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:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2025-12-25 @ 8:44 PM
NCT ID:
NCT01309269
Description:
Safety Analysis Set
Frequency Threshold:
0
Time Frame:
Day 1 up to Month 24
Study:
NCT01309269
Study Brief:
Observational Study to Investigate the Long-term Effects of MIRCERA in Clinical Routine
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Methoxy Polyethylene Glycol-epoetin Beta | Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 24 months. The actual dose was chosen by the physician and was adjusted as necessary. | None | None | 172 | 978 | 120 | 978 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Peripheral ischaemia | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 16.0 | View |
| Thrombophlebitis superficial | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 16.0 | View |
| Vena cava thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 16.0 | View |
| Hemiparesis | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.0 | View |
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 16.0 | View |
| Haemorrhagic anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 16.0 | View |
| Leukopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 16.0 | View |
| Normochromic normocytic anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 16.0 | View |
| Acute myocardial infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.0 | View |
| Angina pectoris | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.0 | View |
| Aortic valve stenosis | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.0 | View |
| Arteriosclerosis coronary artery | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.0 | View |
| Atrial fibrillation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.0 | View |
| Atrial flutter | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.0 | View |
| Atrioventricular block | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.0 | View |
| Bradyarrhythmia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.0 | View |
| Bradycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.0 | View |
| Cardiac arrest | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.0 | View |
| Cardiac disorder | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.0 | View |
| Cardiac failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.0 | View |
| Cardiac tamponade | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.0 | View |
| Cardiogenic shock | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.0 | View |
| Cardiomegaly | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.0 | View |
| Coronary artery disease | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.0 | View |
| Coronary artery stenosis | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.0 | View |
| Mitral valve incompetence | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.0 | View |
| Mitral valve stenosis | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.0 | View |
| Myocardial infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.0 | View |
| Pericardial effusion | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.0 | View |
| Tricuspid valve incompetence | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.0 | View |
| Ventricular tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.0 | View |
| Congenital cystic kidney disease | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA 16.0 | View |
| Hyperthyroidism | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 16.0 | View |
| Hypopituitarism | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 16.0 | View |
| Pupils unequal | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 16.0 | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| Abdominal pain lower | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| Abdominal symptom | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| Colitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| Colitis ulcerative | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| Diarrhoea haemorrhagic | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| Diverticular perforation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| Enteritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| Faecaloma | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| Gastric antral vascular ectasia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| Gastric ulcer haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| Gastritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| Gastrointestinal angiodysplasia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| Gastrointestinal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| Gastrointestinal telangiectasia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| Gastrooesophageal reflux disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| Haematochezia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| Hiatus hernia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| Ileus paralytic | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| Inflammatory bowel disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| Inguinal hernia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| Intestinal ischaemia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| Large intestine perforation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| Lower gastrointestinal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| Melaena | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| Pancreatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| Umbilical hernia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| Upper gastrointestinal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.0 | View |
| Chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.0 | View |
| Death | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.0 | View |
| Device dislocation | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.0 | View |
| Device malfunction | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.0 | View |
| Disease progression | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.0 | View |
| Gait disturbance | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.0 | View |
| General physical health deterioration | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.0 | View |
| Mucosal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.0 | View |
| Multi-organ failure | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.0 | View |
| Oedema peripheral | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.0 | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.0 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.0 | View |
| Sudden cardiac death | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.0 | View |
| Systemic inflammatory response syndrome | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.0 | View |
| Bile duct stenosis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 16.0 | View |
| Biliary dilatation | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 16.0 | View |
| Liver disorder | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 16.0 | View |
| Abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Brain abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Bronchopneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Cytomegalovirus enteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Cytomegalovirus infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Enterobacter bacteraemia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Enterobacter infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Erysipelas | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Gangrene | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Lobar pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Otitis externa | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Perinephric abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Peritonitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Pneumonia chlamydial | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Postoperative wound infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Pyelocystitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Pyonephrosis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Septic shock | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Shunt infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Staphylococcal infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Staphylococcal sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Tracheobronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Vaginal infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Viral myocarditis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Ankle fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.0 | View |
