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 @ 4:28 AM
Ignite Modification Date:
2025-12-26 @ 3:31 AM
NCT ID:
NCT00686920
Description:
All participants who received at least 1 dose of study drug.
Frequency Threshold:
5
Time Frame:
Baseline up to Month 36
Study:
NCT00686920
Study Brief:
Safety and Tolerability Study of Rifaximin in Participants With a History of Hepatic Encephalopathy
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| New Rifaximin | Participants new to receiving rifaximin were administered a single rifaximin 550 milligram (mg) tablet 2 times per day (approximately every 12 hours) for at least 24 months, until regulatory approval of rifaximin for reduction in risk of overt HE recurrence, or until the sponsor closed the study. | None | None | 158 | 252 | 212 | 252 | View |
| Continuing Rifaximin | Participants who received rifaximin in the previous rifaximin HE study were administered a single rifaximin 550 milligram (mg) tablet 2 times per day (approximately every 12 hours) for at least 24 months, until regulatory approval of rifaximin for reduction in risk of overt HE recurrence, or until the sponsor closed the study. | None | None | 49 | 70 | 52 | 70 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 8.1 | View |
| Coagulopathy | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 8.1 | View |
| Disseminated intravascular coagulation | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 8.1 | View |
| Iron deficiency anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 8.1 | View |
| Leukocytosis | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 8.1 | View |
| Pancytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 8.1 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 8.1 | View |
| Acute myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 8.1 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 8.1 | View |
| Atrial flutter | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 8.1 | View |
| Cardiac arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 8.1 | View |
| Cardiac failure acute | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 8.1 | View |
| Cardiac failure congestive | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 8.1 | View |
| Cardio-respiratory arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 8.1 | View |
| Cardiopulmonary failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 8.1 | View |
| Cardiovascular disorder | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 8.1 | View |
| Mitral valve incompetence | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 8.1 | View |
| Mitral valve stenosis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 8.1 | View |
| Pericardial effusion | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 8.1 | View |
| Supraventricular tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 8.1 | View |
| Ventricular hypokinesia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 8.1 | View |
| Oculogyration | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 8.1 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.1 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.1 | View |
| Abdominal strangulated hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.1 | View |
| Ascites | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.1 | View |
| Colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.1 | View |
| Diabetic gastroparesis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.1 | View |
| Diverticulum | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.1 | View |
| Duodenal ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.1 | View |
| Gastric ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.1 | View |
| Gastroduodenal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.1 | View |
| Gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.1 | View |
| Haematemesis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.1 | View |
| Ileus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.1 | View |
| Impaired gastric emptying | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.1 | View |
| Inguinal hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.1 | View |
| Intra-abdominal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.1 | View |
| Lower gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.1 | View |
| Melaena | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.1 | View |
| Oesophageal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.1 | View |
| Oesophageal ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.1 | View |
| Peritonitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.1 | View |
| Pneumatosis intestinalis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.1 | View |
| Rectal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.1 | View |
| Umbilical hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.1 | View |
| Upper gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.1 | View |
| Varices oesophageal | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.1 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 8.1 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 8.1 | View |
| Death | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 8.1 | View |
| Drug intolerance | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 8.1 | View |
| Generalised oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 8.1 | View |
| Gravitational oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 8.1 | View |
| Oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 8.1 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 8.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 8.1 | View |
| Bile duct stone | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 8.1 | View |
| Biliary cirrhosis primary | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 8.1 | View |
| Biliary colic | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 8.1 | View |
| Cholelithiasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 8.1 | View |
| Hepatic cirrhosis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 8.1 | View |
| Hepatic failure | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 8.1 | View |
| Hepatic lesion | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 8.1 | View |
| Hepatic steatosis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 8.1 | View |
| Hepatorenal failure | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 8.1 | View |
| Hepatorenal syndrome | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 8.1 | View |
| Liver disorder | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 8.1 | View |
| Cryoglobulinaemia | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 8.1 | View |
| Liver transplant rejection | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 8.1 | View |
| Transplant rejection | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 8.1 | View |
| Abdominal abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| Abdominal wall abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| Arthritis bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| Bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| Biliary abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| Campylobacter intestinal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| Candida sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| Cellulitis streptococcal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| Central line infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| Clostridial infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| Clostridium colitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| Diverticulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| Enterococcal bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| Escherichia bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| Escherichia sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| Fungal peritonitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| Gastroenteritis viral | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| Gastrointestinal candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| Klebsiella bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| Lobar pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| Peritonitis bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| Pneumococcal sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| Postoperative wound infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| Pseudomonal bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| Pyelonephritis acute | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| Respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| Scrotal abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| Sepsis pasteurella | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| Septic shock | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| Skin infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| Staphylococcal bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| Staphylococcal sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| Streptococcal sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| Subcutaneous abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| Urinary tract infection fungal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| Viral infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| Wound infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| Wound infection staphylococcal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| Anastomotic leak | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 8.1 | View |
| Comminuted fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 8.1 | View |
| Facial bones fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 8.1 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 8.1 | View |
| Femur fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 8.1 | View |
| Graft dysfunction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 8.1 | View |
