TachoSil® Versus Surgicel® Original for the Secondary Tre... | NCT01192022

ID	Type	Description	Link
U1111-1130-9121	Registry Identifier	WHO

Label	Type	Description	Intervention Names
TachoSil®	Active Comparator	TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. 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.	Biological: TachoSil®
Surgicel® Original	Active Comparator	Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. 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.	Device: Surgicel® Original

Name	Type	Description	Arm Group Labels	Other Names
TachoSil®	Biological	Intraoperative application as secondary hemostatic treatment	TachoSil®

Measure	Description	Time Frame
Percentage of Participants With Intraoperative Hemostasis at Target Bleeding Site Within 3 Minutes	3 Minutes after the patch was applied to the target bleeding area, the area was observed to see if the bleeding stopped.	within 3 minutes

Measure	Description	Time Frame
Percentage of Participants With Intraoperative Hemostasis at Target Bleeding Site Within 5 Minutes	3, 4 and 5 minutes after the patch was applied to the target bleeding area, the area was observed to see if the bleeding stopped.	within 5 minutes
Time to Intraoperative Hemostasis at Target Bleeding Site

Name	Affiliation	Role
Medical Director	Takeda	Study Director

PubMed Identifier	Type	Citation	Retractions
26776356	Derived	Genyk Y, Kato T, Pomposelli JJ, Wright JK Jr, Sher LS, Tetens V, Chapman WC. Fibrin Sealant Patch (TachoSil) vs Oxidized Regenerated Cellulose Patch (Surgicel Original) for the Secondary Treatment of Local Bleeding in Patients Undergoing Hepatic Resection: A Randomized Controlled Trial. J Am Coll Surg. 2016 Mar;222(3):261-8. doi: 10.1016/j.jamcollsurg.2015.12.007. Epub 2015 Dec 18.

ID	Title	Description
FG000	TachoSil® (Adult Participants)	TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. 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	Surgicel® Original (Adult Participants)

ID	Title	Description
BG000	TachoSil® (Adult Participants)	TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. 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 (Adult Participants)	Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. 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	TachoSil® (Pediatric Participants)	TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. 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.
BG003	Surgicel® Original (Pediatric Participants)	Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. 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.
BG004	Total	Total of all reporting groups

Units	Counts
Participants	BG000114 BG001110 BG00220 BG0039 BG004253

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

Percentage of Participants With Intraoperative Hemostasis at Target Bleeding Site Within 3 Minutes

3 Minutes after the patch was applied to the target bleeding area, the area was observed to see if the bleeding stopped.

Full Analysis set included all randomized participants analyzed according to the treatment assigned.

Posted

Number

95% Confidence Interval

percentage of participants

within 3 minutes

ID	Title	Description
OG000	TachoSil® (Adult Participants)	TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. 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 (Adult Participants)	Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. 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.
OG002	TachoSil® (Pediatric Participants)	TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. 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.
OG003	Surgicel® Original (Pediatric Participants)	Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. 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.
OG004	TachoSil® Extension Analysis Set (Pediatric Participants)	TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. 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.

Units	Counts
Participants	OG000114 OG001110 OG0028 OG003

Title

Denominators

Categories

Title	Measurements
	OG00080.7(72.3 to 87.5) OG00150.0(40.3 to 59.7) OG00287.5(47.3 to 99.7) OG003

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		<0.001	Logistic regression model with treatment and pooled center as factors.	Odds Ratio (OR)	4.87	Standard Error of the Mean	1.60	2-Sided	95	2.55	9.29				No	Superiority or Other

Secondary

Percentage of Participants With Intraoperative Hemostasis at Target Bleeding Site Within 5 Minutes

3, 4 and 5 minutes after the patch was applied to the target bleeding area, the area was observed to see if the bleeding stopped.

Full Analysis set included all randomized participants analyzed according to the treatment assigned.

