A Study Evaluating the Safety and Preliminary Efficacy of... | NCT04660721

Name	Class
Sintesi Research Srl	INDUSTRY
Home Medics Consulting Ltd.	UNKNOWN

Label	Type	Description	Intervention Names
sFilm-FS	Experimental		Combination Product: sFilm-FS
TACHOSIL®	Active Comparator		Combination Product: TACHOSIL®

Name	Type	Description	Arm Group Labels	Other Names
sFilm-FS	Combination Product	sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.

Measure	Description	Time Frame
To Evaluate the Safety of sFilm-FS Versus an Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Surgery Through ...	Incidence of Treatment-Emergent Adverse Events AEs related to bleeding at TBS, thrombotic events, transfusion-related complications, post-operative adhesions (MRI assessment)	From visit 1 to visit 9 (an average of 6.5 months)
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs	Safety will be assessed from randomization of patients until the last follow-up visit by measuring Systolic Blood Pressure (mmHg)	From visit 1 to visit 9 (an average of 6.5 months)
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through Physical Examinations	Safety will be assessed from randomization of patients until the last follow-up visit by physical examination: the detection of the number of patients with at least one clinical abnormality in different body areas (abdomen, eyes, skin, cardiovascular)	From visit 1 to visit 9 (an average of 6.5 months)
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Urine Analysis Values	Safety will be assessed from randomization of patients until the last follow-up visit by urine analysis (pH)	From visit 1 to visit 9 (an average of 6.5 months)
To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Blood / Coagulation Parameters Profiles

Measure	Description	Time Frame
To Preliminarily Evaluate the Hemostatic Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Surgery, Related to Hemostasis and Treatment Failure Through the Proportion of Patients Achieving Hemostasis at TBS	Proportion of patients achieving hemostasis at TBS (absence of bleeding) at 2 (for sFilm-FS product only), 3, 5, 7 or 10 minutes following first product application, without the occurrence of re-bleeding, starting from 10 minutes after product application and until the completion of surgical closure

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients (males or females) aged ≥ 18 years old.
Patients requiring elective open hepatic surgery.
Hemoglobin ≥ 8.0 g/dL within 24 hours prior to surgical procedure.
Patients understanding the nature of the study and providing their informed consent prior to participation.
Patients willing to participate in the study and able to attend the visits and procedures foreseen by study protocol.

Intra-operative inclusion criteria:
Patients with a target bleeding site (TBS) identified by the Investigator during hepatic surgery (intra-operative inclusion criteria).

Exclusion Criteria:

Patients having undergone a therapeutic surgical procedure within 30 days from the study enrolment.
Patients with a severe coagulopathy defined as INR > 2.0.
Patients with platelet count <50,000 x109 PLT/L at the screening.
Patients admitted to trauma surgery.
Transplant patients due to fulminant hepatic failure.
Patients with known or suspected allergy or hypersensitivity to blood products or to one of the components of sFilm-FS or the active-comparator.
Patients with anesthesia risk judged to be higher than ASA3 by the Investigator.
Patients with at least one of the following concomitant conditions: severe co-morbid conditions known to pose a high risk for surgery and adequate recovery (i.e., liver cirrhosis with Child-Pugh score B or C, cholestasis, heart diseases), immunodeficiency diseases, blood clotting disorders, any conditions known to effect wound healing (i.e., collagen vascular disease), known or current alcohol or drug abusers.
Patients suffering from claustrophobia.
Patients with implanted or embedded metal objects, prostheses, pacemaker, or fragments in the head or body that would present a risk during the MRI scanning procedure or have worked with ferrous metals either as a vocation or hobby or following trauma (i.e., sheet metal workers, welders, or machinists) in such a way that might have led to unknown, indwelling metal fragments that could cause injury if they moved in response to placement in the magnetic field.
Patients being treated with at least one of the following treatments: antibiotic therapy for active infection, fibrin sealants, systemic steroids, or immunosuppressive agents.
Patients who are participating or have participated in other clinical studies within the 30 days before the study enrolment.
Female patients who are pregnant or breast-feeding or who wish to become pregnant during the period of the clinical study and for three months later.
Female patients of childbearing age (less than 24 months after the last menstrual cycle) who do not use adequate contraception.

Intra-operative exclusion criteria:
Patients identified with a TBS with major arterial bleeding requiring suture or mechanical ligation.
Patients identified by the Investigator to have intra-operative bleeding from large defects in large arteries or veins, requiring repair.
Patients identified by the Investigator to have intra-operative findings that may preclude conduct of study procedure.
Patients having an active local infection in the anatomic surgical area.
Patients with occurrence of major intra-operative complications that require resuscitation or deviation from the planned surgical procedure.
Patients with bleeding site in or near to foramina in bone.

Name	Affiliation	Role
Orgad Laub, Professor	Sealantium Medical Ltd.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Washington University in St. Louis, School of Medicine, Department of Surgery		St Louis	Missouri	63100	United States

PubMed Identifier	Type	Citation	Retractions
19820991	Background	Spotnitz WD. Fibrin sealant: past, present, and future: a brief review. World J Surg. 2010 Apr;34(4):632-4. doi: 10.1007/s00268-009-0252-7.
21562405	Background	Vonlanthen R, Slankamenac K, Breitenstein S, Puhan MA, Muller MK, Hahnloser D, Hauri D, Graf R, Clavien PA. The impact of complications on costs of major surgical procedures: a cost analysis of 1200 patients. Ann Surg. 2011 Dec;254(6):907-13. doi: 10.1097/SLA.0b013e31821d4a43.

ID	Title	Description
FG000	sFilm-FS	sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
FG001	TACHOSIL®

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jul 8, 2021	Dec 5, 2024

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

To Evaluate the Safety of sFilm-FS Versus an Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Surgery Through ...