| Arteriovenous fistula occlusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.0 | View |
| Concussion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.0 | View |
| Contusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.0 | View |
| Craniocerebral injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.0 | View |
| Excoriation | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.0 | View |
| Fall | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.0 | View |
| Femoral neck fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.0 | View |
| Foot fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.0 | View |
| Laceration | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.0 | View |
| Ligament sprain | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.0 | View |
| Limb injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.0 | View |
| Lower limb fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.0 | View |
| Overdose | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.0 | View |
| Pelvic fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.0 | View |
| Periorbital haematoma | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.0 | View |
| Post procedural haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.0 | View |
| Procedural hypotension | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.0 | View |
| Seroma | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.0 | View |
| Shunt malfunction | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.0 | View |
| Shunt occlusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.0 | View |
| Shunt thrombosis | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.0 | View |
| Skull fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.0 | View |
| Sternal fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.0 | View |
| Thoracic vertebral fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.0 | View |
| Traumatic haematoma | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.0 | View |
| Vascular graft occlusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.0 | View |
| Blood bicarbonate decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.0 | View |
| Blood lactate dehydrogenase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.0 | View |
| Blood lactic acid increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.0 | View |
| Blood potassium increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.0 | View |
| Blood pressure increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.0 | View |
| C-reactive protein increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.0 | View |
| Haemoglobin decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.0 | View |
| Acidosis | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 16.0 | View |
| Decreased appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 16.0 | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 16.0 | View |
| Hyperammonaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 16.0 | View |
| Hyperkalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 16.0 | View |
| Hypocalcaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 16.0 | View |
| Hypoglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 16.0 | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | View |
| Bone pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | View |
| Flank pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | View |
| Mobility decreased | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | View |
| Neuropathic arthropathy | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | View |
| Osteoarthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | View |
| Osteoporosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | View |
| Spinal column stenosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | View |
| Gastric cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | View |
| Lung cancer metastatic | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | View |
| Malignant melanoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | View |
| Malignant pleural effusion | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | View |
| Metastases to bone | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | View |
| Metastases to liver | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | View |
| Metastases to lymph nodes | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | View |
| Metastatic bronchial carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | View |
| Metastatic carcinoma of the bladder | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | View |
| Neoplasm malignant | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | View |
| Prostate cancer metastatic | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | View |
| Renal cancer recurrent | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | View |
| Thyroid cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | View |
| Alcohol induced persisting dementia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.0 | View |
| Brain injury | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.0 | View |
| Cerebral amyloid angiopathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.0 | View |
| Cerebral haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.0 | View |
| Cerebral infarction | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.0 | View |
| Cerebrovascular accident | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.0 | View |
| Convulsion | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.0 | View |
| Depressed level of consciousness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.0 | View |
| Grand mal convulsion | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.0 | View |
| Hepatic encephalopathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.0 | View |
| Monoplegia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.0 | View |
| Peripheral sensorimotor neuropathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.0 | View |
| Posterior reversible encephalopathy syndrome | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.0 | View |
| Speech disorder | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.0 | View |
| Status epilepticus | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.0 | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.0 | View |
| Confusional state | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 16.0 | View |
| Azotaemia | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 16.0 | View |
| Prerenal failure | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 16.0 | View |
| Renal failure | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 16.0 | View |
| Renal failure acute | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 16.0 | View |
| Renal failure chronic | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 16.0 | View |
| Renal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 16.0 | View |
| Renal impairment | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 16.0 | View |
| Bronchospasm | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | View |
| Dyspnoea at rest | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | View |
| Epistaxis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | View |
| Fibrinous bronchitis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | View |
| Orthopnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | View |
| Pleural effusion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | View |
| Pneumonitis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | View |
| Pulmonary embolism | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | View |
| Respiratory failure | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | View |
| Respiratory tract congestion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | View |
| Decubitus ulcer | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.0 | View |
| Diabetic foot | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.0 | View |
