Multi-national Study Investigating the Effect and Safety... | NCT00914589

ID	Type	Description	Link
JapicCTI-101078	Registry Identifier	JAPIC
2008-006324-62	EudraCT Number

Label	Type	Description	Intervention Names
FXIII17.5IU/Kg	Experimental	Recombinant factor XIII at a single dose of 17.5 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.	Drug: catridecacog
FXIII35IU/Kg	Experimental	Recombinant factor XIII at a single dose of 35 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.	Drug: catridecacog
Placebo	Placebo Comparator	Recombinant factor XIII placebo was administered as a single dose via slow i.v. push at a rate not exceeding two mL per minute.	Drug: placebo

Name	Type	Description	Arm Group Labels	Other Names
catridecacog	Drug	Single dose via slow intravenous (i.v.) push at a rate not exceeding two mL per minute	FXIII17.5IU/Kg

Measure	Description	Time Frame
Percentage of Subjects Avoiding Any Allogeneic Transfusions for Seven Days Post-operative or Until Discharge, Whichever Came First	Proportion of patients avoiding blood products given via allogeneic transfusion. Blood products were defined as any of the following: RBC, platelets, FFP, fibrinogen concentrate and clotting factor(s) concentrate, including cryoprecipitate.	measured ongoing from dosing until day 7 or discharge, whichever came first

Measure	Description	Time Frame
Percentage of Subjects With Thromboembolic Events	Percentage of subjects with thromboembolic events (AMI, cerebrovascular thromboembolic event, peripheral artery occlusion, DVT, pulmonary embolism) until end of trial	measured from screening until 5-7 weeks post Trial Drug Administration
Percentage of Subjects With rFXIII Antibody Reaction

Name	Affiliation	Role
Global Clinical Registry (GCR, 1452)	Novo Nordisk A/S	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novo Nordisk Investigational Site		Atlanta	Georgia	30322-1059	United States
Novo Nordisk Investigational Site

PubMed Identifier	Type	Citation	Retractions
24655469	Result	Song HK, von Heymann C, Jespersen CM, Karkouti K, Korte W, Levy JH, Ranucci M, Saugstrup T, Sellke FW. Safe application of a restrictive transfusion protocol in moderate-risk patients undergoing cardiac operations. Ann Thorac Surg. 2014 May;97(5):1630-5. doi: 10.1016/j.athoracsur.2013.12.025. Epub 2014 Mar 19.
23820174	Derived

Label	URL
Clinical Trials at Novo Nordisk	View source

ID	Title	Description
FG000	Placebo	Recombinant factor XIII placebo was administered as a single dose via slow i.v. push at a rate not exceeding two mL per minute.
FG001	FXIII17.5IU/Kg	Recombinant factor XIII at a single dose of 17.5 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.

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 Subjects Avoiding Any Allogeneic Transfusions for Seven Days Post-operative or Until Discharge, Whichever Came First

Proportion of patients avoiding blood products given via allogeneic transfusion. Blood products were defined as any of the following: RBC, platelets, FFP, fibrinogen concentrate and clotting factor(s) concentrate, including cryoprecipitate.

Full analysis set consisted of all subjects who were randomised and exposed to randomised treatment.

Posted

Number

percentage (%) of subjects

measured ongoing from dosing until day 7 or discharge, whichever came first

ID	Title	Description
OG000	Placebo	Recombinant factor XIII placebo was administered as a single dose via slow i.v. push at a rate not exceeding two mL per minute.
OG001	FXIII17.5IU/Kg	Recombinant factor XIII at a single dose of 17.5 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
OG002	FXIII35IU/Kg	Recombinant factor XIII at a single dose of 35 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.

