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 @ 10:52 PM
Ignite Modification Date:
2025-12-25 @ 8:21 PM
NCT ID:
NCT03636269
Description:
None
Frequency Threshold:
5
Time Frame:
The period of adverse event reporting will start after the signing of the informed consent form (ICF) through the study Follow-up Visit or Early Termination Visit (or 7 days after the last dose if no Early Termination Visit was conducted).
Study:
NCT03636269
Study Brief:
CR845-CLIN3103: A Global Study to Evaluate the Safety and Efficacy of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Double-blind CR845 0.5mcg/kg | IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week) CR845 0.5 mcg/kg: IV CR845 0.5 mcg/kg administered three times/week | 2 | None | 58 | 235 | 56 | 235 | View |
| Double-blind Placebo | IV Placebo administered after each dialysis session (3 times/week) Placebo: IV placebo administered three times/week | 2 | None | 51 | 236 | 43 | 236 | View |
| Open-label CR845 0.5mcg/kg | IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week) CR845 0.5 mcg/kg: IV CR845 0.5 mcg/kg administered three times/week | 15 | None | 130 | 399 | 204 | 399 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA version 20.1 | View |
| Bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 20.1 | View |
| Cardiac failure congestive | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 20.1 | View |
| Acute myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 20.1 | View |
| Cardiac arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 20.1 | View |
| Acute coronary syndrome | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 20.1 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 20.1 | View |
| Atrioventricular block | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 20.1 | View |
| Atrioventricular block second degree | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 20.1 | View |
| Cardiogenic shock | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 20.1 | View |
| Cardiopulmonary failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 20.1 | View |
| Coronary artery stenosis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 20.1 | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 20.1 | View |
| Palpitations | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 20.1 | View |
| Cardio-respiratory arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 20.1 | View |
| Acute left ventricular failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 20.1 | View |
| Angina pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 20.1 | View |
| Angina unstable | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 20.1 | View |
| Aortic valve stenosis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 20.1 | View |
| Coronary artery disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 20.1 | View |
| Myocardial ishaemia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 20.1 | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA version 20.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 20.1 | View |
| Gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 20.1 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 20.1 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 20.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 20.1 | View |
| Impaired gastric emptying | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 20.1 | View |
| Pancreatitis acute | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 20.1 | View |
| Small intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 20.1 | View |
| Upper gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 20.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 20.1 | View |
| Haematochezia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 20.1 | View |
| Colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 20.1 | View |
| Colitis ischaemic | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 20.1 | View |
| Diabetic gastroparesis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 20.1 | View |
| Duodenal ulcer perforation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 20.1 | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 20.1 | View |
| Gastric polyps | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 20.1 | View |
| Haematemesis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 20.1 | View |
| Incarcerated inguinal hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 20.1 | View |
| Intestinal ischaemia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 20.1 | View |
| Melaena | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 20.1 | View |
| Pancreatitis chronic | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 20.1 | View |
| Pneumoperitoneum | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 20.1 | View |
| Rectal polyp | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 20.1 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 20.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 20.1 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 20.1 | View |
| Multiple organ dysfunction syndrome | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 20.1 | View |
| Peripheral swelling | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA version 20.1 | View |
| Pneumobilia | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA version 20.1 | View |
| Acute hepatic failure | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA version 20.1 | View |
| Cholelithiasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA version 20.1 | View |
| Hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA version 20.1 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 20.1 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 20.1 | View |
| Device related infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 20.1 | View |
| Osteomyelitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 20.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 20.1 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 20.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 20.1 | View |
| Abscess limb | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 20.1 | View |
| Arteriovenous fistula site infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 20.1 | View |
| Bacterial sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 20.1 | View |
| Catheter site cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 20.1 | View |
| Endocarditis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 20.1 | View |
| Gangrene | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 20.1 | View |
| Hepatic cyst infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 20.1 | View |
| Incision site cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 20.1 | View |
| Infectious mononucloeosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 20.1 | View |
| Localised infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 20.1 | View |
| Necrotising fasciitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 20.1 | View |
| Pneumonia viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 20.1 | View |
| Septic shock | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 20.1 | View |
| Skin infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 20.1 | View |
| Staphylococcal bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 20.1 | View |
| Staphylococcal sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 20.1 | View |
| Streptococcal bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 20.1 | View |
| Subcutaneous abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 20.1 | View |
| Urosepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 20.1 | View |
| Wound infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 20.1 | View |
| Abdominal wall abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 20.1 | View |
| Bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 20.1 | View |
| Clostridium difficile colitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 20.1 | View |
| Diabetic foot infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 20.1 | View |
| Diverticulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 20.1 | View |
| Emphysematous cystitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 20.1 | View |
| Gasteroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 20.1 | View |
| Gasteroenteritis escherichia coli | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 20.1 | View |
| Groin abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 20.1 | View |
| Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 20.1 | View |
| Lower respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 20.1 | View |
| Mastoiditis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 20.1 | View |
| Perirectal abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 20.1 | View |
| Peritonitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 20.1 | View |
| Peritonitis bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 20.1 | View |
| Respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 20.1 | View |
| Tooth abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 20.1 | View |
| Catheter site infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 20.1 | View |
| Arteriovenous fistula thrombosis | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 20.1 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 20.1 | View |
| Vascular access malfunction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 20.1 | View |
| Femur fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 20.1 | View |
| Fibula fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 20.1 | View |
| Hip fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 20.1 | View |
| Post procedural haemorrhage | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 20.1 | View |
| Subdural haemorrhage | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 20.1 | View |
| Thermal burn | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 20.1 | View |
| Vascular access complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 20.1 | View |
