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: 2025-12-25 @ 12:39 AM
Ignite Modification Date: 2025-12-25 @ 10:49 PM
NCT ID: NCT01963767
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT01963767
Study Brief: Nutraceutical Effects on Long-Term Memory
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
NT-020 Participants received two pills of NT-020 plus Biovin (900 mg proprietary formulation of blueberry, carnosine, green tea, plus 200 U Vitamin D3, 40 mg Biovin), with one to be taken in the morning and the other in the evening. NT-020: Recommended intake of NT-020 (NutraStem®) is two (2) capsules daily. This comprises Vitamin D3 (2000 IU), BioVin® (40 mg) and the proprietary blend (900mg). This recommended intake was calculated from doses analyzed in scientific research and based on the dose within the submitted patent. Scientific description of the ingredients of the product per a 2 capsule dose Vitamin D3 (as cholecalciferol) - 2000 IU BioVin® Grape Extract - 40 mg Proprietary Blend - 900mg Green Tea Extract (Camellia sinensis) Wild Blueberries\* (whole fruit) Carnosine VitaBlue® Wild Blueberry Extract\* * Vaccinium angustifolium None None 1 52 2 52 View
Placebo Subjects took two pills, one in the morning and one in the evening, that were matched in size and shape to the active compound. None None 0 53 1 53 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiac disorders SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Upset Stomach None Gastrointestinal disorders None View