Units	Counts
Participants	OG000128 OG001143 OG002138

Title

Denominators

Categories

Transfused

Title	Measurements
	OG00035.2 OG00135.7 OG00234.1

Not transfused

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		0.8648	P values less than 0.05 are considered statistically significant in this study.	Odds Ratio (OR)	1.0482				95	0.6095	1.8029					Superiority or Other
OG000 OG002		Regression, Logistic

Secondary

Percentage of Subjects With Thromboembolic Events

Percentage of subjects with thromboembolic events (AMI, cerebrovascular thromboembolic event, peripheral artery occlusion, DVT, pulmonary embolism) until end of trial

The safety analysis set included all subjects who were exposed to at least one dose of trial product.

Posted

Number

percentage of subjects

measured from screening until 5-7 weeks post Trial Drug Administration

ID	Title	Description
OG000	Placebo	Recombinant factor XIII placebo was administered as a single dose via slow i.v. push at a rate not exceeding two mL per minute.
OG001	FXIII17.5IU/Kg	Recombinant factor XIII at a single dose of 17.5 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
OG002	FXIII35IU/Kg	Recombinant factor XIII at a single dose of 35 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.

Secondary

Percentage of Subjects With rFXIII Antibody Reaction

Immunogenicity as number of subjects who manifested FXIII antibody reaction until end of trial. The percentage may be derived from the number of subjects treated with rFXIII with available antibody measurement at visit 8.

Safety analysis set includes all subj. exposed to at least one dose of trial product. 1 subj with a low titre antibody at baseline was also reported with low titre FXIII antibody at visit 8. 27, 19 and 17 subjects in placebo, FXIII 17.5 and 35 IU/KG, respectively, did not have antibody measurement.

Posted

Number

participants

measured from screening until 5-7 weeks post Trial Drug Administration

ID	Title	Description
OG000	Placebo	Recombinant factor XIII placebo was administered as a single dose via slow i.v. push at a rate not exceeding two mL per minute.
OG001	FXIII17.5IU/Kg	Recombinant factor XIII at a single dose of 17.5 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
OG002	FXIII35IU/Kg	Recombinant factor XIII at a single dose of 35 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.

Secondary

Percentage of Subjects With Critical Adverse Events

Percentage of subjects with critical adverse events (thromboembolic events (AMI, cerebrovascular thromboembolic event, peripheral artery occlusion, DVT, pulmonary embolism), renal dysfunction, re-operation and death) until end of trial

The safety analysis set included all subjects who were exposed to at least one dose of trial product.

Posted

Number

percentage (%) of subjects

measured from screening until 5-7 weeks post Trial Drug Administration

ID	Title	Description
OG000	Placebo	Recombinant factor XIII placebo was administered as a single dose via slow i.v. push at a rate not exceeding two mL per minute.
OG001	FXIII17.5IU/Kg	Recombinant factor XIII at a single dose of 17.5 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
OG002	FXIII35IU/Kg	Recombinant factor XIII at a single dose of 35 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.

Secondary

Percentage of Subjects With Serious Adverse Events

Percentage of subjects with serious adverse events until end of trial.

The safety analysis set included all subjects who were exposed to at least one dose of trial product.

Posted

Number

percentage (%) of subjects

measured from screening until 5-7 weeks post Trial Drug Administration

ID	Title	Description
OG000	Placebo	Recombinant factor XIII placebo was administered as a single dose via slow i.v. push at a rate not exceeding two mL per minute.
OG001	FXIII17.5IU/Kg	Recombinant factor XIII at a single dose of 17.5 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
OG002	FXIII35IU/Kg	Recombinant factor XIII at a single dose of 35 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.

