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 @ 11:09 PM
Ignite Modification Date: 2025-12-25 @ 8:43 PM
NCT ID: NCT01453569
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT01453569
Study Brief: Safety, Efficacy and Dose Titration of Sodium Oligo-mannurarate Capsule on Mild to Moderate 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
Sodium Oligo-mannurarate 600mg Sodium oligo-mannurarate 600mg: sodium oligo-mannurarate capsule 600mg twice a day for 24 weeks None None 6 84 12 84 View
Sodium Oligo-mannurarate 900mg Sodium oligo-mannurarate 900mg: sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks None None 3 86 3 86 View
Placebo Placebo: simulant of sodium oligo-mannurarate capsule None None 6 85 5 85 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Behavioral and psychiatric symptoms None Psychiatric disorders None View
Osteoarthritis None Musculoskeletal and connective tissue disorders None View
Subdural hematoma None Vascular disorders None View
Stroke None Nervous system disorders None View
Implantation of artificial heart pacemaker None Cardiac disorders None View
Paralysis of oculomotor nerve None Nervous system disorders None View
Cellulitis None Infections and infestations None View
Appendicitis None Gastrointestinal disorders None View
Emptying disorder of intestine and stomach None Gastrointestinal disorders None View
Hypertension None Cardiac disorders None View
Hernia None General disorders None View
Chill None General disorders None View
Compressive fracture of vertebra None Musculoskeletal and connective tissue disorders None View
Lung cancer None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Cerebral hemorrhage None Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Ear and labyrinth None Ear and labyrinth disorders None View
Gastrointestinal None Gastrointestinal disorders None View
Injuries, toxicosis, complications due to surgery None Injury, poisoning and procedural complications None View
Muscular and connective tissue None Musculoskeletal and connective tissue disorders None View
CNS disorders None Nervous system disorders None View
Psychiatiric disorders None Psychiatric disorders None View
Reproductive system and mammary gland None Reproductive system and breast disorders None View
Respiratoty system, chest and mediastinum None Respiratory, thoracic and mediastinal disorders None View
Dermatologic None Skin and subcutaneous tissue disorders None View