50 at risk
Graft thrombosis	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment		EG0000 affected99 at risk EG0011 affected50 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment		EG0000 affected99 at risk EG0011 affected50 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment		EG0001 affected99 at risk EG0010 affected50 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment		EG0000 affected99 at risk EG0011 affected50 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment		EG0000 affected99 at risk EG0011 affected50 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment		EG0001 affected99 at risk EG0010 affected50 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment		EG0001 affected99 at risk EG0010 affected50 at risk
Lung adenocarcinoma stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment		EG0001 affected99 at risk EG0010 affected50 at risk
Small cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 18.0	Systematic Assessment	One treatment-emergent death occurred during treatment with TachoSil® is not related.	EG0001 affected99 at risk EG0010 affected50 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 18.0	Systematic Assessment		EG0001 affected99 at risk EG0010 affected50 at risk
Cranial nerve paralysis	Nervous system disorders	MedDRA 18.0	Systematic Assessment		EG0001 affected99 at risk EG0010 affected50 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 18.0	Systematic Assessment		EG0001 affected99 at risk EG0010 affected50 at risk
Lacunar infarction	Nervous system disorders	MedDRA 18.0	Systematic Assessment		EG0001 affected99 at risk EG0011 affected50 at risk
Metabolic encephalopathy	Nervous system disorders	MedDRA 18.0	Systematic Assessment		EG0001 affected99 at risk EG0010 affected50 at risk
Seizure	Nervous system disorders	MedDRA 18.0	Systematic Assessment		EG0001 affected99 at risk EG0010 affected50 at risk
Mental status changes	Psychiatric disorders	MedDRA 18.0	Systematic Assessment		EG0003 affected99 at risk EG0010 affected50 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	One treatment-emergent death occurred during treatment with Surgicel® Original and is not related.	EG0002 affected99 at risk EG0013 affected50 at risk
Chronic kidney disease	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment		EG0002 affected99 at risk EG0010 affected50 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment		EG0001 affected99 at risk EG0010 affected50 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment		EG0001 affected99 at risk EG0010 affected50 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	One treatment-emergent death occurred during treatment with TachoSil® is not related.	EG0001 affected99 at risk EG0010 affected50 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment		EG0001 affected99 at risk EG0010 affected50 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment		EG0000 affected99 at risk EG0011 affected50 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment		EG0000 affected99 at risk EG0011 affected50 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	One treatment-emergent death occurred during treatment with Surgicel® Original and is not related.	EG0000 affected99 at risk EG0011 affected50 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment		EG0000 affected99 at risk EG0013 affected50 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment		EG0001 affected99 at risk EG0011 affected50 at risk
Haematoma	Vascular disorders	MedDRA 18.0	Systematic Assessment		EG0002 affected99 at risk EG0010 affected50 at risk
Hypotension	Vascular disorders	MedDRA 18.0	Systematic Assessment		EG0002 affected99 at risk EG0011 affected50 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 18.0	Systematic Assessment		EG0002 affected99 at risk EG0012 affected50 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 18.0	Systematic Assessment		EG0001 affected99 at risk EG0010 affected50 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA 18.0	Systematic Assessment		EG0001 affected99 at risk EG0010 affected50 at risk
Steal syndrome	Vascular disorders	MedDRA 18.0	Systematic Assessment		EG0001 affected99 at risk EG0010 affected50 at risk
Thrombosis	Vascular disorders	MedDRA 18.0	Systematic Assessment		EG0001 affected99 at risk EG0010 affected50 at risk
Venous thrombosis	Vascular disorders	MedDRA 18.0	Systematic Assessment		EG0001 affected99 at risk EG0010 affected50 at risk
Aortic aneurysm rupture	Vascular disorders	MedDRA 18.0	Systematic Assessment		EG0000 affected99 at risk EG0011 affected50 at risk
Dry gangrene	Vascular disorders	MedDRA 18.0	Systematic Assessment		EG0000 affected99 at risk EG0011 affected50 at risk
Extremity necrosis	Vascular disorders	MedDRA 18.0	Systematic Assessment		EG0000 affected99 at risk EG0011 affected50 at risk
Peripheral artery stenosis	Vascular disorders	MedDRA 18.0	Systematic Assessment		EG0000 affected99 at risk EG0011 affected50 at risk
Reperfusion injury	Vascular disorders	MedDRA 18.0	Systematic Assessment		EG0000 affected99 at risk EG0011 affected50 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG00014 affected99 at risk EG0016 affected50 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 18.0	Systematic Assessment	EG0005 affected99 at risk EG0010 affected50 at risk
Constipation	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG00011 affected99 at risk EG0015 affected50 at risk
Nausea	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0007 affected99 at risk EG0010 affected50 at risk
Oedema peripheral	General disorders	MedDRA 18.0	Systematic Assessment	EG00010 affected99 at risk EG0010 affected50 at risk
Peripheral swelling	General disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected99 at risk EG0013 affected50 at risk
Urinary tract infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0009 affected99 at risk EG0014 affected50 at risk
Seroma	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0003 affected99 at risk EG0014 affected50 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0003 affected99 at risk EG0016 affected50 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0007 affected99 at risk EG0015 affected50 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0006 affected99 at risk EG0015 affected50 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0009 affected99 at risk EG0013 affected50 at risk
Insomnia	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0000 affected99 at risk EG0013 affected50 at risk
Urinary retention	Renal and urinary disorders	MedDRA 18.0	Systematic Assessment	EG0003 affected99 at risk EG0016 affected50 at risk
Hypotension	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG00011 affected99 at risk EG0015 affected50 at risk
Hypertension	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0005 affected99 at risk EG0012 affected50 at risk

ID	Term
D006470	Hemorrhage

ID	Term
C518955	TachoSil

Units	Counts
Participants	OG000100 OG00150

Units	Counts
Participants	OG000100 OG00150

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms