A Clinical Trial to Assess the Agent Paclitaxel Coated PT... | NCT04647253

Status Module

Label	Type	Description	Intervention Names
AGENT DCB	Experimental	Agent DCB is a Monorail Percutaneous Transluminal Coronary Angioplasty (PTCA) balloon catheter with a semi-compliant balloon coated with a formulation of paclitaxel (drug) and an excipient, Acetyl-Tri-n-butyl citrate (ATBC). The balloon catheter platform is based on the commercially available BSC Emerge™ PTCA balloon catheter system (K130391).	Device: AGENT DCB
Commercially available, PTCA Dilation Catheter	Active Comparator		Device: PTCA balloon catheter

Name	Type	Description	Arm Group Labels	Other Names
AGENT DCB	Device	Drug coated PTCA balloon catheter	AGENT DCB
PTCA balloon catheter

Measure	Description	Time Frame
Number of Participants With Target Lesion Failure	The primary endpoint is the 12-month Target Lesion Failure (TLF) rate, defined as any ischemia-driven revascularization of the target lesion (TLR), myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel, or cardiac death	12-month

Eligibility Module

Eligibility Criteria

Clinical Inclusion Criteria

Subject must be at least 18 years of age
Subject (or legal guardian) understands the trial requirements and the treatment procedures, and provides written informed consent before any trial-specific tests or procedures are performed
Subject is eligible for percutaneous coronary intervention (PCI)
Subject is willing to comply with all protocol-required follow-up evaluation
Women of child-bearing potential must agree to use a reliable method of contraception from the time of screening through 12 months after the index procedure

Angiographic Inclusion Criteria (visual estimate)

In-stent restenosis in a lesion previously treated with either a drug-eluting stent or bare metal stent, located in a native coronary artery with a visually estimated reference vessel diameter (RVD) > 2.0 mm and ≤ 4.0 mm.
Target lesion length must be < 26 mm (by visual estimate) and must be covered by only one balloon.
Target lesion must have visually estimated stenosis > 50% and < 100% in symptomatic patients (>70% and <100% in asymptomatic patients) prior to lesion pre-dilation.
Target lesion must be successfully pre-dilated.

o Note: Successful predilation/pretreatment refers to dilation with a balloon catheter of appropriate length and diameter, or pretreatment with directional or rotational coronary atherectomy, laser or cutting/scoring balloon with no greater than 50% residual stenosis and no dissection greater than National Heart, Lung, Blood Institute (NHLBI) type C. Thrombolysis in Myocardial Infarction (TIMI) grade flow in the target lesion must be >2
If a non-target lesion is treated, it must be treated first and must be deemed a success.
- Note: Successful treatment of a non-target lesion is defined as a residual stenosis of ≤ 30% in 2 near-orthogonal projections with TIMI 3 flow, as visually assessed by the physician, without the occurrence of prolonged chest pain or ECG changes consistent with MI.

Clinical Exclusion Criteria

Subject has other serious medical illness (e.g. cancer, congestive heart failure) that may reduce life expectancy to less than 24 months.
Subject has current problems with substance abuse (e.g. alcohol, cocaine, heroin, etc.).
Subject has planned procedure that may cause non-compliance with the protocol or confound data interpretation.
Subject is participating in another investigational drug or device clinical study that has not reached its primary endpoint.
Subject intends to participate in another investigational drug or device clinical study within 12 months after the index procedure.
Woman who is pregnant or nursing. (A pregnancy test must be performed within 7 days prior to the index procedure, except for women who definitely do not have child-bearing potential.)
Left ventricular ejection fraction known to be < 25%.
Subject had PCI or other coronary interventions within the last 30 days.
Planned PCI or CABG after the index procedure.
STEMI or QWMI <72h prior to the index procedure.
Cardiogenic shock (SBP < 80 mmHg requiring inotropes, IABP or fluid support).
Known allergies against paclitaxel or other components of the used medical devices.
Known hypersensitivity or contraindication for contrast dye that in the opinion of the investigator cannot be adequately pre-medicated.
Intolerance to antiplatelet drugs, anticoagulants required for procedure.
Platelet count < 100k/mm3 (risk of bleeding) or > 700k/mm3.
Subject with renal insufficiency (creatinine ≥2.0 mg/dl) or failure (dialysis dependent).
Subject has suspected or proven COVID-19 at present or within the past 4 weeks with resolution of symptoms.

