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 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:31 AM
NCT ID:
NCT02799602
Description:
Treatment-emergent AEs (TEAEs) were defined as any event(s) arising or worsening after the first dose of darolutamide or placebo, until 30 days after the last dose of darolutamide or placebo administration.
Events causally related to treatment were considered as events causally related to either darolutamide / Docetaxel or Placebo / Docetaxel
A total of 1305 patients were randomized for efficacy analysis, however 1302 patients only started treatment and were included to safety analyses.
Frequency Threshold:
5
Time Frame:
From start of study drug administration until 30 days after the last administration, including adverse event of all-cause mortality at any time during the study, up to cut-off date for the final completion analysis 11 APR 2023 (approximately 77 months)
Study:
NCT02799602
Study Brief:
Darolutamide in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Darolutamide (BAY1841788) + Docetaxel | Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT). Docetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug. ADT administration started \<=12 weeks before randomization. | 231 | None | 306 | 652 | 636 | 652 | View |
| Placebo + Docetaxel | Participants received matching placebo to darolutamide in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT). Docetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug. ADT administration started \<=12 weeks before randomization. | 305 | None | 276 | 650 | 634 | 650 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (25.1) | View |
| Febrile neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (25.1) | View |
| Granulocytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (25.1) | View |
| Leukopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (25.1) | View |
| Lymphadenopathy | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (25.1) | View |
| Myelosuppression | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (25.1) | View |
| Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (25.1) | View |
| Pancytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (25.1) | View |
| Thrombocytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (25.1) | View |
| Bicytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (25.1) | View |
| Bone marrow oedema syndrome | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (25.1) | View |
| Immune thrombocytopenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (25.1) | View |
| Acute myocardial infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (25.1) | View |
| Angina pectoris | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (25.1) | View |
| Angina unstable | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (25.1) | View |
| Aortic valve incompetence | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (25.1) | View |
| Atrial fibrillation | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (25.1) | View |
| Atrioventricular block complete | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (25.1) | View |
| Cardiac arrest | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (25.1) | View |
| Cardiac failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (25.1) | View |
| Cardiac failure acute | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (25.1) | View |
| Cardiac failure congestive | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (25.1) | View |
| Cardio-respiratory arrest | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (25.1) | View |
| Cardiomyopathy | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (25.1) | View |
| Coronary artery occlusion | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (25.1) | View |
| Left ventricular failure | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (25.1) | View |
| Mitral valve incompetence | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (25.1) | View |
| Myocardial infarction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (25.1) | View |
| Myocardial ischaemia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (25.1) | View |
| Sinus tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (25.1) | View |
| Supraventricular tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (25.1) | View |
| Ventricular extrasystoles | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (25.1) | View |
| Ventricular tachycardia | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (25.1) | View |
| Left ventricular dysfunction | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (25.1) | View |
| Acute coronary syndrome | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (25.1) | View |
| Hydrocele | NON_SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA (25.1) | View |
| Vertigo | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (25.1) | View |
| Vestibular disorder | NON_SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (25.1) | View |
| Cataract | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (25.1) | View |
| Diabetic retinopathy | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (25.1) | View |
| Macular oedema | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (25.1) | View |
| Retinal detachment | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (25.1) | View |
| Epiretinal membrane | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (25.1) | View |
| Abdominal discomfort | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| Anal fistula | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| Colitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| Dental caries | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| Dysphagia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| Gastric ulcer | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| Gastric ulcer perforation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| Gastrooesophageal reflux disease | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| Gastrointestinal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| Haematochezia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| Hiatus hernia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| Ileus | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| Inguinal hernia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| Intestinal obstruction | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| Large intestine perforation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| Oesophageal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| Oesophagitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| Pancreatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| Pancreatitis acute | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| Small intestinal obstruction | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| Umbilical hernia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| Upper gastrointestinal haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| Large intestine polyp | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| Gastrointestinal toxicity | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| Intestinal strangulation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| Gastrointestinal polyp | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (25.1) | View |
| Chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (25.1) | View |
| Death | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (25.1) | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (25.1) | View |
| Hernia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (25.1) | View |
| Oedema peripheral | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (25.1) | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (25.1) | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (25.1) | View |
| Sudden death | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (25.1) | View |
| General physical health deterioration | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (25.1) | View |
| Cardiac death | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (25.1) | View |
| Unevaluable event | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (25.1) | View |
| Non-cardiac chest pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (25.1) | View |
| Cholecystitis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (25.1) | View |
| Cholecystitis acute | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (25.1) | View |
| Cholelithiasis | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (25.1) | View |
| Hepatic function abnormal | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (25.1) | View |