| Erythema | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.0 | View |
| Skin necrosis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.0 | View |
| Skin ulcer | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.0 | View |
| Umbilical haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.0 | View |
| Immobile | NON_SYSTEMATIC_ASSESSMENT | Social circumstances | MedDRA 16.0 | View |
| Treatment noncompliance | NON_SYSTEMATIC_ASSESSMENT | Social circumstances | MedDRA 16.0 | View |
| Amputation | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 16.0 | View |
| Aortic valve replacement | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 16.0 | View |
| Arteriovenous shunt operation | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 16.0 | View |
| Cardiac pacemaker insertion | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 16.0 | View |
| Coronary arterial stent insertion | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 16.0 | View |
| Coronary artery bypass | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 16.0 | View |
| Coronary revascularisation | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 16.0 | View |
| Heart valve operation | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 16.0 | View |
| Hospitalisation | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 16.0 | View |
| Hysterectomy | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 16.0 | View |
| Leg amputation | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 16.0 | View |
| Parathyroidectomy | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 16.0 | View |
| Thyroidectomy | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 16.0 | View |
| Aortic aneurysm | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 16.0 | View |
| Aortic aneurysm rupture | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 16.0 | View |
| Aortic stenosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 16.0 | View |
| Arteriosclerosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 16.0 | View |
| Arteriosclerosis moenckeberg-type | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 16.0 | View |
| Brachiocephalic vein stenosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 16.0 | View |
| Haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 16.0 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 16.0 | View |
| Hypertensive crisis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 16.0 | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 16.0 | View |
| Peripheral arterial occlusive disease | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 16.0 | View |
| Peripheral artery stenosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 16.0 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Shunt infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Sinusitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Wound infection staphylococcal | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Concussion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.0 | View |
| C-reactive protein increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.0 | View |
| Endoscopy upper gastrointestinal tract | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.0 | View |
| Sensory disturbance | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.0 | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.0 | View |
| Tremor | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.0 | View |
| Initial insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 16.0 | View |
| Middle insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 16.0 | View |
| Sleep disorder | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 16.0 | View |
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 16.0 | View |
| Anaemia of malignant disease | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 16.0 | View |
| Acute coronary syndrome | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.0 | View |
| Aortic valve incompetence | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.0 | View |
| Bradyarrhythmia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.0 | View |
| Cardiac failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.0 | View |
| Cardiac failure chronic | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.0 | View |
| Coronary artery disease | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.0 | View |
| Hypertensive heart disease | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.0 | View |
| Palpitations | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 16.0 | View |
| Vertigo | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 16.0 | View |
| Hyperparathyroidism | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 16.0 | View |
| Hyperparathyroidism secondary | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 16.0 | View |
| Hypoparathyroidism | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 16.0 | View |
| Hypothyroidism | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 16.0 | View |
| Toxic nodular goitre | NON_SYSTEMATIC_ASSESSMENT | Endocrine disorders | MedDRA 16.0 | View |
| Blindness | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 16.0 | View |
| Conjunctivitis | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 16.0 | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| Dry mouth | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| Duodenal ulcer haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| Faecaloma | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| Flatulence | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| Gastritis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| Gastrointestinal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| Gastrooesophageal reflux disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| Haematemesis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| Ileus | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| Intestinal polyp | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| Oral discomfort | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| Papilla of vater stenosis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 16.0 | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.0 | View |
| Chest discomfort | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.0 | View |
| Chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.0 | View |
| Drug ineffective | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.0 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.0 | View |
| Gait disturbance | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.0 | View |
| General physical health deterioration | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.0 | View |
| Necrosis | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.0 | View |
| Oedema peripheral | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.0 | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.0 | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.0 | View |
| Thrombosis in device | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.0 | View |
| Unevaluable event | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 16.0 | View |
| Bile duct stone | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 16.0 | View |
| Cholestasis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 16.0 | View |
| Jaundice | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 16.0 | View |
| Bacterial disease carrier | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Bronchitis bacterial | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Catheter site infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Colostomy infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Endocarditis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Febrile infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Gangrene | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Haematoma infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Infective myositis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Klebsiella infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Lung abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 16.0 | View |
| Epicondylitis | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.0 | View |
| Fall | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.0 | View |
| Femur fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.0 | View |
