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 @ 4:20 PM
Ignite Modification Date:
2025-12-25 @ 2:16 PM
NCT ID:
NCT00077766
Description:
AE is untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event is with any of the following outcomes: Death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity; congenital anomaly.
Frequency Threshold:
5
Time Frame:
Up to Week 52
Study:
NCT00077766
Study Brief:
A Study of Intravenous Mircera for the Treatment of Anemia in Dialysis Patients.
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| RO0503821 (1x/2 Weeks) | Eligible participants were administered with RO0503821 IV, every 2 weeks during Week 1 through Week 52. The starting dose of RO0503821 (60, 100, or 180 µg) was based on the dose of darbepoetin alfa at the time of randomization (\< 40, 40 to 80, or \> 80 µg per week, respectively). | None | None | 71 | 153 | 97 | 153 | View |
| Darbepoetin (1x/1-2 Weeks) | Eligible participants were administered with darbepoetin alfa IV, every week or every 2 weeks during Week 1 through Week 52. | None | None | 75 | 156 | 93 | 156 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Staphylococal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| Bronchitis acute | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| Bronchopneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| Catheter sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| Central line infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| Diabetic Gangrene | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| Diverticulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| Enterococcal sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| Gastroenteritis viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| Injection site infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| Lobar pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| Localized infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| Orchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| Pneumonia streptococcal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| Postoperative infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| Septic shock | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| Skin infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| Staphylococcal sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| Viral infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| Wound infection staphylococcal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| Wound sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| Arteriovenous fistula | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.0) | View |
| Arteriovenous graft thrombosis | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.0) | View |
| Arteriovenous fistula site haemorrhage | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.0) | View |
| Humerus fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.0) | View |
| Arteriovenous fistula site complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.0) | View |
| Arteriovenous graft site haemorrhage | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.0) | View |
| Pubic rami fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.0) | View |
| Rib fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.0) | View |
| Spinal fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.0) | View |
| Vascular access complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.0) | View |
| Ankle fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.0) | View |
| Brain contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.0) | View |
| Cervical vertebral fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.0) | View |
| Drug toxicity | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.0) | View |
| Jaw fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.0) | View |
| Medical device complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.0) | View |
| Pelvic fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.0) | View |
| Procedural hypotension | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.0) | View |
| Radius fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.0) | View |
| Skull fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.0) | View |
| Sternal fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.0) | View |
| Therapeutic agent toxicity | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.0) | View |
| Tibia fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.0) | View |
| Treatment compliance | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.0) | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (8.0) | View |
| Angina pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (8.0) | View |
| Cardiac arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (8.0) | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (8.0) | View |
| Acute coronary syndrome | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (8.0) | View |
| Acute myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (8.0) | View |
| Angina unstable | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (8.0) | View |
| Atrioventricular block | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (8.0) | View |
| Atrioventricular block second degree | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (8.0) | View |
| Bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (8.0) | View |
| Cardiac failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (8.0) | View |
| Cardiac failure congestive | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (8.0) | View |
| Cardio-respiratory arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (8.0) | View |
| Cardiopulmonary failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (8.0) | View |
| Coronary artery disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (8.0) | View |
| Coronary artery stenosis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (8.0) | View |
| Myocardial ischaemia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (8.0) | View |
| Pericardial effusion | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (8.0) | View |
| Pericarditis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (8.0) | View |
| Postinfarction angina | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (8.0) | View |
| Sick sinus syndrome | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (8.0) | View |
| Supraventricular tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (8.0) | View |
| Tachyarrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (8.0) | View |
| Ventricular fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (8.0) | View |
| Cerebrovascular accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.0) | View |
| Cerebral infarction | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.0) | View |
| Cerebral thrombosis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.0) | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.0) | View |
| Cerebral haemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.0) | View |
| Cerebral ischaemia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (8.0) | View |
| Dementia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.0) | View |
| Dizzinesss | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.0) | View |
| Epilepsy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.0) | View |
| Hypertensive encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.0) | View |
| Hypoasthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.0) | View |
| Myoclonus | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.0) | View |
| Nervous system disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.0) | View |
| Petit mal epilepsy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.0) | View |
| Stupor | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.0) | View |
| Transient ischaemic attack | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.0) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.0) | View |
| Faecaloma | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.0) | View |
| Gastrointestinal hemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.0) | View |
| Inguinal hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.0) | View |
| Intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.0) | View |
| Anal hemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.0) | View |