Posted

Number

95% Confidence Interval

percentage of participants

within 5 minutes

ID	Title	Description
OG000	TachoSil® (Adult Participants)	TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. 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 (Adult Participants)	Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. 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.
OG002	TachoSil® (Pediatric Participants)	TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. 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 Intraoperative Hemostasis at Target Bleeding Site

The target bleeding area was observed at 3, 4, 5, 8, 9, and 10 minutes after the patch was applied to see if the bleeding stopped, and time in minutes until bleeding stopped was recorded.

Full Analysis set included all randomized participants analyzed according to the treatment assigned.

Posted

Median

Full Range

minutes

10 minutes

ID	Title	Description
OG000	TachoSil® (Adult Participants)	TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. 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 (Adult Participants)	Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. 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.
OG002	TachoSil® (Pediatric Participants)	TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. 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.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Atrial fibrillation	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0002 affected114 at risk EG0015 affected109 at risk EG0020 affected20 at risk EG0030 affected9 at risk
Localised intraabdominal fluid collection	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0003 affected114 at risk EG0014 affected109 at risk EG0020 affected20 at risk EG003
Abdominal abscess	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0003 affected114 at risk EG0012 affected109 at risk EG0020 affected20 at risk EG003
Postoperative wound infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0003 affected114 at risk EG0010 affected109 at risk EG0020 affected20 at risk EG003
Post procedural bile leak	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0004 affected114 at risk EG0017 affected109 at risk EG0021 affected20 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0004 affected114 at risk EG0013 affected109 at risk EG0020 affected20 at risk EG003
Pyrexia	General disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected114 at risk EG0012 affected109 at risk EG0022 affected20 at risk EG003
Clostridium difficile colitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 affected114 at risk EG0012 affected109 at risk EG0022 affected20 at risk EG003
Cholangitis	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0011 affected109 at risk EG0021 affected20 at risk EG003
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0012 affected109 at risk EG0021 affected20 at risk EG003
Portal vein thrombosis	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0012 affected109 at risk EG0021 affected20 at risk EG003
Klebsiella infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0011 affected109 at risk EG0021 affected20 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected114 at risk EG0011 affected109 at risk EG0021 affected20 at risk EG003
Viral infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 affected114 at risk EG0010 affected109 at risk EG0020 affected20 at risk EG003
Sepsis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0011 affected109 at risk EG0020 affected20 at risk EG003
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected114 at risk EG0012 affected109 at risk EG0021 affected20 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0012 affected109 at risk EG0021 affected20 at risk EG003
Hypophagia	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected114 at risk EG0010 affected109 at risk EG0021 affected20 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG0002 affected114 at risk EG0012 affected109 at risk EG0020 affected20 at risk EG003
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0011 affected109 at risk EG0020 affected20 at risk EG003
Bundle branch block right	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected114 at risk EG0010 affected109 at risk EG0020 affected20 at risk EG003
Cardiac arrest	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected114 at risk EG0010 affected109 at risk EG0020 affected20 at risk EG003
Cardio-respiratory arrest	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected114 at risk EG0010 affected109 at risk EG0020 affected20 at risk EG003
Myocardial infarction	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected114 at risk EG0010 affected109 at risk EG0020 affected20 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0011 affected109 at risk EG0020 affected20 at risk EG003
Cardiac tamponade	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0011 affected109 at risk EG0020 affected20 at risk EG003
Pericarditis	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0011 affected109 at risk EG0020 affected20 at risk EG003
Supraventricular tachycardia	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0011 affected109 at risk EG0020 affected20 at risk EG003
Syringomyelia	Congenital, familial and genetic disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected114 at risk EG0010 affected109 at risk EG0020 affected20 at risk EG003