| Hip fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 8.1 | View |
| Humerus fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 8.1 | View |
| Open wound | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 8.1 | View |
| Post procedural haemorrhage | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 8.1 | View |
| Renal injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 8.1 | View |
| Road traffic accident | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 8.1 | View |
| Shunt stenosis | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 8.1 | View |
| Shunt thrombosis | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 8.1 | View |
| Spinal compression fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 8.1 | View |
| Spinal fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 8.1 | View |
| Subdural haematoma | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 8.1 | View |
| Tibia fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 8.1 | View |
| Ulna fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 8.1 | View |
| Vena cava injury | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 8.1 | View |
| Wrist fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 8.1 | View |
| Ammonia increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 8.1 | View |
| Blood potassium decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 8.1 | View |
| Central venous pressure decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 8.1 | View |
| Transplant evaluation | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 8.1 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 8.1 | View |
| Diabetes mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 8.1 | View |
| Diabetes mellitus inadequate control | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 8.1 | View |
| Diabetic ketoacidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 8.1 | View |
| Failure to thrive | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 8.1 | View |
| Fluid overload | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 8.1 | View |
| Fluid retention | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 8.1 | View |
| Haemochromatosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 8.1 | View |
| Hyperammonaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 8.1 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 8.1 | View |
| Hyperglycaemic hyperosmolar nonketotic syndrome | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 8.1 | View |
| Hyperkalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 8.1 | View |
| Hypervolaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 8.1 | View |
| Hypoglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 8.1 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 8.1 | View |
| Hypomagnesaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 8.1 | View |
| Hepatic neoplasm malignant | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.1 | View |
| Liver carcinoma ruptured | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.1 | View |
| Uterine cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.1 | View |
| Cerebral haemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 8.1 | View |
| Convulsion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 8.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 8.1 | View |
| Encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 8.1 | View |
| Hepatic encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 8.1 | View |
| Mental impairment | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 8.1 | View |
| Renal failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 8.1 | View |
| Renal failure acute | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 8.1 | View |
| Renal failure chronic | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 8.1 | View |
| Renal impairment | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 8.1 | View |
| Acute respiratory distress syndrome | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | View |
| Pulmonary oedema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | View |
| Respiratory arrest | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | View |
| Respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | View |
| Penile ulceration | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 8.1 | View |
| Skin ulcer | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 8.1 | View |
| Liver transplant | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 8.1 | View |
| Renal transplant | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 8.1 | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 8.1 | View |
| Peripheral occlusive disease | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 8.1 | View |
| Shock haemorrhagic | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 8.1 | View |
| Vena cava thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 8.1 | View |
| Rib fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 8.1 | View |
| Bile duct cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.1 | View |
| Biliary neoplasm | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.1 | View |
| Gastrointestinal tract adenoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 8.1 | View |
| Metabolic encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 8.1 | View |
| Neuropathy peripheral | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 8.1 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 8.1 | View |
| Aggression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 8.1 | View |
| Confusional state | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 8.1 | View |
| Delirium | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 8.1 | View |
| Mental status changes | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 8.1 | View |
| Suicidal ideation | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 8.1 | View |
| Suicide attempt | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 8.1 | View |
| Acute prerenal failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 8.1 | View |
| Acute respiratory failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | View |
| Chronic obstructive pulmonary disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | View |
| Dyspnoea exacerbated | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | View |
| Hepatopulmonary syndrome | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | View |
| Hydrothorax | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | View |
| Pneumonia aspiration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | View |
| Pulmonary hypertension | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | View |
| Oesophageal varices haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.1 | View |
| Pancreatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.1 | View |
| Peritoneal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.1 | View |
| Biliary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| Meningitis cryptococcal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| Osteomyelitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 8.1 | View |
| Hypovolaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 8.1 | View |
| Metabolic acidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 8.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | View |
| Flank pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | View |
| Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | View |
| Rhabdomyolysis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 8.1 | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 8.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.1 | View |
| Ascites | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.1 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.1 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.1 | View |
| Varices oesophageal | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.1 | View |
| Haemorrhoids | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 8.1 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 8.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 8.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 8.1 | View |
| Oedema | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 8.1 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 8.1 | View |
| Cholelithiasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 8.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| Peritonitis bacterial | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 8.1 | View |
| Procedural pain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 8.1 | View |
| Contusion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 8.1 | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 8.1 | View |
| Hyperkalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 8.1 | View |
| Hypomagnesaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 8.1 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 8.1 | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 8.1 | View |
| Diabetes mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 8.1 | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 8.1 | View |
| Muscle spasms | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 8.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 8.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 8.1 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 8.1 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 8.1 | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 8.1 | View |
| Renal failure acute | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 8.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 8.1 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 8.1 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 8.1 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 8.1 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 8.1 | View |