Incidence of Treatment-Emergent Adverse Events AEs related to bleeding at TBS, thrombotic events, transfusion-related complications, post-operative adhesions (MRI assessment)

Descriptive Analysis on Safety Population.

Posted

Number

number of TEAEs

From visit 1 to visit 9 (an average of 6.5 months)

ID	Title	Description
OG000	sFilm-FS	sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
OG001	TACHOSIL®	TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.

Units	Counts
Participants	OG00017 OG00116

Title

Denominators

Categories

Total Number of Treatment-Emergent Adverse Events (TEAE) reported

Title	Measurements
	OG000179 OG001168

Related TEAEs

Title	Measurements
	OG000

Primary

To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through the Count of Participants With Abnormal Vital Signs

Safety will be assessed from randomization of patients until the last follow-up visit by measuring Systolic Blood Pressure (mmHg)

Descriptive Analysis on Safety Population

Posted

Mean

Standard Deviation

mmHg

From visit 1 to visit 9 (an average of 6.5 months)

ID	Title	Description
OG000	sFilm-FS	sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
OG001	TACHOSIL®	TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.

Units	Counts
Participants	OG000

Primary

To Evaluate the Safety of sFilm-FS Versus the Active-comparator (TACHOSIL®) When Used as Adjunct to Conventional Hemostatic Techniques During Elective Hepatic Surgery Through Physical Examinations

Safety will be assessed from randomization of patients until the last follow-up visit by physical examination: the detection of the number of patients with at least one clinical abnormality in different body areas (abdomen, eyes, skin, cardiovascular)

Descriptive Analysis on Safety Population

Posted

Number

number of patients with ≥ 1 abnormality

From visit 1 to visit 9 (an average of 6.5 months)

ID	Title	Description
OG000	sFilm-FS	sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
OG001	TACHOSIL®	TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.

Units	Counts
Participants

Primary

Safety will be assessed from randomization of patients until the last follow-up visit by urine analysis (pH)

Descriptive Analysis on Safety Population

Posted

Mean

Standard Deviation

From visit 1 to visit 9 (an average of 6.5 months)

ID	Title	Description
OG000	sFilm-FS	sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
OG001	TACHOSIL®	TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.

Units	Counts
Participants	OG000

Primary

Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Hemoglobin (g/L))

Descriptive Analysis on Safety Population

Posted

Mean

Standard Deviation

g/L

From visit 1 to visit 9 (an average of 6.5 months)

ID	Title	Description
OG000	sFilm-FS	sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
OG001	TACHOSIL®	TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.

Units	Counts
Participants	OG000

Primary

Safety will be assessed from randomization of patients until the last follow-up visit by Measuring plasma levels of antibodies against human fibrinogen, by performing a screening assay using bridging ELISA based on polyclonal antibodies against human fibrinogen, which was developed with a sensitivity of 1000 ng/ml. Patients whose results were above 1000ng/ml control were considered positive.

Posted

Count of Participants

Participants

Last Follow-Up Visit (Visit 9)

ID	Title	Description
OG000	sFilm-FS	sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
OG001	TACHOSIL®	TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.

Units	Counts
Participants

Primary

Safety will be assessed from randomization of patients until the last follow-up visit by measuring Diastolic Blood Pressure (mmHg)

Descriptive Analysis on Safety Population

Posted

Mean

Standard Deviation

mmHg

From visit 1 to visit 9 (an average of 6.5 months)

ID	Title	Description
OG000	sFilm-FS	sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
OG001	TACHOSIL®	TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.

Units	Counts
Participants	OG000

Primary

Safety will be assessed from randomization of patients until the last follow-up visit by measuring Heart Rate (beats/minute)

Descriptive Analysis on Safety Population

Posted

Mean

Standard Deviation

beats/minute

From visit 1 to visit 9 (an average of 6.5 months)

ID	Title	Description
OG000	sFilm-FS	sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
OG001	TACHOSIL®	TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.

Units	Counts
Participants	OG000

Primary

Safety will be assessed from randomization of patients until the last follow-up visit by measuring Respiratory Rate (breaths/minute)

Descriptive Analysis on Safety Population

Posted

Mean

Standard Deviation

breaths/minute

From visit 1 to visit 9 (an average of 6.5 months)

ID	Title	Description
OG000	sFilm-FS	sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
OG001	TACHOSIL®	TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.

Units	Counts
Participants	OG000

Primary

Safety will be assessed from randomization of patients until the last follow-up visit by measuring Body Temperature (°C)

Descriptive Analysis on Safety Population

Posted

Mean

Standard Deviation

°C

From visit 1 to visit 9 (an average of 6.5 months)

ID	Title	Description
OG000	sFilm-FS	sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
OG001	TACHOSIL®	TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.

Units	Counts
Participants	OG000

Primary

Safety will be assessed from randomization of patients until the last follow-up visit by urine analysis (Specific Gravity (g/L))

Descriptive Analysis on Safety Population

Posted

Mean

Standard Deviation

g/L

From visit 1 to visit 9 (an average of 6.5 months)

ID	Title	Description
OG000	sFilm-FS	sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
OG001	TACHOSIL®	TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.

Units	Counts
Participants	OG000

Primary

Safety will be assessed from randomization of patients until the last follow-up visit by urine analysis (Presence of Glucose)

Descriptive Analysis on Safety Population

Posted

Number

participants

From visit 1 to visit 9 (an average of 6.5 months)

ID	Title	Description
OG000	sFilm-FS	sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
OG001	TACHOSIL®	TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.

Units	Counts
Participants	OG000

Primary

Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Mean Cell Hemoglobin Concentration (g/L))

Descriptive Analysis on Safety Population

Posted

Mean

Standard Deviation

g/L

From visit 1 to visit 9 (an average of 6.5 months)

ID	Title	Description
OG000	sFilm-FS	sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
OG001	TACHOSIL®	TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.