| Fibula fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.0 | View |
| Hand fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.0 | View |
| Joint dislocation | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.0 | View |
| Laceration | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.0 | View |
| Overdose | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.0 | View |
| Post procedural haematoma | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.0 | View |
| Procedural Haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.0 | View |
| Radius fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.0 | View |
| Shunt aneurysm | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.0 | View |
| Shunt malfunction | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.0 | View |
| Shunt occlusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.0 | View |
| Shunt stenosis | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.0 | View |
| Shunt thrombosis | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 16.0 | View |
| Blood calcium abnormal | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.0 | View |
| Blood parathyroid hormone increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.0 | View |
| Haemoglobin abnormal | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.0 | View |
| Haemoglobin decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.0 | View |
| Haemoglobin increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.0 | View |
| Neurological examination normal | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.0 | View |
| Volume blood decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.0 | View |
| Weight decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 16.0 | View |
| Calciphylaxis | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 16.0 | View |
| Decreased appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 16.0 | View |
| Diabetes mellitus | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 16.0 | View |
| Gout | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 16.0 | View |
| Hyperkalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 16.0 | View |
| Iron deficiency | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 16.0 | View |
| Vitamin D deficiency | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 16.0 | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | View |
| Muscle spasms | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | View |
| Muscular weakness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | View |
| Myopathy | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | View |
| Osteoarthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | View |
| Osteonecrosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | View |
| Osteoporosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 16.0 | View |
| Adenocarcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | View |
| Basal cell carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | View |
| Benign pancreatic neoplasm | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | View |
| Bowen's disease | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | View |
| Colon cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | View |
| Hypergammaglobulinaemia benign monoclonal | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | View |
| Prostate cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.0 | View |
| Carotid arteriosclerosis | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.0 | View |
| Convulsion | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.0 | View |
| Dementia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.0 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.0 | View |
| Facial paresis | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.0 | View |
| Neuropathy peripheral | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.0 | View |
| Polyneuropathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.0 | View |
| Restless legs syndrome | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 16.0 | View |
| Azotaemia | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 16.0 | View |
| Renal failure | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 16.0 | View |
| Urinary retention | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 16.0 | View |
| Benign prostatic hyperplasia | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 16.0 | View |
| Adenoidal hypertrophy | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | View |
| Dyspnoea exertional | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | View |
| Epistaxis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | View |
| Oropharyngeal pain | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | View |
| Productive cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 16.0 | View |
| Actinic keratosis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.0 | View |
| Cold sweat | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.0 | View |
| Diabetic foot | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.0 | View |
| Haemorrhage subepidermal | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.0 | View |
| Hyperhidrosis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.0 | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.0 | View |
| Pruritus generalised | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.0 | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.0 | View |
| Skin ulcer | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 16.0 | View |
| Dependence on enabling machine or device | NON_SYSTEMATIC_ASSESSMENT | Social circumstances | MedDRA 16.0 | View |
| Aneurysm repair | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 16.0 | View |
| Angioplasty | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 16.0 | View |
| Arteriovenous fistula operation | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 16.0 | View |
| Arteriovenous shunt operation | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 16.0 | View |
| Cataract operation | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 16.0 | View |
| Central venous catheter removal | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 16.0 | View |
| Central venous catheterisation | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 16.0 | View |
| Choledocholithotomy | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 16.0 | View |
| Coronary angioplasty | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 16.0 | View |
| Coronary arterial stent insertion | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 16.0 | View |
| Duodenal sphincterotomy | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 16.0 | View |
| Haemodialysis | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 16.0 | View |
| Intra-aortic balloon placement | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 16.0 | View |
| Laser therapy | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 16.0 | View |
| Leg amputation | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 16.0 | View |
| Packed red blood cell transfusion | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 16.0 | View |
| Parathyroidectomy | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 16.0 | View |
| Radioactive iodine therapy | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 16.0 | View |
| Rehabilitation therapy | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 16.0 | View |
| Skin lesion excision | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 16.0 | View |
| Skin neoplasm excision | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 16.0 | View |
| Thrombectomy | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 16.0 | View |
| Thrombolysis | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 16.0 | View |
| Vasodilation procedure | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 16.0 | View |
| Haematoma | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 16.0 | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 16.0 | View |
| Hypertensive crisis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 16.0 | View |
| Hypotension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 16.0 | View |
| Peripheral arterial occlusive disease | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 16.0 | View |
| Superior vena cava syndrome | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 16.0 | View |