Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 6:25 PM
Ignite Modification Date: 2025-12-25 @ 3:55 PM
NCT ID: NCT05446168
Description: None
Frequency Threshold: 0
Time Frame: For all subjects, data was collected during the 30 +/- 7 days of tributyrin intervention.
Study: NCT05446168
Study Brief: Brain Small Chain Fatty Acid Metabolism in Parkinson Disease: Tributyrin Supplementation
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Parkinson's Disease Tributyrin Intervention Participants will take 500mg TID tributyrin supplement for 30 days +/- 7 days. tributyrin: Post-biotic short chain fatty acid dietary supplement. Participants will take 500mg TID tributyrin supplement for 30 days +/- 7 days. 0 None 0 14 13 14 View
Healthy Control Tributyrin Intervention Participants will take 500mg TID tributyrin supplement for 30 days +/- 7 days. tributyrin: Post-biotic short chain fatty acid dietary supplement. Participants will take 500mg TID tributyrin supplement for 30 days +/- 7 days. 0 None 0 3 2 3 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
GI Discomfort SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Behavioral Disturbance SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Sleep Disruption SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Shakiness/Dyskinesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Toe Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Claustrophobia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Respiratory Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gait Disturbances SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Leg Swelling SYSTEMATIC_ASSESSMENT Vascular disorders None View
High Blood Glucose SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Shortness of breath SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View