Efficacy and Safety of Allogeneic Mesenchymal Precursor C... | NCT02032004

Label	Type	Description	Intervention Names
Sham Control	Sham Comparator	Participants randomly assigned to control treatment underwent a single cardiac catheterization involving a scripted sham cardiac mapping and cell delivery procedure at a cell injection center at Day 0 by an interventional cardiology team not involved with review or assessment of subsequent study results.	Other: Sham Comparator
Rexlemestrocel-L	Experimental	Participants randomly assigned to treatment underwent a single index cardiac catheterization involving transendocardial delivery of rexlemestrocel-L into the myocardium at a cell injection center at Day 0 by an interventional cardiology team not involved with review or assessment of subsequent study results.	Biological: Rexlemestrocel-L

Name	Type	Description	Arm Group Labels	Other Names
Rexlemestrocel-L	Biological	Rexlemestrocel-L consists of human bone marrow-derived allogeneic mesenchymal precursor cells (MPCs) isolated from bone mononuclear cells with anti-STRO-3 antibodies, expanded ex vivo, and cryopreserved.

Measure	Description	Time Frame
Time to Recurrent Non-fatal Decompensated Heart Failure Major Adverse Cardiac Events (HF-MACE) That Occur Prior to the First Terminal Cardiac Event (TCE)	Non-fatal decompensated heart failure (HF) event was adjudicated when the diagnosis of a nonfatal decompensated HF event demonstrated the presence of signs and symptoms consistent with clinical decompensation of the participant's HF state requiring an in-hospital stay or intravenous (IV) diuretic therapy or aquapheresis during an urgent care outpatient HF visit. TCEs were defined as a composite of cardiac death, left ventricular assist device (LVAD) placement, heart transplant, or artificial heart implantation. Adjudication of all potential non-fatal HF-MACE or TCEs was performed by an independent, blinded Clinical Endpoints Adjudication Committee (CEC) based on the cardiac adjudication manual. Negative number in the time to event range indicates that event occurred to the subject before treatment.	Up to 71 months

Name	Affiliation	Role
Eric Rose, MD	Mesoblast, Ltd.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Mesoblast Investigational Site 10757 - Cardiology, P.C.		Birmingham	Alabama	35211	United States

PubMed Identifier	Type	Citation	Retractions
31318648	Derived	Borow KM, Yaroshinsky A, Greenberg B, Perin EC. Phase 3 DREAM-HF Trial of Mesenchymal Precursor Cells in Chronic Heart Failure. Circ Res. 2019 Jul 19;125(3):265-281. doi: 10.1161/CIRCRESAHA.119.314951. Epub 2019 Jul 18.

Label	URL
Related Info	View source

ID	Title	Description
FG000	Sham Control	Participants randomly assigned to control treatment underwent a single cardiac catheterization involving a scripted sham cardiac mapping and cell delivery procedure at a cell injection center at Day 0 by an interventional cardiology team not involved with review or assessment of subsequent study results.
FG001

