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 @ 1:36 PM
Ignite Modification Date: 2025-12-25 @ 12:35 PM
NCT ID: NCT05778695
Description: None
Frequency Threshold: 0
Time Frame: For all subjects, data was collected during the 30 +/- 7 days of tributyrin intervention.
Study: NCT05778695
Study Brief: Brain Small Chain Fatty Acid Metabolism in Parkinson Disease: Ketones
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Healthy Controls Participants will take the ketone ester supplement for 30 days +/- 7 days. For days 1 through 7, participants will take 12.5g (25mL) of the ketone ester supplement (KetoneAid) TID, and on day 8, the dose will be increased to 25g (50mL) three times daily (TID) as tolerated. KE dose will be titrated down to a tolerated level if necessary. Ketone Ester (R)-3-Hydroxybutyl (R)-3-Hydroxybutyrate: Ketone ester (KE) dietary supplement (KetoneAid) 0 None 0 2 1 2 View
Parkinson Disease Participants will take the ketone ester supplement for 30 days +/- 7 days. For days 1 through 7, participants will take 12.5g (25mL) of the ketone ester supplement (KetoneAid) TID, and on day 8, the dose will be increased to 25g (50mL) three times daily (TID) as tolerated. KE dose will be titrated down to a tolerated level if necessary. Ketone Ester (R)-3-Hydroxybutyl (R)-3-Hydroxybutyrate: Ketone ester (KE) dietary supplement (KetoneAid) 0 None 0 4 4 4 View
Parkinson Disease Dementia/Lewy Body Dementia Participants will take the ketone ester supplement for 30 days +/- 7 days. For days 1 through 7, participants will take 12.5g (25mL) of the ketone ester supplement (KetoneAid) TID, and on day 8, the dose will be increased to 25g (50mL) three times daily (TID) as tolerated. KE dose will be titrated down to a tolerated level if necessary. Ketone Ester (R)-3-Hydroxybutyl (R)-3-Hydroxybutyrate: Ketone ester (KE) dietary supplement (KetoneAid) 0 None 0 10 8 10 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Back Pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Ear Infection SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Freezing of Gait SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hallucinations SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Heartburn SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Lightheadedness SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Low energy SYSTEMATIC_ASSESSMENT General disorders None View
Low glucose SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Discomfort in Scanner SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Sleep changes SYSTEMATIC_ASSESSMENT General disorders None View
Muscle soreness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Stomach ache SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Throat irritation SYSTEMATIC_ASSESSMENT General disorders None View