Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-26 @ 4:17 AM
NCT ID:
NCT00976027
Description:
None
Frequency Threshold:
5.00
Time Frame:
Adverse events data were collected from Day 0 (post-vaccination) up to 8 months post-vaccination.
Study:
NCT00976027
Study Brief:
Multi-Year Study of Fluzone High-Dose Influenza Vaccine Compared With Fluzone® Vaccine in Adults Aged 65 Years and Older
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Fluzone® High Dose | All participants received a single dose of Fluzone High Dose vaccine on Day 0. | None | None | 493 | 6108 | 0 | 6108 | View |
| Fluzone® | All subjects received a single dose of Fluzone vaccine on Day 0. | None | None | 236 | 3050 | 0 | 3050 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 12.0 | View |
| Coagulopathy | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 12.0 | View |
| Iron Deficiency Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 12.0 | View |
| Splenomegaly | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 12.0 | View |
| Thrombocytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 12.0 | View |
| Acute Coronary Syndrome | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.0 | View |
| Acute Myocardial Infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.0 | View |
| Angina Pectoris | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.0 | View |
| Angina Unstable | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.0 | View |
| Aortic Valve Incompetence | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.0 | View |
| Arrhythmia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.0 | View |
| Atrial Fibrillation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.0 | View |
| Atrioventricular Block Complete | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.0 | View |
| Myocardial Ischaemia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.0 | View |
| Pericardial Effusion | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.0 | View |
| Sick Sinus Syndrome | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.0 | View |
| Sinus Bradycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.0 | View |
| Arteriovenous Malformation | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA 12.0 | View |
| Atrial Septal Defect | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA 12.0 | View |
| Retinal Artery Occlusion | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 12.0 | View |
| Colitis Ischaemic | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.0 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.0 | View |
| Bladder transitional cell carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | View |
| Hodgkin's disease stage IV | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | View |
| Intraocular melanoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | View |
| Diverticular Perforation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.0 | View |
| Diverticulitis Intestinal Haemorrhagic | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.0 | View |
| Diverticulum Intestinal Haemorrhagic | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.0 | View |
| Duodenal Ulcer Haemorrhagic | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.0 | View |
| Duodenal Ulcer Perforation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.0 | View |
| Dyspepsia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.0 | View |
| Faecaloma | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.0 | View |
| Faeces Discolored | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.0 | View |
| Food Poisoning | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.0 | View |
| Gastric Ulcer | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.0 | View |
| Gastric Ulcer Haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.0 | View |
| Gastritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.0 | View |
| Gastrointestinal Haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.0 | View |
| Gastrooesophageal Reflux Disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.0 | View |
| Haemorrhoids | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.0 | View |
| Hiatus Hernia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.0 | View |
| Ileus Paralytic | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.0 | View |
| Inguinal Hernia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.0 | View |
| Intestinal Ischaemia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.0 | View |
| Intestinal Obstruction | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.0 | View |
| Intestinal Ulcer | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.0 | View |
| Intra Abdominal Haematoma | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.0 | View |
| Large Intestine Perforation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.0 | View |
| Melaena | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.0 | View |
| Obstruction Gastric | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.0 | View |
| Oesophageal Ulcer | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.0 | View |
| Oesophageal Ulcer Hemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.0 | View |
| Pancreatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.0 | View |
| Pancreatitis Acute | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.0 | View |
| Pancreatitis Relapsing | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.0 | View |
| Peptic Ulcer | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.0 | View |
| Rectal Haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.0 | View |
| Reflux Oesophagitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.0 | View |
| Small Intestinal Obstruction | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.0 | View |
| Spigelian Hernia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.0 | View |
| Swollen Tongue | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.0 | View |
| Umbilical Hernia Obstructive | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.0 | View |
| Upper Gastrointestinal Haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.0 | View |
| Adverse Drug Reaction | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.0 | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.0 | View |
| Catheter Site Haematoma | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.0 | View |
| Chest Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.0 | View |
| Chills | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.0 | View |
| Death | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.0 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.0 | View |
| Hernia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.0 | View |
| Hernia Obstructive | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.0 | View |
| Influenza Like Illness | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.0 | View |
| Non Cardiac Chest Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.0 | View |
| Oedema Peripheral | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.0 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 12.0 | View |
| Cholangitis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 12.0 | View |
| Cholecystitis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 12.0 | View |
| Cholecystitis acute | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 12.0 | View |
| Cholelithiasis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 12.0 | View |
| Portal vein thrombosis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 12.0 | View |
| Drug hypersensitivity | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 12.0 | View |
| Hypersensitivity | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 12.0 | View |
| Abdominal abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Abscess limb | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Actinomycotic pulmonary infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Appendicitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Application site cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Arthritis bacterial | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Bacterial infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Biliary sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Bronchitis viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Cellulitis staphylococcal | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Clostridial infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Clostridium difficile colitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Diverticulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Endocarditis bacterial | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Escherichia urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Gangrene | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Sepsis syndrome | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Septic arthritis staphylococcal | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Septic shock | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Sialoadenitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Staphylococcal bacteraemia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Staphylococcal infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Staphylococcal sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Subcutaneous abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Tracheobronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Urinary tract infection enterococcal | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Urinary tract infection staphylococcal | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Urosepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Viral infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Wound infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Accidental overdose | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.0 | View |
| Anaemia postoperative | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.0 | View |
