Lung Volume Reduction Coil Treatment in Patients With Emp... | NCT01608490

Name	Class
PneumRx, Inc.	INDUSTRY

Label	Type	Description	Intervention Names
RePneu Lung Volume Reduction Coil System	Experimental	The RePneu Lung Volume Reduction Coil System is an implantable device, delivered through a fiber-optic bronchoscope. This is a two part system that consists of 1) sterile Nitinol Coils and 2) a sterile, disposable, single-use (single-patient) Delivery System consisting of a Guidewire, Catheter, Cartridge, and Forceps.	Device: RePneu Lung Volume Reduction Coil System
Control arm is standard medical care	No Intervention	The Control Group will not undergo any bronchoscopies for Coil placement and will not receive prophylactic antibiotics or steroids before and after 'treatment' or chest x-rays in connection with the 'treatment' visits. The frequency of visits to the Study Doctor or designee will be similar to the LVRC Group.

Name	Type	Description	Arm Group Labels	Other Names
RePneu Lung Volume Reduction Coil System	Device	The LVRC group will undergo two bronchoscopic sessions under general or moderate sedation. During the procedure, subjects will be treated with Coils according to the Instructions for Use.

Measure	Description	Time Frame
Meters: 6 Minute Walk Test - Change From Baseline to 12 Months Follow up	mean absolute change from baseline at 12 months in the 6 Minute Walk Test comparing test and control groups (median if skewed)	baseline through 12 months follow up

Measure	Description	Time Frame
Mean Percent Change in FEV1 From Baseline to 12 Months	Mean percent change in FEV1(Forced Expiratory Volume in 1 second) at 12 months (median if skewed)	BL to 12 months
St. George's Respiratory Questionnaire (SGRQ) Mean Absolute Change From Baseline to 12 Months

Measure	Description	Time Frame
SGRQ Responder Analysis	SGRQ Responder Analysis: Responder defined as those with an improvement greater than or equal to 4 points	12 months
Residual Volume (RV) Mean Absolute Difference in RV From Baseline to 12 Months

Name	Affiliation	Role
Charlie Strange, MD	Medical University of South Carolina	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama Lung Health Center		Birmingham	Alabama	35294	United States
Cedars Sinai Medical Center

PubMed Identifier	Type	Citation	Retractions
32267059	Derived	Hartman JE, Shah PL, Sciurba F, Herth FJF, Slebos DJ; RENEW Study Group. Endobronchial coils for emphysema: Dual mechanism of action on lobar residual volume reduction. Respirology. 2020 Nov;25(11):1160-1166. doi: 10.1111/resp.13816. Epub 2020 Apr 8.
30797746	Derived	Slebos DJ, Cicenia J, Sciurba FC, Criner GJ, Hartman JE, Garner J, Deslee G, Delage A, Jantz M, Marquette CH, Strange C, Hatipoglu U, Mehta AC, LaPrad AS, Schmid-Bindert G, Herth FJF, Shah PL; RENEW Study Group. Predictors of Response to Endobronchial Coil Therapy in Patients With Advanced Emphysema. Chest. 2019 May;155(5):928-937. doi: 10.1016/j.chest.2019.02.012. Epub 2019 Feb 21.

ID	Title	Description
FG000	RePneu Lung Volume Reduction Coil System	The RePneu Lung Volume Reduction Coil System is an implantable device, delivered through a fiber-optic bronchoscope. This is a two part system that consists of 1) sterile Nitinol Coils and 2) a sterile, disposable, single-use (single-patient) Delivery System consisting of a Guidewire, Catheter, Cartridge, and Forceps. RePneu Lung Volume Reduction Coil System: The LVRC group will undergo two bronchoscopic sessions under general or moderate sedation. During the procedure, subjects will be treated with Coils according to the Instructions for Use.

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

Meters: 6 Minute Walk Test - Change From Baseline to 12 Months Follow up

mean absolute change from baseline at 12 months in the 6 Minute Walk Test comparing test and control groups (median if skewed)

Patients who were analyzed at 12 months.

