Adverse Events Module

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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 @ 6:28 PM
Ignite Modification Date: 2025-12-25 @ 3:58 PM
NCT ID: NCT00594568
Description: Per statistical analysis plan, participants that had any visit for delayed start period were included in reporting of adverse events. Participants were not included in Participant Flow (PF), if they did not receive a dose during the delayed start period. Therefore, PF in delayed start period has less participant numbers than in Adverse Events.
Frequency Threshold: 5
Time Frame: None
Study: NCT00594568
Study Brief: Effect of LY450139 on the Long Term Progression of Alzheimer's Disease
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo - Initial Treatment Period (NT) Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 milligrams (mg) orally once daily until Week 88. None None 72 501 262 501 View
100 mg LY450139 - NT Participants received 60 mg LY450139 orally once daily for 2 weeks followed by gradual escalation to 100 mg LY450139 orally once daily until Week 88. None None 123 507 310 507 View
140 mg LY450139 - NT Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88. None None 132 529 385 529 View
Placebo - Delayed Start Period (DO) Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88. None None 10 192 0 192 View
100 mg LY450139 - DO Participants received 60 mg LY450139 orally once daily for 2 weeks followed by gradual escalation to 100 mg LY450139 orally once daily until Week 88. None None 9 153 0 153 View
140 mg LY450139 - DO Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88. None None 5 124 0 124 View
Placebo- Safety FU Period (SFU) For SFU, study drug had been stopped and period was optional to enter; Participants entered from Placebo initial treatment or delayed start or did not enter SFU. None None 12 290 0 290 View
100 mg LY450139- SFU For SFU, study drug had been stopped and period was optional to enter; Participants entered from 100 mg LY450139 initial treatment or delayed start or did not enter SFU. None None 22 223 0 223 View
140 mg LY450139- SFU For SFU, study drug had been stopped and period was optional to enter; Participants entered from 140 mg LY450139 initial treatment or delayed start or did not enter SFU. None None 5 214 0 214 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 13.1 View
Subarachnoid haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Thalamus haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Cystitis glandularis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.1 View
Eosinophilic cystitis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.1 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.1 View
Renal failure acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.1 View
Renal injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.1 View
Urethral caruncle SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.1 View
Urethral stenosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.1 View
Benign prostatic hyperplasia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 13.1 View
Prostatic obstruction SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 13.1 View
Rash papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Skin ulcer SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Immobile SYSTEMATIC_ASSESSMENT Social circumstances MedDRA 13.1 View
Aortic aneurysm rupture SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View
Embolism venous SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View
Hypertensive crisis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View
Hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View
Orthostatic hypotension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View
Phlebitis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View
Varicose vein SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View
Venous insufficiency SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 13.1 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Sudden death SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Cholecystitis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 13.1 View
Cholecystitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 13.1 View
Cholelithiasis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 13.1 View
Gallbladder disorder SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 13.1 View
Hepatic steatosis SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 13.1 View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 13.1 View
Abscess oral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Bronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Bronchopneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Campylobacter gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Candidiasis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Cholecystitis infective SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Clostridial infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Clostridium difficile colitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Arteriosclerosis coronary artery SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Atrioventricular block SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Atrioventricular block complete SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Haematochezia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Haemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Ileus paralytic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Inflammatory bowel disease SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Inguinal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Inguinal hernia strangulated SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Aortic valve incompetence SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Myocardial ischaemia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Nodal rhythm SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Pleuropericarditis SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Sick sinus syndrome SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Sinus bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Supraventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Torsade de pointes SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 13.1 View
Cataract SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.1 View
Glaucoma SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 13.1 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Abdominal pain lower SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Colitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Colitis ischaemic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Colonic polyp SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Diarrhoea haemorrhagic SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Gastric ulcer haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Inguinal hernia, obstructive SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Lower gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Oesophageal rupture SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Pancreatitis acute SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Pancreatitis necrotising SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Rectal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Umbilical hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Volvulus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Device dislocation SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Gait disturbance SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Non-cardiac chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Device related infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Epiglottitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Gastric infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Herpes zoster SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Lobar pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Necrotising fasciitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Osteomyelitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Pneumonia bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Pneumonia haemophilus SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Pneumonia legionella SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Pseudomembranous colitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Pyelonephritis acute SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Pyometra SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Renal cyst infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Salmonellosis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Septic shock SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Sinobronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Sinusitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Staphylococcal skin infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Urinary tract infection pseudomonal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Viral infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Wound infection staphylococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Accidental overdose SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Animal bite SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Ankle fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Cervical vertebral fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Femoral neck fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Femur fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Fractured sacrum SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Head injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Hip fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Joint dislocation SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Lumbar vertebral fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Meniscus lesion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Muscle rupture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Patella fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Pubis fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Rib fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Skin laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Spinal compression fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Sternal fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Subdural haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Tendon rupture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Thermal burn SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Gamma-glutamyltransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Hepatic enzyme increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Diabetes mellitus inadequate control SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Starvation SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Type 2 diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Bursitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Costochondritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Intervertebral disc protrusion SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Muscle atrophy SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Spinal column stenosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Spinal osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 13.1 View
Anal cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.1 View
Basal cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.1 View
Bladder cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.1 View
Bowen's disease SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.1 View
Breast cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.1 View
Breast cancer stage iv SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.1 View
Colon cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.1 View
Colon cancer metastatic SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.1 View
Colon neoplasm SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.1 View
Gastrointestinal tract adenoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.1 View
Gingival cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.1 View
Keratoacanthoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.1 View
Lung adenocarcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.1 View
Lung neoplasm malignant SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.1 View
Lung squamous cell carcinoma stage i SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.1 View
Lung squamous cell carcinoma stage unspecified SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.1 View
Mesothelioma malignant SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.1 View
Metastases to liver SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.1 View
Non-hodgkin's lymphoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.1 View
Oesophageal carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.1 View
Ovarian fibroma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.1 View
Pancreatic carcinoma stage iv SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.1 View
Prostate cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.1 View
Prostate cancer metastatic SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.1 View
Squamous cell carcinoma of skin SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.1 View
Uterine cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.1 View
Vaginal cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.1 View
Ataxia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Brain stem stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Cerebellar haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Cerebral haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Dementia alzheimer's type SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Depressed level of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Epilepsy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Grand mal convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Haemorrhage intracranial SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Haemorrhagic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Hypertensive encephalopathy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Ischaemic cerebral infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Ischaemic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Migraine SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Normal pressure hydrocephalus SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Psychomotor skills impaired SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Abnormal behaviour SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Aggression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Behavioural and psychiatric symptoms of dementia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Delusion SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Delusional disorder, unspecified type SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Hallucination, visual SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Hypomania SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Major depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Mental disorder SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Mental status changes SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Paranoia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Suicidal ideation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Bladder disorder SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.1 View
Bladder neck obstruction SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.1 View
Calculus ureteric SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 13.1 View
Acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Asphyxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Atelectasis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Emphysema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Hydropneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Hypoxia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Pneumonia aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Pneumothorax SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Respiratory distress SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Actinic keratosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Drug eruption SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Pemphigoid SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 13.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 13.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Upper respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 13.1 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 13.1 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 13.1 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 13.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 13.1 View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 13.1 View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 13.1 View
Hair colour changes SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Rash erythematous SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Rash macular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View
Rash maculo-papular SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 13.1 View