Goitre	Endocrine disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected114 at risk EG0010 affected109 at risk EG0020 affected20 at risk EG003
Impaired gastric emptying	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0002 affected114 at risk EG0010 affected109 at risk EG0020 affected20 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected114 at risk EG0010 affected109 at risk EG0020 affected20 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected114 at risk EG0012 affected109 at risk EG0020 affected20 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected114 at risk EG0010 affected109 at risk EG0020 affected20 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected114 at risk EG0010 affected109 at risk EG0020 affected20 at risk EG003
Intestinal perforation	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected114 at risk EG0010 affected109 at risk EG0020 affected20 at risk EG003
Oesophagitis	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected114 at risk EG0011 affected109 at risk EG0020 affected20 at risk EG003
Enterocutaneous fistula	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0011 affected109 at risk EG0020 affected20 at risk EG003
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0011 affected109 at risk EG0020 affected20 at risk EG003
Ileal fistula	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0011 affected109 at risk EG0020 affected20 at risk EG003
Ileus	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0012 affected109 at risk EG0020 affected20 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0011 affected109 at risk EG0020 affected20 at risk EG003
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0012 affected109 at risk EG0020 affected20 at risk EG003
Small intestinal perforation	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0011 affected109 at risk EG0020 affected20 at risk EG003
Multi-organ failure	General disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected114 at risk EG0010 affected109 at risk EG0020 affected20 at risk EG003
Non-cardiac chest pain	General disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected114 at risk EG0010 affected109 at risk EG0020 affected20 at risk EG003
Device occlusion	General disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0011 affected109 at risk EG0020 affected20 at risk EG003
Hernia obstructive	General disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0011 affected109 at risk EG0020 affected20 at risk EG003
Acute hepatic failure	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected114 at risk EG0010 affected109 at risk EG0020 affected20 at risk EG003
Bile duct obstruction	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected114 at risk EG0010 affected109 at risk EG0020 affected20 at risk EG003
Biloma	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected114 at risk EG0010 affected109 at risk EG0020 affected20 at risk EG003
Hepatic failure	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected114 at risk EG0010 affected109 at risk EG0020 affected20 at risk EG003
Hepatorenal syndrome	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected114 at risk EG0010 affected109 at risk EG0020 affected20 at risk EG003
Bile duct stenosis	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0012 affected109 at risk EG0020 affected20 at risk EG003
Hepatic ischaemia	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0011 affected109 at risk EG0020 affected20 at risk EG003
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0011 affected109 at risk EG0020 affected20 at risk EG003
Jaundice	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0011 affected109 at risk EG0020 affected20 at risk EG003
Infectious peritonitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0002 affected114 at risk EG0010 affected109 at risk EG0020 affected20 at risk EG003
Liver abscess	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0002 affected114 at risk EG0011 affected109 at risk EG0020 affected20 at risk EG003
Wound infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0002 affected114 at risk EG0010 affected109 at risk EG0020 affected20 at risk EG003
Abdominal infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 affected114 at risk EG0010 affected109 at risk EG0020 affected20 at risk EG003
Bacteraemia	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 affected114 at risk EG0012 affected109 at risk EG0020 affected20 at risk EG003
Clostridial infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 affected114 at risk EG0011 affected109 at risk EG0020 affected20 at risk EG003
Escherichia sepsis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 affected114 at risk EG0010 affected109 at risk EG0020 affected20 at risk EG003
Haematoma infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 affected114 at risk EG0010 affected109 at risk EG0020 affected20 at risk EG003
Lobar pneumonia	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 affected114 at risk EG0010 affected109 at risk EG0020 affected20 at risk EG003
Pneumonia	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 affected114 at risk EG0011 affected109 at risk EG0020 affected20 at risk EG003