| Ankle fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.0 | View |
| Back injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.0 | View |
| Brain contusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.0 | View |
| Burns second degree | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.0 | View |
| Cervical vertebral fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.0 | View |
| Compression fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.0 | View |
| Concussion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.0 | View |
| Drug toxicity | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.0 | View |
| Femoral neck fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.0 | View |
| Femur fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.0 | View |
| Fibula fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.0 | View |
| Fractured sacrum | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.0 | View |
| Hand fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.0 | View |
| Head injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.0 | View |
| Hip fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.0 | View |
| Humerus fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.0 | View |
| Ilium fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.0 | View |
| Incisional hernia | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.0 | View |
| Joint dislocation | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.0 | View |
| Lower limb fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.0 | View |
| Medical device complication | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.0 | View |
| Multiple fractures | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.0 | View |
| Muscle injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.0 | View |
| Muscle strain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.0 | View |
| Pelvic fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.0 | View |
| Post procedural complication | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.0 | View |
| Post procedural haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.0 | View |
| Rib fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.0 | View |
| Road traffic accident | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.0 | View |
| Spinal compression fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.0 | View |
| Splenic rupture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.0 | View |
| Sternal fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.0 | View |
| Subdural haematoma | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.0 | View |
| Subdural haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.0 | View |
| Tendon injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.0 | View |
| Tendon rupture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.0 | View |
| Upper limb fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.0 | View |
| Wrist fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 12.0 | View |
| Heart rate irregular | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 12.0 | View |
| International normalised ratio increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 12.0 | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 12.0 | View |
| Diabetes mellitus inadequate control | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 12.0 | View |
| Diabetic foot | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 12.0 | View |
| Diabetic ketoacidosis | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 12.0 | View |
| Failure to thrive | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 12.0 | View |
| Fluid retention | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 12.0 | View |
| Hyperglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 12.0 | View |
| Hyperkalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 12.0 | View |
| Hypoglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 12.0 | View |
| Hypokalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 12.0 | View |
| Hyponatraemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 12.0 | View |
| Type 2 diabetes mellitus | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 12.0 | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | View |
| Arthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | View |
| Back disorder | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | View |
| Cervical spinal stenosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | View |
| Costochondritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | View |
| Intervertebral disc degeneration | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | View |
| Intervertebral disc disorder | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | View |
| Intervertebral disc protrusion | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | View |
| Lumbar spinal stenosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | View |
| Musculoskeletal chest pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | View |
| Osteoarthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | View |
| Rotator cuff syndrome | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | View |
| Spinal column stenosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | View |
| Spinal disorder | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | View |
| Spinal osteoarthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | View |
| Spondylolisthesis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | View |
| Synovial cyst | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 12.0 | View |
| Adenocarcinoma pancreas | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | View |
| Adenoid cystic carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | View |
| Bladder cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | View |
| Bladder cancer recurrent | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | View |
| Breast cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | View |
| Breast cancer metastatic | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | View |
| Breast neoplasm | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | View |
| Colon adenoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | View |
| Colon cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | View |
| Colorectal cancer metastatic | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | View |
| Glioblastoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | View |
| Large cell lung cancer stage II | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | View |
| Laryngeal cancer stage III | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | View |
| Leiomyosarcoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | View |
| Lung adenocarcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | View |
| Lung neoplasm malignant | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | View |
| Lung squamous cell carcinoma stage unspecified | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | View |
| Lymphoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | View |
| Malignant melanoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | View |
| Metastases to liver | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | View |
| Metastatic neoplasm | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | View |
| Neoplasm malignant | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | View |
| Non-small cell lung cancer metastatic | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | View |
| Oesophageal adenocarcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | View |
| Oesophageal squamous cell carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | View |
| Ovarian cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | View |
| Paget's disease of the breast | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | View |
| Pancreatic carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | View |
| Pancreatic carcinoma metastatic | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | View |
| Prostate cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | View |
| Prostate cancer metastatic | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | View |
| Prostate cancer recurrent | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | View |
| Rectal cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | View |
| Renal cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | View |
| Skin cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | View |
| Small intestine carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | View |
| Splenic marginal zone lymphoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | View |
| Splenic neoplasm malignancy unspecified | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | View |
| Squamous cell carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | View |
| Testis cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | View |
| Thymoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | View |
| Thyroid neoplasm | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | View |
| Uterine cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | View |
| Balance disorder | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.0 | View |
| Carotid artery occlusion | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.0 | View |
| Carotid artery stenosis | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.0 | View |
| Cerebral haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.0 | View |
| Cerebral ischaemia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.0 | View |
| Cerebrovascular accident | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.0 | View |
| Cervicobrachial syndrome | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.0 | View |
| Drug withdrawal convulsions | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.0 | View |
| Epilepsy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.0 | View |