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 6, 2017	Aug 20, 2025

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Cardiac failure chronic	Cardiac disorders	MedDRA 16.1	Systematic Assessment		EG00028 affected276 at risk EG00124 affected261 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 16.1	Systematic Assessment		EG00017 affected276 at risk EG00125 affected261 at risk
Angina pectoris	Cardiac disorders	MedDRA 16.1	Systematic Assessment		EG00013 affected276 at risk EG00114 affected261 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 16.1	Systematic Assessment		EG00011 affected276 at risk EG00114 affected261 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 16.1	Systematic Assessment		EG00013 affected276 at risk EG00111 affected261 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 16.1	Systematic Assessment		EG00010 affected276 at risk EG0015 affected261 at risk
Myocardial infarction	Cardiac disorders	MedDRA 16.1	Systematic Assessment		EG00011 affected276 at risk EG0012 affected261 at risk
Cardiogenic shock	Cardiac disorders	MedDRA 16.1	Systematic Assessment		EG0004 affected276 at risk EG0016 affected261 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA 16.1	Systematic Assessment		EG0004 affected276 at risk EG0016 affected261 at risk
Angina unstable	Cardiac disorders	MedDRA 16.1	Systematic Assessment		EG0006 affected276 at risk EG0012 affected261 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA 16.1	Systematic Assessment		EG0004 affected276 at risk EG0011 affected261 at risk
Atrial flutter	Cardiac disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0013 affected261 at risk
Cardiac arrest	Cardiac disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0013 affected261 at risk
Coronary artery disease	Cardiac disorders	MedDRA 16.1	Systematic Assessment		EG0002 affected276 at risk EG0011 affected261 at risk
Ischaemic cardiomyopathy	Cardiac disorders	MedDRA 16.1	Systematic Assessment		EG0002 affected276 at risk EG0011 affected261 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0012 affected261 at risk
Pericardial effusion	Cardiac disorders	MedDRA 16.1	Systematic Assessment		EG0002 affected276 at risk EG0011 affected261 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0012 affected261 at risk
Ventricular arrhythmia	Cardiac disorders	MedDRA 16.1	Systematic Assessment		EG0002 affected276 at risk EG0011 affected261 at risk
Arrhythmia	Cardiac disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0011 affected261 at risk
Bradycardia	Cardiac disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0011 affected261 at risk
Cardiac perforation	Cardiac disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0011 affected261 at risk
Congestive cardiomyopathy	Cardiac disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0012 affected261 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 16.1	Systematic Assessment		EG0002 affected276 at risk EG0010 affected261 at risk
Intracardiac thrombus	Cardiac disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0012 affected261 at risk
Palpitations	Cardiac disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0011 affected261 at risk
Pulseless electrical activity	Cardiac disorders	MedDRA 16.1	Systematic Assessment		EG0002 affected276 at risk EG0010 affected261 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA 16.1	Systematic Assessment		EG0002 affected276 at risk EG0010 affected261 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Arrhythmia supraventricular	Cardiac disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Atrial thrombosis	Cardiac disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Atrioventricular block	Cardiac disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Bundle branch block left	Cardiac disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Bundle branch block right	Cardiac disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Cardiomyopathy	Cardiac disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Cardiorenal syndrome	Cardiac disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Chronotropic incompetence	Cardiac disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Low cardiac output syndrome	Cardiac disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Sick sinus syndrome	Cardiac disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Tachycardia	Cardiac disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Ventricular tachyarrhythmia	Cardiac disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Pneumonia	Infections and infestations	MedDRA 16.1	Systematic Assessment		EG00017 affected276 at risk EG00113 affected261 at risk
Sepsis	Infections and infestations	MedDRA 16.1	Systematic Assessment		EG00011 affected276 at risk EG0016 affected261 at risk
Cellulitis	Infections and infestations	MedDRA 16.1	Systematic Assessment		EG0007 affected276 at risk EG0015 affected261 at risk
Urinary tract infection	Infections and infestations	MedDRA 16.1	Systematic Assessment		EG0008 affected276 at risk EG0013 affected261 at risk
Septic shock	Infections and infestations	MedDRA 16.1	Systematic Assessment		EG0002 affected276 at risk EG0015 affected261 at risk
Bacteraemia	Infections and infestations	MedDRA 16.1	Systematic Assessment		EG0002 affected276 at risk EG0013 affected261 at risk
Bronchitis	Infections and infestations	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0014 affected261 at risk
Diverticulitis	Infections and infestations	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0014 affected261 at risk
Device related infection	Infections and infestations	MedDRA 16.1	Systematic Assessment		EG0003 affected276 at risk EG0011 affected261 at risk
Gastroenteritis	Infections and infestations	MedDRA 16.1	Systematic Assessment		EG0002 affected276 at risk EG0012 affected261 at risk
Staphylococcal bacteraemia	Infections and infestations	MedDRA 16.1	Systematic Assessment		EG0002 affected276 at risk EG0012 affected261 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 16.1	Systematic Assessment		EG0002 affected276 at risk EG0012 affected261 at risk
Appendicitis	Infections and infestations	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0012 affected261 at risk
Cystitis	Infections and infestations	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0012 affected261 at risk
Lobar pneumonia	Infections and infestations	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0013 affected261 at risk
Osteomyelitis	Infections and infestations	MedDRA 16.1	Systematic Assessment		EG0002 affected276 at risk EG0011 affected261 at risk
Pneumonia bacterial	Infections and infestations	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0012 affected261 at risk
Wound infection	Infections and infestations	MedDRA 16.1	Systematic Assessment		EG0002 affected276 at risk EG0011 affected261 at risk
Arthritis bacterial	Infections and infestations	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0011 affected261 at risk
Corona virus infection	Infections and infestations	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0011 affected261 at risk
Erysipelas	Infections and infestations	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0011 affected261 at risk
Gastrointestinal viral infection	Infections and infestations	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0011 affected261 at risk
Implant site infection	Infections and infestations	MedDRA 16.1	Systematic Assessment		EG0002 affected276 at risk EG0010 affected261 at risk
Influenza	Infections and infestations	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0011 affected261 at risk
Localised infection	Infections and infestations	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0012 affected261 at risk
Muscle abscess	Infections and infestations	MedDRA 16.1	Systematic Assessment		EG0002 affected276 at risk EG0010 affected261 at risk
Perineal abscess	Infections and infestations	MedDRA 16.1	Systematic Assessment		EG0002 affected276 at risk EG0010 affected261 at risk
Pneumonia respiratory syncytial viral	Infections and infestations	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0012 affected261 at risk
Pneumonia staphylococcal	Infections and infestations	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0011 affected261 at risk
Postoperative wound infection	Infections and infestations	MedDRA 16.1	Systematic Assessment		EG0002 affected276 at risk EG0010 affected261 at risk
