A Study of Fibrocaps™ in Surgical Bleeding | NCT01527357

Label	Type	Description	Intervention Names
Fibrocaps + Gelatin Sponge	Experimental	Single application of Fibrocaps plus gelatin sponge.	Biological: Fibrocaps Biological: Gelatin sponge
Gelatin Sponge	Active Comparator	Single application of gelatin sponge alone.	Biological: Gelatin sponge

Name	Type	Description	Arm Group Labels	Other Names
Fibrocaps	Biological	Human fibrinogen and thrombin powder, for topical administration.	Fibrocaps + Gelatin Sponge

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to Hemostasis (TTH) for Participants Receiving Spinal Surgery	The measurement of TTH begins at t=0, which is the time the study product is applied to the Target Bleeding Site (TBS) and ends when hemostasis is achieved or 5-minutes, whichever occurs first, based on data collected by surgery type and treatment.	Within 5 minutes
Time to Hemostasis (TTH) for Participants Receiving Vascular Surgery	The measurement of TTH begins at t=0, which is the time the study product is applied to the Target Bleeding Site (TBS) and ends when hemostasis is achieved or 5-minutes, whichever occurs first, based on data collected by surgery type and treatment.	Within 5 minutes
Time to Hemostasis (TTH) for Participants Receiving Hepatic Resection	The measurement of TTH begins at t=0, which is the time the study product is applied to the Target Bleeding Site (TBS) and ends when hemostasis is achieved or 5-minutes, whichever occurs first, based on data collected by surgery type and treatment.	Within 5 minutes
Time to Hemostasis (TTH) for Participants Receiving Soft Tissue Dissection	The measurement of TTH begins at t=0, which is the time the study product is applied to the Target Bleeding Site (TBS) and ends when hemostasis is achieved or 5-minutes, whichever occurs first, based on data collected by surgery type and treatment.	Within 5 minutes

Secondary Outcomes

Measure	Description	Time Frame
Restricted Mean TTH	Restricted mean TTH over 5 minutes is computed using Irwin's estimator, based on data collected by surgery type and treatment.	Within 5 minutes
Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)

Eligibility Module

Name	Affiliation	Role
Global Clinical Leader	Mallinckrodt	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham		Birmingham	Alabama	35233	United States
Cardio-Thoracic Surgeons, PC

PubMed Identifier	Type	Citation	Retractions
26254451	Derived	Gupta N, Chetter I, Hayes P, O-Yurvati AH, Moneta GL, Shenoy S, Pribble JP, Zuckerman LA. Randomized trial of a dry-powder, fibrin sealant in vascular procedures. J Vasc Surg. 2015 Nov;62(5):1288-95. doi: 10.1016/j.jvs.2015.05.038. Epub 2015 Aug 5.
25458801	Derived	Bochicchio GV, Gupta N, Porte RJ, Renkens KL, Pattyn P, Topal B, Troisi RI, Muir W, Chetter I, Gillen DL, Zuckerman LA, Frohna PA. The FINISH-3 trial: a phase 3, international, randomized, single-blind, controlled trial of topical fibrocaps in intraoperative surgical hemostasis. J Am Coll Surg. 2015 Jan;220(1):70-81. doi: 10.1016/j.jamcollsurg.2014.09.019. Epub 2014 Oct 13.

ID	Title	Description
FG000	Fibrocaps + Gelatin Sponge	Single application of Fibrocaps plus gelatin sponge.
FG001	Gelatin Sponge	Single application of gelatin sponge alone.

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

Time to Hemostasis (TTH) for Participants Receiving Spinal Surgery

The measurement of TTH begins at t=0, which is the time the study product is applied to the Target Bleeding Site (TBS) and ends when hemostasis is achieved or 5-minutes, whichever occurs first, based on data collected by surgery type and treatment.

Efficacy population consists of all participants who were randomized, received study treatment, and had a TTH assessment. Number analyzed is the number of participants in the efficacy population who receive each type of surgery.

Posted

Median

Inter-Quartile Range

minutes

Within 5 minutes

ID	Title	Description
OG000	Fibrocaps + Gelatin Sponge	Single application of Fibrocaps plus gelatin sponge.
OG001	Gelatin Sponge	Single application of gelatin sponge alone.