Posted

Median

Inter-Quartile Range

meters

baseline through 12 months follow up

ID	Title	Description
OG000	RePneu Lung Volume Reduction Coil System	The RePneu Lung Volume Reduction Coil System is an implantable device, delivered through a fiber-optic bronchoscope. This is a two part system that consists of 1) sterile Nitinol Coils and 2) a sterile, disposable, single-use (single-patient) Delivery System consisting of a Guidewire, Catheter, Cartridge, and Forceps. RePneu Lung Volume Reduction Coil System: The LVRC group will undergo two bronchoscopic sessions under general or moderate sedation. During the procedure, subjects will be treated with Coils according to the Instructions for Use.
OG001	Control Arm is Standard Medical Care	The Control Group will not undergo any bronchoscopies for Coil placement and will not receive prophylactic antibiotics or steroids before and after 'treatment' or chest x-rays in connection with the 'treatment' visits. The frequency of visits to the Study Doctor or designee will be similar to the LVRC Group.

Units	Counts
Participants	OG000158 OG001157

Title

Denominators

Categories

Title	Measurements
	OG00010.3(-33.0 to 45.0) OG001-7.6(-40.0 to 26.0)

Secondary

Mean Percent Change in FEV1 From Baseline to 12 Months

Mean percent change in FEV1(Forced Expiratory Volume in 1 second) at 12 months (median if skewed)

Posted

Median

Inter-Quartile Range

percentage change

BL to 12 months

ID	Title	Description
OG000	RePneu Lung Volume Reduction Coil System	The RePneu Lung Volume Reduction Coil System is an implantable device, delivered through a fiber-optic bronchoscope. This is a two part system that consists of 1) sterile Nitinol Coils and 2) a sterile, disposable, single-use (single-patient) Delivery System consisting of a Guidewire, Catheter, Cartridge, and Forceps. RePneu Lung Volume Reduction Coil System: The LVRC group will undergo two bronchoscopic sessions under general or moderate sedation. During the procedure, subjects will be treated with Coils according to the Instructions for Use.
OG001	Control Arm is Standard Medical Care	The Control Group will not undergo any bronchoscopies for Coil placement and will not receive prophylactic antibiotics or steroids before and after 'treatment' or chest x-rays in connection with the 'treatment' visits. The frequency of visits to the Study Doctor or designee will be similar to the LVRC Group.

Units	Counts

Secondary

St. George's Respiratory Questionnaire (SGRQ) Mean Absolute Change From Baseline to 12 Months

mean absolute difference in SGRQ results comparing BL to 12 months, LVRC vs. Control, score is on a scale from 0 to 100, negative change will be a better outcome.

Posted

Mean

Standard Error

score on a scale

BL to 12 months

ID	Title	Description
OG000	RePneu Lung Volume Reduction Coil System	The RePneu Lung Volume Reduction Coil System is an implantable device, delivered through a fiber-optic bronchoscope. This is a two part system that consists of 1) sterile Nitinol Coils and 2) a sterile, disposable, single-use (single-patient) Delivery System consisting of a Guidewire, Catheter, Cartridge, and Forceps. RePneu Lung Volume Reduction Coil System: The LVRC group will undergo two bronchoscopic sessions under general or moderate sedation. During the procedure, subjects will be treated with Coils according to the Instructions for Use.
OG001	Control Arm is Standard Medical Care	The Control Group will not undergo any bronchoscopies for Coil placement and will not receive prophylactic antibiotics or steroids before and after 'treatment' or chest x-rays in connection with the 'treatment' visits. The frequency of visits to the Study Doctor or designee will be similar to the LVRC Group.