Angiographic Exclusion Criteria (visual estimate)

Target lesion is located within a bifurcation with planned treatment of side branch vessel.
Target lesion is located within a saphenous vein or arterial graft.
Thrombus present in the target vessel
> 50% stenosis of an additional lesion proximal or clinically significant distal (>2.0mm RVD) to the target lesion.
Patient with unprotected left main coronary artery disease. (>50% diameter stenosis)

Name	Affiliation	Role
Robert Yeh, MD	Beth Israel Deaconess Medical Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham		Birmingham	Alabama	35233	United States
Carondelet Medical Group St. Mary's Hospital

PubMed Identifier	Type	Citation	Retractions
34314727	Background	Yeh RW, Bachinsky W, Stoler R, Bateman C, Tremmel JA, Abbott JD, Dohad S, Batchelor W, Underwood P, Allocco DJ, Kirtane AJ. Rationale and design of a randomized study comparing the agent drug coated balloon to plain old balloon angioplasty in patients with In-stent restenosis. Am Heart J. 2021 Nov;241:101-107. doi: 10.1016/j.ahj.2021.07.008. Epub 2021 Jul 24.
38460161

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	AGENT DCB	Agent DCB is a Monorail Percutaneous Transluminal Coronary Angioplasty (PTCA) balloon catheter with a semi-compliant balloon coated with a formulation of paclitaxel (drug) and an excipient, Acetyl-Tri-n-butyl citrate (ATBC). The balloon catheter platform is based on the commercially available BSC Emerge™ PTCA balloon catheter system (K130391). AGENT DCB: Drug coated PTCA balloon catheter

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Apr 14, 2023	Apr 11, 2024

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG00071 OG00154

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		z-test with unpooled variance		0.0025	a priori threshold for statistical significance was 0.025	Rate difference between treatment groups	-10.8			2-Sided	95	-18.4	-3.3					Superiority

