Effectiveness and Safety of CELSTAT for Hemostasis in Int... | NCT02640235

Label	Type	Description	Intervention Names
CELSTAT	Experimental	Oxidized cellulose strip (CELSTAT), Single-use treatment, Intraoperative, direct application to target bleeding site	Device: CELSTAT
Surgicel Original	Active Comparator	Oxidized regenerated cellulose strip (Surgicel Original), Single-use treatment, Intraoperative, direct application to target bleeding site	Device: Surgicel Original

Name	Type	Description	Arm Group Labels	Other Names
CELSTAT	Device		CELSTAT
Surgicel Original

Measure	Description	Time Frame
Number of Participants With Hemostasis Achieved at Target Bleeding Site Within 5 Minutes After Application	Hemostasis is a process to prevent and stop bleeding within damaged blood vessels. Once the product(s) is applied it absorbs blood, turns brown, and adheres to the wound, thereby preventing thrombocytes from being washed out and accelerating hemostasis. Target bleeding sites include mild to moderate parenchymal (organ tissue),vascular (small arteries or veins or surgical reconnections) and soft tissue (muscle, fat, ligament, connective tissue) bleeding.	5 minute (post-application)
Number of Participants With Post-operative Re-bleeding at Target Bleeding Site Requiring Surgical Re-exploration	Findings are reported in this outcome measure and would have also been reported as an AE.	Day 1 to Day 91

Measure	Description	Time Frame
Time to Final Hemostasis at Target Bleeding Site by Percentage of Participants	Data presented is an interpretation of a Kaplan-Meier plot based on quartiles of the survival distribution estimate. "Survival" times need not relate to actual survival with death being the event; the "event" may be any event of interest. The Kaplan-Meier curves and estimates of survival data have become a familiar way of dealing with differing survival times (times-to-event).

Name	Affiliation	Role
Qing Li, MD	Baxter Healthcare Corporation	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Washington Hospital Center		Washington D.C.	District of Columbia	20010	United States
University of Florida College of Medicine

ID	Title	Description
FG000	CELSTAT	Oxidized cellulose strip (CELSTAT), Single-use treatment, Intraoperative, direct application to target bleeding site CELSTAT
FG001	Surgicel Original	Oxidized regenerated cellulose strip (Surgicel Original), Single-use treatment, Intraoperative, direct application to target bleeding site Surgicel Original

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Nov 9, 2015	Jun 23, 2020

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

Number of Participants With Hemostasis Achieved at Target Bleeding Site Within 5 Minutes After Application

Hemostasis is a process to prevent and stop bleeding within damaged blood vessels. Once the product(s) is applied it absorbs blood, turns brown, and adheres to the wound, thereby preventing thrombocytes from being washed out and accelerating hemostasis. Target bleeding sites include mild to moderate parenchymal (organ tissue),vascular (small arteries or veins or surgical reconnections) and soft tissue (muscle, fat, ligament, connective tissue) bleeding.

PPS

Posted

Count of Participants

Participants

5 minute (post-application)

ID	Title	Description
OG000	CELSTAT	Oxidized cellulose strip (CELSTAT), Single-use treatment, Intraoperative, direct application to target bleeding site CELSTAT
OG001	Surgicel Original	Oxidized regenerated cellulose strip (Surgicel Original), Single-use treatment, Intraoperative, direct application to target bleeding site Surgicel Original

Units	Counts
Participants	OG000126 OG001124

Title

Denominators

Categories

Title	Measurements
Yes	OG00094 OG001109
No	OG00032

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				Difference in avg predicted proportion	-8.5			2-Sided	95	-15.6	-1.4					Non-Inferiority	The logistic regression estimates are generated from predicted values of the fitted logistic regression model. If the lower bound of the 95% confidence interval is greater than -10, Celstat is non-inferior to Surgicel. If the lower bound of the 95% confidence interval is greater than 0, Celstat will be declared superior to Surgicel.