Subdiaphragmatic abscess	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 affected114 at risk EG0011 affected109 at risk EG0020 affected20 at risk EG003
Appendicitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0011 affected109 at risk EG0020 affected20 at risk EG003
Bacterial infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0011 affected109 at risk EG0020 affected20 at risk EG003
Enterococcal bacteraemia	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0011 affected109 at risk EG0020 affected20 at risk EG003
Peritoneal abscess	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0011 affected109 at risk EG0020 affected20 at risk EG003
Postoperative abscess	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0011 affected109 at risk EG0020 affected20 at risk EG003
Staphylococcal infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0011 affected109 at risk EG0020 affected20 at risk EG003
Urosepsis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0011 affected109 at risk EG0020 affected20 at risk EG003
Wound abscess	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0011 affected109 at risk EG0020 affected20 at risk EG003
Wound infection staphylococcal	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0011 affected109 at risk EG0020 affected20 at risk EG003
Postoperative adhesion	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 affected114 at risk EG0010 affected109 at risk EG0020 affected20 at risk EG003
Seroma	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 affected114 at risk EG0011 affected109 at risk EG0020 affected20 at risk EG003
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0012 affected109 at risk EG0020 affected20 at risk EG003
Vascular graft thrombosis	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0011 affected109 at risk EG0020 affected20 at risk EG003
Antibiotic resistant Staphylococcus test positive	Investigations	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0011 affected109 at risk EG0020 affected20 at risk EG003
False positive investigation result	Investigations	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0011 affected109 at risk EG0020 affected20 at risk EG003
Fluid overload	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected114 at risk EG0010 affected109 at risk EG0020 affected20 at risk EG003
Failure to thrive	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0011 affected109 at risk EG0020 affected20 at risk EG003
Hyperglycaemic hyperosmolar nonketotic syndrome	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0011 affected109 at risk EG0020 affected20 at risk EG003
Hepatic neoplasm malignant recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0002 affected114 at risk EG0012 affected109 at risk EG0020 affected20 at risk EG003
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0002 affected114 at risk EG0012 affected109 at risk EG0020 affected20 at risk EG003
Metastases to lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0002 affected114 at risk EG0011 affected109 at risk EG0020 affected20 at risk EG003
Metastases to peritoneum	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0001 affected114 at risk EG0010 affected109 at risk EG0020 affected20 at risk EG003
Colorectal cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0011 affected109 at risk EG0020 affected20 at risk EG003
Hepatic cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0011 affected109 at risk EG0020 affected20 at risk EG003
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0011 affected109 at risk EG0020 affected20 at risk EG003
Metastases to lymph nodes	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0011 affected109 at risk EG0020 affected20 at risk EG003
Cerebral infarction	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0011 affected109 at risk EG0020 affected20 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0011 affected109 at risk EG0020 affected20 at risk EG003
Confusional state	Psychiatric disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected114 at risk EG0010 affected109 at risk EG0020 affected20 at risk EG003
Delirium	Psychiatric disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected114 at risk EG0010 affected109 at risk EG0020 affected20 at risk EG003
Mental status changes	Psychiatric disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected114 at risk EG0012 affected109 at risk EG0020 affected20 at risk EG003
Renal failure acute	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected114 at risk EG0011 affected109 at risk EG0020 affected20 at risk EG003
Urethral haemorrhage	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected114 at risk EG0010 affected109 at risk EG0020 affected20 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0011 affected109 at risk EG0020 affected20 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0002 affected114 at risk EG0011 affected109 at risk EG0020 affected20 at risk EG003
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected114 at risk EG0010 affected109 at risk EG0020 affected20 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected114 at risk EG0012 affected109 at risk EG0020 affected20 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected114 at risk EG0010 affected109 at risk EG0020 affected20 at risk EG003