Units	Counts
Participants

Primary

Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Mean Cell Hemoglobin (pg))

Descriptive Analysis on Safety Population

Posted

Mean

Standard Deviation

From visit 1 to visit 9 (an average of 6.5 months)

ID	Title	Description
OG000	sFilm-FS	sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
OG001	TACHOSIL®	TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.

Units	Counts
Participants

Primary

Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Mean Corpuscular Volume (fL))

Descriptive Analysis on Safety Population

Posted

Mean

Standard Deviation

From visit 1 to visit 9 (an average of 6.5 months)

ID	Title	Description
OG000	sFilm-FS	sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
OG001	TACHOSIL®	TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.

Units	Counts
Participants

Primary

Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Red Blood Cell (10^12cells/L))

Descriptive Analysis on Safety Population

Posted

Mean

Standard Deviation

10^12cells/L

From visit 1 to visit 9 (an average of 6.5 months)

ID	Title	Description
OG000	sFilm-FS	sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
OG001	TACHOSIL®	TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.

Units	Counts
Participants

Primary

Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (White Blood Cell (10^9cells/L))

Descriptive Analysis on Safety Population

Posted

Mean

Standard Deviation

10^9cells/L

From visit 1 to visit 9 (an average of 6.5 months)

ID	Title	Description
OG000	sFilm-FS	sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
OG001	TACHOSIL®	TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.

Units	Counts
Participants

Primary

Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Platelet (10^9cells/L))

Descriptive Analysis on Safety Population

Posted

Mean

Standard Deviation

10^9cells/L

From visit 1 to visit 9 (an average of 6.5 months)

ID	Title	Description
OG000	sFilm-FS	sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
OG001	TACHOSIL®	TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.

Units	Counts
Participants

Primary

Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Fibrinogen (g/L))

Descriptive Analysis on Safety Population

Posted

Mean

Standard Deviation

g/L

From visit 1 to visit 9 (an average of 6.5 months)

ID	Title	Description
OG000	sFilm-FS	sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
OG001	TACHOSIL®	TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.

Units	Counts
Participants	OG000

Primary

Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (D-Dimer (microg/mL))

Descriptive Analysis on Safety Population

Posted

Mean

Standard Deviation

microg/mL

From visit 1 to visit 9 (an average of 6.5 months)

ID	Title	Description
OG000	sFilm-FS	sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
OG001	TACHOSIL®	TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.

Units	Counts
Participants

Primary

Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Erythrocyte Sedimentation Rate (mm/hr))

Descriptive Analysis on Safety Population

Posted

Mean

Standard Deviation

mm/hr

From visit 1 to visit 9 (an average of 6.5 months)

ID	Title	Description
OG000	sFilm-FS	sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
OG001	TACHOSIL®	TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.

Units	Counts
Participants

Primary

Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (C-Reactive Protein (mg/dL))

Descriptive Analysis on Safety Population

Posted

Mean

Standard Deviation

mg/dL

From visit 1 to visit 9 (an average of 6.5 months)

ID	Title	Description
OG000	sFilm-FS	sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
OG001	TACHOSIL®	TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.

Units	Counts
Participants

Primary

Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Blood Urea Nitrogen (mmol/L))

Descriptive Analysis on Safety Population

Posted

Mean

Standard Deviation

mmol/L

From visit 1 to visit 9 (an average of 6.5 months)

ID	Title	Description
OG000	sFilm-FS	sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
OG001	TACHOSIL®	TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.

Units	Counts
Participants

Primary

Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Creatinine (micromol/L))

Descriptive Analysis on Safety Population

Posted

Mean

Standard Deviation

micromol/L

From visit 1 to visit 9 (an average of 6.5 months)

ID	Title	Description
OG000	sFilm-FS	sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
OG001	TACHOSIL®	TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.

Units	Counts
Participants

Primary

Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Uric Acid (micromol/L))

Descriptive Analysis on Safety Population

Posted

Mean

Standard Deviation

micromol/L

From visit 1 to visit 9 (an average of 6.5 months)

ID	Title	Description
OG000	sFilm-FS	sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
OG001	TACHOSIL®	TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.

Units	Counts
Participants

Primary

Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Total Bilirubin (micromol/L))

Descriptive Analysis on Safety Population

Posted

Mean

Standard Deviation

micromol/L

From visit 1 to visit 9 (an average of 6.5 months)

ID	Title	Description
OG000	sFilm-FS	sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
OG001	TACHOSIL®	TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.

Units	Counts
Participants

Primary

Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Lactate Dehydrogenase (microkat/L))

Descriptive Analysis on Safety Population

Posted

Mean

Standard Deviation

microkat/L

From visit 1 to visit 9 (an average of 6.5 months)

ID	Title	Description
OG000	sFilm-FS	sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
OG001	TACHOSIL®	TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.

Units	Counts
Participants

Primary

Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Serum Glutamic Oxaloacetic Transaminase/Aspartate Aminotransferase (microkat/L))

Descriptive Analysis on Safety Population

Posted

Mean

Standard Deviation

microkat/L

From visit 1 to visit 9 (an average of 6.5 months)

ID	Title	Description
OG000	sFilm-FS	sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
OG001	TACHOSIL®	TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.

Units	Counts
Participants

Primary

Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Serum Glutamic Pyruvic Transaminase/Alanine Aminotransferase (microkat/L))

Descriptive Analysis on Safety Population

Posted

Mean

Standard Deviation

microkat/L

From visit 1 to visit 9 (an average of 6.5 months)

ID	Title	Description
OG000	sFilm-FS	sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
OG001	TACHOSIL®	TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.

Units	Counts
Participants

Primary

Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Gamma-GT (microkat/L))

Descriptive Analysis on Safety Population

Posted

Mean

Standard Deviation

microkat/L

From visit 1 to visit 9 (an average of 6.5 months)

ID	Title	Description
OG000	sFilm-FS	sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
OG001	TACHOSIL®	TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.

