Study: NCT02279888

Adverse event: Anemia deficiencies
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1214 at risk

Adverse event: Anaemia NEC
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 52 affected / 1214 at risk

Adverse event: Coagulopathies
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1214 at risk

Adverse event: Leukocytoses NEC
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 1 affected / 1214 at risk

Adverse event: Marrow Depression and Hypoplastic Anaemias
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 1214 at risk

Adverse event: Neutropenias
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1214 at risk

Adverse event: Thrombocytopenias
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 8 affected / 1214 at risk

Adverse event: Cardiac Disorders NEC
Serious: yes
Organ System: Cardiac disorders
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 1 affected / 1214 at risk

Adverse event: Cardiac Signs and Symptoms NEC
Serious: yes
Organ System: Cardiac disorders
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 2 affected / 1214 at risk

Adverse event: Cardiomyopathies
Serious: yes
Organ System: Cardiac disorders
Frequency: 10 affected / 1214 at risk

Adverse event: Coronary Artery Disorders NEC
Serious: yes
Organ System: Cardiac disorders
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 4 affected / 1214 at risk

Adverse event: Heart Failures NEC
Serious: yes
Organ System: Cardiac disorders
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 468 affected / 1214 at risk

Adverse event: Ischaemic Coronary Artery Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 61 affected / 1214 at risk

Adverse event: Mitral Valvular Disorders
Serious: yes
Organ System: Cardiac disorders
Frequency: 11 affected / 1214 at risk

Adverse event: Myocardial Disorders NEC
Serious: yes
Organ System: Cardiac disorders
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 1 affected / 1214 at risk

Adverse event: Pericardial Disorders NEC
Serious: yes
Organ System: Cardiac disorders
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 2 affected / 1214 at risk

Adverse event: Rate and Rhythm Disorders NEC
Serious: yes
Organ System: Cardiac disorders
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 23 affected / 1214 at risk

Adverse event: Supraventricular Arrhythmias
Serious: yes
Organ System: Cardiac disorders
Frequency: 70 affected / 1214 at risk

Adverse event: Ventricular Arrhythmias and Cardiac Arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 93 affected / 1214 at risk

Adverse event: Inner Ear Signs and Symptoms
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 3 affected / 1214 at risk

Adverse event: Adrenal Cortical Hypofunctriuons
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 1214 at risk

Adverse event: Hyperparathyroid Disorders
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 1214 at risk

Adverse event: Partial Vision Loss
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 1214 at risk

Adverse event: Visual Disorders NEC
Serious: yes
Organ System: Eye disorders
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 1 affected / 1214 at risk

Adverse event: Abdominal Hernias, site unspecified
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1214 at risk

Adverse event: Abdominal Wall Conditions NEC
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 1 affected / 1214 at risk

Adverse event: Acute and Chronic Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 6 affected / 1214 at risk

Adverse event: Anal and Rectal Disorders NEC
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 1 affected / 1214 at risk

Adverse event: Colitis (excl infective)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1214 at risk

Adverse event: Diarrhoea (excl infective)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 1214 at risk

Adverse event: Duodenal and Small Intestinal stenosis and obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 1214 at risk

Adverse event: Flatulence, bloating and Distension
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1214 at risk

Adverse event: Gastric Ulcers and Perforation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 1214 at risk

Adverse event: Gastritis (excl infective)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1214 at risk

Adverse event: Gastrointestinal and Abdominal Pain (excl oral and throat)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 31 affected / 1214 at risk

Adverse event: Gastrointestinal atonic and hypomobility disorders NEC
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 3 affected / 1214 at risk

Adverse event: Gastrointestinal disorders NEC
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 2 affected / 1214 at risk

Adverse event: Gastrointestinal signs and symptoms NEC
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 8 affected / 1214 at risk

Adverse event: Gastrointestinal stenosis and obstruction NEC
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 9 affected / 1214 at risk

Adverse event: Gastrointestinal vascular occlusion and infarction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1214 at risk

Adverse event: Haemorrhoids and gastointestinal varices (excl oesophageal)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1214 at risk

Adverse event: Intestinal Haemorrhages
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1214 at risk

