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 @ 5:09 PM
Ignite Modification Date:
2025-12-25 @ 2:47 PM
NCT ID:
NCT01234350
Description:
An AE was defined as any untoward medical occurrence in a subject participating in a clinical investigation who received a pharmaceutical product.
The safety analysis set comprised of all subjects treated with at least one dose of medicinal product. The data was restricted to main treatment period (from signing of informed consent and administration of first dose until loss to follow-up, change/discontinuation in ADT, or end-of-study visit, whatever came first).
Frequency Threshold:
5
Time Frame:
From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)
Study:
NCT01234350
Study Brief:
A Safety Study in Patients With Advanced Prostate Cancer Treated With FIRMAGON
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| FIRMAGON | FIRMAGON (Degarelix, a GnRH antagonist) was prescribed in accordance with the approved label | 141 | None | 236 | 1000 | 294 | 1000 | View |
| GnRH Agonist | Any GnRH agonist prescribed in accordance with the approved labels | 72 | None | 144 | 493 | 110 | 493 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (19.0) | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (19.0) | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (19.0) | View |
| Immune thrombocytopenic purpura | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (19.0) | View |
| Lymphadenopathy | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (19.0) | View |
| Cardiac failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.0) | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.0) | View |
| Cardiac arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.0) | View |
| Cardiopulmonary failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.0) | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.0) | View |
| Coronary artery disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.0) | View |
| Myocardial ischemia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.0) | View |
| Acute myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.0) | View |
| Acute coronary syndrome | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.0) | View |
| Cardiac failure congestive | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.0) | View |
| Left ventricular hypertrophy | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.0) | View |
| Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.0) | View |
| Angina pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.0) | View |
| Angina unstable | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.0) | View |
| Arrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.0) | View |
| Cardiac disorder | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.0) | View |
| Coronary artery insufficiency | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.0) | View |
| Coronary artery occlusion | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.0) | View |
| Hypertensive heart disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.0) | View |
| Mitral valve incompetence | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.0) | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.0) | View |
| Subventricular tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.0) | View |
| Ventricular tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (19.0) | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (19.0) | View |
| Vestibular disorder | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (19.0) | View |
| Cataract | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (19.0) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Large intestine polyp | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Rectal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Abdominal discomfort | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Crohn's disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Diverticulum intestinal haemorrhagic | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Duodenal ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Haematochezia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Incarcerated umbilical hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Inguinal hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Intestinal perforation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Melaena | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Pancreatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Pancreatitis acute | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Proctalgia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Rectal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Small intestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Umbilical hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (19.0) | View |
| Disease progression | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.0) | View |
| Death | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.0) | View |
| General physical health deterioration | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.0) | View |
| Multiple organ dysfunction syndrome | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.0) | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.0) | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.0) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.0) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.0) | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.0) | View |
| Sudden death | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.0) | View |
| Injection site pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.0) | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (19.0) | View |
| Bile duct stone | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (19.0) | View |
| Biliary tract disorder | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (19.0) | View |
| Hepatic cyst | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (19.0) | View |
| Hepatic failure | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (19.0) | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.0) | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.0) | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.0) | View |
| Gangrene | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.0) | View |
| Pyelonephritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.0) | View |
| Urosepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.0) | View |
| Appendicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.0) | View |
| Catheter site infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.0) | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.0) | View |
| Echinococciasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.0) | View |
| Erysipelas | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.0) | View |
| Herpes zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.0) | View |
| Injection site abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.0) | View |
| Injection site infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.0) | View |
| Kidney infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.0) | View |
| Lower respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.0) | View |
| Lung infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.0) | View |
| Oral fungal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.0) | View |
| Peritoneal abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.0) | View |
| Periumbilical abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.0) | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.0) | View |
| Postoperative wound infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.0) | View |
| Respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.0) | View |
| Septic shock | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.0) | View |
| Severe acute respiratory syndrome | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.0) | View |
| Skin infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.0) | View |
| Staphylococcal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.0) | View |