Units	Counts
Participants

Primary

Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Sodium (mmol/L))

Descriptive Analysis on Safety Population

Posted

Mean

Standard Deviation

mmol/L

From visit 1 to visit 9 (an average of 6.5 months)

ID	Title	Description
OG000	sFilm-FS	sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
OG001	TACHOSIL®	TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.

Units	Counts
Participants	OG000

Primary

Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Calcium (mmol/L))

Descriptive Analysis on Safety Population

Posted

Mean

Standard Deviation

mmol/L

From visit 1 to visit 9 (an average of 6.5 months)

ID	Title	Description
OG000	sFilm-FS	sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
OG001	TACHOSIL®	TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.

Units	Counts
Participants	OG000

Primary

Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Phosphorous (mmol/L))

Descriptive Analysis on Safety Population

Posted

Mean

Standard Deviation

mmol/L

From visit 1 to visit 9 (an average of 6.5 months)

ID	Title	Description
OG000	sFilm-FS	sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
OG001	TACHOSIL®	TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.

Units	Counts
Participants	OG000

Primary

Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Glucose (mmol/L))

Descriptive Analysis on Safety Population

Posted

Mean

Standard Deviation

mmol/L

From visit 1 to visit 9 (an average of 6.5 months)

ID	Title	Description
OG000	sFilm-FS	sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
OG001	TACHOSIL®	TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.

Units	Counts
Participants	OG000

Primary

Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Albumin (g/L))

Descriptive Analysis on Safety Population

Posted

Mean

Standard Deviation

g/L

From visit 1 to visit 9 (an average of 6.5 months)

ID	Title	Description
OG000	sFilm-FS	sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
OG001	TACHOSIL®	TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.

Units	Counts
Participants	OG000

Primary

Safety will be assessed from randomization of patients until the last follow-up visit by blood/coagulation parameters profiles analysis (Total Protein (g/L))

Descriptive Analysis on Safety Population

Posted

Mean

Standard Deviation

g/L

From visit 1 to visit 9 (an average of 6.5 months)

ID	Title	Description
OG000	sFilm-FS	sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
OG001	TACHOSIL®	TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.

Units	Counts
Participants	OG000

Secondary

To Preliminarily Evaluate the Hemostatic Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Surgery, Related to Hemostasis and Treatment Failure Through the Proportion of Patients Achieving Hemostasis at TBS

Proportion of patients achieving hemostasis at TBS (absence of bleeding) at 2 (for sFilm-FS product only), 3, 5, 7 or 10 minutes following first product application, without the occurrence of re-bleeding, starting from 10 minutes after product application and until the completion of surgical closure

Posted

Count of Participants

Participants

Day of surgery

ID	Title	Description
OG000	sFilm-FS	sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
OG001	TACHOSIL®	TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.

Units	Counts
Participants	OG000

Secondary

To Preliminarily Evaluate the Hemostatic Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Surgery, Related to Hemostasis and Treatment Failure Through the Incidence of Re-treatment at the TBS

Incidence of re-treatment (one or more additional patch of sFilm-FS or TACHOSIL®) at the TBS at the different time points (2 for sFilm-FS, 3, 5, 7, 10 minutes from first product application)

Descriptive statistics of all randomized patients who underwent surgery, received at least one dose of study treatment and having no major violations of inclusion and exclusion criteria

Posted

Count of Participants

Participants

Day of surgery

ID	Title	Description
OG000	sFilm-FS	sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
OG001	TACHOSIL®	TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.

Units	Counts
Participants

Secondary

To Preliminarily Evaluate the Hemostatic Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Surgery, Related to Hemostasis and Treatment Failure Through the Percentage of Total Patients That Have Achieved Hemostasis

Percentage of total patients (patients that achieved hemostasis with a single patch application and patients that required additional patches) that have achieved hemostasis 10 minutes after first product application and therefore did not need to convert to standard of care treatment at the end of these 10 minutes

Descriptive statistics of all randomized patients who underwent surgery, received at least one dose of study treatment and having no major violations of inclusion and exclusion criteria

Posted

Count of Participants

Participants

Day of surgery

ID	Title	Description
OG000	sFilm-FS	sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
OG001	TACHOSIL®	TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.

Units	Counts

Secondary

To Preliminarily Evaluate the Hemostatic Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Surgery, Related to Hemostasis and Treatment Failure Through Incidence of Treatment Failure

Incidence of treatment failure, based on pre-defined treatment failure criteria (in case the bleeding at TBS (or re-bleeding) is still observed after 10 minutes following first application of study product; if hemostasis at TBS is achieved, but the Investigator decides that an additional treatment is required to ensure the durability of hemostasis; if there is a breakthrough bleeding requiring treatment other than the study product, at any time)

Descriptive statistics of all randomized patients who underwent surgery, received at least one dose of study treatment and having no major violations of inclusion and exclusion criteria

Posted

Count of Participants

Participants

Day of surgery

ID	Title	Description
OG000	sFilm-FS	sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
OG001	TACHOSIL®	TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.

Secondary

To Preliminarily Evaluate the Hemostatic Efficacy of sFilm-FS in Controlling Parenchymal Bleeding During Surgery, Related to Hemostasis and Treatment Failure.

Incidence of transfusion requirements in the 6 months follow-up period

Descriptive statistics of all randomized patients who underwent surgery, received at least one dose of study treatment and having no major violations of inclusion and exclusion criteria

Posted

Number

participants

From surgery, up to 6 months

ID	Title	Description
OG000	sFilm-FS	sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
OG001	TACHOSIL®	TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.