Adverse event: Intestinal ulcers and perforation NEC
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 1 affected / 1214 at risk

Adverse event: Nausea and vomiting symptoms
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 1214 at risk

Adverse event: Non-site specific gastrointestinal haemorrhages
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 73 affected / 1214 at risk

Adverse event: Oesophageal stenosis and obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1214 at risk

Adverse event: Oesophagitis (excl infective)
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1214 at risk

Adverse event: Pancreatic and retroperitoneal disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 1214 at risk

Adverse event: Pancreatic disorders NEC
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 1 affected / 1214 at risk

Adverse event: Peritoneal and retroperitoneal disorders
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 1214 at risk

Adverse event: Peritoneal and retroperitoneal fibrosis and adhesions
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1214 at risk

Adverse event: Asthenic conditions
Serious: yes
Organ System: General disorders
Frequency: 50 affected / 1214 at risk

Adverse event: Febrile disorders
Serious: yes
Organ System: General disorders
Frequency: 15 affected / 1214 at risk

Adverse event: General signs and symptoms NEC
Serious: yes
Organ System: General disorders
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 9 affected / 1214 at risk

Adverse event: Hernias NEC
Serious: yes
Organ System: General disorders
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 2 affected / 1214 at risk

Adverse event: Implant and catheter site reactions
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1214 at risk

Adverse event: Mass conditions NEC
Serious: yes
Organ System: General disorders
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 1 affected / 1214 at risk

Adverse event: Oedema NEC
Serious: yes
Organ System: General disorders
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 11 affected / 1214 at risk

Adverse event: Pain and discomfort NEC
Serious: yes
Organ System: General disorders
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 96 affected / 1214 at risk

Adverse event: Bile duct infections and inflammations
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1214 at risk

Adverse event: Cholecystitis and cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 9 affected / 1214 at risk

Adverse event: Hepatic and hepatobiliary disorders NEC
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 1 affected / 1214 at risk

Adverse event: Hepatic failure and associated disorders
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 1214 at risk

Adverse event: Hepatic fibrosis and cirrhosis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 2 affected / 1214 at risk

Adverse event: Hepatobiliary signs and symptoms
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1214 at risk

Adverse event: Allergic conditions NEC
Serious: yes
Organ System: Immune system disorders
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 1 affected / 1214 at risk

Adverse event: Allergies to food, food additives, drugs and other chemicals
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 1214 at risk

Adverse event: Amyloidoses
Serious: yes
Organ System: Immune system disorders
Frequency: 3 affected / 1214 at risk

Adverse event: Transplant rejections
Serious: yes
Organ System: Immune system disorders
Frequency: 3 affected / 1214 at risk

Adverse event: Abdominal and gastrointestinal infections
Serious: yes
Organ System: Infections and infestations
Frequency: 13 affected / 1214 at risk

Adverse event: Bacterial infections NEC
Serious: yes
Organ System: Infections and infestations
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 44 affected / 1214 at risk

Adverse event: Bone and join infections NEC
Serious: yes
Organ System: Infections and infestations
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 6 affected / 1214 at risk

Adverse event: Breast infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1214 at risk

Adverse event: Cardiac infections
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 1214 at risk

Adverse event: Chlostridia infections
Serious: yes
Organ System: Infections and infestations
Frequency: 10 affected / 1214 at risk

Adverse event: Herpes viral infections
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1214 at risk

Adverse event: Infections NEC
Serious: yes
Organ System: Infections and infestations
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 25 affected / 1214 at risk

Adverse event: Influenza viral infections
Serious: yes
Organ System: Infections and infestations
Frequency: 12 affected / 1214 at risk

Adverse event: Klebsiella infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1214 at risk

Adverse event: Lower respiratory tract and lung infections
Serious: yes
Organ System: Infections and infestations
Frequency: 104 affected / 1214 at risk

Adverse event: Pseudomonal infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1214 at risk

Adverse event: Sepsis, bacteraemia, viraemia and fungaemia NEC
Serious: yes
Organ System: Infections and infestations
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 87 affected / 1214 at risk

Adverse event: Skin structures and soft tissue infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1214 at risk