Secondary

6MWT Responder Analysis

6MWT Responder Analysis: Responder is defined as those with an improvement of greater than or equal to 25 meters

Posted

Count of Participants

Participants

12 months

ID	Title	Description
OG000	RePneu Lung Volume Reduction Coil System	The RePneu Lung Volume Reduction Coil System is an implantable device, delivered through a fiber-optic bronchoscope. This is a two part system that consists of 1) sterile Nitinol Coils and 2) a sterile, disposable, single-use (single-patient) Delivery System consisting of a Guidewire, Catheter, Cartridge, and Forceps. RePneu Lung Volume Reduction Coil System: The LVRC group will undergo two bronchoscopic sessions under general or moderate sedation. During the procedure, subjects will be treated with Coils according to the Instructions for Use.
OG001	Control Arm is Standard Medical Care	The Control Group will not undergo any bronchoscopies for Coil placement and will not receive prophylactic antibiotics or steroids before and after 'treatment' or chest x-rays in connection with the 'treatment' visits. The frequency of visits to the Study Doctor or designee will be similar to the LVRC Group.

Units	Counts

Other Pre-specified

SGRQ Responder Analysis

SGRQ Responder Analysis: Responder defined as those with an improvement greater than or equal to 4 points

Posted

Count of Participants

Participants

12 months

ID	Title	Description
OG000	RePneu Lung Volume Reduction Coil System	The RePneu Lung Volume Reduction Coil System is an implantable device, delivered through a fiber-optic bronchoscope. This is a two part system that consists of 1) sterile Nitinol Coils and 2) a sterile, disposable, single-use (single-patient) Delivery System consisting of a Guidewire, Catheter, Cartridge, and Forceps. RePneu Lung Volume Reduction Coil System: The LVRC group will undergo two bronchoscopic sessions under general or moderate sedation. During the procedure, subjects will be treated with Coils according to the Instructions for Use.
OG001	Control Arm is Standard Medical Care	The Control Group will not undergo any bronchoscopies for Coil placement and will not receive prophylactic antibiotics or steroids before and after 'treatment' or chest x-rays in connection with the 'treatment' visits. The frequency of visits to the Study Doctor or designee will be similar to the LVRC Group.

Units	Counts

Other Pre-specified

Residual Volume (RV) Mean Absolute Difference in RV From Baseline to 12 Months

Mean absolute difference in RV results measured using plethysmography, comparing BL to 12 months, LVRC vs. Control

Posted

Mean

Standard Error

liters

12 months

ID	Title	Description
OG000	RePneu Lung Volume Reduction Coil System	The RePneu Lung Volume Reduction Coil System is an implantable device, delivered through a fiber-optic bronchoscope. This is a two part system that consists of 1) sterile Nitinol Coils and 2) a sterile, disposable, single-use (single-patient) Delivery System consisting of a Guidewire, Catheter, Cartridge, and Forceps. RePneu Lung Volume Reduction Coil System: The LVRC group will undergo two bronchoscopic sessions under general or moderate sedation. During the procedure, subjects will be treated with Coils according to the Instructions for Use.
OG001	Control Arm is Standard Medical Care	The Control Group will not undergo any bronchoscopies for Coil placement and will not receive prophylactic antibiotics or steroids before and after 'treatment' or chest x-rays in connection with the 'treatment' visits. The frequency of visits to the Study Doctor or designee will be similar to the LVRC Group.

Units	Counts

Other Pre-specified

RV/TLC Mean Absolute Difference From Baseline to 12 Months

Mean absolute difference in RV/TLC (residual volume/total lung capacity - a measure done during lung function testing where residual volume is air left over in lung after completely breathing out and total lung capacity is how much air the lung can breathe in) results measured using plethysmography, comparing BL to 12 months, LVRC vs. Control