| Hyperbilirubinaemia | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (25.1) | View |
| Hypertransaminasaemia | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (25.1) | View |
| Drug-induced liver injury | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (25.1) | View |
| Biliary obstruction | NON_SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (25.1) | View |
| Anaphylactic reaction | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (25.1) | View |
| Hypersensitivity | NON_SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (25.1) | View |
| Appendicitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
| Bacteraemia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
| Bronchitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
| Cellulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
| Clostridium difficile colitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
| Cystitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
| Diverticulitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
| Epididymitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
| Epstein-Barr virus infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
| Erysipelas | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
| Fournier's gangrene | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
| Gastroenteritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
| Gastroenteritis clostridial | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
| Gingivitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
| Herpes zoster | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
| Infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
| Influenza | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
| Laryngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
| Myelitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
| Osteomyelitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
| Peritonitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
| Pneumonia aspiration | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
| Pyelonephritis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
| Pyelonephritis acute | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
| Pyomyositis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
| Sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
| Septic shock | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
| Sialoadenitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
| Sinusitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
| Skin infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
| Tonsillitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
| Urosepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
| Tooth infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
| Anal abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
| Neutropenic sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
| Spinal cord infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
| Pulmonary sepsis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
| Infective exacerbation of chronic obstructive airways disease | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
| West Nile viral infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
| Enterocolitis infectious | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
| Abdominal abscess | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
| Pneumonia bacterial | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
| Arthritis infective | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
| Anorectal infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
| Respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
| Device related infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
| Vascular device infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
| COVID-19 | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
| COVID-19 pneumonia | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
| Anaesthetic complication cardiac | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (25.1) | View |
| Ankle fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (25.1) | View |
| Extradural haematoma | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (25.1) | View |
| Fall | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (25.1) | View |
| Femoral neck fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (25.1) | View |
| Femur fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (25.1) | View |
| Fibula fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (25.1) | View |
| Hip fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (25.1) | View |
| Radius fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (25.1) | View |
| Road traffic accident | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (25.1) | View |
| Snake bite | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (25.1) | View |
| Spinal compression fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (25.1) | View |
| Spinal fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (25.1) | View |
| Subdural haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (25.1) | View |
| Tendon rupture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (25.1) | View |
| Tibia fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (25.1) | View |
| Traumatic fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (25.1) | View |
| Lumbar vertebral fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (25.1) | View |
| Thoracic vertebral fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (25.1) | View |
| Contusion | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (25.1) | View |
| Post laminectomy syndrome | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (25.1) | View |
| Skin laceration | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (25.1) | View |
| Pelvic fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (25.1) | View |
| Limb injury | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (25.1) | View |
| Lower limb fracture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (25.1) | View |
| Ligament rupture | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (25.1) | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (25.1) | View |
| Aspartate aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (25.1) | View |
| Biopsy lymph gland | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (25.1) | View |
| Blood bilirubin increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (25.1) | View |
| Blood glucose increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (25.1) | View |
| Haemoglobin decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (25.1) | View |
| Lymphocyte count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (25.1) | View |
| Neutrophil count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (25.1) | View |
| Platelet count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (25.1) | View |
| White blood cell count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (25.1) | View |
| White blood cell count increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (25.1) | View |
| Prostatic specific antigen abnormal | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (25.1) | View |
| Cachexia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (25.1) | View |
| Dehydration | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (25.1) | View |
| Diabetes mellitus | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (25.1) | View |
| Gout | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (25.1) | View |
| Hypercalcaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (25.1) | View |
| Hyperglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (25.1) | View |
| Hyperkalaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (25.1) | View |
| Hypocalcaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (25.1) | View |
| Hypoglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (25.1) | View |
| Hyponatraemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (25.1) | View |
| Tumour lysis syndrome | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (25.1) | View |
| Vitamin B12 deficiency | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (25.1) | View |
| Decreased appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (25.1) | View |
| Type 2 diabetes mellitus | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (25.1) | View |
| Hyperferritinaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (25.1) | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | View |
| Arthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | View |
