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 @ 7:13 PM
Ignite Modification Date:
2025-12-25 @ 4:49 PM
NCT ID:
NCT00724503
Description:
Adverse Events monitored for all participants who were randomized and received at least 1 cycle of study treatment.
Of the 267 in 'mFOLFOX6 Plus SIRT' arm, 18 switched study treatment arms and 3 did not get any treatment. Hence safety population in this arm comprises 246 participants.
The 'mFOLFOX6 alone' arm includes the initial 263 plus 18 that switched over. 11 did not receive any treatment. Hence safety population in this arm comprises 270 participants.
Frequency Threshold:
5
Time Frame:
From consent until 28 days post last dose of protocol chemotherapy.
Study:
NCT00724503
Study Brief:
FOLFOX Plus SIR-SPHERES MICROSPHERES Versus FOLFOX Alone in Patients With Liver Mets From Primary Colorectal Cancer
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| mFOLFOX6 Plus SIRT | A single injection of SIR-Spheres microspheres into the liver plus systemic chemotherapy consisting of Oxaliplatin + Leucovorin + 5-Fluorouracil (FOLFOX) | 190 | None | 134 | 246 | 112 | 246 | View |
| mFOLFOX6 Alone | systemic chemotherapy consisting of Oxaliplatin + Leucovorin + 5-Fluorouracil (FOLFOX) | 182 | None | 112 | 270 | 157 | 270 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (16.1) | View |
| Febrile Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (16.1) | View |
| Heparin-Induced Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (16.1) | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (16.1) | View |
| Splenic Infarction | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (16.1) | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (16.1) | View |
| Acute Coronary Syndrome | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (16.1) | View |
| Acute Myocardial Infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (16.1) | View |
| Angina Pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (16.1) | View |
| Arrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (16.1) | View |
| Arteriospasm Coronary | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (16.1) | View |
| Atrial Fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (16.1) | View |
| Atrial Flutter | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (16.1) | View |
| Atrioventricular Block Complete | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (16.1) | View |
| Cardiac Arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (16.1) | View |
| Cardiac Failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (16.1) | View |
| Intracardiac Thrombus | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (16.1) | View |
| Myocardial Infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (16.1) | View |
| Stress Cardiomyopathy | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (16.1) | View |
| Supraventricular Tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA (16.1) | View |
| Hydrocele | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | MedDRA (16.1) | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA (16.1) | View |
| Abdominal Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Abdominal Pain Upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Anal Fissure | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Anal Inflammation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Ascites | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Duodenal Ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Duodenal Ulcer Haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Duodenitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Erosive Oesophagitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Gastric Haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Gastric Ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Gastritis Atrophic | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Gastritis Erosive | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Gastroduodenitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Gastrointestinal Haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Haematemesis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Haemorrhoidal Haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Haemorrhoids | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Ileus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Intestinal Haematoma | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Intestinal Obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Intestinal Perforation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Large Intestinal Obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Large Intestinal Stenosis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Large Intestine Perforation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Melaena | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Oesophageal Ulcer | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Oesophageal Varices Haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Oesophagitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Oesophagitis Haemorrhagic | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Oral Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Pancreatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Proctalgia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Rectal Haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Rectal Stenosis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Small Intestinal Obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Volvulus Of Small Bowel | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.1) | View |
| Chest Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.1) | View |
| Chills | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.1) | View |
| Device Dislocation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.1) | View |
| Device Occlusion | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.1) | View |
| Extravasation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.1) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.1) | View |
| General Physical Health Deterioration | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.1) | View |
| Gallbladder Perforation | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (16.1) | View |
| Hepatic Failure | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (16.1) | View |
| Hepatic Fibrosis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (16.1) | View |
| Hepatic Infarction | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (16.1) | View |
| Hepatic Pain | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (16.1) | View |
| Hyperbilirubinaemia | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (16.1) | View |
| Jaundice | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (16.1) | View |
| Jaundice Cholestatic | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (16.1) | View |
| Drug Hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (16.1) | View |