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected114 at risk EG0010 affected109 at risk EG0020 affected20 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected114 at risk EG0011 affected109 at risk EG0020 affected20 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0011 affected109 at risk EG0020 affected20 at risk EG003
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0011 affected109 at risk EG0020 affected20 at risk EG003
Pulmonary artery thrombosis	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0011 affected109 at risk EG0020 affected20 at risk EG003
Activities of daily living impaired	Social circumstances	MedDRA 15.1	Systematic Assessment	EG0001 affected114 at risk EG0010 affected109 at risk EG0020 affected20 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0012 affected109 at risk EG0020 affected20 at risk EG003
Shock	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0011 affected109 at risk EG0020 affected20 at risk EG003
Disseminated intravasular coagulation	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0010 affected109 at risk EG0021 affected20 at risk EG003
Hydrocele	Congenital, familial and genetic disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0010 affected109 at risk EG0021 affected20 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0010 affected109 at risk EG0022 affected20 at risk EG003
Catheter site swelling	General disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0010 affected109 at risk EG0021 affected20 at risk EG003
Hepatic artery thrombosis	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0010 affected109 at risk EG0021 affected20 at risk EG003
Hepatic necrosis	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0010 affected109 at risk EG0021 affected20 at risk EG003
Alpha haemolytic streptococcal infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0010 affected109 at risk EG0021 affected20 at risk EG003
Enterobacter infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0010 affected109 at risk EG0021 affected20 at risk EG003
Enterococcal infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0010 affected109 at risk EG0021 affected20 at risk EG003
Mycobacterium abscessus infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0010 affected109 at risk EG0021 affected20 at risk EG003
Septic shock	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0010 affected109 at risk EG0021 affected20 at risk EG003
Stenotrophomonas infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0010 affected109 at risk EG0021 affected20 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0010 affected109 at risk EG0021 affected20 at risk EG003
Viraemia	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0010 affected109 at risk EG0021 affected20 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0010 affected109 at risk EG0020 affected20 at risk EG003
Pneumonia klebsiella	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0010 affected109 at risk EG0020 affected20 at risk EG003
Anastomotic complication	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0010 affected109 at risk EG0021 affected20 at risk EG003
Incision site haematoma	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0010 affected109 at risk EG0021 affected20 at risk EG003
Splenic rupture	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0010 affected109 at risk EG0021 affected20 at risk EG003
Convulsion	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0010 affected109 at risk EG0020 affected20 at risk EG003
Exsanguination	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0010 affected109 at risk EG0021 affected20 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG00026 affected114 at risk EG00123 affected109 at risk EG0026 affected20 at risk EG0032 affected9 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG0005 affected114 at risk EG0013 affected109 at risk EG0022 affected20 at risk EG003
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0010 affected109 at risk EG0020 affected20 at risk EG003
Leukocytosis	Blood and lymphatic system disorders	MedDRA 15.1	Systematic Assessment	EG0008 affected114 at risk EG00110 affected109 at risk EG0020 affected20 at risk EG003
Tachycardia	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG00011 affected114 at risk EG00117 affected109 at risk EG0023 affected20 at risk EG003
Ventricular extrasystoles	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected114 at risk EG0010 affected109 at risk EG0021 affected20 at risk EG003
Sinus tachycardia	Cardiac disorders	MedDRA 15.1	Systematic Assessment	EG0009 affected114 at risk EG0018 affected109 at risk EG0020 affected20 at risk EG003
Eyelid ptosis	Eye disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0010 affected109 at risk EG0021 affected20 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG00012 affected114 at risk EG0014 affected109 at risk EG0022 affected20 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG00028 affected114 at risk EG00131 affected109 at risk EG0022 affected20 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG00013 affected114 at risk EG00119 affected109 at risk EG0022 affected20 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG00015 affected114 at risk EG00115 affected109 at risk EG0022 affected20 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG00010 affected114 at risk EG0019 affected109 at risk EG0021 affected20 at risk EG003