Posted

Mean

Standard Error

percent

12 months

ID	Title	Description
OG000	RePneu Lung Volume Reduction Coil System	The RePneu Lung Volume Reduction Coil System is an implantable device, delivered through a fiber-optic bronchoscope. This is a two part system that consists of 1) sterile Nitinol Coils and 2) a sterile, disposable, single-use (single-patient) Delivery System consisting of a Guidewire, Catheter, Cartridge, and Forceps. RePneu Lung Volume Reduction Coil System: The LVRC group will undergo two bronchoscopic sessions under general or moderate sedation. During the procedure, subjects will be treated with Coils according to the Instructions for Use.
OG001	Control Arm is Standard Medical Care	The Control Group will not undergo any bronchoscopies for Coil placement and will not receive prophylactic antibiotics or steroids before and after 'treatment' or chest x-rays in connection with the 'treatment' visits. The frequency of visits to the Study Doctor or designee will be similar to the LVRC Group.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute myocardial infarction	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0002 events2 affected155 at risk EG0010 events0 affected157 at risk
Angina pectoris	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0002 events2 affected155 at risk EG0010 events0 affected157 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0002 events2 affected155 at risk EG0010 events0 affected157 at risk
Cardiac failure	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Cardiomyopathy	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Sinus tachycardia	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Tachycardia	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Colitis	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0002 events1 affected155 at risk EG0010 events0 affected157 at risk
Diverticulum	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Food poisoning	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Pneumoperitoneum	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0011 events1 affected157 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0011 events1 affected157 at risk
Adverse drug reaction	General disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Asthenia	General disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Chest pain	General disorders	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Medical device complication	General disorders	MedDRA (15.0)	Systematic Assessment	EG0005 events5 affected155 at risk EG0010 events0 affected157 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Allergy to metals	Immune system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Latex allergy	Immune system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Abdominal sepsis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Bronchitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0005 events5 affected155 at risk EG0012 events2 affected157 at risk
Bronchitis bacterial	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Bronchopulmonary aspergillosis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0003 events3 affected155 at risk EG0010 events0 affected157 at risk
Diverticulitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Gastrointestinal infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Influenza	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0002 events2 affected155 at risk EG0011 events1 affected157 at risk
Lung infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0003 events2 affected155 at risk EG0011 events1 affected157 at risk
Lung infection pseudomonal	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Pneumonia	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG00034 events31 affected155 at risk EG00110 events8 affected157 at risk
Pneumonia staphylococcal	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Pseudomonas infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Sepsis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Septic shock	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Subacute endocarditis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Tracheobronchitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Wound infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Anastomotic leak	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Pneumothorax traumatic	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Influenza A virus test positive	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0011 events1 affected157 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Benign lymph node neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Bone neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Thyroid neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Ischaemic stroke	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Sciatica	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Syncope	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0012 events2 affected157 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Renal failure acute	Renal and urinary disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0003 events3 affected155 at risk EG0012 events1 affected157 at risk
Bronchial secretion retention	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG00070 events43 affected155 at risk EG00146 events32 affected157 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0006 events5 affected155 at risk EG0011 events1 affected157 at risk
Emphysema	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0011 events1 affected157 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0004 events4 affected155 at risk EG0010 events0 affected157 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG00015 events15 affected155 at risk EG0011 events1 affected157 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0002 events2 affected155 at risk EG0010 events0 affected157 at risk
Pulmonary venous thrombosis	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0005 events5 affected155 at risk EG0011 events1 affected157 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Aortic aneurysm	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Coeliac artery occlusion	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Deep vein thrombosis	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0002 events2 affected155 at risk EG0010 events0 affected157 at risk
Haemotoma	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Hypotension	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0002 events1 affected155 at risk EG0010 events0 affected157 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (15.0)	Systematic Assessment	EG0003 events3 affected155 at risk EG0010 events0 affected157 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0002 events2 affected155 at risk EG0010 events0 affected157 at risk
Angina pectoris	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0002 events2 affected155 at risk EG0011 events1 affected157 at risk
Atrial fibrillation	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0003 events3 affected155 at risk EG0012 events2 affected157 at risk
Cardiac failure	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Cardiomyopathy	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Left ventricular failure	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Palpitations	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Sinus tachycardia	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0003 events3 affected155 at risk EG0010 events0 affected157 at risk