Units	Counts

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Haemolytic anaemia	Blood and lymphatic system disorders	MedDRA version 13.1	Systematic Assessment	EG0000 events0 affected128 at risk EG0011 events1 affected143 at risk EG0020 events0 affected138 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA version 13.1	Systematic Assessment	EG0000 events0 affected128 at risk EG0013 events3 affected143 at risk EG0020 events0 affected138 at risk
Angina pectoris	Cardiac disorders	MedDRA version 13.1	Systematic Assessment	EG0000 events0 affected128 at risk EG0010 events0 affected143 at risk EG0021 events1 affected138 at risk
Arrhythmia	Cardiac disorders	MedDRA version 13.1	Systematic Assessment	EG0000 events0 affected128 at risk EG0012 events2 affected143 at risk EG0020 events0 affected138 at risk
Arrhythmia supraventricular	Cardiac disorders	MedDRA version 13.1	Systematic Assessment	EG0000 events0 affected128 at risk EG0010 events0 affected143 at risk EG0021 events1 affected138 at risk
Atrial fibrillation	Cardiac disorders	MedDRA version 13.1	Systematic Assessment	EG0005 events5 affected128 at risk EG0013 events3 affected143 at risk EG0022 events2 affected138 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA version 13.1	Systematic Assessment	EG0000 events0 affected128 at risk EG0011 events1 affected143 at risk EG0023 events3 affected138 at risk
Bradyarrhythmia	Cardiac disorders	MedDRA version 13.1	Systematic Assessment	EG0001 events1 affected128 at risk EG0010 events0 affected143 at risk EG0020 events0 affected138 at risk
Bradycardia	Cardiac disorders	MedDRA version 13.1	Systematic Assessment	EG0000 events0 affected128 at risk EG0011 events1 affected143 at risk EG0020 events0 affected138 at risk
Cardiac arrest	Cardiac disorders	MedDRA version 13.1	Systematic Assessment	EG0000 events0 affected128 at risk EG0012 events2 affected143 at risk EG0020 events0 affected138 at risk
Cardiac failure	Cardiac disorders	MedDRA version 13.1	Systematic Assessment	EG0001 events1 affected128 at risk EG0011 events1 affected143 at risk EG0020 events0 affected138 at risk
Cardiac failure acute	Cardiac disorders	MedDRA version 13.1	Systematic Assessment	EG0000 events0 affected128 at risk EG0013 events3 affected143 at risk EG0020 events0 affected138 at risk
Cardiac tamponade	Cardiac disorders	MedDRA version 13.1	Systematic Assessment	EG0001 events1 affected128 at risk EG0012 events2 affected143 at risk EG0021 events1 affected138 at risk
Cardiogenic shock	Cardiac disorders	MedDRA version 13.1	Systematic Assessment	EG0000 events0 affected128 at risk EG0011 events1 affected143 at risk EG0020 events0 affected138 at risk
Dressler	Cardiac disorders	MedDRA version 13.1	Systematic Assessment	EG0000 events0 affected128 at risk EG0011 events1 affected143 at risk EG0020 events0 affected138 at risk
Mitral valve stenosis	Cardiac disorders	MedDRA version 13.1	Systematic Assessment	EG0000 events0 affected128 at risk EG0010 events0 affected143 at risk EG0021 events1 affected138 at risk
Myocardial infarction	Cardiac disorders	MedDRA version 13.1	Systematic Assessment	EG0002 events2 affected128 at risk EG0011 events1 affected143 at risk EG0020 events0 affected138 at risk
Nodal rhythm	Cardiac disorders	MedDRA version 13.1	Systematic Assessment	EG0000 events0 affected128 at risk EG0010 events0 affected143 at risk EG0021 events1 affected138 at risk
Pericardial effusion	Cardiac disorders	MedDRA version 13.1	Systematic Assessment	EG0000 events0 affected128 at risk EG0011 events1 affected143 at risk EG0021 events1 affected138 at risk
Pericarditis	Cardiac disorders	MedDRA version 13.1	Systematic Assessment	EG0001 events1 affected128 at risk EG0010 events0 affected143 at risk EG0020 events0 affected138 at risk
Tachyarrhythmia	Cardiac disorders	MedDRA version 13.1	Systematic Assessment	EG0001 events1 affected128 at risk EG0010 events0 affected143 at risk EG0020 events0 affected138 at risk