Adverse event: Upper respiratory tract infections
Serious: yes
Organ System: Infections and infestations
Frequency: 9 affected / 1214 at risk

Adverse event: Urinary tract infections
Serious: yes
Organ System: Infections and infestations
Frequency: 42 affected / 1214 at risk

Adverse event: Viral infections NEC
Serious: yes
Organ System: Infections and infestations
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 6 affected / 1214 at risk

Adverse event: Cerebral injuries NEC
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 7 affected / 1214 at risk

Adverse event: Device malfunction events
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 1214 at risk

Adverse event: Device related complications (pacemaker complications)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1214 at risk

Adverse event: Device related complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 1214 at risk

Adverse event: Fractures and dislocations NEC
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 10 affected / 1214 at risk

Adverse event: Injuries NEC (head injury)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 1 affected / 1214 at risk

Adverse event: Limb injuries NEC (incl. traumatic amputation)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 1 affected / 1214 at risk

Adverse event: lower limb fractures and dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1214 at risk

Adverse event: Non-site specific injuries NEC (fall)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 1 affected / 1214 at risk

Adverse event: Non-site specific injuries NEC
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 38 affected / 1214 at risk

Adverse event: Non-site specific procedural complications
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1214 at risk

Adverse event: Overdoses
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1214 at risk

Adverse event: Pelvic fractures and dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 1214 at risk

Adverse event: Poisoning and toxicity
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1214 at risk

Adverse event: Renal and urinary tract injuries NEC
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 14 affected / 1214 at risk

Adverse event: Site specific injuries NEC
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 1 affected / 1214 at risk

Adverse event: Skin injuries NEC
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 4 affected / 1214 at risk

Adverse event: Spinal fractures and dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 1214 at risk

Adverse event: Thoracic cage fractures and dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 1214 at risk

Adverse event: Upper limb fractures and dislocations
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 1214 at risk

Adverse event: Carbohydrate tolerance analysis (incl. diabetes)
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1214 at risk

Adverse event: Cardiac function diagnostic procedures
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 1214 at risk

Adverse event: Coagulation and bleeding analyses
Serious: yes
Organ System: Investigations
Frequency: 9 affected / 1214 at risk

Adverse event: Investigations NEC
Serious: yes
Organ System: Investigations
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 2 affected / 1214 at risk

Adverse event: Liver function analyses
Serious: yes
Organ System: Investigations
Frequency: 4 affected / 1214 at risk

Adverse event: Physical examination procedures
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 1214 at risk

Adverse event: Renal function analyses
Serious: yes
Organ System: Investigations
Frequency: 3 affected / 1214 at risk

Adverse event: Therapeutic drug monitoring analyses
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1214 at risk

Adverse event: Diabetes mellitus (incl. subtypes)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 6 affected / 1214 at risk

Adverse event: Diabetic complications NEC
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 1 affected / 1214 at risk

Adverse event: Electrolyte imbalance NEC
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 1 affected / 1214 at risk

Adverse event: General nutrition disorders NEC
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 8 affected / 1214 at risk

Adverse event: Hyperglycaemic conditions NEC
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 14 affected / 1214 at risk

Adverse event: Hypoglicaemic conditions NEC
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 5 affected / 1214 at risk

Adverse event: Iron deficiencies
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1214 at risk

Adverse event: Magnesium metabolism disorders
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1214 at risk

Adverse event: Metabolic acidoses (excl diabetic acidoses)
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 1214 at risk

Adverse event: Potassium imbalance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 37 affected / 1214 at risk

Adverse event: Purine metabolism disorders NEC
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 10 affected / 1214 at risk

Adverse event: Sodium imbalance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 14 affected / 1214 at risk

Adverse event: Total fluid volume decreased
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 33 affected / 1214 at risk

Adverse event: Total fluid volume increased
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 32 affected / 1214 at risk

Adverse event: Arthropaties NEC
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 3 affected / 1214 at risk

Adverse event: Bursal disorders
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 1214 at risk

Adverse event: Joint related disorders NEC
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 1 affected / 1214 at risk

Adverse event: Joint related signs and symptoms
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 1214 at risk

Adverse event: Muscle related signs and symptoms NEC
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 1 affected / 1214 at risk