Supraventricular extrasystoles	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Tachyarrhthmia	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Tachycardia	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0003 events3 affected155 at risk EG0015 events4 affected157 at risk
Hydrocele	Congenital, familial and genetic disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Ear pain	Ear and labyrinth disorders	MedDRA (15.0)	Systematic Assessment	EG0002 events1 affected155 at risk EG0010 events0 affected157 at risk
Vertigo	Ear and labyrinth disorders	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Hypothyroidism	Endocrine disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0013 events3 affected157 at risk
Cataract	Eye disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0013 events3 affected157 at risk
Conjunctival haemorrhage	Eye disorders	MedDRA (15.0)	Systematic Assessment	EG0002 events2 affected155 at risk EG0010 events0 affected157 at risk
Conjunctivitis	Eye disorders	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0012 events2 affected157 at risk
Eye haemorrhage	Eye disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Glaucoma	Eye disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0006 events6 affected155 at risk EG0011 events1 affected157 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0002 events2 affected155 at risk EG0010 events0 affected157 at risk
Colitis	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0002 events1 affected155 at risk EG0010 events0 affected157 at risk
Constipation	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0003 events2 affected155 at risk EG0010 events0 affected157 at risk
Dental caries	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0004 events4 affected155 at risk EG0012 events2 affected157 at risk
Diverticulum	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Dry mouth	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Dysphagia	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0012 events2 affected157 at risk
Food poisoning	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Gastroesophageal reflux disease	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0005 events5 affected155 at risk EG0011 events1 affected157 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Nausea	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0004 events4 affected155 at risk EG0011 events1 affected157 at risk
Pneumoperitoneum	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Rectal haemorrhage	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0011 events1 affected157 at risk
Tooth disorder	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Tooth fracture	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Tooth loss	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Toothache	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0011 events1 affected157 at risk
Vomiting	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Adverse drug reaction	General disorders	MedDRA (15.0)	Systematic Assessment	EG0002 events2 affected155 at risk EG0010 events0 affected157 at risk
Asthenia	General disorders	MedDRA (15.0)	Systematic Assessment	EG0003 events3 affected155 at risk EG0010 events0 affected157 at risk
Chest discomfort	General disorders	MedDRA (15.0)	Systematic Assessment	EG00030 events20 affected155 at risk EG0011 events1 affected157 at risk
Chest pain	General disorders	MedDRA (15.0)	Systematic Assessment	EG00014 events10 affected155 at risk EG0014 events4 affected157 at risk
Face oedema	General disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Fatigue	General disorders	MedDRA (15.0)	Systematic Assessment	EG0002 events2 affected155 at risk EG0011 events1 affected157 at risk
Hyperthermia	General disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Influenza like illness	General disorders	MedDRA (15.0)	Systematic Assessment	EG0003 events3 affected155 at risk EG0010 events0 affected157 at risk
Injection site extravasation	General disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Medical device complication	General disorders	MedDRA (15.0)	Systematic Assessment	EG0008 events7 affected155 at risk EG0010 events0 affected157 at risk
Medical device pain	General disorders	MedDRA (15.0)	Systematic Assessment	EG0002 events2 affected155 at risk EG0010 events0 affected157 at risk
Non-cardiac chest pain	General disorders	MedDRA (15.0)	Systematic Assessment	EG00028 events21 affected155 at risk EG0010 events0 affected157 at risk
Oedema	General disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Oedema peripheral	General disorders	MedDRA (15.0)	Systematic Assessment	EG00011 events11 affected155 at risk EG0014 events4 affected157 at risk
Pain	General disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Pyrexia	General disorders	MedDRA (15.0)	Systematic Assessment	EG0002 events2 affected155 at risk EG0010 events0 affected157 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Hyperbilirubinemia	Hepatobiliary disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Allergy to metals	Immune system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Drug hypersensitivity	Immune system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Hypersensitivity	Immune system disorders	MedDRA (15.0)	Systematic Assessment	EG0002 events2 affected155 at risk EG0010 events0 affected157 at risk
Latex allergy	Immune system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Seasonal allergy	Immune system disorders	MedDRA (15.0)	Systematic Assessment	EG0002 events2 affected155 at risk EG0012 events2 affected157 at risk
Abdominal sepsis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Acute sinusitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0002 events1 affected155 at risk EG0012 events2 affected157 at risk
Bronchiolitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Bronchitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG00031 events21 affected155 at risk EG00132 events25 affected157 at risk
Bronchitis bacterial	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Bronchitis viral	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Bronchopulmonary aspergillosis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0004 events4 affected155 at risk EG0010 events0 affected157 at risk
Candidiasis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0005 events5 affected155 at risk EG0014 events3 affected157 at risk
Cellulitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Cystitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0013 events2 affected157 at risk
Diverticulitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Endophthalmitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Ersipelas	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Fungal infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Furuncle	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0011 events1 affected157 at risk
Gastroenteritis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0002 events2 affected155 at risk EG0012 events2 affected157 at risk
Gastroenteritis viral	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0002 events2 affected155 at risk EG0010 events0 affected157 at risk
Gastrointestinal infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Gastrointestinal viral infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Genital abscess	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Herpes simplex	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Herpes zoster	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0002 events2 affected155 at risk EG0010 events0 affected157 at risk
Infected bites	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Infectious disease carrier	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Influenza	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0005 events5 affected155 at risk EG0013 events3 affected157 at risk
