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: 2025-12-25 @ 2:41 AM
Ignite Modification Date: 2025-12-26 @ 1:20 AM
NCT ID: NCT00857233
Description: None
Frequency Threshold: 3
Time Frame: 24 weeks plus 30 days safety follow-up period
Study: NCT00857233
Study Brief: Safety and Tolerability of Memantine in Moderate to Severe 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
Memantine 20 mg Oral Tablets Once Daily None None 27 297 85 297 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.1 View
Acute myocardial infarction None Cardiac disorders None View
Bradycardia None Cardiac disorders None View
Cardiac failure None Cardiac disorders None View
Supraventricular tachycardia None Cardiac disorders None View
Asthenia None General disorders None View
Bile duct stone None Hepatobiliary disorders None View
Gastroenteritis None Infections and infestations None View
Pneumonia None Infections and infestations None View
Scrotal infection None Infections and infestations None View
Urinary tract infection bacterial None Infections and infestations None View
Acetabulum fracture None Injury, poisoning and procedural complications None View
Fall None Injury, poisoning and procedural complications None View
Hip fracture None Injury, poisoning and procedural complications None View
Lumbar vertebral fracture None Injury, poisoning and procedural complications None View
Upper limb fracture None Injury, poisoning and procedural complications None View
Muscular weakness None Musculoskeletal and connective tissue disorders None View
Oesophageal carcinoma None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Prostate cancer None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Dementia Alzheimer's type None Nervous system disorders None View
Dizziness None Nervous system disorders None View
Syncope None Nervous system disorders None View
Abnormal behaviour None Psychiatric disorders None View
Aggression None Psychiatric disorders None View
Hallucination None Psychiatric disorders None View
Restlessness None Psychiatric disorders None View
Pneumonia aspiration None Respiratory, thoracic and mediastinal disorders None View
Pulmonary embolism None Respiratory, thoracic and mediastinal disorders None View
Social stay hospitalisation None Social circumstances None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Constipation None Gastrointestinal disorders None View
Diarrhoea None Gastrointestinal disorders None View
Nausea None Gastrointestinal disorders None View
Gait disturbance None General disorders None View
Fall None Injury, poisoning and procedural complications None View
Dizziness None Nervous system disorders None View
Headache None Nervous system disorders None View
Agitation None Psychiatric disorders None View
Confusional state None Psychiatric disorders None View