Abdominal pain lower	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0010 affected109 at risk EG0021 affected20 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0003 affected114 at risk EG0014 affected109 at risk EG0021 affected20 at risk EG003
Gastrointestinal sounds abnormal	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected114 at risk EG0010 affected109 at risk EG0021 affected20 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected114 at risk EG0013 affected109 at risk EG0021 affected20 at risk EG003
Haematochezia	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0013 affected109 at risk EG0021 affected20 at risk EG003
Localised intraabdominal fluid collection	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0004 affected114 at risk EG00110 affected109 at risk EG0021 affected20 at risk EG003
Mallory-Weiss syndrome	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0010 affected109 at risk EG0021 affected20 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG00035 affected114 at risk EG00129 affected109 at risk EG0021 affected20 at risk EG003
Oesophageal ulcer	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0011 affected109 at risk EG0021 affected20 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0002 affected114 at risk EG0012 affected109 at risk EG0020 affected20 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG00013 affected114 at risk EG00110 affected109 at risk EG0021 affected20 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 15.1	Systematic Assessment	EG0006 affected114 at risk EG0014 affected109 at risk EG0020 affected20 at risk EG003
Pyrexia	General disorders	MedDRA 15.1	Systematic Assessment	EG00016 affected114 at risk EG00122 affected109 at risk EG0028 affected20 at risk EG003
Catheter site haematoma	General disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0010 affected109 at risk EG0021 affected20 at risk EG003
Fibrosis	General disorders	MedDRA 15.1	Systematic Assessment	EG0002 affected114 at risk EG0011 affected109 at risk EG0021 affected20 at risk EG003
Oedema	General disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0014 affected109 at risk EG0021 affected20 at risk EG003
Oedema peripheral	General disorders	MedDRA 15.1	Systematic Assessment	EG00016 affected114 at risk EG00116 affected109 at risk EG0021 affected20 at risk EG003
Generalised oedema	General disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected114 at risk EG0011 affected109 at risk EG0020 affected20 at risk EG003
Fatigue	General disorders	MedDRA 15.1	Systematic Assessment	EG0008 affected114 at risk EG00114 affected109 at risk EG0020 affected20 at risk EG003
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0003 affected114 at risk EG0011 affected109 at risk EG0021 affected20 at risk EG003
Hepatic vein stenosis	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0010 affected109 at risk EG0021 affected20 at risk EG003
Portal vein stenosis	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0010 affected109 at risk EG0021 affected20 at risk EG003
Venoocclusive liver disease	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0010 affected109 at risk EG0021 affected20 at risk EG003
Hepatic steatosis	Hepatobiliary disorders	MedDRA 15.1	Systematic Assessment	EG00019 affected114 at risk EG00110 affected109 at risk EG0020 affected20 at risk EG003
Drug hypersensitivity	Immune system disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0010 affected109 at risk EG0021 affected20 at risk EG003
Liver transplant rejection	Immune system disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0010 affected109 at risk EG0021 affected20 at risk EG003
Transplant rejection	Immune system disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0010 affected109 at risk EG0021 affected20 at risk EG003
Seasonal allergy	Immune system disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0010 affected109 at risk EG0020 affected20 at risk EG003
Human herpesvirus 6 infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0010 affected109 at risk EG0022 affected20 at risk EG003
Bacteraemia	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0010 affected109 at risk EG0021 affected20 at risk EG003
Clostridial infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0002 affected114 at risk EG0011 affected109 at risk EG0021 affected20 at risk EG003
Epstein-Barr viraemia	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0010 affected109 at risk EG0021 affected20 at risk EG003
Influenza	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0010 affected109 at risk EG0021 affected20 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0001 affected114 at risk EG0011 affected109 at risk EG0021 affected20 at risk EG003
Parainfluenzae virus infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0010 affected109 at risk EG0021 affected20 at risk EG003
Peritonitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0010 affected109 at risk EG0021 affected20 at risk EG003
Pharyngitis	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0011 affected109 at risk EG0021 affected20 at risk EG003
Device related infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0011 affected109 at risk EG0020 affected20 at risk EG003
Febrile infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0010 affected109 at risk EG0020 affected20 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 15.1	Systematic Assessment	EG0009 affected114 at risk EG0014 affected109 at risk EG0021 affected20 at risk EG003