Laryngitis fungal	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Lower respiratory tract infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0002 events2 affected155 at risk EG0010 events0 affected157 at risk
Lung infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0004 events2 affected155 at risk EG0012 events2 affected157 at risk
Lung infection pseudomonal	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Nasopharyngitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG00013 events10 affected155 at risk EG0016 events6 affected157 at risk
Onychomycosis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Oral candidiasis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG00013 events10 affected155 at risk EG0016 events4 affected157 at risk
Oral fungal infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0002 events1 affected155 at risk EG0012 events2 affected157 at risk
Oral herpes	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Orchitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Pharyngitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Pneumonia	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG00044 events36 affected155 at risk EG00114 events12 affected157 at risk
Pneumonia staphylococcal	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Pseudomonas bronchitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Pseudomonas infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Respiratory monoliasis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Respiratory tract infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0012 events1 affected157 at risk
Rhinitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0002 events2 affected155 at risk EG0015 events5 affected157 at risk
Sepsis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Septic shock	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Sinusitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0004 events4 affected155 at risk EG00112 events8 affected157 at risk
Skin infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Sputum purulent	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0012 events2 affected157 at risk
Subacute endocarditis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Tinea infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Tooth abscess	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0012 events1 affected157 at risk
Tracheobronchitis	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0004 events3 affected155 at risk EG0011 events1 affected157 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG00010 events9 affected155 at risk EG0019 events9 affected157 at risk
Urinary tract infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0008 events5 affected155 at risk EG0016 events6 affected157 at risk
Volvovaginal mycotic infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0011 events1 affected157 at risk
Wound infection	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Anastomotic leak	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0004 events4 affected155 at risk EG0012 events2 affected157 at risk
Muscle rupture	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0012 events2 affected157 at risk
Pneumothorax traumatic	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Post procedural complication	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Procedural complication	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Procedural hemorrhage	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0002 events2 affected155 at risk EG0010 events0 affected157 at risk
Procedural nausea	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0003 events2 affected155 at risk EG0010 events0 affected157 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0002 events2 affected155 at risk EG0010 events0 affected157 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0004 events4 affected155 at risk EG0010 events0 affected157 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Skin wound	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Spinal compression fracture	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0002 events2 affected155 at risk EG0011 events1 affected157 at risk
Tooth injury	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Wound	Injury, poisoning and procedural complications	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Antibiotic resistant Staphylococcus test positive	Investigations	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
C-reactive protein increased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Eosinophil count increased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Influenza A virus test positive	Investigations	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Neutrophil count increased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Oxygen saturation decreased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Platelet count increased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Sputum abnormal	Investigations	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Weight decreased	Investigations	MedDRA (15.0)	Systematic Assessment	EG0002 events2 affected155 at risk EG0013 events3 affected157 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Gout	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0002 events2 affected155 at risk EG0011 events1 affected157 at risk
Hyperlipidaemia	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0002 events2 affected155 at risk EG0010 events0 affected157 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Overweight	Metabolism and nutrition disorders	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0002 events2 affected155 at risk EG0012 events2 affected157 at risk
Arthropathy	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0007 events6 affected155 at risk EG0013 events3 affected157 at risk
Bursitis	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0011 events1 affected157 at risk
Flank pain	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0002 events2 affected155 at risk EG0013 events3 affected157 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0005 events5 affected155 at risk EG0011 events1 affected157 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0005 events5 affected155 at risk EG0010 events0 affected157 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Myalgia intercostal	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0004 events4 affected155 at risk EG0011 events1 affected157 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0002 events2 affected155 at risk EG0010 events0 affected157 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0012 events2 affected157 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Bone neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Lung neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Systematic Assessment	EG00011 events11 affected155 at risk EG0011 events1 affected157 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Thyroid neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Convulsion	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Dizziness	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0002 events2 affected155 at risk EG0011 events1 affected157 at risk
Headache	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG00023 events18 affected155 at risk EG0010 events0 affected157 at risk
Ischaemic stroke	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Peripheral paralysis	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Radiculopathy	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Sciatica	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0013 events3 affected157 at risk