| Abdominal Wall Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Abscess Limb | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Acute Sinusitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Anorectal Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Campylobacter Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Catheter Site Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Device Related Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Diverticulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Escherichia Bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Gastroenteritis Salmonella | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Infusion Site Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Klebsiella Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Liver Abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Lobar Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Lower Respiratory Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Lung Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Neutropenic Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Neutropenic Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Oesophageal Candidiasis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Pelvic Abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Perihepatic Abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Peritonitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Salmonellosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Subcutaneous Abscess | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Upper Respiratory Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Urinary Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Wound Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Anastomotic Complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (16.1) | View |
| Anastomotic Leak | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (16.1) | View |
| Contrast Media Reaction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (16.1) | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (16.1) | View |
| Femoral Neck Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (16.1) | View |
| Gastroenteritis Radiation | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (16.1) | View |
| Hip Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (16.1) | View |
| Pelvic Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (16.1) | View |
| Post Embolisation Syndrome | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (16.1) | View |
| Post Procedural Bile Leak | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (16.1) | View |
| Post Procedural Complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (16.1) | View |
| Post Procedural Diarrhoea | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (16.1) | View |
| Procedural Complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (16.1) | View |
| Procedural Pain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (16.1) | View |
| Radiation Hepatitis | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (16.1) | View |
| Rib Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (16.1) | View |
| Spinal Fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (16.1) | View |
| Subdural Haematoma | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (16.1) | View |
| Toxicity To Various Agents | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (16.1) | View |
| Vascular Procedure Complication | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (16.1) | View |
| Wound Evisceration | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (16.1) | View |
| Alanine Aminotransferase Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (16.1) | View |
| Aspartate Aminotransferase Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (16.1) | View |
| Blood Albumin Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (16.1) | View |
| Blood Alkaline Phosphatase Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (16.1) | View |
| Blood Bilirubin Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (16.1) | View |
| Haemoglobin Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (16.1) | View |
| Neutrophil Count Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (16.1) | View |
| Troponin I Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (16.1) | View |
| Decreased Appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (16.1) | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (16.1) | View |
| Diabetes Mellitus | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (16.1) | View |
| Diabetic Ketoacidosis | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (16.1) | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (16.1) | View |
| Hypoglycaemi | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (16.1) | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (16.1) | View |
| Hyponatraemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (16.1) | View |
| Hypovolaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (16.1) | View |
| Musculoskeletal Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | View |
| Neck Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | View |
| Pain In Extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | View |
| Breast Cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.1) | View |
| Colon Neoplasm | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.1) | View |
| Malignant Ascites | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.1) | View |
| Metastatic Pain | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.1) | View |
| Thyroid Cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.1) | View |
| Balance Disorder | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (16.1) | View |
| Cerebral Haemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (16.1) | View |
| Cerebral Infarction | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (16.1) | View |
| Cerebrovascular Accident | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (16.1) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (16.1) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (16.1) | View |
| Hepatic Encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (16.1) | View |
| Ischaemic Stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (16.1) | View |
| Loss Of Consciousness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (16.1) | View |
| Presyncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (16.1) | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (16.1) | View |
| Transient Ischaemic Attack | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (16.1) | View |
| Confusional State | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (16.1) | View |
| Hallucination | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (16.1) | View |
| Mental Status Changes | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (16.1) | View |
| Oliguria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (16.1) | View |
| Renal Failure Acute | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (16.1) | View |
| Renal Impairment | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA (16.1) | View |
| Acute Respiratory Distress Syndrome | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | View |
| Chronic Obstructive Pulmonary Disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | View |
| Dyspnea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | View |
| Hiccups | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | View |
| Laryngeal Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | View |
| Pneumonitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | View |
| Respiratory Failure | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | View |
| Respiratory Tract Haemorrhage | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | View |
| Urticaria | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (16.1) | View |