Adverse event: Muscle weakness condition
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 1214 at risk

Adverse event: Musculoskeletal and connective tissue signs and symptoms NEC
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 37 affected / 1214 at risk

Adverse event: Osteoarthropathies
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 9 affected / 1214 at risk

Adverse event: Spine and neck deformities
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1214 at risk

Adverse event: Breast and nipple neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1214 at risk

Adverse event: Endocrine neoplasm benign NEC
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 1 affected / 1214 at risk

Adverse event: Gastric neoplasms malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1214 at risk

Adverse event: Lymphomas unspecified NEC
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 1 affected / 1214 at risk

Adverse event: Neoplasms benign site unspecified NEC
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 1 affected / 1214 at risk

Adverse event: Neoplasms malignant site unspecified NEC
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 1 affected / 1214 at risk

Adverse event: Ovarian neoplasms malignant (excl germ cell)
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1214 at risk

Adverse event: Respiratory tract and pleural neoplasms malignant cell type undisclosed NEC
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 5 affected / 1214 at risk

Adverse event: Central nervous system haemorrhages and cerebrovascular accidents
Serious: yes
Organ System: Nervous system disorders
Frequency: 30 affected / 1214 at risk

Adverse event: Central nervous system vascular disorders NEC
Serious: yes
Organ System: Nervous system disorders
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 6 affected / 1214 at risk

Adverse event: Cerebellar coordination and balance disturbances
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1214 at risk

Adverse event: Dementia (excl Alzheimer's type)
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1214 at risk

Adverse event: Disturbances in consciousness NEC
Serious: yes
Organ System: Nervous system disorders
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 85 affected / 1214 at risk

Adverse event: Encephalopaties NEC
Serious: yes
Organ System: Nervous system disorders
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 16 affected / 1214 at risk

Adverse event: Encephalopaties toxic and metabolic
Serious: yes
Organ System: Nervous system disorders
Frequency: 12 affected / 1214 at risk

Adverse event: Headaches NEC
Serious: yes
Organ System: Nervous system disorders
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 3 affected / 1214 at risk

Adverse event: Neurological signs and symptoms
Serious: yes
Organ System: Nervous system disorders
Frequency: 22 affected / 1214 at risk

Adverse event: Paralysis and paresis (excl. cranial nerve)
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1214 at risk

Adverse event: Peripheral neuropathies NEC
Serious: yes
Organ System: Nervous system disorders
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 1 affected / 1214 at risk

Adverse event: Seizures and seizure disorders NEC
Serious: yes
Organ System: Nervous system disorders
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 6 affected / 1214 at risk

Adverse event: Sensory abnormalities NEC
Serious: yes
Organ System: Nervous system disorders
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 2 affected / 1214 at risk

Adverse event: Speech and languages abnormalities
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1214 at risk

Adverse event: Spinal chord and nerve root disorders NEC
Serious: yes
Organ System: Nervous system disorders
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 1 affected / 1214 at risk

Adverse event: Structural brain disorders NEC
Serious: yes
Organ System: Nervous system disorders
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 1 affected / 1214 at risk

Adverse event: Transient cerebrovascular events
Serious: yes
Organ System: Nervous system disorders
Frequency: 10 affected / 1214 at risk

Adverse event: Tremor (excl congenital)
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1214 at risk

Adverse event: Device component findings (lead fracture)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1214 at risk

Adverse event: Device malfunctions (lead dislodgement)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1214 at risk

Adverse event: Non-site specific procedural complications (seroma)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1214 at risk

Adverse event: Device malfunction events (sensor recalibration)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1214 at risk

Adverse event: Implant procedure failure
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1214 at risk

Adverse event: Non-site specific procedural complications (hematoma post-operative)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 1214 at risk

Adverse event: Pacemaker complication (lead dislodgement)
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1214 at risk

Adverse event: Anxiety symptoms
Serious: yes
Organ System: Psychiatric disorders
Frequency: 3 affected / 1214 at risk

Adverse event: Confusion and disorientation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 10 affected / 1214 at risk

Adverse event: Depressive disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1214 at risk

