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 @ 4:04 AM
Ignite Modification Date:
2025-12-26 @ 2:58 AM
NCT ID:
NCT00332202
Description:
None
Frequency Threshold:
5
Time Frame:
None
Study:
NCT00332202
Study Brief:
PRELUDE:Study to Investigate the Prevention of Relapse in Lymphoma Using Daily Enzastaurin
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Enzastaurin: Arm A - Experimental | Administered orally as four 125-mg tablets daily (after an initial loading dose of three 125-mg tablets given three times on Day 1) | None | None | 135 | 493 | 406 | 493 | View |
| Placebo: Arm B - Control | Administered orally as four tablets daily (after an initial loading dose of three tablets given three times on Day 1) | None | None | 72 | 249 | 185 | 249 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 15.1 | View |
| Febrile neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 15.1 | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 15.1 | View |
| Lymphadenopathy | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 15.1 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 15.1 | View |
| Acute coronary syndrome | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.1 | View |
| Angina pectoris | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.1 | View |
| Angina unstable | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.1 | View |
| Arrhythmia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.1 | View |
| Atrial fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.1 | View |
| Atrial flutter | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.1 | View |
| Atrioventricular block complete | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.1 | View |
| Bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.1 | View |
| Cardiac arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.1 | View |
| Cardiac failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.1 | View |
| Cardiac failure chronic | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.1 | View |
| Cardiac failure congestive | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.1 | View |
| Cardio-respiratory arrest | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.1 | View |
| Cardiomyopathy | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.1 | View |
| Coronary artery disease | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.1 | View |
| Coronary artery stenosis | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.1 | View |
| Left ventricular dysfunction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.1 | View |
| Myocardial infarction | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.1 | View |
| Myocardial ischaemia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.1 | View |
| Sick sinus syndrome | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.1 | View |
| Sinus bradycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.1 | View |
| Torsade de pointes | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.1 | View |
| Ventricular fibrillation | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.1 | View |
| Ventricular tachycardia | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 15.1 | View |
| Vertigo | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 15.1 | View |
| Cataract | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 15.1 | View |
| Conjunctival haemorrhage | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 15.1 | View |
| Eyelid ptosis | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 15.1 | View |
| Ophthalmoplegia | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 15.1 | View |
| Retinal detachment | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 15.1 | View |
| Retinal vein occlusion | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 15.1 | View |
| Vision blurred | SYSTEMATIC_ASSESSMENT | Eye disorders | MedDRA 15.1 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Anal prolapse | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Colitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Colonic polyp | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Dysphagia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Food poisoning | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Gastritis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Gastrointestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Gingivitis ulcerative | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Haemorrhoids | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Ileus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Ileus paralytic | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Inguinal hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Jejunal perforation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Oral lichen planus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Pancreatitis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Pancreatitis acute | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Pseudopolyposis | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Small intestinal obstruction | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Subileus | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Umbilical hernia | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Volvulus of small bowel | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Asthenia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.1 | View |
| Chest pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.1 | View |
| Death | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.1 | View |
| General physical health deterioration | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.1 | View |
| Multi-organ disorder | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.1 | View |
| Multi-organ failure | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.1 | View |
| Pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.1 | View |
| Spinal pain | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.1 | View |
| Cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 15.1 | View |
| Cholecystitis acute | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 15.1 | View |
| Cholelithiasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 15.1 | View |
| Hepatic cirrhosis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 15.1 | View |
| Hepatic function abnormal | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 15.1 | View |
| Hepatotoxicity | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 15.1 | View |
| Allergy to arthropod sting | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 15.1 | View |
| Contrast media allergy | SYSTEMATIC_ASSESSMENT | Immune system disorders | MedDRA 15.1 | View |
| Abdominal sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Arthritis infective | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Beta haemolytic streptococcal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Bronchitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Bronchopneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Bronchopulmonary aspergillosis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Cervicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Clostridium difficile colitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Enteritis infectious | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Enterocolitis infectious | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Escherichia sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Escherichia urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Helicobacter gastritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Hepatic cyst infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Hepatitis b | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Hepatitis c | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Herpes zoster | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Infectious peritonitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Intervertebral discitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Lobar pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Lung infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Myelitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Necrotising fasciitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Neutropenic infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Periodontitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Pseudomembranous colitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Pseudomonal bacteraemia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Pyelonephritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Scrub typhus | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Sepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Septic shock | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Staphylococcal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Urosepsis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Viral upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Wound infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Acetabulum fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.1 | View |
| Ankle fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.1 | View |
| Cervical vertebral fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.1 | View |
| Concussion | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.1 | View |
| Fall | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.1 | View |
| Hip fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.1 | View |
| Lumbar vertebral fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.1 | View |