Post procedural bile leak	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0005 affected114 at risk EG0016 affected109 at risk EG0022 affected20 at risk EG003
Accidental overdose	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0010 affected109 at risk EG0021 affected20 at risk EG003
Gastrointestinal anastomotic leak	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0010 affected109 at risk EG0021 affected20 at risk EG003
Hepatic haematoma	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 affected114 at risk EG0010 affected109 at risk EG0021 affected20 at risk EG003
Inadequate analgesia	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0011 affected109 at risk EG0021 affected20 at risk EG003
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0010 affected109 at risk EG0021 affected20 at risk EG003
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0012 affected109 at risk EG0021 affected20 at risk EG003
Procedural hypertension	Injury, poisoning and procedural complications	MedDRA 15.1	Systematic Assessment	EG0001 affected114 at risk EG0011 affected109 at risk EG0020 affected20 at risk EG003
Transaminases increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0004 affected114 at risk EG0012 affected109 at risk EG0022 affected20 at risk EG003
Blood glucose decreased	Investigations	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0010 affected109 at risk EG0021 affected20 at risk EG003
Blood potassium decreased	Investigations	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0010 affected109 at risk EG0021 affected20 at risk EG003
Coagulation time prolonged	Investigations	MedDRA 15.1	Systematic Assessment	EG0001 affected114 at risk EG0010 affected109 at risk EG0021 affected20 at risk EG003
International normalised ratio increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0010 affected109 at risk EG0021 affected20 at risk EG003
Lipase increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0001 affected114 at risk EG0010 affected109 at risk EG0021 affected20 at risk EG003
Urine output decreased	Investigations	MedDRA 15.1	Systematic Assessment	EG0004 affected114 at risk EG0012 affected109 at risk EG0021 affected20 at risk EG003
White blood cell count increased	Investigations	MedDRA 15.1	Systematic Assessment	EG0002 affected114 at risk EG0016 affected109 at risk EG0021 affected20 at risk EG003
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG00012 affected114 at risk EG00110 affected109 at risk EG0022 affected20 at risk EG003
Acidosis	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected114 at risk EG0012 affected109 at risk EG0021 affected20 at risk EG003
Fluid imbalance	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0010 affected109 at risk EG0021 affected20 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG00011 affected114 at risk EG00112 affected109 at risk EG0021 affected20 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG00017 affected114 at risk EG00124 affected109 at risk EG0021 affected20 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0005 affected114 at risk EG0013 affected109 at risk EG0021 affected20 at risk EG003
Hypophagia	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0010 affected109 at risk EG0021 affected20 at risk EG003
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG00018 affected114 at risk EG0018 affected109 at risk EG0021 affected20 at risk EG003
Iron deficiency	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0010 affected109 at risk EG0021 affected20 at risk EG003
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0011 affected109 at risk EG0021 affected20 at risk EG003
Vitamin D deficiency	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0010 affected109 at risk EG0021 affected20 at risk EG003
Dehydration	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0005 affected114 at risk EG0014 affected109 at risk EG0020 affected20 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0002 affected114 at risk EG0012 affected109 at risk EG0020 affected20 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG00014 affected114 at risk EG0019 affected109 at risk EG0020 affected20 at risk EG003
Fluid overload	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0007 affected114 at risk EG0012 affected109 at risk EG0020 affected20 at risk EG003
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0007 affected114 at risk EG0017 affected109 at risk EG0020 affected20 at risk EG003
Hypovolaemia	Metabolism and nutrition disorders	MedDRA 15.1	Systematic Assessment	EG0007 affected114 at risk EG0012 affected109 at risk EG0020 affected20 at risk EG003
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0011 affected109 at risk EG0021 affected20 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 15.1	Systematic Assessment	EG0007 affected114 at risk EG0015 affected109 at risk EG0020 affected20 at risk EG003
Dizziness	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0003 affected114 at risk EG0015 affected109 at risk EG0021 affected20 at risk EG003
Somnolence	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected114 at risk EG0010 affected109 at risk EG0021 affected20 at risk EG003