Respiratory syncytial virus infection	Infections and infestations	MedDRA 16.1	Systematic Assessment		EG0002 affected276 at risk EG0010 affected261 at risk
Staphylococcal infection	Infections and infestations	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0011 affected261 at risk
Abdominal abscess	Infections and infestations	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Anal abscess	Infections and infestations	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Bacterial diarrhoea	Infections and infestations	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Breast abscess	Infections and infestations	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Bronchitis bacterial	Infections and infestations	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Bronchitis viral	Infections and infestations	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Bronchopneumonia	Infections and infestations	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Campylobacter infection	Infections and infestations	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Cardiac valve vegetation	Infections and infestations	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Clostridium difficile infection	Infections and infestations	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Cytomegalovirus colitis	Infections and infestations	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Emphysematous cholecystitis	Infections and infestations	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Enteritis infectious	Infections and infestations	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Fungal sepsis	Infections and infestations	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Gastroenteritis norovirus	Infections and infestations	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Gastrointestinal bacterial infection	Infections and infestations	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Groin abscess	Infections and infestations	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Incision site infection	Infections and infestations	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Infectious pleural effusion	Infections and infestations	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Kidney infection	Infections and infestations	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Lung infection	Infections and infestations	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Parotitis	Infections and infestations	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Periorbital cellulitis	Infections and infestations	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Pneumonia influenzal	Infections and infestations	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Pneumonia legionella	Infections and infestations	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Pneumonia pseudomonas aeruginosa	Infections and infestations	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Pneumonia viral	Infections and infestations	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Post procedural cellulitis	Infections and infestations	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Pseudomonal bacteraemia	Infections and infestations	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Psoas abscess	Infections and infestations	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Respiratory tract infection	Infections and infestations	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Scrotal abscess	Infections and infestations	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Subcutaneous abscess	Infections and infestations	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Urinary tract infection enterococcal	Infections and infestations	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Urosepsis	Infections and infestations	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Viral upper respiratory tract infection	Infections and infestations	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment		EG00011 affected276 at risk EG0014 affected261 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment		EG0008 affected276 at risk EG0015 affected261 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment		EG0006 affected276 at risk EG0016 affected261 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment		EG0004 affected276 at risk EG0013 affected261 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment		EG0003 affected276 at risk EG0012 affected261 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0013 affected261 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0012 affected261 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0013 affected261 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment		EG0002 affected276 at risk EG0011 affected261 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0012 affected261 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0011 affected261 at risk
Acute interstitial pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Acute pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Bronchiectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Hypercapnia	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Respiratory depression	Respiratory, thoracic and mediastinal disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Syncope	Nervous system disorders	MedDRA 16.1	Systematic Assessment		EG0007 affected276 at risk EG00113 affected261 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 16.1	Systematic Assessment		EG0006 affected276 at risk EG0013 affected261 at risk
Dizziness	Nervous system disorders	MedDRA 16.1	Systematic Assessment		EG0006 affected276 at risk EG0013 affected261 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 16.1	Systematic Assessment		EG0005 affected276 at risk EG0012 affected261 at risk
Encephalopathy	Nervous system disorders	MedDRA 16.1	Systematic Assessment		EG0004 affected276 at risk EG0011 affected261 at risk
Presyncope	Nervous system disorders	MedDRA 16.1	Systematic Assessment		EG0002 affected276 at risk EG0013 affected261 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 16.1	Systematic Assessment		EG0002 affected276 at risk EG0011 affected261 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0012 affected261 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0012 affected261 at risk
Altered state of consciousness	Nervous system disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Cerebrospinal fluid leakage	Nervous system disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Convulsion	Nervous system disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Embolic stroke	Nervous system disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Headache	Nervous system disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Hypersomnia	Nervous system disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Intracranial aneurysm	Nervous system disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Metabolic encephalopathy	Nervous system disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Migraine	Nervous system disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Myasthenia gravis crisis	Nervous system disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Neuropathy peripheral	Nervous system disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Radiculopathy	Nervous system disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Sciatica	Nervous system disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Spinal claudication	Nervous system disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
VIIth nerve paralysis	Nervous system disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Non-cardiac chest pain	General disorders	MedDRA 16.1	Systematic Assessment		EG0008 affected276 at risk EG0018 affected261 at risk
Death	General disorders	MedDRA 16.1	Systematic Assessment		EG0004 affected276 at risk EG0017 affected261 at risk
Chest pain	General disorders	MedDRA 16.1	Systematic Assessment		EG0004 affected276 at risk EG0012 affected261 at risk
Device dislocation	General disorders	MedDRA 16.1	Systematic Assessment		EG0002 affected276 at risk EG0012 affected261 at risk
Asthenia	General disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0012 affected261 at risk
Device lead damage	General disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0013 affected261 at risk