| Maternal exposure during pregnancy | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.1 | View |
| Radius fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.1 | View |
| Road traffic accident | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.1 | View |
| Spinal compression fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.1 | View |
| Subdural haematoma | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.1 | View |
| Tendon rupture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.1 | View |
| Tibia fracture | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 15.1 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 15.1 | View |
| Ejection fraction decreased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 15.1 | View |
| Electrocardiogram abnormal | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 15.1 | View |
| Electrocardiogram qt prolonged | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 15.1 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 15.1 | View |
| Dehydration | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 15.1 | View |
| Hypoglycaemia | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 15.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | View |
| Haemarthrosis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | View |
| Intervertebral disc protrusion | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | View |
| Myalgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | View |
| Neck pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | View |
| Osteoarthritis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | View |
| Osteolysis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | View |
| Plantar fasciitis | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | View |
| Acute myeloid leukaemia | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Basal cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Breast cancer in situ | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Cerebellar tumour | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Colon adenoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Colon cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Diffuse large b-cell lymphoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Gastric cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Hepatic cancer metastatic | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Hypopharyngeal cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Large intestine carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Lung neoplasm | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Lung neoplasm malignant | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Multiple myeloma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Myelodysplastic syndrome | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Ovarian neoplasm | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Pancreatic neoplasm | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Prostate cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Rectal cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Salivary gland adenoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Squamous cell carcinoma | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Thyroid neoplasm | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | View |
| Basal ganglia infarction | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.1 | View |
| Cerebral haemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.1 | View |
| Convulsion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.1 | View |
| Cranial nerve paralysis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.1 | View |
| Dysaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.1 | View |
| Epilepsy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.1 | View |
| Grand mal convulsion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.1 | View |
| Hypoaesthesia | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.1 | View |
| Hypoxic-ischaemic encephalopathy | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.1 | View |
| Ischaemic stroke | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.1 | View |
| Nerve root compression | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.1 | View |
| Neuropathy peripheral | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.1 | View |
| Posterior reversible encephalopathy syndrome | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.1 | View |
| Sciatica | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.1 | View |
| Syncope | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.1 | View |
| Tongue paralysis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.1 | View |
| Tonic convulsion | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.1 | View |
| Transient ischaemic attack | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.1 | View |
| Vith nerve paralysis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.1 | View |
| Vocal cord paralysis | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.1 | View |
| Delirium | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 15.1 | View |
| Depression | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 15.1 | View |
| Calculus ureteric | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 15.1 | View |
| Hydronephrosis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 15.1 | View |
| Incontinence | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 15.1 | View |
| Oliguria | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 15.1 | View |
| Renal failure | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 15.1 | View |
| Renal failure acute | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 15.1 | View |
| Renal pain | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 15.1 | View |
| Urinary retention | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 15.1 | View |
| Prostatic obstruction | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 15.1 | View |
| Prostatitis | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 15.1 | View |
| Acute pulmonary oedema | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | View |
| Asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | View |
| Interstitial lung disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | View |
| Lung infiltration | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | View |
| Pleural effusion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | View |
| Pleurisy | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | View |
| Pneumonitis | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | View |
| Pulmonary embolism | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | View |
| Dermal cyst | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 15.1 | View |
| Skin fibrosis | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 15.1 | View |
| Skin ulcer | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 15.1 | View |
| Abdominal hernia repair | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 15.1 | View |
| Anal fissure excision | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 15.1 | View |
| Meniscus removal | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 15.1 | View |
| Spinal fusion surgery | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 15.1 | View |
| Aortic aneurysm | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 15.1 | View |
| Deep vein thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 15.1 | View |
| Hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 15.1 | View |
| Thrombosis | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 15.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 15.1 | View |
| Leukopenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 15.1 | View |
| Neutropenia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 15.1 | View |
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Constipation | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Dry mouth | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Faeces discoloured | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Nausea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 15.1 | View |
| Oedema peripheral | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.1 | View |
| Weight increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 15.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.1 | View |
| Pruritus | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 15.1 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 15.1 | View |
| Alanine aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 15.1 | View |
| Aspartate aminotransferase increased | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 15.1 | View |
| Electrocardiogram qt prolonged | SYSTEMATIC_ASSESSMENT | Investigations | MedDRA 15.1 | View |
| Decreased appetite | SYSTEMATIC_ASSESSMENT | Metabolism and nutrition disorders | MedDRA 15.1 | View |
| Arthralgia | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | View |
| Back pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | View |
| Musculoskeletal pain | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | View |
| Pain in extremity | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 15.1 | View |
| Insomnia | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 15.1 | View |
| Chromaturia | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA 15.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA 15.1 | View |
| Hypertension | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 15.1 | View |
| Fatigue | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | MedDRA 15.1 | View |