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
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| High Polyphenol Milk Chocolate | High polyphenol milk chocolate containing approximately 1 mg/g of epicatechin Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given | None | None | 1 | 20 | 0 | 20 | View |
| Nestle Noir 70 % Chocolate | Nestle Noir 70 % chocolate containing approximately 1 mg/g of epicatechin Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given | None | None | 0 | 21 | 0 | 21 | View |
| Low Polyphenol Milk | Low polyphenol milk control (matched to product 1 as closely as possible for milk content, carbohydrate, fat and calories, made from cocoa butter, sugar, milk powder and small amount of cocoa liquor to improve taste, giving approximately 0.05mg/g epicatechin. Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given | None | None | 1 | 21 | 0 | 21 | View |