| Bone pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | View |
| Groin pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | View |
| Lumbar spinal stenosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | View |
| Muscle spasms | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | View |
| Muscular weakness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | View |
| Musculoskeletal pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | View |
| Neck pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | View |
| Osteoarthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | View |
| Osteoporosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | View |
| Pathological fracture | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | View |
| Periarthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | View |
| Rheumatoid arthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | View |
| Spinal osteoarthritis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | View |
| Trigger finger | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | View |
| Pubic pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | View |
| Intervertebral disc protrusion | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | View |
| Osteonecrosis of jaw | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | View |
| Spinal pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | View |
| Spinal stenosis | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | View |
| Brain neoplasm malignant | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | View |
| Colon cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | View |
| Gastric cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | View |
| Laryngeal cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | View |
| Malignant melanoma in situ | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | View |
| Medulloblastoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | View |
| Metastases to lung | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | View |
| Metastatic malignant melanoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | View |
| Myelofibrosis | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | View |
| Oesophageal adenocarcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | View |
| Oesophageal carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | View |
| Pancreatic carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | View |
| Papillary thyroid cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | View |
| Phaeochromocytoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | View |
| Rectal adenocarcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | View |
| Rectal cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | View |
| Squamous cell carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | View |
| Squamous cell carcinoma of lung | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | View |
| Squamous cell carcinoma of skin | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | View |
| Transitional cell carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | View |
| Tumour pain | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | View |
| Waldenstrom's macroglobulinaemia | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | View |
| Cancer pain | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | View |
| Lung neoplasm malignant | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | View |
| Metastases to central nervous system | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | View |
| Thyroid cancer | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | View |
| Tumour compression | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | View |
| Oral papilloma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | View |
| Sebaceous carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | View |
| Hepatocellular carcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | View |
| Small intestine adenocarcinoma | NON_SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.1) | View |
| Aphasia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (25.1) | View |
| Carotid artery stenosis | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (25.1) | View |
| Carotid artery thrombosis | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (25.1) | View |
| Cerebellar syndrome | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (25.1) | View |
| Cerebral infarction | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (25.1) | View |
| Cerebrovascular accident | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (25.1) | View |
| Depressed level of consciousness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (25.1) | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (25.1) | View |
| Epilepsy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (25.1) | View |
| Haemorrhage intracranial | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (25.1) | View |
| Haemorrhagic stroke | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (25.1) | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (25.1) | View |
| Hypoaesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (25.1) | View |
| IIIrd nerve paralysis | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (25.1) | View |
| Paraparesis | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (25.1) | View |
| Paraplegia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (25.1) | View |
| Peripheral sensory neuropathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (25.1) | View |
| Presyncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (25.1) | View |
| Sciatica | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (25.1) | View |
| Seizure | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (25.1) | View |
| Spinal cord compression | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (25.1) | View |
| Subarachnoid haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (25.1) | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (25.1) | View |
| Transient ischaemic attack | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (25.1) | View |
| Brain oedema | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (25.1) | View |
| Carotid artery occlusion | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (25.1) | View |
| Lacunar infarction | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (25.1) | View |
| Vagus nerve disorder | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (25.1) | View |
| Parkinson's disease | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (25.1) | View |
| Basal ganglia infarction | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (25.1) | View |
| Confusional state | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (25.1) | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (25.1) | View |
| Calculus bladder | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (25.1) | View |
| Calculus urethral | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (25.1) | View |
| Calculus urinary | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (25.1) | View |
| Cystitis haemorrhagic | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (25.1) | View |
| Dysuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (25.1) | View |
| Haematuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (25.1) | View |
| Hydronephrosis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (25.1) | View |
| Micturition disorder | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (25.1) | View |
| Nephrolithiasis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (25.1) | View |
| Renal failure | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (25.1) | View |
| Urinary bladder haemorrhage | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (25.1) | View |
| Urinary incontinence | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (25.1) | View |
| Urinary retention | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (25.1) | View |
| Haemorrhage urinary tract | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (25.1) | View |
| Postrenal failure | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (25.1) | View |
| Urinary tract obstruction | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (25.1) | View |
| Urinary tract pain | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (25.1) | View |
| Renal impairment | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (25.1) | View |
| Bladder tamponade | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (25.1) | View |
| Urinary fistula | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (25.1) | View |