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Angina unstable	Cardiac disorders	Systematic Assessment	EG00043 events35 affected406 at risk EG00136 events25 affected194 at risk
Angina pectoris	Cardiac disorders	Systematic Assessment	EG00043 events40 affected406 at risk EG00128 events23 affected194 at risk
Acute myocardial infarction	Cardiac disorders	Systematic Assessment	EG00025 events21 affected406 at risk EG00116 events14 affected194 at risk
Coronary artery disease	Cardiac disorders	Systematic Assessment	EG00021 events21 affected406 at risk EG00112 events11 affected194 at risk
Atrial fibrillation	Cardiac disorders	Systematic Assessment	EG00016 events14 affected406 at risk EG0015 events5 affected194 at risk
Cardiac failure	Cardiac disorders	Systematic Assessment	EG00017 events10 affected406 at risk EG0012 events2 affected194 at risk
Cardiac failure congestive	Cardiac disorders	Systematic Assessment	EG0008 events7 affected406 at risk EG00110 events8 affected194 at risk
Myocardial infarction	Cardiac disorders	Systematic Assessment	EG0007 events7 affected406 at risk EG0012 events2 affected194 at risk
Acute coronary syndrome	Cardiac disorders	Systematic Assessment	EG0005 events5 affected406 at risk EG0012 events2 affected194 at risk
Cardiac failure acute	Cardiac disorders	Systematic Assessment	EG0003 events3 affected406 at risk EG0014 events4 affected194 at risk
Left ventricular failure	Cardiac disorders	Systematic Assessment	EG0003 events3 affected406 at risk EG0012 events2 affected194 at risk
Atrial flutter	Cardiac disorders	Systematic Assessment	EG0003 events3 affected406 at risk EG0011 events1 affected194 at risk
Coronary artery stenosis	Cardiac disorders	Systematic Assessment	EG0003 events3 affected406 at risk EG0011 events1 affected194 at risk
Ischaemic cardiomyopathy	Cardiac disorders	Systematic Assessment	EG0004 events4 affected406 at risk EG0010 events0 affected194 at risk
Ventricular fibrillation	Cardiac disorders	Systematic Assessment	EG0003 events3 affected406 at risk EG0011 events1 affected194 at risk
Aortic valve stenosis	Cardiac disorders	Systematic Assessment	EG0002 events2 affected406 at risk EG0011 events1 affected194 at risk
Atrioventricular block second degree	Cardiac disorders	Systematic Assessment	EG0003 events3 affected406 at risk EG0010 events0 affected194 at risk
Bradycardia	Cardiac disorders	Systematic Assessment	EG0002 events2 affected406 at risk EG0011 events1 affected194 at risk
Cardiogenic shock	Cardiac disorders	Systematic Assessment	EG0002 events2 affected406 at risk EG0011 events1 affected194 at risk
Arteriosclerosis coronary artery	Cardiac disorders	Systematic Assessment	EG0002 events2 affected406 at risk EG0010 events0 affected194 at risk
Bundle branch block right	Cardiac disorders	Systematic Assessment	EG0002 events2 affected406 at risk EG0010 events0 affected194 at risk
Cardiac arrest	Cardiac disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0011 events1 affected194 at risk
Cardiac tamponade	Cardiac disorders	Systematic Assessment	EG0002 events1 affected406 at risk EG0010 events0 affected194 at risk
Cardiomyopathy	Cardiac disorders	Systematic Assessment	EG0000 events0 affected406 at risk EG0012 events2 affected194 at risk
Coronary artery perforation	Cardiac disorders	Systematic Assessment	EG0002 events2 affected406 at risk EG0010 events0 affected194 at risk
Pericardial effusion	Cardiac disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0011 events1 affected194 at risk
Sinus node dysfunction	Cardiac disorders	Systematic Assessment	EG0002 events2 affected406 at risk EG0010 events0 affected194 at risk
Ventricular tachycardia	Cardiac disorders	Systematic Assessment	EG0002 events2 affected406 at risk EG0010 events0 affected194 at risk
Acute left ventricular failure	Cardiac disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Atrioventricular block complete	Cardiac disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Cardiac valve disease	Cardiac disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Cardio-respiratory arrest	Cardiac disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Cardiorenal syndrome	Cardiac disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Chronic left ventricular failure	Cardiac disorders	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected194 at risk
Coronary artery dissection	Cardiac disorders	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected194 at risk
Coronary artery occlusion	Cardiac disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Mitral valve incompetence	Cardiac disorders	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected194 at risk
Mitral valve stenosis	Cardiac disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Myocardial ischaemia	Cardiac disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Tachycardia	Cardiac disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Torsade de pointes	Cardiac disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Ventricular extrasystoles	Cardiac disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Pneumonia	Infections and infestations	Systematic Assessment	EG00010 events9 affected406 at risk EG0015 events5 affected194 at risk
COVID-19	Infections and infestations	Systematic Assessment	EG0003 events3 affected406 at risk EG0012 events2 affected194 at risk
Cellulitis	Infections and infestations	Systematic Assessment	EG0003 events3 affected406 at risk EG0012 events2 affected194 at risk
Urinary tract infection	Infections and infestations	Systematic Assessment	EG0003 events3 affected406 at risk EG0012 events2 affected194 at risk
Appendicitis	Infections and infestations	Systematic Assessment	EG0003 events3 affected406 at risk EG0011 events1 affected194 at risk
COVID-19 pneumonia	Infections and infestations	Systematic Assessment	EG0002 events2 affected406 at risk EG0012 events2 affected194 at risk
Sepsis	Infections and infestations	Systematic Assessment	EG0004 events4 affected406 at risk EG0010 events0 affected194 at risk
Diverticulitis	Infections and infestations	Systematic Assessment	EG0002 events2 affected406 at risk EG0011 events1 affected194 at risk
Upper respiratory tract infection	Infections and infestations	Systematic Assessment	EG0002 events2 affected406 at risk EG0010 events0 affected194 at risk
