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 @ 2:32 PM
Ignite Modification Date: 2025-12-25 @ 1:05 PM
NCT ID: NCT03856359
Description: None
Frequency Threshold: 0
Time Frame: 1 year, 1 month
Study: NCT03856359
Study Brief: Trial of Rifaximin in Probable 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
Rifaximin rifaximin 550 milligrams (mg) orally twice daily for 3 months Rifaximin 550 milligrams (MG): Rifaximin (Xifaxan, Salix Pharmaceuticals, Bridgewater, N.J.) (See Package Insert) is a drug that is approved by the FDA for use in humans for the treatment of Hepatic Encephalopathy, Traveler's Diarrhea and Irritable Bowel Syndrome. It is commercially available. It will be used in accordance with approved labeling as pertains to dosage and administration for Hepatic Encephalopathy, contraindications and warnings. However, it will be used investigationally in this trial as rifaximin is not FDA approved for the treatment of Alzheimer's Disease. 0 None 0 10 10 10 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Decline in cognitive ability NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Increased confusion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Upset stomach NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hand tremor NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Fell out of chair NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Fell NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View