Units	Counts
Participants	OG000122 OG00161

Title

Denominators

Categories

Title	Measurements
	OG0001.0(0.5 to 1.5) OG0012.5(1.5 to 4.0)

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		Log Rank		< 0.0001														Superiority

Primary

Time to Hemostasis (TTH) for Participants Receiving Vascular Surgery

Efficacy population

Posted

Median

95% Confidence Interval

minutes

Within 5 minutes

ID	Title	Description
OG000	Fibrocaps + Gelatin Sponge	Single application of Fibrocaps plus gelatin sponge.
OG001	Gelatin Sponge	Single application of gelatin sponge alone.

Units	Counts
Participants	OG000

Primary

Time to Hemostasis (TTH) for Participants Receiving Hepatic Resection

Efficacy population

Posted

Median

95% Confidence Interval

minutes

Within 5 minutes

ID	Title	Description
OG000	Fibrocaps + Gelatin Sponge	Single application of Fibrocaps plus gelatin sponge.
OG001	Gelatin Sponge	Single application of gelatin sponge alone.

Units	Counts
Participants	OG000

Primary

Time to Hemostasis (TTH) for Participants Receiving Soft Tissue Dissection

Efficacy population

Posted

Median

95% Confidence Interval

minutes

Within 5 minutes

ID	Title	Description
OG000	Fibrocaps + Gelatin Sponge	Single application of Fibrocaps plus gelatin sponge.
OG001	Gelatin Sponge	Single application of gelatin sponge alone.

Units	Counts
Participants	OG000

Secondary

Restricted Mean TTH

Restricted mean TTH over 5 minutes is computed using Irwin's estimator, based on data collected by surgery type and treatment.

Efficacy population. Number analyzed is the number of participants with data available for analysis in each surgery type.

Posted

Mean

Standard Error

minutes

Within 5 minutes

ID	Title	Description
OG000	Fibrocaps + Gelatin Sponge	Single application of Fibrocaps plus gelatin sponge.
OG001	Gelatin Sponge	Single application of gelatin sponge alone.

Units	Counts
Participants	OG000

Secondary

Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)

An adverse event (AE) is any untoward medical occurrence (including clinically significant changes in laboratory values or other clinical tests) experienced by a participant administered a pharmaceutical product regardless of causal relationship with the treatment. A TEAE is any adverse event reported on the case report form that occurs after start of treatment or any adverse event with a missing start date.

Safety population, defined as all participants who were randomized and received study treatment.

Posted

Count of Participants

Participants

Within 29 days

ID	Title	Description
OG000	Fibrocaps + Gelatin Sponge	Single application of Fibrocaps plus gelatin sponge.
OG001	Gelatin Sponge	Single application of gelatin sponge alone.

Units	Counts
Participants	OG000

Secondary

Number of Participants Who Require Alternative Hemostatic Agents at 5 Minutes

If hemostasis is not achieved within 5 minutes, the treatment is considered to have failed, and the surgeon is to implement additional hemostatic measures.

Efficacy population

Posted

Count of Participants

Participants

At 5 minutes

ID	Title	Description
OG000	Fibrocaps + Gelatin Sponge	Single application of Fibrocaps plus gelatin sponge.
OG001	Gelatin Sponge	Single application of gelatin sponge alone.

Units	Counts
Participants	OG000

Secondary

Number of Participants Who Required Red Blood Cells

Red blood cells are defined as including World Health Organization (WHO) DRUG terms of "Blood cells, packed human", "Blood, whole", "Red blood cells", "Red blood cells, concentrated" and "Red blood cells, leucocyte depleted".

