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 @ 11:54 PM
Ignite Modification Date: 2025-12-25 @ 9:50 PM
NCT ID: NCT01977651
Description: None
Frequency Threshold: 5
Time Frame: From first dose of study drug up to 30 days after last dose of study drug (approximately 52 months)
Study: NCT01977651
Study Brief: A Study to Evaluate the Potential Increased Risk of Seizures Among Metastatic Castration-Resistant Prostate Cancer (mCRPC) Patients Treated With Enzalutamide
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Enzalutamide 160 mg Participants received 160 mg of enzalutamide orally once a day, for 4 months. At the end of the 4-month treatment period, participants who were assessed as deriving benefit from enzalutamide treatment continued in the extension period. The total study drug treatment duration for the extended period depended on individual clinical benefit. If a participant experienced a Grade 3 or higher toxicity that was attributed to enzalutamide and could not be ameliorated by the use of adequate medical intervention, treatment with enzalutamide was allowed to be interrupted for 1 week or until the toxicity grade improved to Grade 2 or lower severity. Subsequently, enzalutamide was restarted at the original dose 160 mg per day or a reduced dose 120 or 80 mg per day in consultation with the medical monitor. 62 None 193 423 318 423 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Enterocolitis infectious SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16 View
Erysipelas SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16 View
Escherichia urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16 View
Localised infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16 View
Lower respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16 View
Lung infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16 View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16 View
Pyelonephritis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16 View
Pyelonephritis acute SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16 View
Respiratory tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16 View
Sepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16 View
Spinal cord infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16 View
Streptococcal urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16 View
Tracheobronchitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16 View
Urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16 View
Urinary tract infection bacterial SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16 View
Urinary tract infection enterococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16 View
Urinary tract infection staphylococcal SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16 View
Urosepsis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16 View
Cervical vertebral fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16 View
Femoral neck fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16 View
Femur fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16 View
Hip fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16 View
Humerus fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16 View
Lower limb fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16 View
Pelvic fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16 View
Procedural pain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16 View
Subdural haematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16 View
Subdural haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16 View
Upper limb fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16 View
Urostomy complication SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16 View
Alanine aminotransferase increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 16 View
C-reactive protein increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 16 View
Cystoscopy SYSTEMATIC_ASSESSMENT Investigations MedDRA 16 View
Haemoglobin decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 16 View
Cachexia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 16 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 16 View
Dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 16 View
Failure to thrive SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 16 View
Hypercalcaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 16 View
Hyperkalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 16 View
Hypoglycaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 16 View
Hypokalaemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 16 View
Hyponatraemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 16 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16 View
Bone pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16 View
Flank pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16 View
Lumbar spinal stenosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16 View
Muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16 View
Musculoskeletal chest pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16 View
Pathological fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16 View
Pubic pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16 View
Basal cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 16 View
Benign neoplasm of ureter SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 16 View
Bladder cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 16 View
Cholangiocarcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 16 View
Lung neoplasm malignant SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 16 View
Malignant neoplasm progression SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 16 View
Metastases to liver SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 16 View
Metastases to lymph nodes SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 16 View
Metastases to spine SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 16 View
Neoplasm malignant SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 16 View
Rectal cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 16 View
Skin cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 16 View
Squamous cell carcinoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 16 View
Altered state of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16 View
Brain stem stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16 View
Carotid artery stenosis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16 View
Central nervous system haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16 View
Cerebral artery occlusion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16 View
Cerebral artery stenosis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16 View
Cerebral haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16 View
Diplegia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16 View
Dysgeusia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16 View
Epilepsy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16 View
Grand mal convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16 View
Haemorrhage intracranial SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16 View
Haemorrhagic stroke SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16 View
IIIrd nerve paralysis SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16 View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16 View
Parkinson's disease SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16 View
Spinal cord compression SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16 View
Transient global amnesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16 View
Transient ischaemic attack SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16 View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 16 View
Mental status changes SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 16 View
Panic attack SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 16 View
Paranoia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 16 View
Anuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 16 View
Bladder dilatation SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 16 View
Dysuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 16 View
Haematuria SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 16 View
Hydronephrosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 16 View