| Facial palsy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.0 | View |
| Global amnesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.0 | View |
| Haemorrhage intracranial | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.0 | View |
| Haemorrhagic stroke | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.0 | View |
| Hypertensive encephalopathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.0 | View |
| Intracranial aneurysm | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.0 | View |
| Ischaemic stroke | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.0 | View |
| Lumbar radiculopathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.0 | View |
| Myelitis transverse | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.0 | View |
| Nerve compression | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.0 | View |
| Normal pressure hydrocephalus | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.0 | View |
| Paraesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.0 | View |
| Presyncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.0 | View |
| Subarachnoid haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.0 | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.0 | View |
| Transient ischaemic attack | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.0 | View |
| Alcohol abuse | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 12.0 | View |
| Alcoholism | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 12.0 | View |
| Anxiety disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 12.0 | View |
| Bipolar disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 12.0 | View |
| Completed suicide | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 12.0 | View |
| Delusion | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 12.0 | View |
| Depressed mood | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 12.0 | View |
| Depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 12.0 | View |
| Disorientation | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 12.0 | View |
| Major depression | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 12.0 | View |
| Mental disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 12.0 | View |
| Mental status changes | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 12.0 | View |
| Anuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 12.0 | View |
| Bladder obstruction | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 12.0 | View |
| Calculus bladder | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 12.0 | View |
| Calculus ureteric | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 12.0 | View |
| Haematuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 12.0 | View |
| Incontinence | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 12.0 | View |
| Nephrolithiasis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 12.0 | View |
| Renal artery stenosis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 12.0 | View |
| Renal failure | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 12.0 | View |
| Renal failure acute | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 12.0 | View |
| Renal failure chronic | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 12.0 | View |
| Renal mass | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 12.0 | View |
| Urinary incontinence | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 12.0 | View |
| Urinary retention | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 12.0 | View |
| Benign prostatic hyperplasia | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 12.0 | View |
| Cystocele | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 12.0 | View |
| Uterine prolapse | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 12.0 | View |
| Vaginal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 12.0 | View |
| Acute respiratory distress syndrome | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | View |
| Acute respiratory failure | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | View |
| Asthma | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | View |
| Chronic obstructive pulmonary disease | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | View |
| Dyspnoea exertional | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | View |
| Haemoptysis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | View |
| Hypoxia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | View |
| Pleural effusion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | View |
| Pneumonia aspiration | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | View |
| Pneumothorax | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | View |
| Pulmonary embolism | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | View |
| Pulmonary fibrosis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | View |
| Pulmonary oedema | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | View |
| Respiratory failure | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | View |
| Angioedema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 12.0 | View |
| Diabetic ulcer | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 12.0 | View |
| Colectomy | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 12.0 | View |
| Hospitalisation | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 12.0 | View |
| Knee arthroplasty | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 12.0 | View |
| Shoulder arthroplasty | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 12.0 | View |
| Aneurysm | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 12.0 | View |
| Aortic aneurysm | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 12.0 | View |
| Arterial occlusive disease | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 12.0 | View |
| Arterial thrombosis limb | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 12.0 | View |
| Arteriosclerosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 12.0 | View |
| Deep vein thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 12.0 | View |
| Embolism | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 12.0 | View |
| Femoral artery embolism | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 12.0 | View |
| Femoral artery occlusion | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 12.0 | View |
| Haematoma | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 12.0 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 12.0 | View |
| Hypertensive crisis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 12.0 | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 12.0 | View |
| Ischaemia | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 12.0 | View |
| Ischaemic limb pain | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 12.0 | View |
| Orthostatic hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 12.0 | View |
| Peripheral artery aneurysm | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 12.0 | View |
| Thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 12.0 | View |
| Vascular rupture | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 12.0 | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Kidney infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Klebsiella infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Lobar pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Orchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Osteomyelitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Otitis media | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Perineal abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Pneumonia staphylococcal | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Post procedural infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.0 | View |
| Atrioventricular Block First Degree | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.0 | View |
| Atrioventricular Block Second Degree | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.0 | View |
| Bradyarrhythmia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.0 | View |
| Bradycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.0 | View |
| Cardiac Arrest | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.0 | View |
| Cardiac Failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.0 | View |
| Cardiac Failure Acute | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.0 | View |
| Cardiac Failure Chronic | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.0 | View |
| Cardiac Failure Congestive | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.0 | View |
| Cardiac Valve Disease | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.0 | View |
| Cardiomegaly | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.0 | View |
| Cardiomyopathy | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.0 | View |
| Coronary Artery Disease | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.0 | View |
| Coronary Artery Occlusion | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.0 | View |
| Coronary Artery Stenosis | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.0 | View |
| Ischaemic Cardiomyopathy | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.0 | View |
| Mitral Valve Incompetence | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.0 | View |
| Myocardial Infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.0 | View |
| Pericarditis | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.0 | View |
| Vertigo | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 12.0 | View |
| Abdominal Hernia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.0 | View |
| Abdominal Pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.0 | View |
| Abdominal Pain Upper | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.0 | View |
| Colitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.0 | View |
| Colitis Ulcerative | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.0 | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.0 | View |
Other Events(If Any):