| Vestibular neuronitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.0) | View |
| Wound infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (19.0) | View |
| Femur fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.0) | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.0) | View |
| Hip fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.0) | View |
| Femoral neck fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.0) | View |
| Road traffic accident | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.0) | View |
| Urinary retention postoperative | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.0) | View |
| Abdominal injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.0) | View |
| Ankle fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.0) | View |
| Cervical vertebral fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.0) | View |
| Concussion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.0) | View |
| Cystitis radiation | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.0) | View |
| Head Injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.0) | View |
| Humerus fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.0) | View |
| Laceration | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.0) | View |
| Post procedural haematuria | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.0) | View |
| Radiation proctitis | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.0) | View |
| Radius fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.0) | View |
| Rib fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.0) | View |
| Skull fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.0) | View |
| Spinal fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.0) | View |
| Subdural haematoma | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.0) | View |
| Ulna fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.0) | View |
| Wound | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (19.0) | View |
| Prostatic specific antigen increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.0) | View |
| Blood creatinine increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.0) | View |
| Haemoglobin decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.0) | View |
| Blood alkaline phosphatase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.0) | View |
| Blood urea increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.0) | View |
| Haematocrit dereased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.0) | View |
| Platelet count decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.0) | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (19.0) | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.0) | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.0) | View |
| Hyperglycemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.0) | View |
| Hyperkalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.0) | View |
| Hypocalcaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.0) | View |
| Hypoglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.0) | View |
| Lactic acidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.0) | View |
| Malnutrition | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.0) | View |
| Obesity | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.0) | View |
| Type 2 diabetes mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (19.0) | View |
| Pathological fracture | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | View |
| Bone pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | View |
| Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | View |
| Osteonecrosis of jaw | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | View |
| Arthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | View |
| Osteoporotic fracture | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | View |
| Intervertebral disc protrusion | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | View |
| Osteonecrosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | View |
| Synovial cyst | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | View |
| Vertebral lesion | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | View |
| Prostate cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | View |
| Metastases to bone | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | View |
| Cancer pain | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | View |
| Prostate cancer metastatic | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | View |
| Lung neoplasm malignant | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | View |
| Bladder cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | View |
| Bladder neoplasm | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | View |
| Colon cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | View |
| Metastases to liver | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | View |
| Colon neoplasm | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | View |
| Colorectal cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | View |
| Metastases to central nervous system | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | View |
| Neoplasm progression | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | View |
| Pancreatic carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | View |
| Basal cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | View |
| Benign neoplasm of ureter | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | View |
| Bladder adenocarcinoma stage unspecified | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | View |
| Bladder cancer recurrent | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | View |
| Bladder transitional cell carcinoma recurrent | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | View |
| Bronchial carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | View |
| Chronic myeloid leukaemia | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | View |
| Colon cancer metastatic | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | View |
| Gastric cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | View |
| Gastrointestinal cancer metastatic | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | View |
| Glioblastoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | View |
| Hepatic neoplasm | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | View |
| Hormone-refractory prostate cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | View |
| Intestinal adenocarcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | View |
| Laryngeal cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | View |
| Lymphoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | View |
| Malignant neoplasm of renal pelvis | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | View |
| Malignant neoplasm progression | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | View |
| Metastases to bladder | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | View |
| Metastases to spine | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | View |
| Neoplasm of thymus | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | View |
| Non-small cell lung cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | View |
| Rectal cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | View |
| Renal cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | View |
| Retroperitoneal neoplasm | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | View |
| Squamous cell carcinoma of lung | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | View |
| Squamous cell carcinoma of the oral cavity | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | View |
| Transitional cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | View |
| Cerebrovascular accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.0) | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.0) | View |
| Spinal cord compression | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.0) | View |
| Transient ischaemic attack | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.0) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.0) | View |