| Diabetic gastroparesis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.0) | View |
| Duodenal ulcer haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.0) | View |
| Gastric ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.0) | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.0) | View |
| Gastrooesophageal reflux disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.0) | View |
| Intestinal infarction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.0) | View |
| Mallory-Weiss syndrome | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.0) | View |
| Melaena | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.0) | View |
| Pancreatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.0) | View |
| Pancreatitis acute | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.0) | View |
| Rectal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.0) | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (8.0) | View |
| Peripheral ischaemia | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (8.0) | View |
| Haematoma | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (8.0) | View |
| Aortic stenosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (8.0) | View |
| Arteriopathic disease | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (8.0) | View |
| Arteriosclerosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (8.0) | View |
| Arteritis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (8.0) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (8.0) | View |
| Hypertensive crisis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (8.0) | View |
| Intermittent claudication | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (8.0) | View |
| Peripheral vascular disorder | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (8.0) | View |
| Superior vena caval occlusion | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (8.0) | View |
| Fluid overload | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (8.0) | View |
| Cachexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (8.0) | View |
| Hypoglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (8.0) | View |
| Anorexia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (8.0) | View |
| Calciphylaxis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (8.0) | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (8.0) | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (8.0) | View |
| Hyperkalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (8.0) | View |
| Catheter site haemorrhage | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.0) | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.0) | View |
| Hyperpyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.0) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.0) | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.0) | View |
| Catheter related complication | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.0) | View |
| Hyperthermia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.0) | View |
| Influenza like illness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.0) | View |
| Sudden death | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.0) | View |
| Pulmonary oedema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | View |
| Chronic obstructive pulmonary disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | View |
| Acute pulmonary oedema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | View |
| Laryngeal polyp | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | View |
| Pneumonia aspiration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | View |
| Haemarthrosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | View |
| Muscular weakness | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | View |
| Osteonecrosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | View |
| Osteoporotic fracture | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | View |
| Polymyalgia rheumatica | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | View |
| Benign gastric neoplasm | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.0) | View |
| Colon cancer metastatic | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.0) | View |
| Glioblastoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.0) | View |
| Lung neoplasm malignant | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.0) | View |
| Non-small cell lung cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.0) | View |
| Oesophageal adenocarcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.0) | View |
| Prostate cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.0) | View |
| Renal cell carcinoma stage unspecified | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.0) | View |
| Cholangitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (8.0) | View |
| Cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (8.0) | View |
| Cholecystitis acute | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (8.0) | View |
| Cholelithiasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (8.0) | View |
| Hepatitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (8.0) | View |
| Renal failure chronic | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (8.0) | View |
| Urinary retention | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (8.0) | View |
| Nephrolithiasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (8.0) | View |
| Confusional state | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (8.0) | View |
| Adjustment disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (8.0) | View |
| Mental disorder | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (8.0) | View |
| Skin ulcer | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (8.0) | View |
| Angioneurotic oedema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (8.0) | View |
| Decubitus ulcer | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (8.0) | View |
| Hyperkeratosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (8.0) | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (8.0) | View |
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (8.0) | View |
| Deafness unilateral | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (8.0) | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (8.0) | View |
| Kidney transplant rejection | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (8.0) | View |
| Transplant rejection | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (8.0) | View |
| Cataract | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA (8.0) | View |
| Vaginal haemorrhage | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA (8.0) | View |
| Disability | SYSTEMATIC_ASSESSMENT | Social circumstances | MedDRA (8.0) | View |
| Corneal transplant | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (8.0) | View |
| Bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| Arteriovenous graft site Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| Gangrene | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| Infected skin ulcer | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| Lower respiratory tract | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| Osteomyelitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.0) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.0) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.0) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.0) | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (8.0) | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (8.0) | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (8.0) | View |
| Wound | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.0) | View |
| Arteriovenous fistula site complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.0) | View |
| Procedural hypotension | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (8.0) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | View |
| Fluid overload | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (8.0) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (8.0) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (8.0) | View |
| Angina pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (8.0) | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (8.0) | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (8.0) | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | View |
| Haematoma | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (8.0) | View |