Abdominal abscess	Infections and infestations	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Abscess limb	Infections and infestations	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Arthritis infective	Infections and infestations	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Bacterial sepsis	Infections and infestations	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Bronchitis	Infections and infestations	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Catheter site abscess	Infections and infestations	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Clostridium difficile infection	Infections and infestations	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Cystitis	Infections and infestations	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Enterococcal bacteraemia	Infections and infestations	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Gastroenteritis	Infections and infestations	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Influenza	Infections and infestations	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected194 at risk
Mediastinitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected194 at risk
Necrotising fasciitis	Infections and infestations	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected194 at risk
Osteomyelitis	Infections and infestations	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Purulence	Infections and infestations	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Pyelonephritis	Infections and infestations	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected194 at risk
Respiratory tract infection	Infections and infestations	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Septic shock	Infections and infestations	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected194 at risk
Staphylococcal bacteraemia	Infections and infestations	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Subcutaneous abscess	Infections and infestations	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Urosepsis	Infections and infestations	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Viral infection	Infections and infestations	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Wound infection staphylococcal	Infections and infestations	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG00010 events5 affected406 at risk EG0014 events4 affected194 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0008 events4 affected406 at risk EG0013 events3 affected194 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0006 events6 affected406 at risk EG0013 events3 affected194 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0004 events4 affected406 at risk EG0010 events0 affected194 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 events2 affected406 at risk EG0012 events2 affected194 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 events2 affected406 at risk EG0012 events2 affected194 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0002 events2 affected406 at risk EG0011 events1 affected194 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected406 at risk EG0012 events2 affected194 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0011 events1 affected194 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected194 at risk
Bronchial secretion retention	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Bronchitis chronic	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected194 at risk
Emphysema	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Laryngeal mass	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected194 at risk
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Pulmonary air leakage	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected194 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected194 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Non-cardiac chest pain	General disorders	Systematic Assessment	EG00011 events11 affected406 at risk EG0015 events5 affected194 at risk
Chest pain	General disorders	Systematic Assessment	EG0005 events5 affected406 at risk EG0014 events3 affected194 at risk
Vascular stent stenosis	General disorders	Systematic Assessment	EG0005 events5 affected406 at risk EG0013 events3 affected194 at risk
Catheter site haematoma	General disorders	Systematic Assessment	EG0003 events3 affected406 at risk EG0011 events1 affected194 at risk
Catheter site haemorrhage	General disorders	Systematic Assessment	EG0002 events2 affected406 at risk EG0011 events1 affected194 at risk
Death of unknown cause	General disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0011 events1 affected194 at risk
Fatigue	General disorders	Systematic Assessment	EG0002 events2 affected406 at risk EG0010 events0 affected194 at risk
Multiple organ dysfunction syndrome	General disorders	Systematic Assessment	EG0002 events2 affected406 at risk EG0010 events0 affected194 at risk
Oedema peripheral	General disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0011 events1 affected194 at risk
Vascular stent thrombosis	General disorders	Systematic Assessment	EG0000 events0 affected406 at risk EG0012 events2 affected194 at risk
Chest discomfort	General disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Gait disturbance	General disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Mass	General disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Medical device site thrombosis	General disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Pain	General disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Pyrexia	General disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Stenosis	General disorders	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected194 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0006 events4 affected406 at risk EG0010 events0 affected194 at risk
Dental caries	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected406 at risk EG0012 events2 affected194 at risk
Intestinal ischaemia	Gastrointestinal disorders	Systematic Assessment	EG0004 events2 affected406 at risk EG0010 events0 affected194 at risk
Abdominal pain	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected406 at risk EG0011 events1 affected194 at risk
Oesophageal stenosis	Gastrointestinal disorders	Systematic Assessment	EG0002 events1 affected406 at risk EG0011 events1 affected194 at risk
Diarrhoea	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0011 events1 affected194 at risk
Inguinal hernia	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0011 events1 affected194 at risk
Nausea	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0011 events1 affected194 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0002 events2 affected406 at risk EG0010 events0 affected194 at risk
Vomiting	Gastrointestinal disorders	Systematic Assessment	EG0002 events1 affected406 at risk EG0010 events0 affected194 at risk