Fatigue	General disorders	MedDRA 16.1	Systematic Assessment		EG0002 affected276 at risk EG0011 affected261 at risk
Oedema	General disorders	MedDRA 16.1	Systematic Assessment		EG0002 affected276 at risk EG0011 affected261 at risk
Pyrexia	General disorders	MedDRA 16.1	Systematic Assessment		EG0002 affected276 at risk EG0011 affected261 at risk
Device failure	General disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0011 affected261 at risk
Device malfunction	General disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0012 affected261 at risk
Multi-organ failure	General disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0011 affected261 at risk
BRCA2 gene mutation	General disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Catheter site haemorrhage	General disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Device electrical finding	General disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Device leakage	General disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Device occlusion	General disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Facial pain	General disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Hernia	General disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Hypothermia	General disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Impaired healing	General disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Implant site haematoma	General disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Implant site inflammation	General disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Medical device complication	General disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Medical device pain	General disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Medical device site reaction	General disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Pelvic mass	General disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Vaccination site reaction	General disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment		EG00024 affected276 at risk EG00123 affected261 at risk
Renal failure chronic	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0015 affected261 at risk
Renal failure	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment		EG0002 affected276 at risk EG0011 affected261 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0011 affected261 at risk
Urinary retention	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0011 affected261 at risk
Anuria	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Atonic urinary bladder	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Bladder outlet obstruction	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Calculus ureteric	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Haematuria	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Pneumaturia	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Renal disorder	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Renal infarct	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Renal injury	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Renal ischaemia	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Renal tubular necrosis	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Stress urinary incontinence	Renal and urinary disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment		EG0004 affected276 at risk EG00110 affected261 at risk
Gastritis	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment		EG0003 affected276 at risk EG0013 affected261 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment		EG0002 affected276 at risk EG0013 affected261 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment		EG0002 affected276 at risk EG0012 affected261 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0013 affected261 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment		EG0002 affected276 at risk EG0011 affected261 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0012 affected261 at risk
Ascites	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0011 affected261 at risk
Constipation	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment		EG0002 affected276 at risk EG0010 affected261 at risk
Enteritis	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment		EG0002 affected276 at risk EG0010 affected261 at risk
Ileus	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0012 affected261 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment		EG0002 affected276 at risk EG0010 affected261 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment		EG0002 affected276 at risk EG0010 affected261 at risk
Melaena	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0012 affected261 at risk
Nausea	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment		EG0002 affected276 at risk EG0010 affected261 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0011 affected261 at risk
Peritoneal haemorrhage	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0012 affected261 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0011 affected261 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment		EG0002 affected276 at risk EG0010 affected261 at risk
Vomiting	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0011 affected261 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Colitis	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Enterovesical fistula	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Food poisoning	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Gastritis haemorrhagic	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Inguinal hernia, obstructive	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Large intestinal ulcer haemorrhage	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Mesenteric artery stenosis	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Oesophageal ulcer	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Retroperitoneal haematoma	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Retroperitoneal haemorrhage	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment		EG0004 affected276 at risk EG0017 affected261 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment		EG0003 affected276 at risk EG0014 affected261 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment		EG0002 affected276 at risk EG0014 affected261 at risk
Gout	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment		EG0002 affected276 at risk EG0013 affected261 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment		EG0002 affected276 at risk EG0013 affected261 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment		EG0002 affected276 at risk EG0012 affected261 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment		EG0002 affected276 at risk EG0012 affected261 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment		EG0002 affected276 at risk EG0011 affected261 at risk
Hypovolaemia	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0012 affected261 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Diabetes mellitus inadequate control	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Hyperammonaemia	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Hyperglycaemic hyperosmolar nonketotic syndrome	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Hypervolaemia	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Lactic acidosis	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Metabolic alkalosis	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Hypotension	Vascular disorders	MedDRA 16.1	Systematic Assessment		EG0007 affected276 at risk EG0018 affected261 at risk
Haematoma	Vascular disorders	MedDRA 16.1	Systematic Assessment		EG0002 affected276 at risk EG0013 affected261 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 16.1	Systematic Assessment		EG0004 affected276 at risk EG0011 affected261 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 16.1	Systematic Assessment		EG0002 affected276 at risk EG0012 affected261 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0013 affected261 at risk
Hypertensive crisis	Vascular disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0012 affected261 at risk
Aortic aneurysm	Vascular disorders	MedDRA 16.1	Systematic Assessment		EG0002 affected276 at risk EG0010 affected261 at risk
Hypertension	Vascular disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0012 affected261 at risk
Venous occlusion	Vascular disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0012 affected261 at risk