Primary

Number of Participants With Post-operative Re-bleeding at Target Bleeding Site Requiring Surgical Re-exploration

Findings are reported in this outcome measure and would have also been reported as an AE.

Safety Analysis Set - all subjects who were treated with CELSTAT or Surgicel.

Posted

Count of Participants

Participants

Day 1 to Day 91

ID	Title	Description
OG000	CELSTAT	Oxidized cellulose strip (CELSTAT), Single-use treatment, Intraoperative, direct application to target bleeding site CELSTAT
OG001	Surgicel Original	Oxidized regenerated cellulose strip (Surgicel Original), Single-use treatment, Intraoperative, direct application to target bleeding site Surgicel Original

Units	Counts
Participants	OG000

Secondary

Time to Final Hemostasis at Target Bleeding Site by Percentage of Participants

Data presented is an interpretation of a Kaplan-Meier plot based on quartiles of the survival distribution estimate. "Survival" times need not relate to actual survival with death being the event; the "event" may be any event of interest. The Kaplan-Meier curves and estimates of survival data have become a familiar way of dealing with differing survival times (times-to-event).

PPS

Posted

Mean

95% Confidence Interval

minutes

0 to 10 minutes (post-application)

ID	Title	Description
OG000	CELSTAT	Oxidized cellulose strip (CELSTAT), Single-use treatment, Intraoperative, direct application to target bleeding site CELSTAT
OG001	Surgicel Original	Oxidized regenerated cellulose strip (Surgicel Original), Single-use treatment, Intraoperative, direct application to target bleeding site Surgicel Original

Units	Counts
Participants	OG000

Secondary

Number of Participants Achieving Intraoperative Hemostasis at Target Bleeding Site Within 3 Minutes After Application

The achievement or lack of hemostasis following treatment application to the treatment bleeding site was recorded at different (intraoperative) time points during the first 10 minutes after the start of device application.

PPS

Posted

Count of Participants

Participants

3 minutes (post application)

ID	Title	Description
OG000	CELSTAT	Oxidized cellulose strip (CELSTAT), Single-use treatment, Intraoperative, direct application to target bleeding site CELSTAT
OG001	Surgicel Original	Oxidized regenerated cellulose strip (Surgicel Original), Single-use treatment, Intraoperative, direct application to target bleeding site Surgicel Original

Units	Counts
Participants	OG000

Secondary

Number of Participants Achieving Intraoperative Hemostasis at Target Bleeding Site Within 7 Minutes After Application

PPS

Posted

Count of Participants

Participants

7 minutes (post application)

ID	Title	Description
OG000	CELSTAT	Oxidized cellulose strip (CELSTAT), Single-use treatment, Intraoperative, direct application to target bleeding site CELSTAT
OG001	Surgicel Original	Oxidized regenerated cellulose strip (Surgicel Original), Single-use treatment, Intraoperative, direct application to target bleeding site Surgicel Original

Units	Counts
Participants	OG000

Secondary

Number of Participants Achieving Intraoperative Hemostasis at Target Bleeding Site Within 10 Minutes After Application

PPS

Posted

Count of Participants

Participants

10 minutes (post application)

ID	Title	Description
OG000	CELSTAT	Oxidized cellulose strip (CELSTAT), Single-use treatment, Intraoperative, direct application to target bleeding site CELSTAT
OG001	Surgicel Original	Oxidized regenerated cellulose strip (Surgicel Original), Single-use treatment, Intraoperative, direct application to target bleeding site Surgicel Original

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Intra-operative Re-bleeding at Target Bleeding Site After Achieving Hemostasis

If intraoperative re-bleeding occurred, the primary endpoint was considered "treatment failure."