Abdominal distension	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Abdominal wall haematoma	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected194 at risk
Acquired oesophageal web	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Colitis	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Constipation	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Diverticulum	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected194 at risk
Diverticulum intestinal	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected194 at risk
Duodenal ulcer haemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Dyspepsia	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Enteritis	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Eructation	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Gastritis	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Gastritis erosive	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Gastrointestinal obstruction	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected194 at risk
Haemorrhoidal haemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected194 at risk
Hiatus hernia	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Intestinal obstruction	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Intussusception	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Toothache	Gastrointestinal disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Cerebrovascular accident	Nervous system disorders	Systematic Assessment	EG0002 events2 affected406 at risk EG0014 events4 affected194 at risk
Syncope	Nervous system disorders	Systematic Assessment	EG0003 events3 affected406 at risk EG0012 events2 affected194 at risk
Dizziness	Nervous system disorders	Systematic Assessment	EG0004 events4 affected406 at risk EG0010 events0 affected194 at risk
Carpal tunnel syndrome	Nervous system disorders	Systematic Assessment	EG0002 events1 affected406 at risk EG0011 events1 affected194 at risk
Presyncope	Nervous system disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0012 events2 affected194 at risk
Encephalopathy	Nervous system disorders	Systematic Assessment	EG0000 events0 affected406 at risk EG0012 events1 affected194 at risk
Paraesthesia	Nervous system disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0011 events1 affected194 at risk
Seizure	Nervous system disorders	Systematic Assessment	EG0002 events2 affected406 at risk EG0010 events0 affected194 at risk
Transient ischaemic attack	Nervous system disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0011 events1 affected194 at risk
Aphasia	Nervous system disorders	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected194 at risk
Carotid artery stenosis	Nervous system disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Cerebral haemorrhage	Nervous system disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Cerebral infarction	Nervous system disorders	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected194 at risk
Cerebrospinal fluid leakage	Nervous system disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Cervical radiculopathy	Nervous system disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Cluster headache	Nervous system disorders	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected194 at risk
Cranial nerve paralysis	Nervous system disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Dyskinesia	Nervous system disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Hemianopia homonymous	Nervous system disorders	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected194 at risk
Hypoaesthesia	Nervous system disorders	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected194 at risk
Lacunar infarction	Nervous system disorders	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected194 at risk
Lumbar radiculopathy	Nervous system disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Metabolic encephalopathy	Nervous system disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Myelopathy	Nervous system disorders	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected194 at risk
Myoclonus	Nervous system disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Optic perineuritis	Nervous system disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Sciatica	Nervous system disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Subarachnoid haemorrhage	Nervous system disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Thalamic infarction	Nervous system disorders	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected194 at risk
Vocal cord paralysis	Nervous system disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Hypotension	Vascular disorders	Systematic Assessment	EG0008 events8 affected406 at risk EG0013 events3 affected194 at risk
Hypertension	Vascular disorders	Systematic Assessment	EG0003 events3 affected406 at risk EG0014 events4 affected194 at risk
Aortic stenosis	Vascular disorders	Systematic Assessment	EG0002 events2 affected406 at risk EG0012 events2 affected194 at risk
Haematoma	Vascular disorders	Systematic Assessment	EG0000 events0 affected406 at risk EG0013 events3 affected194 at risk
Haemodynamic instability	Vascular disorders	Systematic Assessment	EG0002 events2 affected406 at risk EG0011 events1 affected194 at risk
Orthostatic hypotension	Vascular disorders	Systematic Assessment	EG0003 events3 affected406 at risk EG0010 events0 affected194 at risk
Peripheral arterial occlusive disease	Vascular disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0012 events2 affected194 at risk
Peripheral artery occlusion	Vascular disorders	Systematic Assessment	EG0002 events2 affected406 at risk EG0010 events0 affected194 at risk
Peripheral ischaemia	Vascular disorders	Systematic Assessment	EG0002 events2 affected406 at risk EG0010 events0 affected194 at risk
Deep vein thrombosis	Vascular disorders	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected194 at risk
Dry gangrene	Vascular disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Hypertensive urgency	Vascular disorders	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected194 at risk
Intermittent claudication	Vascular disorders	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected194 at risk
Orthostatic hypertension	Vascular disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Peripheral vascular disorder	Vascular disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Shock	Vascular disorders	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected194 at risk