Headache	Nervous system disorders	MedDRA 15.1	Systematic Assessment	EG0005 affected114 at risk EG0015 affected109 at risk EG0020 affected20 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 15.1	Systematic Assessment	EG0004 affected114 at risk EG0013 affected109 at risk EG0021 affected20 at risk EG003
Emotional distress	Psychiatric disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0010 affected109 at risk EG0021 affected20 at risk EG003
Emotional poverty	Psychiatric disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0010 affected109 at risk EG0021 affected20 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 15.1	Systematic Assessment	EG0007 affected114 at risk EG0017 affected109 at risk EG0021 affected20 at risk EG003
Suicidal ideation	Psychiatric disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0010 affected109 at risk EG0021 affected20 at risk EG003
Restlessness	Psychiatric disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0010 affected109 at risk EG0020 affected20 at risk EG003
Confusional state	Psychiatric disorders	MedDRA 15.1	Systematic Assessment	EG0007 affected114 at risk EG0016 affected109 at risk EG0020 affected20 at risk EG003
Dysuria	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0002 affected114 at risk EG0011 affected109 at risk EG0021 affected20 at risk EG003
Renal failure acute	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0005 affected114 at risk EG0014 affected109 at risk EG0021 affected20 at risk EG003
Ketonuria	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0010 affected109 at risk EG0020 affected20 at risk EG003
Oliguria	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG00012 affected114 at risk EG0015 affected109 at risk EG0020 affected20 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA 15.1	Systematic Assessment	EG0009 affected114 at risk EG0013 affected109 at risk EG0020 affected20 at risk EG003
Scrotal swelling	Reproductive system and breast disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0011 affected109 at risk EG0021 affected20 at risk EG003
Menorrhagia	Reproductive system and breast disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0010 affected109 at risk EG0020 affected20 at risk EG003
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG00017 affected114 at risk EG00118 affected109 at risk EG0022 affected20 at risk EG003
Tachypnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected114 at risk EG0013 affected109 at risk EG0022 affected20 at risk EG003
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG00022 affected114 at risk EG00113 affected109 at risk EG0021 affected20 at risk EG003
Hypercapnia	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0011 affected109 at risk EG0021 affected20 at risk EG003
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0005 affected114 at risk EG0013 affected109 at risk EG0021 affected20 at risk EG003
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0011 affected109 at risk EG0021 affected20 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0003 affected114 at risk EG0012 affected109 at risk EG0021 affected20 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected114 at risk EG0010 affected109 at risk EG0020 affected20 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0002 affected114 at risk EG0010 affected109 at risk EG0020 affected20 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 15.1	Systematic Assessment	EG0006 affected114 at risk EG0013 affected109 at risk EG0020 affected20 at risk EG003
Dermatitis diaper	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0010 affected109 at risk EG0021 affected20 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG00012 affected114 at risk EG00113 affected109 at risk EG0021 affected20 at risk EG003
Skin disorder	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected114 at risk EG0010 affected109 at risk EG0021 affected20 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 15.1	Systematic Assessment	EG0001 affected114 at risk EG0018 affected109 at risk EG0020 affected20 at risk EG003
Hypertension	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG00014 affected114 at risk EG00110 affected109 at risk EG0023 affected20 at risk EG003
Hypotension	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG00022 affected114 at risk EG00120 affected109 at risk EG0023 affected20 at risk EG003
Vena cava thrombosis	Vascular disorders	MedDRA 15.1	Systematic Assessment	EG0000 affected114 at risk EG0011 affected109 at risk EG0020 affected20 at risk EG003

Facility	Status	City	State	ZIP	Country	Contacts
		Los Angeles	California		United States

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

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	TachoSil® (Adult Participants)	TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. 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.	44	114	92	114
EG001	Surgicel® Original (Adult Participants)	Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. 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.	54	109	83	109
EG002	TachoSil® (Pediatric Participants)	TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. 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.	12	20	19	20
EG003	Surgicel® Original (Pediatric Participants)	Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. 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.	4	9	8	9