PPS

Posted

Number

Percentage of Participants

0 to 10 minutes (post-application)

ID	Title	Description
OG000	CELSTAT	Oxidized cellulose strip (CELSTAT), Single-use treatment, Intraoperative, direct application to target bleeding site CELSTAT
OG001	Surgicel Original	Oxidized regenerated cellulose strip (Surgicel Original), Single-use treatment, Intraoperative, direct application to target bleeding site Surgicel Original

Units	Counts
Participants	OG000

Secondary

Number of Occurrences of Treatment Emergent Adverse Events (Serious and Non-Serious)

Adverse Events (AEs) that occurred after the start of study treatment application are referred to as "treatment-emergent AEs" (TEAE). Timeframe for tracking AE's up to Day 91 (minus/plus 10 days=from Day 81 to Day 101).

Safety Analysis Set

Posted

Number

events

Day 1 to Day 91

ID	Title	Description
OG000	CELSTAT	Oxidized cellulose strip (CELSTAT), Single-use treatment, Intraoperative, direct application to target bleeding site CELSTAT
OG001	Surgicel Original	Oxidized regenerated cellulose strip (Surgicel Original), Single-use treatment, Intraoperative, direct application to target bleeding site Surgicel Original

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Acute Myocardial Infarction	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0002 events2 affected133 at risk EG0010 events0 affected127 at risk
Angina Pectoris	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0002 events2 affected133 at risk EG0013 events3 affected127 at risk
Atrioventricular Block Complete	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Bradycardia	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Cardiac Arrest	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Cardiac Failure Congestive	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk
Pulseless Electrical Activity	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk
Supraventricular Tachycardia	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0011 events1 affected127 at risk
Tachycardia	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk
Enterovesical Fistula	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Chest Pain	General disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Impaired Healing	General disorders	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk
Multi-Organ Failure	General disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0011 events1 affected127 at risk
Pyrexia	General disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Thrombosis In Device	General disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Bronchitis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk
Cellulitis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0012 events2 affected127 at risk
Pneumonia	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0012 events2 affected127 at risk
Postoperative Wound Infection	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0011 events1 affected127 at risk
Sepsis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0002 events2 affected133 at risk EG0010 events0 affected127 at risk
Urinary Tract Infection	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0002 events2 affected133 at risk EG0010 events0 affected127 at risk
Post Procedural Haemorrhage	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0012 events2 affected127 at risk
Postoperative Thoracic Procedure Complication	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Vascular Graft Occlusion	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0002 events2 affected133 at risk EG0010 events0 affected127 at risk
Vascular Graft Thrombosis	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk
Wound Dehiscence	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0012 events2 affected127 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk
Lung Adenocarcinoma Metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk
Metastases To Liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk
Cerebrovascular Accident	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Encephalopathy	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk
Partial Seizures	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Syncope	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Tremor	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk
Acute Kidney Injury	Renal and urinary disorders	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk
Chronic Kidney Disease	Renal and urinary disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Vaginal Haemorrhage	Reproductive system and breast disorders	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk
Acute Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0011 events1 affected127 at risk
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0011 events1 affected127 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Aortic Occlusion	Vascular disorders	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk
Lymphorrhoea	Vascular disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Orthostatic Hypotension	Vascular disorders	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk
Peripheral Arterial Occlusive	Vascular disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Peripheral Artery Stenosis	Vascular disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Peripheral Vascular Disorder	Vascular disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (18.0)	Systematic Assessment	EG0005 events5 affected133 at risk EG0016 events6 affected127 at risk
Coagulopathy	Blood and lymphatic system disorders	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk
Haemolysis	Blood and lymphatic system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Haemorrhagic Anaemia	Blood and lymphatic system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (18.0)	Systematic Assessment	EG0002 events2 affected133 at risk EG0011 events1 affected127 at risk
Thrombocytosis	Blood and lymphatic system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Acute Myocardial Infarction	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG00016 events16 affected133 at risk EG00113 events13 affected127 at risk
Atrial Flutter	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk
Bradycardia	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0012 events2 affected127 at risk
Cardiac Failure Acute	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk
Cardiac Tamponade	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Cardiogenic Shock	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk
Mitral Valve Incompetence	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0011 events1 affected127 at risk
Nodal Rhythm	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Pericardial Effusion	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk
Supraventricular Tachycardia	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0012 events2 affected127 at risk
Tachycardia	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0003 events3 affected133 at risk EG0011 events1 affected127 at risk
Ventricular Tachycardia	Cardiac disorders	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0012 events2 affected127 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Vertigo	Ear and labyrinth disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0011 events1 affected127 at risk
Vertigo Positional	Ear and labyrinth disorders	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk
Conjunctival Haemorrhage	Eye disorders	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk
Vision Blurred	Eye disorders	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk
Abdominal Distension	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Abdominal Mass	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0011 events1 affected127 at risk
Acquired Oesophageal Web	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Ascites	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk
Constipation	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0002 events2 affected133 at risk EG0015 events5 affected127 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0006 events6 affected133 at risk EG0013 events3 affected127 at risk
Diverticulum	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Dysphagia	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0013 events3 affected127 at risk
Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0003 events3 affected133 at risk EG0010 events0 affected127 at risk
Gastrooesophageal Reflux Disease	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0002 events2 affected133 at risk EG0011 events1 affected127 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Ileus	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk
Impaired Gastric Emptying	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0002 events2 affected133 at risk EG0010 events0 affected127 at risk
Nausea	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0009 events9 affected133 at risk EG0014 events4 affected127 at risk
Rectal Haemorrhage	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk
Vomiting	Gastrointestinal disorders	MedDRA (18.0)	Systematic Assessment	EG0002 events2 affected133 at risk EG0012 events2 affected127 at risk
Asthenia	General disorders	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk
Catheter Site Pain	General disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Chest Pain	General disorders	MedDRA (18.0)	Systematic Assessment	EG0002 events2 affected133 at risk EG0014 events4 affected127 at risk
Device Leakage	General disorders	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk
Device Occlusion	General disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Fatigue	General disorders	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk
General Physical Health Deterioration	General disorders	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk
Hyperthermia	General disorders	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk
Impaired Healing	General disorders	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk
Implant Site Pain	General disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Implant Site Swelling	General disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Mucosal Inflammation	General disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Oedema Peripheral	General disorders	MedDRA (18.0)	Systematic Assessment	EG0003 events3 affected133 at risk EG0013 events3 affected127 at risk
Peripheral Swelling	General disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Polyp	General disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Pyrexia	General disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0011 events1 affected127 at risk
Stent-Graft Endoleak	General disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA (18.0)	Systematic Assessment	EG0002 events2 affected133 at risk EG0011 events1 affected127 at risk
Ischaemic Hepatitis	Hepatobiliary disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Drug Hypersensitivity	Immune system disorders	MedDRA (18.0)	Systematic Assessment	EG0002 events2 affected133 at risk EG0010 events0 affected127 at risk
Bronchitis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0002 events2 affected133 at risk EG0011 events1 affected127 at risk
Cellulitis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0012 events2 affected127 at risk
Clostridium Difficile Colitis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk
Endometritis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk
Fungal Skin Infection	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk
Gastritis Viral	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk
Gastrointestinal Infection	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk
Groin Infection	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Implant Site Infection	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Incision Site Infection	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Liver Abscess	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk
Oral Candidiasis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Oral Fungal Infection	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk
Pneumonia	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk
Post Procedural Cellulitis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Postoperative Abscess	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Postoperative Wound Infection	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0002 events2 affected133 at risk EG0011 events1 affected127 at risk