Nephritic syndrome SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 16 View
Renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 16 View
Renal failure acute SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 16 View
Urethral stenosis SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 16 View
Urinary bladder haemorrhage SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 16 View
Urinary retention SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 16 View
Urinary tract obstruction SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 16 View
Pelvic pain SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 16 View
Epistaxis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16 View
Haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16 View
Orthopnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16 View
Pleural effusion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16 View
Pulmonary congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16 View
Pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16 View
Pulmonary oedema SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16 View
Respiratory arrest SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16 View
Respiratory disorder SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16 View
Bladder lesion excision SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 16 View
Internal fixation of fracture SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 16 View
Joint arthroplasty SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 16 View
Aortic aneurysm SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 16 View
Deep vein thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 16 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 16 View
Atrial fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16 View
Atrial flutter SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16 View
Atrioventricular block complete SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16 View
Cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16 View
Cardiac failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16 View
Cardiac failure chronic SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16 View
Cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16 View
Cardiogenic shock SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16 View
Right ventricular failure SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16 View
Ventricular tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16 View
Hypoacusis SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 16 View
Vertigo SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 16 View
Blindness SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 16 View
Eye pain SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 16 View
Vision blurred SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 16 View
Abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16 View
Colonic obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16 View
Duodenal ulcer haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16 View
Dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16 View
Ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16 View
Intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16 View
Lower gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16 View
Proctalgia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 16 View
Chest pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 16 View
Death SYSTEMATIC_ASSESSMENT General disorders MedDRA 16 View
Device leakage SYSTEMATIC_ASSESSMENT General disorders MedDRA 16 View
Drug ineffective SYSTEMATIC_ASSESSMENT General disorders MedDRA 16 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 16 View
Gait disturbance SYSTEMATIC_ASSESSMENT General disorders MedDRA 16 View
General physical health deterioration SYSTEMATIC_ASSESSMENT General disorders MedDRA 16 View
Glassy eyes SYSTEMATIC_ASSESSMENT General disorders MedDRA 16 View
Multi-organ failure SYSTEMATIC_ASSESSMENT General disorders MedDRA 16 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 16 View
Performance status decreased SYSTEMATIC_ASSESSMENT General disorders MedDRA 16 View
Pyrexia SYSTEMATIC_ASSESSMENT General disorders MedDRA 16 View
Spinal pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 16 View
Sudden cardiac death SYSTEMATIC_ASSESSMENT General disorders MedDRA 16 View
Hepatocellular injury SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 16 View
Jaundice cholestatic SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MedDRA 16 View
Anal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16 View
Appendicitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16 View
Bacteraemia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16 View
Bronchopneumonia SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16 View
Corona virus infection SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 16 View
Anaemia of malignant disease SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 16 View
Aplastic anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 16 View
Febrile neutropenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 16 View
Thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 16 View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16 View
Angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16 View
Coronary artery disease SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16 View
Mitral valve incompetence SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16 View
Myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 16 View
Candiduria SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16 View
Cellulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16 View
Clostridium difficile colitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16 View
Cystitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16 View
Diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 16 View
Ankle fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16 View
Post procedural haemorrhage SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16 View
Prostatic specific antigen increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 16 View
Hypophagia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 16 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16 View
Cerebral infarction SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16 View
Cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16 View
Cognitive disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16 View
Convulsion SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16 View
Loss of consciousness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16 View
Nerve root compression SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16 View
Normal pressure hydrocephalus SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16 View
Confusional state SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 16 View
Delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 16 View
Disorientation SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 16 View
Fear of falling SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 16 View
Chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16 View
Dyspnoea exertional SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 16 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 16 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 16 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 16 View
Anaemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 16 View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 16 View
Asthenia SYSTEMATIC_ASSESSMENT General disorders MedDRA 16 View
Oedema peripheral SYSTEMATIC_ASSESSMENT General disorders MedDRA 16 View
Pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 16 View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 16 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16 View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16 View
Musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16 View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 16 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 16 View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 16 View
Dyspnoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 16 View
Hot flush SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 16 View