| Vascular graft complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 20.1 | View |
| Arteriovenous fistula aneurysm | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 20.1 | View |
| Arteriovenous fistula site haemorrhage | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 20.1 | View |
| Abdominal wall wound | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 20.1 | View |
| Femoral neck fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 20.1 | View |
| Fractured ischium | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 20.1 | View |
| Haemodialysis complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 20.1 | View |
| Hand fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 20.1 | View |
| Ligament rupture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 20.1 | View |
| Overdose | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 20.1 | View |
| Vascular access site thrombosis | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 20.1 | View |
| Blood pressure increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 20.1 | View |
| Chest x-ray abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 20.1 | View |
| Paracentesis | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 20.1 | View |
| Weight decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 20.1 | View |
| Haemoglobin decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 20.1 | View |
| Bleeding time prolonged | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 20.1 | View |
| C-reactive protein increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA version 20.1 | View |
| Hyperkalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 20.1 | View |
| Fluid overload | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 20.1 | View |
| Hypoglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 20.1 | View |
| Calciphylaxis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 20.1 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 20.1 | View |
| Diabetes mellitus inadequate control | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 20.1 | View |
| Diabetic ketoacidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 20.1 | View |
| Diabetic ketosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 20.1 | View |
| Hypervolaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 20.1 | View |
| Metabolic acidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA version 20.1 | View |
| Flank pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 20.1 | View |
| Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 20.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 20.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 20.1 | View |
| Lung neoplasm | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 20.1 | View |
| Lung neoplasm malignant | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 20.1 | View |
| Squamous cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 20.1 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 20.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 20.1 | View |
| Hepatic encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 20.1 | View |
| Hypertensive encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 20.1 | View |
| Hypoaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 20.1 | View |
| Loss of consciousness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 20.1 | View |
| Metabolic encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 20.1 | View |
| Somnolence | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 20.1 | View |
| Toxic encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 20.1 | View |
| Amnesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 20.1 | View |
| Cerebrovascular accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 20.1 | View |
| Delayed ischaemic neurological deficit | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 20.1 | View |
| Lethargy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 20.1 | View |
| Lumbar radiculopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 20.1 | View |
| Posterior reversible encephalopathy syndrome | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 20.1 | View |
| Vertebrobasilar insufficiency | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 20.1 | View |
| Device malfunction | SYSTEMATIC_ASSESSMENT | Product Issues | MedDRA version 20.1 | View |
| Mental status changes | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 20.1 | View |
| Confusional state | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 20.1 | View |
| Delirium | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 20.1 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA version 20.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 20.1 | View |
| End stage renal disease | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA version 20.1 | View |
| Nephrolithiasis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA version 20.1 | View |
| Haematuria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA version 20.1 | View |
| Urinary retention | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA version 20.1 | View |
| Pulmonary oedema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 20.1 | View |
| Asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 20.1 | View |
| Chronic respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 20.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 20.1 | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 20.1 | View |
| Haemothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 20.1 | View |
| Hypoxia | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 20.1 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 20.1 | View |
| Respiratory distress | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 20.1 | View |
| Diabetic foot | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 20.1 | View |
| Angioedema | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA version 20.1 | View |
| Abdominal hernia repair | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA version 20.1 | View |
| Catheter placement | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA version 20.1 | View |
| Multiple drug therapy | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA version 20.1 | View |
| Hypertensive crisis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 20.1 | View |
| Jugular vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 20.1 | View |
| Peripheral artery stenosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 20.1 | View |
| Shock haemorrhagic | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 20.1 | View |
| Dry gangrene | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 20.1 | View |
| Hypertensive emergency | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 20.1 | View |
| Circulatory collapse | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 20.1 | View |
| Haematoma | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 20.1 | View |
| Orthostatic hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 20.1 | View |
| Peripheral arterial occlusive disease | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 20.1 | View |
| Temporal arteritis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 20.1 | View |
| Thrombophlebitis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 20.1 | View |
| Varicose vein | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 20.1 | View |
| Peripheral artery occlusion | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 20.1 | View |
| Lower gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 20.1 | View |
| Alcoholic pancreatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 20.1 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 20.1 | View |
| Arteriovenous fistula site complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 20.1 | View |
| Arteriovenous graft site haemorrhage | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 20.1 | View |
| Arteriovenous graft thrombosis | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 20.1 | View |
| Head injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 20.1 | View |
| Lung adenocarcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 20.1 | View |
| Adenocarcinoma of colon | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 20.1 | View |
| Gastric neoplasm | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 20.1 | View |
| Dementia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 20.1 | View |
| Encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 20.1 | View |
| Epilepsy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 20.1 | View |
| Chronic obstructive pulmonary disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 20.1 | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 20.1 | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 20.1 | View |
| Pulmonary mass | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA version 20.1 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 20.1 | View |
| Peripheral ischaemia | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 20.1 | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 20.1 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 20.1 | View |
| Cardiac failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA version 20.1 | View |
| Pneumonia escherichia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 20.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 20.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 20.1 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA version 20.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA version 20.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 20.1 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 20.1 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA version 20.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA version 20.1 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA version 20.1 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA version 20.1 | View |