Tachycardia	Cardiac disorders	MedDRA version 13.1	Systematic Assessment	EG0001 events1 affected128 at risk EG0010 events0 affected143 at risk EG0020 events0 affected138 at risk
Retinal ischaemia	Eye disorders	MedDRA version 13.1	Systematic Assessment	EG0000 events0 affected128 at risk EG0011 events1 affected143 at risk EG0020 events0 affected138 at risk
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA version 13.1	Systematic Assessment	EG0000 events0 affected128 at risk EG0011 events1 affected143 at risk EG0020 events0 affected138 at risk
Gastric haemorrhage	Gastrointestinal disorders	MedDRA version 13.1	Systematic Assessment	EG0001 events1 affected128 at risk EG0010 events0 affected143 at risk EG0020 events0 affected138 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA version 13.1	Systematic Assessment	EG0001 events1 affected128 at risk EG0010 events0 affected143 at risk EG0020 events0 affected138 at risk
Peritonitis	Gastrointestinal disorders	MedDRA version 13.1	Systematic Assessment	EG0001 events1 affected128 at risk EG0010 events0 affected143 at risk EG0020 events0 affected138 at risk
Chest pain	General disorders	MedDRA version 13.1	Systematic Assessment	EG0001 events1 affected128 at risk EG0010 events0 affected143 at risk EG0020 events0 affected138 at risk
Drug intolerance	General disorders	MedDRA version 13.1	Systematic Assessment	EG0001 events1 affected128 at risk EG0010 events0 affected143 at risk EG0020 events0 affected138 at risk
Impaired healing	General disorders	MedDRA version 13.1	Systematic Assessment	EG0000 events0 affected128 at risk EG0010 events0 affected143 at risk EG0021 events1 affected138 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA version 13.1	Systematic Assessment	EG0000 events0 affected128 at risk EG0010 events0 affected143 at risk EG0022 events2 affected138 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA version 13.1	Systematic Assessment	EG0000 events0 affected128 at risk EG0010 events0 affected143 at risk EG0021 events1 affected138 at risk
Endocarditis bacterial	Infections and infestations	MedDRA version 13.1	Systematic Assessment	EG0000 events0 affected128 at risk EG0011 events1 affected143 at risk EG0020 events0 affected138 at risk
Enterococcal infection	Infections and infestations	MedDRA version 13.1	Systematic Assessment	EG0001 events1 affected128 at risk EG0010 events0 affected143 at risk EG0020 events0 affected138 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA version 13.1	Systematic Assessment	EG0000 events0 affected128 at risk EG0011 events1 affected143 at risk EG0020 events0 affected138 at risk
Lung infection pseudomonal	Infections and infestations	MedDRA version 13.1	Systematic Assessment	EG0000 events0 affected128 at risk EG0011 events1 affected143 at risk EG0020 events0 affected138 at risk
Mediastinitis	Infections and infestations	MedDRA version 13.1	Systematic Assessment	EG0000 events0 affected128 at risk EG0010 events0 affected143 at risk EG0021 events1 affected138 at risk
Pneumonia	Infections and infestations	MedDRA version 13.1	Systematic Assessment	EG0002 events2 affected128 at risk EG0011 events1 affected143 at risk EG0021 events1 affected138 at risk
Pneumonia klebsiella	Infections and infestations	MedDRA version 13.1	Systematic Assessment	EG0001 events1 affected128 at risk EG0010 events0 affected143 at risk EG0020 events0 affected138 at risk
Postoperative wound infection	Infections and infestations	MedDRA version 13.1	Systematic Assessment	EG0001 events1 affected128 at risk EG0010 events0 affected143 at risk EG0020 events0 affected138 at risk
Sepsis	Infections and infestations	MedDRA version 13.1	Systematic Assessment	EG0000 events0 affected128 at risk EG0010 events0 affected143 at risk EG0022 events2 affected138 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA version 13.1	Systematic Assessment	EG0000 events0 affected128 at risk EG0011 events1 affected143 at risk EG0020 events0 affected138 at risk