Units	Counts
Participants	OG000

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
ANAEMIA	Blood and lymphatic system disorders	MedDRA (26.0)	Systematic Assessment	EG0002 events2 affected17 at risk EG0011 events1 affected16 at risk
BLOOD LOSS ANAEMIA	Blood and lymphatic system disorders	MedDRA (26.0)	Systematic Assessment	EG0002 events2 affected17 at risk EG0010 events0 affected16 at risk
COAGULOPATHY	Blood and lymphatic system disorders	MedDRA (26.0)	Systematic Assessment	EG0002 events2 affected17 at risk EG0010 events0 affected16 at risk
IRON DEFICIENTY ANAEMIA	Blood and lymphatic system disorders	MedDRA (26.0)	Systematic Assessment	EG0001 events1 affected17 at risk EG0011 events1 affected16 at risk
LEUKOCYTOSIS	Blood and lymphatic system disorders	MedDRA (26.0)	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected16 at risk
SPLENIC INFARCTION	Blood and lymphatic system disorders	MedDRA (26.0)	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected16 at risk
THROMBOCYTOPENIA	Blood and lymphatic system disorders	MedDRA (26.0)	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected16 at risk
THROMBOCYTOSIS	Blood and lymphatic system disorders	MedDRA (26.0)	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected16 at risk
AORTIC VALVE INCOMPETENCE	Cardiac disorders	MedDRA (26.0)	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected16 at risk
ATRIAL FIBRILLATION	Cardiac disorders	MedDRA (26.0)	Systematic Assessment	EG0003 events2 affected17 at risk EG0012 events1 affected16 at risk
ATRIAL TACHYCARDIA	Cardiac disorders	MedDRA (26.0)	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected16 at risk
BRADYCARDIA	Cardiac disorders	MedDRA (26.0)	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected16 at risk
COR PULMONALE	Cardiac disorders	MedDRA (26.0)	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected16 at risk
CARDIOMEGALY	Cardiac disorders	MedDRA (26.0)	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected16 at risk
MITRAL VALVE INCOMPETENCE	Cardiac disorders	MedDRA (26.0)	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected16 at risk
PERICARDIAL CYST	Cardiac disorders	MedDRA (26.0)	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected16 at risk
RIGHT VENTRICULAR ENLARGEMENT	Cardiac disorders	MedDRA (26.0)	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected16 at risk
RIGHT VENTRICULA FAILURE	Cardiac disorders	MedDRA (26.0)	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected16 at risk
SINUS BRADYCARDIA	Cardiac disorders	MedDRA (26.0)	Systematic Assessment	EG0002 events2 affected17 at risk EG0010 events0 affected16 at risk
SUPRAVENTRICULAR TACHYCARDIA	Cardiac disorders	MedDRA (26.0)	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected16 at risk
SYSTOLIC DYSFUNCTION	Cardiac disorders	MedDRA (26.0)	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected16 at risk
TACHYCARDIA	Cardiac disorders	MedDRA (26.0)	Systematic Assessment	EG0002 events1 affected17 at risk EG0014 events3 affected16 at risk
TRICUSPID VALVE INCOMPETENCE	Cardiac disorders	MedDRA (26.0)	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected16 at risk
VENTRICULA EXTRASYSTOLES	Cardiac disorders	MedDRA (26.0)	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected16 at risk
VENTRICULAR HYPOKINESIA	Cardiac disorders	MedDRA (26.0)	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected16 at risk
FACTOR II DEFICIENCY	Congenital, familial and genetic disorders	MedDRA (26.0)	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected16 at risk
VERTIGO	Ear and labyrinth disorders	MedDRA (26.0)	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected16 at risk
ABDOMINAL DISTENSION	Gastrointestinal disorders	MedDRA (26.0)	Systematic Assessment	EG0000 events0 affected17 at risk EG0013 events2 affected16 at risk
ABDOMINAL PAIN	Gastrointestinal disorders	MedDRA (26.0)	Systematic Assessment	EG0003 events2 affected17 at risk EG0011 events1 affected16 at risk
ABDOMINAL PAIN UPPER	Gastrointestinal disorders	MedDRA (26.0)	Systematic Assessment	EG0002 events2 affected17 at risk EG0010 events0 affected16 at risk
ABDOMINAL WALL HAEMATOMA	Gastrointestinal disorders	MedDRA (26.0)	Systematic Assessment	EG0002 events2 affected17 at risk EG0012 events2 affected16 at risk
ABNORMAL FAECES	Gastrointestinal disorders	MedDRA (26.0)	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected16 at risk
CONSTIPATION	Gastrointestinal disorders	MedDRA (26.0)	Systematic Assessment	EG0003 events3 affected17 at risk EG0011 events1 affected16 at risk
DIARRHOEA	Gastrointestinal disorders	MedDRA (26.0)	Systematic Assessment	EG0002 events2 affected17 at risk EG0015 events2 affected16 at risk
DUODENAL ULCER	Gastrointestinal disorders	MedDRA (26.0)	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected16 at risk
DUODENITIS	Gastrointestinal disorders	MedDRA (26.0)	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected16 at risk
DYSPEPSIA	Gastrointestinal disorders	MedDRA (26.0)	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected16 at risk
DYSPHAGIA	Gastrointestinal disorders	MedDRA (26.0)	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected16 at risk
GASTRIC ILEUS	Gastrointestinal disorders	MedDRA (26.0)	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected16 at risk
HAEMATEMESIS	Gastrointestinal disorders	MedDRA (26.0)	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected16 at risk
HAEMORRHOIDS	Gastrointestinal disorders	MedDRA (26.0)	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected16 at risk
ILEUS	Gastrointestinal disorders	MedDRA (26.0)	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected16 at risk
INFLAMMATORY BOWEL DISEASE	Gastrointestinal disorders	MedDRA (26.0)	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected16 at risk
INTESTINAL OBSTRUCTION	Gastrointestinal disorders	MedDRA (26.0)	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected16 at risk