Efficacy population

Posted

Count of Participants

Participants

Within 29 days

ID	Title	Description
OG000	Fibrocaps + Gelatin Sponge	Single application of Fibrocaps plus gelatin sponge.
OG001	Gelatin Sponge	Single application of gelatin sponge alone.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Pneumonia	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0004 affected480 at risk EG0012 affected239 at risk
Abdominal abscess	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0004 affected480 at risk EG0011 affected239 at risk
Postoperative wound infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0004 affected480 at risk EG0010 affected239 at risk
Sepsis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0003 affected480 at risk EG0010 affected239 at risk
Wound infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0002 affected480 at risk EG0011 affected239 at risk
Abdominal sepsis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected480 at risk EG0010 affected239 at risk
Cellulitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected480 at risk EG0010 affected239 at risk
Infectious peritonitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected480 at risk EG0010 affected239 at risk
Liver abscess	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected480 at risk EG0010 affected239 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected480 at risk EG0011 affected239 at risk
Lung infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected480 at risk EG0010 affected239 at risk
Osteomyelitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected480 at risk EG0011 affected239 at risk
Peritonitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected480 at risk EG0011 affected239 at risk
Psoas abscess	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected480 at risk EG0011 affected239 at risk
Rectal abscess	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 affected480 at risk EG0011 affected239 at risk
Septic shock	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected480 at risk EG0010 affected239 at risk
Subcutaneous abscess	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected480 at risk EG0010 affected239 at risk
Subdiaphragmatic abscess	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected480 at risk EG0010 affected239 at risk
Urinary tract infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected480 at risk EG0010 affected239 at risk
Urosepsis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 affected480 at risk EG0010 affected239 at risk
Gastrointestinal anastomotic leak	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0003 affected480 at risk EG0011 affected239 at risk
Post procedural bile leak	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0002 affected480 at risk EG0012 affected239 at risk
Seroma	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0002 affected480 at risk EG0012 affected239 at risk
Anastomotic leak	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0002 affected480 at risk EG0010 affected239 at risk
Post procedural haematoma	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0002 affected480 at risk EG0010 affected239 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0002 affected480 at risk EG0010 affected239 at risk
Small-for-size liver syndrome	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0002 affected480 at risk EG0010 affected239 at risk
Vascular graft thrombosis	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0001 affected480 at risk EG0011 affected239 at risk
Anaesthetic complication	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0001 affected480 at risk EG0010 affected239 at risk
Anastomotic haemorrhage	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0001 affected480 at risk EG0010 affected239 at risk
Arteriovenous fistula thrombosis	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0001 affected480 at risk EG0010 affected239 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0001 affected480 at risk EG0010 affected239 at risk
Gastrointestinal disorder postoperative	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0001 affected480 at risk EG0010 affected239 at risk
Pancreatic leak	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0001 affected480 at risk EG0010 affected239 at risk
Postoperative fever	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0001 affected480 at risk EG0010 affected239 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0001 affected480 at risk EG0010 affected239 at risk
Pseudomeningocele	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0001 affected480 at risk EG0010 affected239 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0001 affected480 at risk EG0010 affected239 at risk
Ileus	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0003 affected480 at risk EG0012 affected239 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected480 at risk EG0011 affected239 at risk
Impaired gastric emptying	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected480 at risk EG0011 affected239 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected480 at risk EG0011 affected239 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected480 at risk EG0010 affected239 at risk
Anal haemorrhage	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected480 at risk EG0010 affected239 at risk
Gastric perforation	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected480 at risk EG0010 affected239 at risk
Gastroduodenal haemorrhage	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected480 at risk EG0010 affected239 at risk
Ileus paralytic	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected480 at risk EG0010 affected239 at risk
Intestinal ischaemia	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected480 at risk EG0011 affected239 at risk
Localised intraabdominal fluid collection	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected480 at risk EG0011 affected239 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected480 at risk EG0010 affected239 at risk
Small intestinal ulcer haemorrhage	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected480 at risk EG0010 affected239 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected480 at risk EG0011 affected239 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected480 at risk EG0013 affected239 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected480 at risk EG0010 affected239 at risk
Respiratory depression	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected480 at risk EG0011 affected239 at risk
Chylothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected480 at risk EG0010 affected239 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected480 at risk EG0011 affected239 at risk
Hypercapnia	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected480 at risk EG0011 affected239 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected480 at risk EG0010 affected239 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected480 at risk EG0011 affected239 at risk