Arterial haemorrhage	Vascular disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Arterial insufficiency	Vascular disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Haemorrhage	Vascular disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Intermittent claudication	Vascular disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Intra-abdominal haematoma	Vascular disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Lymphorrhoea	Vascular disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Peripheral artery aneurysm	Vascular disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Peripheral artery dissection	Vascular disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Shock	Vascular disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Shock haemorrhagic	Vascular disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Subclavian artery stenosis	Vascular disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment		EG0005 affected276 at risk EG0012 affected261 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0013 affected261 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment		EG0002 affected276 at risk EG0010 affected261 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0012 affected261 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0012 affected261 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0011 affected261 at risk
Wound	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0011 affected261 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Clavicle fracture	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Compression fracture	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Head injury	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Incisional hernia	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Nerve injury	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Post procedural discharge	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Postoperative respiratory failure	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Transplant failure	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Ulna fracture	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Urethral injury	Injury, poisoning and procedural complications	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment		EG0004 affected276 at risk EG0011 affected261 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0012 affected261 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment		EG0002 affected276 at risk EG0010 affected261 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0012 affected261 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0011 affected261 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0011 affected261 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Joint swelling	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Myositis	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Polymyalgia rheumatica	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Synovial cyst	Musculoskeletal and connective tissue disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0013 affected261 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0013 affected261 at risk
Acute myeloid leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Anal squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Chronic myelomonocytic leukaemia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Hepatocellular carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Metastases to meninges	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Pituitary tumour	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Prostate cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Prostate cancer recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Squamous cell carcinoma of the oral cavity	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Anticoagulation drug level below therapeutic	Investigations	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0011 affected261 at risk
Haemoglobin decreased	Investigations	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0012 affected261 at risk
Troponin increased	Investigations	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0011 affected261 at risk
Anticoagulation drug level above therapeutic	Investigations	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Blood alcohol increased	Investigations	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Blood creatinine increased	Investigations	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Blood glucose increased	Investigations	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Blood magnesium decreased	Investigations	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Blood potassium decreased	Investigations	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Blood pressure increased	Investigations	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Cardiac enzymes increased	Investigations	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Cardioactive drug level increased	Investigations	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Electrocardiogram PR prolongation	Investigations	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Haematocrit decreased	Investigations	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Heart rate increased	Investigations	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Hepatic enzyme increased	Investigations	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment		EG0004 affected276 at risk EG0015 affected261 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment		EG0002 affected276 at risk EG0011 affected261 at risk
Coagulopathy	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Haemorrhagic anaemia	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Heparin-induced thrombocytopenia	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Completed suicide	Psychiatric disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0012 affected261 at risk
Mental status changes	Psychiatric disorders	MedDRA 16.1	Systematic Assessment		EG0003 affected276 at risk EG0010 affected261 at risk
Anxiety	Psychiatric disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0011 affected261 at risk
Delirium	Psychiatric disorders	MedDRA 16.1	Systematic Assessment		EG0002 affected276 at risk EG0010 affected261 at risk
Depression	Psychiatric disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Homicidal ideation	Psychiatric disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Suicidal ideation	Psychiatric disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 16.1	Systematic Assessment		EG0002 affected276 at risk EG0012 affected261 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 16.1	Systematic Assessment		EG0002 affected276 at risk EG0010 affected261 at risk
Ischaemic hepatitis	Hepatobiliary disorders	MedDRA 16.1	Systematic Assessment		EG0002 affected276 at risk EG0010 affected261 at risk
Biliary dyskinesia	Hepatobiliary disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Cardiac cirrhosis	Hepatobiliary disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Hepatic cirrhosis	Hepatobiliary disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0012 affected261 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Arteriovenous malformation	Congenital, familial and genetic disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk
Haemorrhagic arteriovenous malformation	Congenital, familial and genetic disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Adrenal insufficiency	Endocrine disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Hypothyroidism	Endocrine disorders	MedDRA 16.1	Systematic Assessment		EG0000 affected276 at risk EG0011 affected261 at risk
Heart transplant rejection	Immune system disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0011 affected261 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 16.1	Systematic Assessment	The At Risk population for this preferred term is based on the male population in this study.	EG0000 affected221 at risk EG0011 affected222 at risk
Erectile dysfunction	Reproductive system and breast disorders	MedDRA 16.1	Systematic Assessment	The At Risk population for this preferred term is based on the male population in this study.	EG0000 affected221 at risk EG0011 affected222 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA 16.1	Systematic Assessment		EG0001 affected276 at risk EG0010 affected261 at risk