INTRA ABDOMINAL HAEMATOMA	Gastrointestinal disorders	MedDRA (26.0)	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected16 at risk
LOWER GASTROINTESTINAL HAEMORRHAGE	Gastrointestinal disorders	MedDRA (26.0)	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected16 at risk
NAUSEA	Gastrointestinal disorders	MedDRA (26.0)	Systematic Assessment	EG00014 events12 affected17 at risk EG0015 events5 affected16 at risk
VOMITING	Gastrointestinal disorders	MedDRA (26.0)	Systematic Assessment	EG0002 events2 affected17 at risk EG0010 events0 affected16 at risk
ASTHENIA	General disorders	MedDRA (26.0)	Systematic Assessment	EG0000 events0 affected17 at risk EG0012 events1 affected16 at risk
CHEST PAIN	General disorders	MedDRA (26.0)	Systematic Assessment	EG0001 events1 affected17 at risk EG0011 events1 affected16 at risk
DEATH	General disorders	MedDRA (26.0)	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected16 at risk
DISEASE PROGRESSION	General disorders	MedDRA (26.0)	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected16 at risk
FATIGUE	General disorders	MedDRA (26.0)	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected16 at risk
GENERALISED OEDEMA	General disorders	MedDRA (26.0)	Systematic Assessment	EG0000 events0 affected17 at risk EG0012 events1 affected16 at risk
IMPAIRED HEALING	General disorders	MedDRA (26.0)	Systematic Assessment	EG0001 events1 affected17 at risk EG0011 events1 affected16 at risk
INFLAMMATORY PAIN	General disorders	MedDRA (26.0)	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected16 at risk
OEDEMA PERIPHERAL	General disorders	MedDRA (26.0)	Systematic Assessment	EG0001 events1 affected17 at risk EG0015 events2 affected16 at risk
PAIN	General disorders	MedDRA (26.0)	Systematic Assessment	EG0004 events3 affected17 at risk EG00111 events5 affected16 at risk
PYREXIA	General disorders	MedDRA (26.0)	Systematic Assessment	EG0002 events2 affected17 at risk EG0013 events3 affected16 at risk
CHOLANGITIS	Hepatobiliary disorders	MedDRA (26.0)	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected16 at risk
HEPATIC FAILURE	Hepatobiliary disorders	MedDRA (26.0)	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected16 at risk
HEPATIC STEATOSIS	Hepatobiliary disorders	MedDRA (26.0)	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected16 at risk
HEPATORENAL FAILURE	Hepatobiliary disorders	MedDRA (26.0)	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected16 at risk
HYPERBILIRUBINAEMIA	Hepatobiliary disorders	MedDRA (26.0)	Systematic Assessment	EG0002 events1 affected17 at risk EG0010 events0 affected16 at risk
HYPERTRANSAMINASAEMIA	Hepatobiliary disorders	MedDRA (26.0)	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected16 at risk
ABDOMINAL INFECTION	Infections and infestations	MedDRA (26.0)	Systematic Assessment	EG0002 events2 affected17 at risk EG0010 events0 affected16 at risk
BACTERIAL INFECTION	Infections and infestations	MedDRA (26.0)	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected16 at risk
CANDIDA INFECTION	Infections and infestations	MedDRA (26.0)	Systematic Assessment	EG0001 events1 affected17 at risk EG0011 events1 affected16 at risk
CLOSTRIDIUM DIFFICILE INFECTION	Infections and infestations	MedDRA (26.0)	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected16 at risk
COVID-19	Infections and infestations	MedDRA (26.0)	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected16 at risk
INFECTION SUSCEPTIBILITY INCREASED	Infections and infestations	MedDRA (26.0)	Systematic Assessment	EG0002 events1 affected17 at risk EG0010 events0 affected16 at risk
ORAL CANDIDIASIS	Infections and infestations	MedDRA (26.0)	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected16 at risk
POST PROCEDURAL INFECTION	Infections and infestations	MedDRA (26.0)	Systematic Assessment	EG0002 events1 affected17 at risk EG0010 events0 affected16 at risk
RESPIRATORY TRACT INFECTION	Infections and infestations	MedDRA (26.0)	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected16 at risk
STAPHYLOCOCCAL INFECTION	Infections and infestations	MedDRA (26.0)	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected16 at risk
URINARY TRACT INFECTION	Infections and infestations	MedDRA (26.0)	Systematic Assessment	EG0003 events2 affected17 at risk EG0015 events3 affected16 at risk
CONFUSION	Injury, poisoning and procedural complications	MedDRA (26.0)	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected16 at risk
DRAIN SITE COMPLICATION	Injury, poisoning and procedural complications	MedDRA (26.0)	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected16 at risk
FALL	Injury, poisoning and procedural complications	MedDRA (26.0)	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected16 at risk
HEPATIC SEROMA	Injury, poisoning and procedural complications	MedDRA (26.0)	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected16 at risk
LUMBAR VERTEBRAL BILE LEAK	Injury, poisoning and procedural complications	MedDRA (26.0)	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected16 at risk
POST PROCEDURAL BILE LEAK	Injury, poisoning and procedural complications	MedDRA (26.0)	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected16 at risk
PROCEDURAL HYPOTENSION	Injury, poisoning and procedural complications	MedDRA (26.0)	Systematic Assessment	EG0003 events3 affected17 at risk EG0010 events0 affected16 at risk
PROCEDURAL PAIN	Injury, poisoning and procedural complications	MedDRA (26.0)	Systematic Assessment	EG00013 events11 affected17 at risk EG00111 events9 affected16 at risk
SEROMA	Injury, poisoning and procedural complications	MedDRA (26.0)	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected16 at risk
THORACIC VERTEBRAL FRACTURE	Injury, poisoning and procedural complications	MedDRA (26.0)	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected16 at risk
WOUND	Injury, poisoning and procedural complications	MedDRA (26.0)	Systematic Assessment	EG0000 events0 affected17 at risk EG0013 events2 affected16 at risk