| Physical Assault | SYSTEMATIC_ASSESSMENT | Social circumstances | MedDRA (16.1) | View |
| Social Stay Hospitalisation | SYSTEMATIC_ASSESSMENT | Social circumstances | MedDRA (16.1) | View |
| Abscess Drainage | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (16.1) | View |
| Gastrointestinal Surgery | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (16.1) | View |
| Hernia Repair | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (16.1) | View |
| Surgery NOS | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA (16.1) | View |
| Artery Dissection | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (16.1) | View |
| Circulatory Collapse | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (16.1) | View |
| Deep Vein Thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (16.1) | View |
| Embolism | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (16.1) | View |
| Femoral Artery Occlusion | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (16.1) | View |
| Haematoma | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (16.1) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (16.1) | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (16.1) | View |
| Hypovolaemic Shock | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (16.1) | View |
| Ischaemia | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (16.1) | View |
| Orthostatic Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (16.1) | View |
| Peripheral Artery Stenosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (16.1) | View |
| Peripheral Artery Thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (16.1) | View |
| Peripheral Embolism | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (16.1) | View |
| Phlebitis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (16.1) | View |
| Thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (16.1) | View |
| Venous Thrombosis Limb | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (16.1) | View |
| Hernia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.1) | View |
| Influenza Like Illness | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.1) | View |
| Infusion Site Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.1) | View |
| Malaise | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.1) | View |
| Oedema Peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.1) | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.1) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.1) | View |
| Bile Duct Obstruction | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (16.1) | View |
| Bile Duct Stone | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (16.1) | View |
| Cholangitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (16.1) | View |
| Cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (16.1) | View |
| Cholecystitis Acute | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (16.1) | View |
| Cholelithiasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA (16.1) | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (16.1) | View |
| Febrile Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (16.1) | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (16.1) | View |
| Lymphopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (16.1) | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (16.1) | View |
| Thrombocytopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA (16.1) | View |
| Abdominal Pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Abdominal Pain Upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Ascites | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Dyspepsia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Gastrooesophageal Reflux Disease | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Rectal Haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Stomatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA (16.1) | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.1) | View |
| Chest Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.1) | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.1) | View |
| Mucosal Inflammation | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.1) | View |
| Oedema Peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.1) | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA (16.1) | View |
| Drug Hypersensitivity | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA (16.1) | View |
| Upper Respiratory Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Urinary Tract Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA (16.1) | View |
| Procedural Pain | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (16.1) | View |
| Aspartate Aminotransferase Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (16.1) | View |
| Blood Alkaline Phosphatase Increased | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA (16.1) | View |
| Neutrophil Count Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (16.1) | View |
| Platelet Count Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (16.1) | View |
| Weight Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (16.1) | View |
| Weight Increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (16.1) | View |
| White Blood Cell Count Decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA (16.1) | View |
| Decreased Appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (16.1) | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (16.1) | View |
| Hyperglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (16.1) | View |
| Hypokalaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA (16.1) | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | View |
| Back Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | View |
| Musculoskeletal Pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | View |
| Pain In Extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (16.1) | View |
| Dysgeusia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (16.1) | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (16.1) | View |
| Lethargy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (16.1) | View |
| Neuropathy Peripheral | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (16.1) | View |
| Paraesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (16.1) | View |
| Peripheral Sensory Neuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (16.1) | View |
| Polyneuropathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA (16.1) | View |
| Anxiety | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (16.1) | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (16.1) | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA (16.1) | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | View |
| Epistaxis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | View |
| Hiccups | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | View |
| Oropharyngeal Pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | View |
| Pulmonary Embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | View |
| Alopecia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (16.1) | View |
| Dry Skin | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (16.1) | View |
| Palmar-Plantar Erythrodysaesthesia | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (16.1) | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA (16.1) | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (16.1) | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA (16.1) | View |