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Sham Control	Participants randomly assigned to control treatment underwent a single cardiac catheterization involving a scripted sham cardiac mapping and cell delivery procedure at a cell injection center at Day 0 by an interventional cardiology team not involved with review or assessment of subsequent study results.	74	282	191	276	260	276
EG001	Rexlemestrocel-L	Participants randomly assigned to treatment underwent a single index cardiac catheterization involving transendocardial delivery of rexlemestrocel-L into the myocardium at a cell injection center at Day 0 by an interventional cardiology team not involved with review or assessment of subsequent study results.	79	283	170	261	244	261

ID	Term
D018487	Ventricular Dysfunction, Left
D007249	Inflammation

ID	Term
D018754	Ventricular Dysfunction
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Title	Description
BG000	Sham Control	Participants randomly assigned to control treatment underwent a single cardiac catheterization involving a scripted sham cardiac mapping and cell delivery procedure at a cell injection center at Day 0 by an interventional cardiology team not involved with review or assessment of subsequent study results.
BG001	Rexlemestrocel-L	Participants randomly assigned to treatment underwent a single index cardiac catheterization involving transendocardial delivery of rexlemestrocel-L into the myocardium at a cell injection center at Day 0 by an interventional cardiology team not involved with review or assessment of subsequent study results.
BG002	Total	Total of all reporting groups