Staphylococcal infection	Infections and infestations	MedDRA version 13.1	Systematic Assessment	EG0001 events1 affected128 at risk EG0010 events0 affected143 at risk EG0020 events0 affected138 at risk
Wound infection	Infections and infestations	MedDRA version 13.1	Systematic Assessment	EG0001 events1 affected128 at risk EG0014 events4 affected143 at risk EG0021 events1 affected138 at risk
Wound infection bacterial	Infections and infestations	MedDRA version 13.1	Systematic Assessment	EG0001 events1 affected128 at risk EG0010 events0 affected143 at risk EG0020 events0 affected138 at risk
Collapse of lung	Injury, poisoning and procedural complications	MedDRA version 13.1	Systematic Assessment	EG0000 events0 affected128 at risk EG0010 events0 affected143 at risk EG0021 events1 affected138 at risk
Graft dysfunction	Injury, poisoning and procedural complications	MedDRA version 13.1	Systematic Assessment	EG0000 events0 affected128 at risk EG0012 events2 affected143 at risk EG0020 events0 affected138 at risk
Graft thrombosis	Injury, poisoning and procedural complications	MedDRA version 13.1	Systematic Assessment	EG0000 events0 affected128 at risk EG0011 events1 affected143 at risk EG0020 events0 affected138 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA version 13.1	Systematic Assessment	EG0002 events2 affected128 at risk EG0012 events2 affected143 at risk EG0021 events1 affected138 at risk
Postoperative thoracic procedure comp	Injury, poisoning and procedural complications	MedDRA version 13.1	Systematic Assessment	EG0000 events0 affected128 at risk EG0011 events1 affected143 at risk EG0020 events0 affected138 at risk
Postpericardiotomy syndrome	Injury, poisoning and procedural complications	MedDRA version 13.1	Systematic Assessment	EG0000 events0 affected128 at risk EG0011 events1 affected143 at risk EG0020 events0 affected138 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA version 13.1	Systematic Assessment	EG0001 events1 affected128 at risk EG0010 events0 affected143 at risk EG0020 events0 affected138 at risk
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA version 13.1	Systematic Assessment	EG0000 events0 affected128 at risk EG0010 events0 affected143 at risk EG0021 events1 affected138 at risk
Wound secretion	Injury, poisoning and procedural complications	MedDRA version 13.1	Systematic Assessment	EG0000 events0 affected128 at risk EG0010 events0 affected143 at risk EG0021 events1 affected138 at risk
Ejection fraction decreased	Investigations	MedDRA version 13.1	Systematic Assessment	EG0000 events0 affected128 at risk EG0010 events0 affected143 at risk EG0021 events1 affected138 at risk
Mobility decreased	Musculoskeletal and connective tissue disorders	MedDRA version 13.1	Systematic Assessment	EG0000 events0 affected128 at risk EG0011 events1 affected143 at risk EG0020 events0 affected138 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA version 13.1	Systematic Assessment	EG0001 events1 affected128 at risk EG0010 events0 affected143 at risk EG0020 events0 affected138 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA version 13.1	Systematic Assessment	EG0002 events2 affected128 at risk EG0011 events1 affected143 at risk EG0020 events0 affected138 at risk
Convulsion	Nervous system disorders	MedDRA version 13.1	Systematic Assessment	EG0002 events2 affected128 at risk EG0010 events0 affected143 at risk EG0021 events1 affected138 at risk
Grand mal convulsion	Nervous system disorders	MedDRA version 13.1	Systematic Assessment	EG0000 events0 affected128 at risk EG0010 events0 affected143 at risk EG0021 events1 affected138 at risk
Ischaemic cerebral infarction	Nervous system disorders	MedDRA version 13.1	Systematic Assessment	EG0000 events0 affected128 at risk EG0011 events1 affected143 at risk EG0020 events0 affected138 at risk
Ischaemic stroke	Nervous system disorders	MedDRA version 13.1	Systematic Assessment	EG0001 events1 affected128 at risk EG0010 events0 affected143 at risk EG0020 events0 affected138 at risk