Adverse event: Mental disorders NEC
Serious: yes
Organ System: Psychiatric disorders
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 19 affected / 1214 at risk

Adverse event: Substance-related disorders
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1214 at risk

Adverse event: Suicidal and self-injurious behaviour
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 1214 at risk

Adverse event: Bladder and urethral symptoms
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 5 affected / 1214 at risk

Adverse event: Renal disorders NEC
Serious: yes
Organ System: Renal and urinary disorders
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 4 affected / 1214 at risk

Adverse event: Renal failure and impairment
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 136 affected / 1214 at risk

Adverse event: Renal failure complications
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 1214 at risk

Adverse event: Renal lithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 2 affected / 1214 at risk

Adverse event: Renal vascular and ischaemic conditions
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1214 at risk

Adverse event: Urinary abnormalitiues
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 4 affected / 1214 at risk

Adverse event: Prostate and seminal vesicles infections and inflammations
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 1214 at risk

Adverse event: Prostatic neoplasms and hypertrophy
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 1214 at risk

Adverse event: Scrotal disorders NEC
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 1 affected / 1214 at risk

Adverse event: Vulvovaginal disorders NEC
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 4 affected / 1214 at risk

Adverse event: Breathing abnormalities
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 158 affected / 1214 at risk

Adverse event: Bronchospasm and obstruction
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 46 affected / 1214 at risk

Adverse event: Conditions associated with abnormal gas exchange
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 1214 at risk

Adverse event: Coughing and associated symptoms
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 1214 at risk

Adverse event: Lower respiratory tract inflammatory and immunologic conditions
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 1214 at risk

Adverse event: Lower respiratory tract signs and symptoms
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1214 at risk

Adverse event: Nasal disorders NEC
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 4 affected / 1214 at risk

Adverse event: Parenchymal lung disorders NEC
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 1 affected / 1214 at risk

Adverse event: Pleural infections and inflammations
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1214 at risk

Adverse event: Pneumothorax and pleural effusions NEC
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 15 affected / 1214 at risk

Adverse event: Pulmonary hypertensions
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1214 at risk

Adverse event: Pulmonary oedemas
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 1214 at risk

Adverse event: Pulmonary thrombotic and embolic conditions
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 11 affected / 1214 at risk

Adverse event: Respiratory failures (excl neonatal)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 67 affected / 1214 at risk

Adverse event: Respiratory tract disorders NEC
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1214 at risk

Adverse event: Angioedemas
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 1214 at risk

Adverse event: Bullous conditions
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 1214 at risk

Adverse event: Dermal and epidermal conditions NEC
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 1 affected / 1214 at risk

Adverse event: Skin and subcutaneous tissue ulcerations
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 4 affected / 1214 at risk

Adverse event: Biliary tract and gallbladder therapeutic procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1214 at risk

Adverse event: Bladder therapeutic procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1214 at risk

Adverse event: Cardiac device therapeutic procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 27 affected / 1214 at risk

Adverse event: Cardiac therapeutic procedures NEC
Serious: yes
Organ System: Surgical and medical procedures
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 13 affected / 1214 at risk

Adverse event: Cardiac valve therapeutic procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 4 affected / 1214 at risk

Adverse event: Gastric therapeutic procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 9 affected / 1214 at risk

Adverse event: Hernia repairs
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 3 affected / 1214 at risk

Adverse event: Joint therapeutic procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 7 affected / 1214 at risk

Adverse event: Limb therapeutic procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 1214 at risk

Adverse event: Therapeutic procedures NEC
Serious: yes
Organ System: Surgical and medical procedures
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 4 affected / 1214 at risk

Adverse event: Tongue therapeutic procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1214 at risk

Adverse event: Ureteric therapeutic procedures
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1214 at risk

Adverse event: Uterine therapeutic procedure
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 1214 at risk

Adverse event: Vascular therapeutic procedures NEC
Serious: yes
Organ System: Surgical and medical procedures
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 2 affected / 1214 at risk

Adverse event: Accelerated and malignant hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 2 affected / 1214 at risk

Adverse event: Aortic aneurysm and dissections
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 1214 at risk

