Study: NCT03502811

Adverse event: ANAEMIAS NONHAEMOLYTIC AND MARROW DEPRESSION
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 1041 at risk

Adverse event: HAEMOLYSES AND RELATED CONDITIONS
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1041 at risk

Adverse event: CARDIAC ARRHYTHMIAS
Serious: yes
Organ System: Cardiac disorders
Frequency: 54 affected / 1041 at risk

Adverse event: CARDIAC DISORDER SIGNS AND SYMPTOMS
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1041 at risk

Adverse event: CARDIAC VALVE DISORDERS
Serious: yes
Organ System: Cardiac disorders
Frequency: 32 affected / 1041 at risk

Adverse event: CORONARY ARTERY DISORDERS
Serious: yes
Organ System: Cardiac disorders
Frequency: 23 affected / 1041 at risk

Adverse event: HEART FAILURES
Serious: yes
Organ System: Cardiac disorders
Frequency: 181 affected / 1041 at risk

Adverse event: MYOCARDIAL DISORDERS
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 1041 at risk

Adverse event: PERICARDIAL DISORDERS
Serious: yes
Organ System: Cardiac disorders
Frequency: 4 affected / 1041 at risk

Adverse event: CARDIAC AND VASCULAR DISORDERS CONGENITAL
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 3 affected / 1041 at risk

Adverse event: GASTROINTESTINAL HAEMORRHAGES NEC
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1041 at risk

Adverse event: GASTROINTESTINAL SIGNS AND SYMPTOMS
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1041 at risk

Adverse event: GASTROINTESTINAL STENOSIS AND OBSTRUCTION
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1041 at risk

Adverse event: GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS COMPLICATIONS ASSOCIATED WITH DEVICE
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1041 at risk

Adverse event: DEVICE ISSUES
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 1041 at risk

Adverse event: FATAL OUTCOMES
Serious: yes
Organ System: General disorders
Frequency: 32 affected / 1041 at risk

Adverse event: GENERAL SYSTEM DISORDERS NEC
Serious: yes
Organ System: General disorders
Frequency: 6 affected / 1041 at risk

Adverse event: HEPATIC AND HEPATOBILIARY DISORDERS
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1041 at risk

Adverse event: INFECTIONS - PATHOGEN UNSPECIFIED
Serious: yes
Organ System: Infections and infestations
Frequency: 19 affected / 1041 at risk

Adverse event: INJURIES NEC
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 1041 at risk

Adverse event: PROCEDURAL RELATED INJURIES AND COMPLICATIONS NEC
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 1041 at risk

Adverse event: CARDIAC AND VASCULAR INVESTIGATIONS
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1041 at risk

Adverse event: HAEMATOLOGY INVESTIGATIONS
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1041 at risk

Adverse event: ELECTROLYTE AND FLUID BALANCE CONDITIONS
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1041 at risk

Adverse event: GASTROINTESTINAL NEOPLASMS MALIGNANT AND UNSPECIFIED
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1041 at risk

Adverse event: LEUKAEMIAS
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 1041 at risk

Adverse event: LYMPHOMAS NON-HODGKIN'S B-CELL
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1041 at risk

Adverse event: MISCELLANEOUS AND SITE UNSPECIFIED NEOPLASMS MALIGNANT AND UNSPECIFIED
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1041 at risk

Adverse event: REPRODUCTIVE NEOPLASMS MALE MALIGNANT AND UNSPECIFIED
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1041 at risk

Adverse event: RESPIRATORY AND MEDIASTINAL NEOPLASMS MALIGNANT AND UNSPECIFIED
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 1041 at risk

Adverse event: CENTRAL NERVOUS SYSTEM VASCULAR DISORDERS
Serious: yes
Organ System: Nervous system disorders
Frequency: 23 affected / 1041 at risk

Adverse event: ENCEPHALOPATHIES
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1041 at risk

Adverse event: MENTAL IMPAIRMENT DISORDERS
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1041 at risk

Adverse event: NEUROLOGICAL DISORDERS NEC
Serious: yes
Organ System: Nervous system disorders
Frequency: 5 affected / 1041 at risk

Adverse event: NEPHROPATHIES
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1041 at risk

Adverse event: RENAL DISORDERS
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 8 affected / 1041 at risk

Adverse event: URINARY TRACT SIGNS AND SYMPTOMS
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 1041 at risk

Adverse event: BRONCHIAL DISORDERS
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1041 at risk

Adverse event: LOWER RESPIRATORY TRACT DISORDERS
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 1041 at risk

Adverse event: PLEURAL DISORDERS
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 1041 at risk

Adverse event: PULMONARY VASCULAR DISORDERS
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1041 at risk

Adverse event: RESPIRATORY DISORDERS NEC
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 18 affected / 1041 at risk

Adverse event: CARDIAC THERAPEUTIC PROCEDURES
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 1041 at risk

Adverse event: SOFT TISSUE THERAPEUTIC PROCEDURES
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1041 at risk

Adverse event: ANEURYSMS AND ARTERY DISSECTIONS
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 1041 at risk

Adverse event: ARTERIOSCLEROSIS, STENOSIS, VASCULAR INSUFFICIENCY AND NECROSIS
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 1041 at risk

Adverse event: DECREASED AND NONSPECIFIC BLOOD PRESSURE DISORDERS AND SHOCK
Serious: yes
Organ System: Vascular disorders
Frequency: 12 affected / 1041 at risk

Adverse event: EMBOLISM AND THROMBOSIS
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 1041 at risk

Adverse event: VASCULAR DISORDERS NEC
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 1041 at risk

Adverse event: VASCULAR HAEMORRHAGIC DISORDERS
Serious: yes
Organ System: Vascular disorders
Frequency: 37 affected / 1041 at risk

Adverse event: VASCULAR HYPERTENSIVE DISORDERS
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 1041 at risk

Adverse event: VASCULAR INJURIES
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1041 at risk