Sinusitis	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk
Soft Tissue Infection	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Urinary Tract Infection	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0004 events4 affected133 at risk EG0016 events6 affected127 at risk
Viral Upper Respiratory Tract Infection	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Wound Infection	Infections and infestations	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0011 events1 affected127 at risk
Anaemia Postoperative	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0004 events4 affected133 at risk EG0014 events4 affected127 at risk
Corneal Abrasion	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0012 events2 affected127 at risk
Incision Site Erythema	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk
Incision Site Swelling	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Inflammation Of Wound	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk
Post Procedural Discharge	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Post Procedural Haemorrhage	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Postoperative Ileus	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0003 events3 affected133 at risk EG0011 events1 affected127 at risk
Postoperative Wound Complication	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0011 events1 affected127 at risk
Procedural Dizziness	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk
Procedural Haemorrhage	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0011 events1 affected127 at risk
Procedural Hypotension	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0004 events4 affected133 at risk EG0016 events6 affected127 at risk
Procedural Nausea	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk
Procedural Pain	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0002 events2 affected133 at risk EG0010 events0 affected127 at risk
Rib Fracture	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk
Seroma	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Skin Abrasion	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Wound	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Wound Dehiscence	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0002 events2 affected133 at risk EG0010 events0 affected127 at risk
Wound Haematoma	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk
Wound Secretion	Injury, poisoning and procedural complications	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk
Alanine Aminotransferase Increased	Investigations	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0012 events2 affected127 at risk
Anticoagulation Drug Level Below Therapeutic	Investigations	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk
Blood Alkaline Phosphatase Increased	Investigations	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0011 events1 affected127 at risk
Blood Creatinine Increased	Investigations	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0012 events2 affected127 at risk
Blood Gases Abnormal	Investigations	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk
Blood Glucose Increased	Investigations	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk
Blood Parathyroid Hormone Increased	Investigations	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Blood Potassium Decreased	Investigations	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Blood Urea Increased	Investigations	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk
Breath Sounds Abnormal	Investigations	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Cardiac Index Decreased	Investigations	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk
Heart Rate Increased	Investigations	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Transaminases Increased	Investigations	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0012 events2 affected127 at risk
Urine Output Decreased	Investigations	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0012 events2 affected127 at risk
Weight Decreased	Investigations	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
White Blood Cell Count Increased	Investigations	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Decreased Appetite	Metabolism and nutrition disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk
Electrolyte Imbalance	Metabolism and nutrition disorders	MedDRA (18.0)	Systematic Assessment	EG0002 events2 affected133 at risk EG0010 events0 affected127 at risk
Fluid Overload	Metabolism and nutrition disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0011 events1 affected127 at risk
Gout	Metabolism and nutrition disorders	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Hypermagnesaemia	Metabolism and nutrition disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Hypernatraemia	Metabolism and nutrition disorders	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0013 events3 affected127 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (18.0)	Systematic Assessment	EG0003 events3 affected133 at risk EG0013 events3 affected127 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (18.0)	Systematic Assessment	EG0007 events7 affected133 at risk EG0012 events2 affected127 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA (18.0)	Systematic Assessment	EG0003 events3 affected133 at risk EG0010 events0 affected127 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (18.0)	Systematic Assessment	EG0004 events4 affected133 at risk EG0011 events1 affected127 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0012 events2 affected127 at risk
Metabolic Acidosis	Metabolism and nutrition disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Vitamin D Deficiency	Metabolism and nutrition disorders	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0002 events2 affected133 at risk EG0010 events0 affected127 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk
Muscular Weakness	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0002 events2 affected133 at risk EG0011 events1 affected127 at risk
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0002 events2 affected133 at risk EG0010 events0 affected127 at risk