Muscle contractions involuntary	Nervous system disorders	MedDRA version 13.1	Systematic Assessment	EG0000 events0 affected128 at risk EG0010 events0 affected143 at risk EG0021 events1 affected138 at risk
Reversible ischaemic neurological def.	Nervous system disorders	MedDRA version 13.1	Systematic Assessment	EG0000 events0 affected128 at risk EG0011 events1 affected143 at risk EG0020 events0 affected138 at risk
Syncope	Nervous system disorders	MedDRA version 13.1	Systematic Assessment	EG0000 events0 affected128 at risk EG0011 events1 affected143 at risk EG0020 events0 affected138 at risk
Delirium	Psychiatric disorders	MedDRA version 13.1	Systematic Assessment	EG0000 events0 affected128 at risk EG0011 events1 affected143 at risk EG0020 events0 affected138 at risk
Mental disorder	Psychiatric disorders	MedDRA version 13.1	Systematic Assessment	EG0000 events0 affected128 at risk EG0010 events0 affected143 at risk EG0021 events1 affected138 at risk
Renal failure	Renal and urinary disorders	MedDRA version 13.1	Systematic Assessment	EG0000 events0 affected128 at risk EG0011 events1 affected143 at risk EG0021 events1 affected138 at risk
Renal failure acute	Renal and urinary disorders	MedDRA version 13.1	Systematic Assessment	EG0000 events0 affected128 at risk EG0011 events1 affected143 at risk EG0021 events1 affected138 at risk
Renal impairment	Renal and urinary disorders	MedDRA version 13.1	Systematic Assessment	EG0001 events1 affected128 at risk EG0011 events1 affected143 at risk EG0021 events1 affected138 at risk
Urinary retention	Renal and urinary disorders	MedDRA version 13.1	Systematic Assessment	EG0001 events1 affected128 at risk EG0010 events0 affected143 at risk EG0020 events0 affected138 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA version 13.1	Systematic Assessment	EG0001 events1 affected128 at risk EG0010 events0 affected143 at risk EG0020 events0 affected138 at risk
Bronchial haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA version 13.1	Systematic Assessment	EG0000 events0 affected128 at risk EG0011 events1 affected143 at risk EG0020 events0 affected138 at risk
Bronchopleural fistula	Respiratory, thoracic and mediastinal disorders	MedDRA version 13.1	Systematic Assessment	EG0001 events1 affected128 at risk EG0010 events0 affected143 at risk EG0020 events0 affected138 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA version 13.1	Systematic Assessment	EG0000 events0 affected128 at risk EG0011 events1 affected143 at risk EG0021 events1 affected138 at risk
Chylothorax	Respiratory, thoracic and mediastinal disorders	MedDRA version 13.1	Systematic Assessment	EG0000 events0 affected128 at risk EG0010 events0 affected143 at risk EG0021 events1 affected138 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA version 13.1	Systematic Assessment	EG0001 events1 affected128 at risk EG0010 events0 affected143 at risk EG0021 events1 affected138 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA version 13.1	Systematic Assessment	EG0001 events1 affected128 at risk EG0010 events0 affected143 at risk EG0022 events2 affected138 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA version 13.1	Systematic Assessment	EG0001 events1 affected128 at risk EG0010 events0 affected143 at risk EG0020 events0 affected138 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA version 13.1	Systematic Assessment	EG0003 events3 affected128 at risk EG0013 events3 affected143 at risk EG0022 events2 affected138 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA version 13.1	Systematic Assessment	EG0000 events0 affected128 at risk EG0012 events2 affected143 at risk EG0021 events1 affected138 at risk
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	MedDRA version 13.1	Systematic Assessment	EG0000 events0 affected128 at risk EG0010 events0 affected143 at risk EG0021 events1 affected138 at risk