Shock haemorrhagic	Vascular disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Thrombophlebitis superficial	Vascular disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Fall	Injury, poisoning and procedural complications	Systematic Assessment	EG0003 events3 affected406 at risk EG0012 events2 affected194 at risk
Plaque shift	Injury, poisoning and procedural complications	Systematic Assessment	EG0003 events3 affected406 at risk EG0012 events2 affected194 at risk
Contusion	Injury, poisoning and procedural complications	Systematic Assessment	EG0002 events2 affected406 at risk EG0011 events1 affected194 at risk
Procedural pain	Injury, poisoning and procedural complications	Systematic Assessment	EG0002 events2 affected406 at risk EG0011 events1 affected194 at risk
Skin laceration	Injury, poisoning and procedural complications	Systematic Assessment	EG0003 events3 affected406 at risk EG0010 events0 affected194 at risk
Anaemia postoperative	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected406 at risk EG0011 events1 affected194 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	Systematic Assessment	EG0002 events2 affected406 at risk EG0010 events0 affected194 at risk
Facial bones fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0002 events2 affected406 at risk EG0010 events0 affected194 at risk
Humerus fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected406 at risk EG0012 events2 affected194 at risk
Subdural haematoma	Injury, poisoning and procedural complications	Systematic Assessment	EG0002 events2 affected406 at risk EG0010 events0 affected194 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected406 at risk EG0012 events2 affected194 at risk
Burns third degree	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Fibula fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Hand fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected194 at risk
Hip fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Incision site haemorrhage	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected194 at risk
Meniscus injury	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected194 at risk
Musculoskeletal injury	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Postoperative hypertension	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Procedural shock	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Tibia fracture	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Vascular access site haemorrhage	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Vascular procedure complication	Injury, poisoning and procedural complications	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Wound	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected194 at risk
Hyperglycaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0003 events3 affected406 at risk EG0015 events5 affected194 at risk
Hypokalaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0012 events2 affected194 at risk
Metabolic acidosis	Metabolism and nutrition disorders	Systematic Assessment	EG0002 events2 affected406 at risk EG0011 events1 affected194 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	Systematic Assessment	EG0002 events2 affected406 at risk EG0010 events0 affected194 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	Systematic Assessment	EG0002 events2 affected406 at risk EG0010 events0 affected194 at risk
Hyponatraemia	Metabolism and nutrition disorders	Systematic Assessment	EG0002 events2 affected406 at risk EG0010 events0 affected194 at risk
Lactic acidosis	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0011 events1 affected194 at risk
Cachexia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Fluid overload	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected194 at risk
Hyperglycaemic hyperosmolar nonketotic syndrome	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Hyperkalaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Hypertriglyceridaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Hypophosphataemia	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Iron deficiency	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Starvation ketoacidosis	Metabolism and nutrition disorders	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected194 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Acute kidney injury	Renal and urinary disorders	Systematic Assessment	EG00012 events10 affected406 at risk EG0013 events3 affected194 at risk
Urinary retention	Renal and urinary disorders	Systematic Assessment	EG0005 events5 affected406 at risk EG0010 events0 affected194 at risk
End stage renal disease	Renal and urinary disorders	Systematic Assessment	EG0002 events2 affected406 at risk EG0010 events0 affected194 at risk
Ureterolithiasis	Renal and urinary disorders	Systematic Assessment	EG0002 events2 affected406 at risk EG0010 events0 affected194 at risk
Urinary incontinence	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0011 events1 affected194 at risk
Bladder outlet obstruction	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Cystitis haemorrhagic	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Haematuria	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected194 at risk
Renal failure	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Urethral cyst	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected194 at risk
Urethral obstruction	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Urinary bladder polyp	Renal and urinary disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Anaemia	Blood and lymphatic system disorders	Systematic Assessment	EG0007 events7 affected406 at risk EG0015 events5 affected194 at risk
Blood loss anaemia	Blood and lymphatic system disorders	Systematic Assessment	EG0002 events2 affected406 at risk EG0010 events0 affected194 at risk
Heparin-induced thrombocytopenia	Blood and lymphatic system disorders	Systematic Assessment	EG0000 events0 affected406 at risk EG0012 events2 affected194 at risk
Anaemia of chronic disease	Blood and lymphatic system disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Coagulopathy	Blood and lymphatic system disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Febrile neutropenia	Blood and lymphatic system disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Haemolytic anaemia	Blood and lymphatic system disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Leukocytosis	Blood and lymphatic system disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Normocytic anaemia	Blood and lymphatic system disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Thrombocytopenia	Blood and lymphatic system disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0004 events4 affected406 at risk EG0011 events1 affected194 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0002 events2 affected406 at risk EG0010 events0 affected194 at risk