WOUND COMPLICATION	Injury, poisoning and procedural complications	MedDRA (26.0)	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected16 at risk
ASPARTATE AMINOTRANSFERASE INCREASED	Investigations	MedDRA (26.0)	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected16 at risk
BLOOD ALBUMIN INCREASED	Investigations	MedDRA (26.0)	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected16 at risk
BLOOD BILIRUBIN INCREASE	Investigations	MedDRA (26.0)	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected16 at risk
BLOOD LACTATE DEHYDROGENASE INCREASED	Investigations	MedDRA (26.0)	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected16 at risk
GAMMA GLUTAMYLTRANSFERASE INCREASED	Investigations	MedDRA (26.0)	Systematic Assessment	EG0002 events1 affected17 at risk EG0010 events0 affected16 at risk
HAEMOGLOBIN DECREASED	Investigations	MedDRA (26.0)	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected16 at risk
WHITE BLOOD CELL COUNT INCREASED	Investigations	MedDRA (26.0)	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected16 at risk
DECREASED APPETITE	Metabolism and nutrition disorders	MedDRA (26.0)	Systematic Assessment	EG0002 events1 affected17 at risk EG0011 events1 affected16 at risk
DEHYDRATION	Metabolism and nutrition disorders	MedDRA (26.0)	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected16 at risk
DIABETES MELLITUS	Metabolism and nutrition disorders	MedDRA (26.0)	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected16 at risk
FOLATE DEFICIENCY	Metabolism and nutrition disorders	MedDRA (26.0)	Systematic Assessment	EG0002 events1 affected17 at risk EG0010 events0 affected16 at risk
HYPERCHOLESTEROLAEMIA	Metabolism and nutrition disorders	MedDRA (26.0)	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected16 at risk
HYPERGLYCAEMIA	Metabolism and nutrition disorders	MedDRA (26.0)	Systematic Assessment	EG0001 events1 affected17 at risk EG0012 events2 affected16 at risk
HYPERKALAEMIA	Metabolism and nutrition disorders	MedDRA (26.0)	Systematic Assessment	EG0000 events0 affected17 at risk EG0012 events1 affected16 at risk
HYPOALBUMINAEMIA	Metabolism and nutrition disorders	MedDRA (26.0)	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected16 at risk
HYPOCALCAEMIA	Metabolism and nutrition disorders	MedDRA (26.0)	Systematic Assessment	EG0000 events0 affected17 at risk EG0012 events2 affected16 at risk
HYPOKALAEMIA	Metabolism and nutrition disorders	MedDRA (26.0)	Systematic Assessment	EG00012 events8 affected17 at risk EG0015 events5 affected16 at risk
HYPONATRAEMIA	Metabolism and nutrition disorders	MedDRA (26.0)	Systematic Assessment	EG0001 events1 affected17 at risk EG0011 events1 affected16 at risk
HYPOPHAGIA	Metabolism and nutrition disorders	MedDRA (26.0)	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected16 at risk
HYPOPHOSPHATAEMIA	Metabolism and nutrition disorders	MedDRA (26.0)	Systematic Assessment	EG0004 events3 affected17 at risk EG0013 events3 affected16 at risk
MAGNESIUM DEFICIENCY	Metabolism and nutrition disorders	MedDRA (26.0)	Systematic Assessment	EG0005 events5 affected17 at risk EG0011 events1 affected16 at risk
MALNUTRITION	Metabolism and nutrition disorders	MedDRA (26.0)	Systematic Assessment	EG0000 events0 affected17 at risk EG0012 events1 affected16 at risk
ARTHRALGIA	Musculoskeletal and connective tissue disorders	MedDRA (26.0)	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected16 at risk
BACK PAIN	Musculoskeletal and connective tissue disorders	MedDRA (26.0)	Systematic Assessment	EG0002 events2 affected17 at risk EG0010 events0 affected16 at risk
FLANK PAIN	Musculoskeletal and connective tissue disorders	MedDRA (26.0)	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected16 at risk
INTERVERTEBRAL DISC DEGENERATION	Musculoskeletal and connective tissue disorders	MedDRA (26.0)	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected16 at risk
MUSCLE ATRHOPHY	Musculoskeletal and connective tissue disorders	MedDRA (26.0)	Systematic Assessment	EG0000 events0 affected17 at risk EG0012 events1 affected16 at risk
PAIN IN EXTREMITY	Musculoskeletal and connective tissue disorders	MedDRA (26.0)	Systematic Assessment	EG0001 events1 affected17 at risk EG0011 events1 affected16 at risk
ADRENAL GLAND CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.0)	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected16 at risk
CHOLANGIOCARCINOMA	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.0)	Systematic Assessment	EG0002 events2 affected17 at risk EG0010 events0 affected16 at risk
GALLBLADDER CANCER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.0)	Systematic Assessment	EG0000 events0 affected17 at risk EG0012 events2 affected16 at risk
HAEMANGIOMA OF SPLEEN	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.0)	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected16 at risk
METASTASES TO LIVER	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.0)	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected16 at risk
METASTASES TO LUNG	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.0)	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected16 at risk
NEUROENDOCRINE CARCINOMA METASTATIC	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (26.0)	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected16 at risk
COGNITIVE DISORDER	Nervous system disorders	MedDRA (26.0)	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected16 at risk
DIZZINESS	Nervous system disorders	MedDRA (26.0)	Systematic Assessment	EG0000 events0 affected17 at risk EG0012 events2 affected16 at risk
HYPOAESTHESIA	Nervous system disorders	MedDRA (26.0)	Systematic Assessment	EG0000 events0 affected17 at risk EG0012 events2 affected16 at risk
LETHARGY	Nervous system disorders	MedDRA (26.0)	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected16 at risk