Neck Pain	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Prostate Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Carotid Artery Stenosis	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Carpal Tunnel Syndrome	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Cerebrovascular Accident	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Dizziness	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Dizziness Postural	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk
Dysgeusia	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0002 events2 affected133 at risk EG0010 events0 affected127 at risk
Headache	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0011 events1 affected127 at risk
Hypoaesthesia	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0011 events1 affected127 at risk
Hypoglossal Nerve Disorder	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Neuralgia	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Paraesthesia	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0013 events3 affected127 at risk
Restless Legs Syndrome	Nervous system disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Anxiety	Psychiatric disorders	MedDRA (18.0)	Systematic Assessment	EG0002 events2 affected133 at risk EG0012 events2 affected127 at risk
Confusional State	Psychiatric disorders	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk
Delirium	Psychiatric disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Depression	Psychiatric disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Insomnia	Psychiatric disorders	MedDRA (18.0)	Systematic Assessment	EG0002 events2 affected133 at risk EG0011 events1 affected127 at risk
Acute Kidney Injury	Renal and urinary disorders	MedDRA (18.0)	Systematic Assessment	EG0004 events4 affected133 at risk EG0012 events2 affected127 at risk
Calculus Bladder	Renal and urinary disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Chronic Kidney Disease	Renal and urinary disorders	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0012 events2 affected127 at risk
Dysuria	Renal and urinary disorders	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk
Haematuria	Renal and urinary disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Oliguria	Renal and urinary disorders	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk
Renal Cyst	Renal and urinary disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Urinary Retention	Renal and urinary disorders	MedDRA (18.0)	Systematic Assessment	EG0002 events2 affected133 at risk EG0013 events3 affected127 at risk
Epididymal Tenderness	Reproductive system and breast disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Scrotal Swelling	Reproductive system and breast disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Acute Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0002 events2 affected133 at risk EG0011 events1 affected127 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0014 events4 affected127 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0002 events2 affected133 at risk EG0011 events1 affected127 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0004 events4 affected133 at risk EG0011 events1 affected127 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0011 events1 affected127 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Lung Infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0006 events6 affected133 at risk EG0016 events6 affected127 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0012 events2 affected127 at risk
Productive Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Pulmonary Hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Respiratory Distress	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Systematic Assessment	EG0002 events2 affected133 at risk EG0014 events4 affected127 at risk
Blister	Skin and subcutaneous tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Decubitus Ulcer	Skin and subcutaneous tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Dermatitis Allergic	Skin and subcutaneous tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk
Drug Eruption	Skin and subcutaneous tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk
Dry Skin	Skin and subcutaneous tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0012 events2 affected127 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0011 events1 affected127 at risk
Pruritus Allergic	Skin and subcutaneous tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Pruritus Generalised	Skin and subcutaneous tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk
Skin Irritation	Skin and subcutaneous tissue disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Deep Vein Thrombosis	Vascular disorders	MedDRA (18.0)	Systematic Assessment	EG0002 events2 affected133 at risk EG0010 events0 affected127 at risk
Haematoma	Vascular disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Hypertension	Vascular disorders	MedDRA (18.0)	Systematic Assessment	EG0005 events5 affected133 at risk EG0014 events4 affected127 at risk
Hypotension	Vascular disorders	MedDRA (18.0)	Systematic Assessment	EG0003 events3 affected133 at risk EG0013 events3 affected127 at risk
Hypovolaemic Shock	Vascular disorders	MedDRA (18.0)	Systematic Assessment	EG0001 events1 affected133 at risk EG0010 events0 affected127 at risk
Thrombophlebitis	Vascular disorders	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk
Vasodilatation	Vascular disorders	MedDRA (18.0)	Systematic Assessment	EG0000 events0 affected133 at risk EG0011 events1 affected127 at risk

ID	Title	Description
BG000	CELSTAT	Oxidized cellulose strip (CELSTAT), Single-use treatment, Intraoperative, direct application to target bleeding site CELSTAT
BG001	Surgicel Original	Oxidized regenerated cellulose strip (Surgicel Original), Single-use treatment, Intraoperative, direct application to target bleeding site Surgicel Original
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	CELSTAT	Oxidized cellulose strip (CELSTAT), Single-use treatment, Intraoperative, direct application to target bleeding site CELSTAT	2	133	27	133	72	133
EG001	Surgicel Original	Oxidized regenerated cellulose strip (Surgicel Original), Single-use treatment, Intraoperative, direct application to target bleeding site Surgicel Original	3	127	23	127	68	127