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: 2025-12-26 @ 1:19 PM
Ignite Modification Date: 2025-12-26 @ 1:19 PM
NCT ID: NCT02634606
Description: Adverse events were not reported/collected because no participants were assigned to an intervention arm prior to study termination
Frequency Threshold: 0
Time Frame: None
Study: NCT02634606
Study Brief: Effects of a Supplement Derived From Palm Oil on Cholesterol Levels in the Blood
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Gamma Delta Tocotrienols - Low Dose 33 subjects with cholesterol level (\>180 mg/dl), ages 35-70, currently taking statins who meet all of the eligibility criteria in the screening phase of the study will be assigned to the TRF (63mg) arm of the study to evaluate the cholesterol suppressive actions of TRF. Subjects will be asked to take 2 tablets per day and to maintain the American Heart Association (AHA) diet for 12 weeks. Gamma Delta Tocotrienols - Low Dose: 250 mg capsule containing 63 mg Gamma Delta Tocotrienols 2x/day for 12 weeks. 0 None 0 0 0 0 View
Gamma Delta Tocotrienols - High Dose 33 subjects with cholesterol level (\>180 mg/dl), ages 35-70, currently taking statins who meet all of the eligibility criteria in the screening phase of the study will be assigned to the TRF (127mg) arm of the study to evaluate the cholesterol suppressive actions of TRF. Subjects will be asked to take 2 tablets per day and to maintain the American Heart Association (AHA) diet for 12 weeks. Gamma Delta Tocotrienols - High Dose: 250 mg capsule containing 127 mg Gamma Delta Tocotrienols 2x/day for 12 weeks. 0 None 0 0 0 0 View
Sugar Pill 33 subjects with cholesterol level (\>180 mg/dl), ages 35-70, currently taking statins who meet all of the eligibility criteria in the screening phase of the study will be assigned to the Placebo arm of the study to evaluate the cholesterol suppressive actions of Placebo. Subjects will be asked to take 2 tablets per day and to maintain the American Heart Association (AHA) diet for 12 weeks. Sugar Pill: 250 mg Placebo capsule containing 50% medium chain triglycerides and 50% glycerin 2x/day for 12 weeks. 0 None 0 0 0 0 View
Serious Events(If Any):
Other Events(If Any):