Lymphorrhoea	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0003 affected480 at risk EG0010 affected239 at risk
Peripheral ischaemia	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected480 at risk EG0011 affected239 at risk
Deep vein thrombosis	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected480 at risk EG0011 affected239 at risk
Aortic aneurysm rupture	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected480 at risk EG0010 affected239 at risk
Arterial haemorrhage	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected480 at risk EG0011 affected239 at risk
Hypotension	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected480 at risk EG0011 affected239 at risk
Vena cava thrombosis	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected480 at risk EG0010 affected239 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected480 at risk EG0010 affected239 at risk
Cardiac arrest	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected480 at risk EG0010 affected239 at risk
Myocardial infarction	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected480 at risk EG0011 affected239 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected480 at risk EG0010 affected239 at risk
Cardiac failure	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected480 at risk EG0011 affected239 at risk
Silent myocardial infarction	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected480 at risk EG0010 affected239 at risk
Cardiac death	General disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected480 at risk EG0010 affected239 at risk
Chest pain	General disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected480 at risk EG0011 affected239 at risk
Death	General disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected480 at risk EG0010 affected239 at risk
Hernia obstructive	General disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected480 at risk EG0011 affected239 at risk
Malaise	General disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected480 at risk EG0010 affected239 at risk
Pyrexia	General disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected480 at risk EG0010 affected239 at risk
Unintentional medical device removal by patient	General disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected480 at risk EG0010 affected239 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA (15.0)	Systematic Assessment	EG0004 affected480 at risk EG0010 affected239 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected480 at risk EG0010 affected239 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected480 at risk EG0011 affected239 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected480 at risk EG0011 affected239 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0002 affected480 at risk EG0010 affected239 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected480 at risk EG0010 affected239 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected480 at risk EG0010 affected239 at risk
Gallbladder perforation	Hepatobiliary disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected480 at risk EG0010 affected239 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected480 at risk EG0011 affected239 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected480 at risk EG0010 affected239 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected480 at risk EG0011 affected239 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected480 at risk EG0010 affected239 at risk
Cerebral infarction	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected480 at risk EG0010 affected239 at risk
Paraplegia	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected480 at risk EG0010 affected239 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected480 at risk EG0010 affected239 at risk
Hepatitis C antibody positive	Investigations	MedDRA (15.0)	Systematic Assessment	EG0001 affected480 at risk EG0011 affected239 at risk
Meningioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Systematic Assessment	EG0001 affected480 at risk EG0010 affected239 at risk
Small intestine carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Systematic Assessment	EG0001 affected480 at risk EG0010 affected239 at risk
Delirium	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG0000 affected480 at risk EG0011 affected239 at risk
Mental status changes	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected480 at risk EG0010 affected239 at risk
Renal failure acute	Renal and urinary disorders	MedDRA (15.0)	Systematic Assessment	EG0001 affected480 at risk EG0010 affected239 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Procedural Pain	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG000257 affected480 at risk EG001134 affected239 at risk
Nausea	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG000120 affected480 at risk EG00148 affected239 at risk
Constipation	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG00072 affected480 at risk EG00131 affected239 at risk
Incision site pain	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG00063 affected480 at risk EG00132 affected239 at risk
Hypotension	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG00038 affected480 at risk EG00116 affected239 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA (15.0)	Systematic Assessment	EG00033 affected480 at risk EG00117 affected239 at risk
Insomnia	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG00041 affected480 at risk EG00110 affected239 at risk
Pyrexia	General disorders	MedDRA (15.0)	Systematic Assessment	EG00037 affected480 at risk EG00111 affected239 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG00033 affected480 at risk EG0018 affected239 at risk
Hypertension	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG00025 affected480 at risk EG00110 affected239 at risk
Vomiting	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG00026 affected480 at risk EG00112 affected239 at risk
Procedural nausea	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG00022 affected480 at risk EG0018 affected239 at risk

ID	Term
D008228	Lymphoma, Non-Hodgkin
D008223	Lymphoma
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases

ID	Term
D015718	Fibrin Tissue Adhesive
D005781	Gelatin Sponge, Absorbable
D005339	Fibrin Foam

ID	Term
D005337	Fibrin
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D015503	Surgical Sponges
D013523	Surgical Equipment
D004864	Equipment and Supplies

ID	Title	Description
BG000	Fibrocaps + Gelatin Sponge	Single application of Fibrocaps plus gelatin sponge.
BG001	Gelatin Sponge	Single application of gelatin sponge alone.
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	Fibrocaps + Gelatin Sponge	Single application of Fibrocaps plus gelatin sponge.	8	480	81	480	426	480
EG001	Gelatin Sponge	Single application of gelatin sponge alone.	2	239	29	239	214	239