POLYNEUROPATHY	Nervous system disorders	MedDRA (26.0)	Systematic Assessment	EG0002 events1 affected17 at risk EG0010 events0 affected16 at risk
RADICULOPATHY	Nervous system disorders	MedDRA (26.0)	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected16 at risk
AGITATION	Psychiatric disorders	MedDRA (26.0)	Systematic Assessment	EG0002 events2 affected17 at risk EG0010 events0 affected16 at risk
ANXIETY	Psychiatric disorders	MedDRA (26.0)	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected16 at risk
CONFUSIONAL STATE	Psychiatric disorders	MedDRA (26.0)	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected16 at risk
DEPRESSION	Psychiatric disorders	MedDRA (26.0)	Systematic Assessment	EG0001 events1 affected17 at risk EG0011 events1 affected16 at risk
INSOMNIA	Psychiatric disorders	MedDRA (26.0)	Systematic Assessment	EG0002 events2 affected17 at risk EG0011 events1 affected16 at risk
RESTLESSNESS	Psychiatric disorders	MedDRA (26.0)	Systematic Assessment	EG0001 events1 affected17 at risk EG0011 events1 affected16 at risk
SLEEP DISORDER	Psychiatric disorders	MedDRA (26.0)	Systematic Assessment	EG0003 events3 affected17 at risk EG0013 events2 affected16 at risk
ACUTE KIDNEY INJURY	Renal and urinary disorders	MedDRA (26.0)	Systematic Assessment	EG0002 events2 affected17 at risk EG0013 events3 affected16 at risk
OLIGURIA	Renal and urinary disorders	MedDRA (26.0)	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected16 at risk
RENAL INFARCT	Renal and urinary disorders	MedDRA (26.0)	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected16 at risk
URINARY INCONTINENCE	Renal and urinary disorders	MedDRA (26.0)	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected16 at risk
URINARY RETENTION	Renal and urinary disorders	MedDRA (26.0)	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected16 at risk
GENITAL HAEMORRHAGE	Reproductive system and breast disorders	MedDRA (26.0)	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected16 at risk
PENILE HAEMATOMA	Reproductive system and breast disorders	MedDRA (26.0)	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected16 at risk
PENILE PAIN	Reproductive system and breast disorders	MedDRA (26.0)	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected16 at risk
ACUTE RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	MedDRA (26.0)	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected16 at risk
ATELECTASIS	Respiratory, thoracic and mediastinal disorders	MedDRA (26.0)	Systematic Assessment	EG0000 events0 affected17 at risk EG0013 events3 affected16 at risk
DYSPNOEA	Respiratory, thoracic and mediastinal disorders	MedDRA (26.0)	Systematic Assessment	EG0000 events0 affected17 at risk EG0012 events1 affected16 at risk
HICCUPS	Respiratory, thoracic and mediastinal disorders	MedDRA (26.0)	Systematic Assessment	EG0001 events1 affected17 at risk EG0011 events1 affected16 at risk
HYPOXIA	Respiratory, thoracic and mediastinal disorders	MedDRA (26.0)	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected16 at risk
LUNG INFILTRATION	Respiratory, thoracic and mediastinal disorders	MedDRA (26.0)	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected16 at risk
OROPHARYNGEAL PAIN	Respiratory, thoracic and mediastinal disorders	MedDRA (26.0)	Systematic Assessment	EG0002 events1 affected17 at risk EG0013 events3 affected16 at risk
PLEURAL EFFUSION	Respiratory, thoracic and mediastinal disorders	MedDRA (26.0)	Systematic Assessment	EG0001 events1 affected17 at risk EG0012 events2 affected16 at risk
PULMONARY EMBOLISM	Respiratory, thoracic and mediastinal disorders	MedDRA (26.0)	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected16 at risk
PULMONARY HYPERTENSION	Respiratory, thoracic and mediastinal disorders	MedDRA (26.0)	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected16 at risk
RESPIRATORY FAILURE	Respiratory, thoracic and mediastinal disorders	MedDRA (26.0)	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected16 at risk
EXCESSIVE GRANULATION TISSUE	Skin and subcutaneous tissue disorders	MedDRA (26.0)	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected16 at risk
LIPODYSTROPHY ACQUIRED	Skin and subcutaneous tissue disorders	MedDRA (26.0)	Systematic Assessment	EG0000 events0 affected17 at risk EG0012 events1 affected16 at risk
PRURITUS ALLERGIC	Skin and subcutaneous tissue disorders	MedDRA (26.0)	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected16 at risk
BLOOD VOLUME EXPANSION	Surgical and medical procedures	MedDRA (26.0)	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected16 at risk
COLONIC LAVAGE	Surgical and medical procedures	MedDRA (26.0)	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected16 at risk
DERMABRASION	Surgical and medical procedures	MedDRA (26.0)	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected16 at risk
HAEMATOMA EVACUATION	Surgical and medical procedures	MedDRA (26.0)	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected16 at risk
PROPHYLAXIS	Surgical and medical procedures	MedDRA (26.0)	Systematic Assessment	EG0001 events1 affected17 at risk EG0010 events0 affected16 at risk
HYPERTENSION	Vascular disorders	MedDRA (26.0)	Systematic Assessment	EG0003 events3 affected17 at risk EG0012 events2 affected16 at risk
HYPOTENSION	Vascular disorders	MedDRA (26.0)	Systematic Assessment	EG0003 events2 affected17 at risk EG0015 events2 affected16 at risk
INFERIOR VENA CAVA DILATATION	Vascular disorders	MedDRA (26.0)	Systematic Assessment	EG0000 events0 affected17 at risk EG0011 events1 affected16 at risk

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

ID	Title	Description
BG000	sFilm-FS	sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
BG001	TACHOSIL®	TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.
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	sFilm-FS	sFilm-FS: sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.	1	17	6	17	17	17
EG001	TACHOSIL®	TACHOSIL®: TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.	1	16	5	16	16	16