Cervical spinal stenosis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected406 at risk EG0012 events2 affected194 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0002 events2 affected406 at risk EG0010 events0 affected194 at risk
Back pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Myopathy	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Neck pain	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected194 at risk
Pathological fracture	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected194 at risk
SARS-CoV-2 test positive	Investigations	Systematic Assessment	EG0003 events3 affected406 at risk EG0012 events2 affected194 at risk
Acid base balance abnormal	Investigations	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Blood glucose abnormal	Investigations	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Blood pressure diastolic increased	Investigations	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Coagulation test abnormal	Investigations	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Electrocardiogram QT prolonged	Investigations	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Fibrin D dimer increased	Investigations	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
International normalised ratio abnormal	Investigations	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Low density lipoprotein increased	Investigations	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Pulmonary function test decreased	Investigations	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Pulse absent	Investigations	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Urine output decreased	Investigations	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected194 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Chronic lymphocytic leukaemia stage 3	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Clear cell renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Colon cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Follicular lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected194 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected194 at risk
Metastases to lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Metastases to meninges	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Non-small cell lung cancer stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Oesophageal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected194 at risk
Pancreatic carcinoma metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected194 at risk
Pancreatic neuroendocrine tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Post transplant lymphoproliferative disorder	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Cataract	Eye disorders	Systematic Assessment	EG0004 events3 affected406 at risk EG0010 events0 affected194 at risk
Vision blurred	Eye disorders	Systematic Assessment	EG0002 events2 affected406 at risk EG0010 events0 affected194 at risk
Macular hole	Eye disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Visual impairment	Eye disorders	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected194 at risk
Blister	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected194 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Granuloma annulare	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Pruritus	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected194 at risk
Agitation	Psychiatric disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Confusional state	Psychiatric disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Depression	Psychiatric disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Mental status changes	Psychiatric disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Vertigo	Ear and labyrinth disorders	Systematic Assessment	EG0002 events2 affected406 at risk EG0011 events1 affected194 at risk
Biliary obstruction	Hepatobiliary disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Cholecystitis acute	Hepatobiliary disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Cholelithiasis	Hepatobiliary disorders	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected194 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	Systematic Assessment	EG0002 events2 affected406 at risk EG0010 events0 affected194 at risk
Prostatitis	Reproductive system and breast disorders	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected194 at risk
Breast conserving surgery	Surgical and medical procedures	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Mitral valve replacement	Surgical and medical procedures	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Spinal operation	Surgical and medical procedures	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Hypersensitivity	Immune system disorders	Systematic Assessment	EG0000 events0 affected406 at risk EG0012 events2 affected194 at risk
Pyloric stenosis	Congenital, familial and genetic disorders	Systematic Assessment	EG0001 events1 affected406 at risk EG0010 events0 affected194 at risk
Device lead damage	Product Issues	Systematic Assessment	EG0000 events0 affected406 at risk EG0011 events1 affected194 at risk

ID	Title	Description
BG000	AGENT DCB	Agent DCB is a Monorail Percutaneous Transluminal Coronary Angioplasty (PTCA) balloon catheter with a semi-compliant balloon coated with a formulation of paclitaxel (drug) and an excipient, Acetyl-Tri-n-butyl citrate (ATBC). The balloon catheter platform is based on the commercially available BSC Emerge™ PTCA balloon catheter system (K130391). AGENT DCB: Drug coated PTCA balloon catheter
BG001	Commercially Available, PTCA Dilation Catheter	PTCA balloon catheter: PTCA balloon catheter
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	AGENT DCB	Agent DCB is a Monorail Percutaneous Transluminal Coronary Angioplasty (PTCA) balloon catheter with a semi-compliant balloon coated with a formulation of paclitaxel (drug) and an excipient, Acetyl-Tri-n-butyl citrate (ATBC). The balloon catheter platform is based on the commercially available BSC Emerge™ PTCA balloon catheter system (K130391). AGENT DCB: Drug coated PTCA balloon catheter	17	406	226	406	79	406
EG001	Commercially Available, PTCA Dilation Catheter	PTCA balloon catheter: PTCA balloon catheter	8	194	113	194	50	194