Pulmonary infarction	Respiratory, thoracic and mediastinal disorders	MedDRA version 13.1	Systematic Assessment	EG0001 events1 affected128 at risk EG0010 events0 affected143 at risk EG0020 events0 affected138 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA version 13.1	Systematic Assessment	EG0001 events1 affected128 at risk EG0010 events0 affected143 at risk EG0020 events0 affected138 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA version 13.1	Systematic Assessment	EG0001 events1 affected128 at risk EG0013 events2 affected143 at risk EG0022 events2 affected138 at risk
Subcutaneous emphysema	Skin and subcutaneous tissue disorders	MedDRA version 13.1	Systematic Assessment	EG0001 events1 affected128 at risk EG0010 events0 affected143 at risk EG0020 events0 affected138 at risk
Deep vein thrombosis	Vascular disorders	MedDRA version 13.1	Systematic Assessment	EG0001 events1 affected128 at risk EG0010 events0 affected143 at risk EG0021 events1 affected138 at risk
Haemorrhage	Vascular disorders	MedDRA version 13.1	Systematic Assessment	EG0000 events0 affected128 at risk EG0012 events2 affected143 at risk EG0020 events0 affected138 at risk
Hypertension	Vascular disorders	MedDRA version 13.1	Systematic Assessment	EG0001 events1 affected128 at risk EG0010 events0 affected143 at risk EG0020 events0 affected138 at risk
Peripheral ischaemia	Vascular disorders	MedDRA version 13.1	Systematic Assessment	EG0000 events0 affected128 at risk EG0010 events0 affected143 at risk EG0021 events1 affected138 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA version 13.1	Systematic Assessment	EG00025 events25 affected128 at risk EG00125 events24 affected143 at risk EG00219 events19 affected138 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA version 13.1	Systematic Assessment	EG0009 events9 affected128 at risk EG0016 events6 affected143 at risk EG00211 events11 affected138 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA version 13.1	Systematic Assessment	EG00011 events10 affected128 at risk EG0015 events5 affected143 at risk EG0027 events7 affected138 at risk
Atrial fibrillation	Cardiac disorders	MedDRA version 13.1	Systematic Assessment	EG00056 events50 affected128 at risk EG00148 events45 affected143 at risk EG00249 events44 affected138 at risk
Low cardiac output syndrome	Cardiac disorders	MedDRA version 13.1	Systematic Assessment	EG0009 events9 affected128 at risk EG0013 events3 affected143 at risk EG00210 events10 affected138 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA version 13.1	Systematic Assessment	EG0006 events6 affected128 at risk EG0014 events4 affected143 at risk EG0027 events7 affected138 at risk
Constipation	Gastrointestinal disorders	MedDRA version 13.1	Systematic Assessment	EG0006 events6 affected128 at risk EG0016 events6 affected143 at risk EG0029 events9 affected138 at risk
Nausea	Gastrointestinal disorders	MedDRA version 13.1	Systematic Assessment	EG00034 events34 affected128 at risk EG00138 events38 affected143 at risk EG00246 events46 affected138 at risk
Vomiting	Gastrointestinal disorders	MedDRA version 13.1	Systematic Assessment	EG00013 events10 affected128 at risk EG00115 events15 affected143 at risk EG00221 events21 affected138 at risk
Chills	General disorders	MedDRA version 13.1	Systematic Assessment	EG00012 events12 affected128 at risk EG0015 events5 affected143 at risk EG0028 events8 affected138 at risk
Oedema peripheral	General disorders	MedDRA version 13.1	Systematic Assessment	EG00019 events18 affected128 at risk EG00127 events23 affected143 at risk EG00228 events25 affected138 at risk
Pyrexia	General disorders	MedDRA version 13.1	Systematic Assessment	EG00017 events17 affected128 at risk EG00115 events15 affected143 at risk EG00215 events14 affected138 at risk
Anaemia postoperative	Injury, poisoning and procedural complications	MedDRA version 13.1	Systematic Assessment	EG0008 events8 affected128 at risk EG0017 events7 affected143 at risk EG0029 events8 affected138 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA version 13.1	Systematic Assessment	EG00035 events34 affected128 at risk EG00147 events45 affected143 at risk EG00247 events45 affected138 at risk