Somnolence	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Syncope	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0002 events2 affected155 at risk EG0010 events0 affected157 at risk
Tension headache	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0012 events2 affected157 at risk
VIIth nerve paralysis	Nervous system disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Anxiety	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG0003 events3 affected155 at risk EG0014 events4 affected157 at risk
Delirium	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Depression	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG0003 events3 affected155 at risk EG0015 events4 affected157 at risk
Insomnia	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG0002 events2 affected155 at risk EG0012 events2 affected157 at risk
Major depression	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Panic attack	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0011 events1 affected157 at risk
Somnambulism	Psychiatric disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Cystitis haemorrhagic	Renal and urinary disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Dysuria	Renal and urinary disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Haematuria	Renal and urinary disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0011 events1 affected157 at risk
Hypertonic bladder	Renal and urinary disorders	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0011 events1 affected157 at risk
Renal failure acute	Renal and urinary disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Urinary incontinence	Renal and urinary disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Urinary retention	Renal and urinary disorders	MedDRA (15.0)	Systematic Assessment	EG0006 events6 affected155 at risk EG0011 events1 affected157 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0011 events1 affected157 at risk
Cervix haemorrhage uterine	Reproductive system and breast disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Gynaecomastia	Reproductive system and breast disorders	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0011 events1 affected157 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0003 events3 affected155 at risk EG0012 events1 affected157 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Bronchial disorder	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Bronchial secretion retention	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Bronchitis chronic	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0012 events1 affected157 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0004 events4 affected155 at risk EG0010 events0 affected157 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG000228 events108 affected155 at risk EG001185 events91 affected157 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG00041 events28 affected155 at risk EG0013 events3 affected157 at risk
Dysaesthesia pharynx	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0002 events2 affected155 at risk EG0010 events0 affected157 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG00041 events33 affected155 at risk EG00115 events12 affected157 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0002 events2 affected155 at risk EG0010 events0 affected157 at risk
Emphysema	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0011 events1 affected157 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG000140 events91 affected155 at risk EG0010 events0 affected157 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0011 events1 affected157 at risk
Increased upper airway secretion	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Lung consolidation	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0003 events3 affected155 at risk EG0010 events0 affected157 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Lung infiltration	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0002 events2 affected155 at risk EG0011 events1 affected157 at risk
Nasal discomfort	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG00016 events12 affected155 at risk EG0014 events4 affected157 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0006 events5 affected155 at risk EG0010 events0 affected157 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG00018 events18 affected155 at risk EG0011 events1 affected157 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0013 events2 affected157 at risk
Pulmonary congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0007 events6 affected155 at risk EG0011 events1 affected157 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0002 events2 affected155 at risk EG0010 events0 affected157 at risk
Pulmonary venous thrombosis	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0005 events5 affected155 at risk EG0011 events1 affected157 at risk
Respiratory tract haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Respiratory tract irritation	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0012 events2 affected157 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0012 events2 affected157 at risk
Sputum discolored	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0004 events2 affected155 at risk EG0010 events0 affected157 at risk
Sputum increased	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Sputum retention	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Throat irritation	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG00022 events14 affected155 at risk EG0011 events1 affected157 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Dermal cyst	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0012 events2 affected157 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Livedo reticularis	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0011 events1 affected157 at risk
Rash erythematous	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Rosacea	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Swelling face	Skin and subcutaneous tissue disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Sinus operation	Surgical and medical procedures	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Aortic aneurysm	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Coeliac artery occlusion	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Deep vein thrombosis	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0002 events2 affected155 at risk EG0010 events0 affected157 at risk
Haemotoma	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0002 events2 affected155 at risk EG0011 events1 affected157 at risk
Hypertension	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0005 events5 affected155 at risk EG0012 events2 affected157 at risk
Hypotension	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0007 events6 affected155 at risk EG0010 events0 affected157 at risk
Phlebitis superficial	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Venous insufficiency	Vascular disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Supraventricular Tachycardia	Cardiac disorders	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Genital Herpes	Infections and infestations	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Benign Lymph Node Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Breast Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (15.0)	Systematic Assessment	EG0001 events1 affected155 at risk EG0010 events0 affected157 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA (15.0)	Systematic Assessment	EG0000 events0 affected155 at risk EG0011 events1 affected157 at risk