| Hypoaesthesis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.0) | View |
| Anterograde amnesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.0) | View |
| Balance disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.0) | View |
| Cerebral arteriosclerosis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.0) | View |
| Cerebral haemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.0) | View |
| Cerebral ischaemia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.0) | View |
| Cognitive disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.0) | View |
| Dementia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.0) | View |
| Embolic stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.0) | View |
| Encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.0) | View |
| Haemorrhage intracranial | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.0) | View |
| Haemorrhagic stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.0) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.0) | View |
| Hemiplegia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.0) | View |
| Ischemic stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.0) | View |
| Loss of consciosness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.0) | View |
| Mobility decreased | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.0) | View |
| Orthostatic intolerance | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.0) | View |
| Peripheral sensorimotor neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.0) | View |
| Presyncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.0) | View |
| Subarachnoid haemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.0) | View |
| Vertebrobasilar insufficiency | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (19.0) | View |
| Confusional state | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (19.0) | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (19.0) | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (19.0) | View |
| Completed suicide | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (19.0) | View |
| Delirium | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (19.0) | View |
| Anxiety disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (19.0) | View |
| Hallucination | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (19.0) | View |
| Urinary retention | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (19.0) | View |
| Acute kidney injury | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (19.0) | View |
| Hydronephrosis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (19.0) | View |
| Renal failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (19.0) | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (19.0) | View |
| Urinary incontinence | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (19.0) | View |
| Dysuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (19.0) | View |
| Nephrolithiasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (19.0) | View |
| Ureteric dilatation | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (19.0) | View |
| Urethral stenosis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (19.0) | View |
| Anuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (19.0) | View |
| Bladder neck obstruction | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (19.0) | View |
| Calculus bladder | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (19.0) | View |
| Incontinence | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (19.0) | View |
| Kidney enlargement | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (19.0) | View |
| Lower urinary tract symptoms | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (19.0) | View |
| Nocturia | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (19.0) | View |
| Pollakiuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (19.0) | View |
| Renal impairment | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (19.0) | View |
| Stress urinary incontinence | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (19.0) | View |
| Urethral disorder | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (19.0) | View |
| Urinary tract obstruction | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (19.0) | View |
| Vesical fistula | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (19.0) | View |
| Benign prostatic hyperplasia | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (19.0) | View |
| Prostatic obstruction | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (19.0) | View |
| Rectoprostatic fistula | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (19.0) | View |
| Testicular pain | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (19.0) | View |
| Dyapnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | View |
| Chronic obstructive pulmonary disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | View |
| Lung disorder | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | View |
| Pulmonary oedema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | View |
| Acute pulmonary oedema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | View |
| Aspiration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | View |
| Haemothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | View |
| Laryngeal oedema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | View |
| Lung consolidation | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | View |
| Pneumonia aspiration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | View |
| Pneumothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | View |
| Respiratory arrest | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | View |
| Thoracic haemorrhage | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | View |
| Skin ulcer | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.0) | View |
| Hyperhidrosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.0) | View |
| Stevens-johnson syndrome | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.0) | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (19.0) | View |
| Eye prosthesis insertion | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (19.0) | View |
| Ileostomy closure | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (19.0) | View |
| Flank pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (19.0) | View |
| Obstructive airways disorder | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (19.0) | View |
| Medical induction of coma | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (19.0) | View |
| Nephrostomy | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (19.0) | View |
| Spinal operation | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (19.0) | View |
| Circulatory collapse | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.0) | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.0) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.0) | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.0) | View |
| Thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.0) | View |
| Aortic aneurysm | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.0) | View |
| Aortic aneurysm rupture | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.0) | View |
| Aortic stenosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.0) | View |
| Dry gangrene | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.0) | View |
| Lymphoedema | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.0) | View |
| Peripheral arterial occlusive disease | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.0) | View |
| Peripheral artery occlusion | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.0) | View |
| Peripheral ischaemia | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.0) | View |
| Shock haemorrhagic | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.0) | View |
| Thrombophlebitis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (19.0) | View |
| Iron deficiency anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (19.0) | View |
Other Events(If Any):