Adverse event: Aortic necrosis and vascular insufficiency
Serious: yes
Organ System: Vascular disorders
Frequency: 7 affected / 1214 at risk

Adverse event: Circulatory collapse an shock
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 1214 at risk

Adverse event: Haemorrhages NEC
Serious: yes
Organ System: Vascular disorders
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 22 affected / 1214 at risk

Adverse event: Non-site specific embolism and thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 4 affected / 1214 at risk

Adverse event: Non-site specific necrosis and vascular insufficiency NEC
Serious: yes
Organ System: Vascular disorders
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 3 affected / 1214 at risk

Adverse event: Non-site specific vascular disorders NEC
Serious: yes
Organ System: Vascular disorders
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 1 affected / 1214 at risk

Adverse event: Peripheral embolism and thrombosis
Serious: yes
Organ System: Vascular disorders
Frequency: 7 affected / 1214 at risk

Adverse event: Peripheral vascular disorders NEC
Serious: yes
Organ System: Vascular disorders
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 6 affected / 1214 at risk

Adverse event: Peripheral vasoconstriction, necrosis and vascular insufficiency
Serious: yes
Organ System: Vascular disorders
Frequency: 6 affected / 1214 at risk

Adverse event: Vascular hypertensive disorders NEC
Serious: yes
Organ System: Vascular disorders
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 4 affected / 1214 at risk

Adverse event: Vascular hypotensive disorders
Serious: yes
Organ System: Vascular disorders
Frequency: 52 affected / 1214 at risk

Adverse event: Vascular injuries NEC
Serious: yes
Organ System: Vascular disorders
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 1 affected / 1214 at risk

Adverse event: Rate and rhythm disorders NEC
Serious: no
Organ System: Cardiac disorders
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 1 affected / 1214 at risk

Adverse event: Febrile disorders
Serious: no
Organ System: General disorders
Frequency: 1 affected / 1214 at risk

Adverse event: General signs and symptoms NEC
Serious: no
Organ System: General disorders
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 1 affected / 1214 at risk

Adverse event: Pain and discomfort NEC
Serious: no
Organ System: General disorders
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 2 affected / 1214 at risk

Adverse event: Allergic conditions NEC
Serious: no
Organ System: Immune system disorders
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 1 affected / 1214 at risk

Adverse event: Skin structures and soft tissue infections
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 1214 at risk

Adverse event: Device malfunctions events
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 14 affected / 1214 at risk

Adverse event: Device related complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 1214 at risk

Adverse event: Non-site specific procedural complications
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1214 at risk

Adverse event: Blood gas and acid base analyses
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1214 at risk

Adverse event: Cardiac function diagnostic procedures
Serious: no
Organ System: Investigations
Frequency: 5 affected / 1214 at risk

Adverse event: Musculoskeletal and connective tissue signs and symptoms NEC
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 1 affected / 1214 at risk

Adverse event: Soft tissue disorders NEC
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 1 affected / 1214 at risk

Adverse event: Device malfunctions events (sensor recalibration, repositioning, difficulty obtaining readings)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 9 affected / 1214 at risk

Adverse event: Device-related complications (migration of implant)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 1214 at risk

Adverse event: Non-site specific procedural complications (hematoma, bleeding, incision site complications)
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 1214 at risk

Adverse event: Non-site specific injuries NEC (wound)
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 1 affected / 1214 at risk

Adverse event: Skin injuries NEC (bruising)
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 1 affected / 1214 at risk

Adverse event: Renal failure and impairment
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1214 at risk

Adverse event: Coughing and associated symptoms
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1214 at risk

Adverse event: Therapeutic procedures NEC
Serious: no
Organ System: Surgical and medical procedures
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 1 affected / 1214 at risk

Adverse event: Vascular therapeutic procedures NEC
Serious: no
Organ System: Surgical and medical procedures
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 1 affected / 1214 at risk

Adverse event: Haemorrhages NEC
Serious: no
Organ System: Vascular disorders
Notes: Not Elsewhere Classifiable (NEC) is used in a MedDRA code description that indicates that a more specific category is not provided in the tabular list of codes and no amount of additional information will alter the code.
Frequency: 4 affected / 1214 at risk