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease
D020969	Disease Attributes

ID	Title	Description
BG000	RePneu Lung Volume Reduction Coil System	The RePneu Lung Volume Reduction Coil System is an implantable device, delivered through a fiber-optic bronchoscope. This is a two part system that consists of 1) sterile Nitinol Coils and 2) a sterile, disposable, single-use (single-patient) Delivery System consisting of a Guidewire, Catheter, Cartridge, and Forceps. RePneu Lung Volume Reduction Coil System: The LVRC group will undergo two bronchoscopic sessions under general or moderate sedation. During the procedure, subjects will be treated with Coils according to the Instructions for Use.
BG001	Control Arm is Standard Medical Care	The Control Group will not undergo any bronchoscopies for Coil placement and will not receive prophylactic antibiotics or steroids before and after 'treatment' or chest x-rays in connection with the 'treatment' visits. The frequency of visits to the Study Doctor or designee will be similar to the LVRC Group.
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	RePneu Lung Volume Reduction Coil System	The RePneu Lung Volume Reduction Coil System is an implantable device, delivered through a fiber-optic bronchoscope. This is a two part system that consists of 1) sterile Nitinol Coils and 2) a sterile, disposable, single-use (single-patient) Delivery System consisting of a Guidewire, Catheter, Cartridge, and Forceps. RePneu Lung Volume Reduction Coil System: The LVRC group will undergo two bronchoscopic sessions under general or moderate sedation. During the procedure, subjects will be treated with Coils according to the Instructions for Use.	10	155	78	155	155	155
EG001	Control Arm is Standard Medical Care	The Control Group will not undergo any bronchoscopies for Coil placement and will not receive prophylactic antibiotics or steroids before and after 'treatment' or chest x-rays in connection with the 'treatment' visits. The frequency of visits to the Study Doctor or designee will be similar to the LVRC Group.	8	157	44	157	142	157

ID	Term
D004646	Emphysema
D029424	Pulmonary Disease, Chronic Obstructive