| Acute kidney injury | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (25.1) | View |
| Ureterolithiasis | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (25.1) | View |
| Malignant urinary tract obstruction | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (25.1) | View |
| Benign prostatic hyperplasia | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (25.1) | View |
| Pelvic pain | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (25.1) | View |
| Prostatomegaly | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (25.1) | View |
| Prostatic obstruction | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (25.1) | View |
| Acute respiratory distress syndrome | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | View |
| Acute respiratory failure | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | View |
| Bronchiectasis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | View |
| Bronchitis chronic | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | View |
| Chronic obstructive pulmonary disease | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | View |
| Haemoptysis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | View |
| Hypoxia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | View |
| Interstitial lung disease | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | View |
| Nasal polyps | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | View |
| Pleural effusion | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | View |
| Pneumonitis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | View |
| Pneumothorax | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | View |
| Pneumothorax spontaneous | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | View |
| Pulmonary embolism | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | View |
| Respiratory distress | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | View |
| Respiratory failure | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | View |
| Obstructive airways disorder | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | View |
| Drug eruption | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (25.1) | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (25.1) | View |
| Skin ulcer | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (25.1) | View |
| Skin mass | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (25.1) | View |
| Loss of personal independence in daily activities | NON_SYSTEMATIC_ASSESSMENT | Social circumstances | MedDRA (25.1) | View |
| Cardioversion | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (25.1) | View |
| Hip arthroplasty | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (25.1) | View |
| Inguinal hernia repair | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (25.1) | View |
| Orchidectomy | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (25.1) | View |
| Spinal laminectomy | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (25.1) | View |
| Bilateral orchidectomy | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (25.1) | View |
| Spinal fusion surgery | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (25.1) | View |
| Radical prostatectomy | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (25.1) | View |
| Cancer surgery | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (25.1) | View |
| Atrial appendage closure | NON_SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (25.1) | View |
| Aortic aneurysm | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (25.1) | View |
| Aortic dissection | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (25.1) | View |
| Arteriosclerosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (25.1) | View |
| Haematoma | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (25.1) | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (25.1) | View |
| Hypertensive crisis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (25.1) | View |
| Lymphoedema | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (25.1) | View |
| Phlebitis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (25.1) | View |
| Deep vein thrombosis | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (25.1) | View |
| Hypertensive emergency | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (25.1) | View |
| Peripheral arterial occlusive disease | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (25.1) | View |
| Arterial occlusive disease | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (25.1) | View |
| Device dislocation | NON_SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA (25.1) | View |
| Device occlusion | NON_SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA (25.1) | View |
| Product contamination | NON_SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA (25.1) | View |
| Device deposit issue | NON_SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA (25.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (25.1) | View |
| Neutropenia | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (25.1) | View |
| Lacrimation increased | NON_SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (25.1) | View |
| Abdominal pain | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| Diarrhoea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| Stomatitis | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (25.1) | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (25.1) | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (25.1) | View |
| Malaise | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (25.1) | View |
| Oedema peripheral | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (25.1) | View |
| Pain | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (25.1) | View |
| Pyrexia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (25.1) | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
| Urinary tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (25.1) | View |
| Fall | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (25.1) | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (25.1) | View |
| Aspartate aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (25.1) | View |
| Neutrophil count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (25.1) | View |
| Weight decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (25.1) | View |
| Weight increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (25.1) | View |
| White blood cell count decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (25.1) | View |
| Blood alkaline phosphatase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (25.1) | View |
| Hyperglycaemia | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (25.1) | View |
| Decreased appetite | NON_SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (25.1) | View |
| Arthralgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | View |
| Back pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | View |
| Bone pain | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | View |
| Muscular weakness | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (25.1) | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (25.1) | View |
| Dysgeusia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (25.1) | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (25.1) | View |
| Hypoaesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (25.1) | View |
| Neuropathy peripheral | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (25.1) | View |
| Paraesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (25.1) | View |
| Peripheral sensory neuropathy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (25.1) | View |
| Insomnia | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (25.1) | View |
| Haematuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (25.1) | View |
| Pollakiuria | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (25.1) | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | View |
| Dyspnoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | View |
| Epistaxis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (25.1) | View |
| Alopecia | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (25.1) | View |
| Dry skin | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (25.1) | View |
| Nail discolouration | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (25.1) | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (25.1) | View |
| Rash | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (25.1) | View |
| Hypertension | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (25.1) | View |
| Hot flush | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (25.1) | View |