Wound secretion	Injury, poisoning and procedural complications	MedDRA version 13.1	Systematic Assessment	EG0004 events4 affected128 at risk EG0014 events4 affected143 at risk EG00210 events10 affected138 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA version 13.1	Systematic Assessment	EG0004 events4 affected128 at risk EG0018 events8 affected143 at risk EG0023 events3 affected138 at risk
Urine output decreased	Investigations	MedDRA version 13.1	Systematic Assessment	EG0009 events9 affected128 at risk EG0019 events9 affected143 at risk EG0029 events9 affected138 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA version 13.1	Systematic Assessment	EG00011 events11 affected128 at risk EG00110 events10 affected143 at risk EG00215 events15 affected138 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA version 13.1	Systematic Assessment	EG00016 events16 affected128 at risk EG00119 events19 affected143 at risk EG00221 events21 affected138 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA version 13.1	Systematic Assessment	EG00012 events12 affected128 at risk EG00112 events12 affected143 at risk EG0027 events7 affected138 at risk
Dizziness	Nervous system disorders	MedDRA version 13.1	Systematic Assessment	EG0004 events4 affected128 at risk EG0019 events8 affected143 at risk EG0029 events9 affected138 at risk
Agitation	Psychiatric disorders	MedDRA version 13.1	Systematic Assessment	EG0009 events8 affected128 at risk EG0015 events5 affected143 at risk EG0024 events4 affected138 at risk
Delirium	Psychiatric disorders	MedDRA version 13.1	Systematic Assessment	EG00010 events10 affected128 at risk EG0013 events3 affected143 at risk EG0021 events1 affected138 at risk
Renal impairment	Renal and urinary disorders	MedDRA version 13.1	Systematic Assessment	EG00010 events9 affected128 at risk EG00111 events10 affected143 at risk EG0024 events4 affected138 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA version 13.1	Systematic Assessment	EG00013 events13 affected128 at risk EG00116 events15 affected143 at risk EG00213 events13 affected138 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA version 13.1	Systematic Assessment	EG0007 events7 affected128 at risk EG0017 events7 affected143 at risk EG0029 events9 affected138 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA version 13.1	Systematic Assessment	EG00050 events48 affected128 at risk EG00145 events42 affected143 at risk EG00254 events52 affected138 at risk
Hypertension	Vascular disorders	MedDRA version 13.1	Systematic Assessment	EG0005 events5 affected128 at risk EG0015 events5 affected143 at risk EG00213 events13 affected138 at risk
Hypotension	Vascular disorders	MedDRA version 13.1	Systematic Assessment	EG00029 events28 affected128 at risk EG00117 events17 affected143 at risk EG00222 events21 affected138 at risk
Haemorrhage	Vascular disorders	MedDRA version 13.1	Systematic Assessment	EG0004 events4 affected128 at risk EG0019 events9 affected143 at risk EG0025 events5 affected138 at risk

ID	Title	Description
BG000	Placebo	Recombinant factor XIII placebo was administered as a single dose via slow i.v. push at a rate not exceeding two mL per minute.
BG001	FXIII17.5IU/Kg	Recombinant factor XIII at a single dose of 17.5 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
BG002	FXIII35IU/Kg	Recombinant factor XIII at a single dose of 35 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
BG003	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Recombinant factor XIII placebo was administered as a single dose via slow i.v. push at a rate not exceeding two mL per minute.	35	128	120	128
EG001	FXIII17.5IU/Kg	Recombinant factor XIII at a single dose of 17.5 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.	43	143	129	143
EG002	FXIII35IU/Kg	Recombinant factor XIII at a single dose of 35 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.	32	138	128	138