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 @ 1:26 AM
Ignite Modification Date: 2025-12-25 @ 11:37 PM
NCT ID: NCT01651793
Description: None
Frequency Threshold: 0
Time Frame: The study personnel monitored participants through study completion, an average of 4 weeks, for adverse events. No adverse events were reported to study personnel.
Study: NCT01651793
Study Brief: Effect of Phytochemicals From Theobroma Cacao on Mental Energy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Caffeinated Cocoa High flavanol, high theobromine, high caffeine, single dose administration in hot water vehicle Active comparator 1: High flavanol, high theobromine, high caffeine, single dose administration in hot water vehicle None None 0 23 0 23 View
Cocoa High flavanol, high theobromine, low caffeine, single dose administration in hot water vehicle Active comparator 2: High flavanol, high theobromine, low caffeine, single dose administration in hot water vehicle None None 0 23 0 23 View
Cafeine Low flavanol, low theobromine, high caffeine, single dose administration in hot water vehicle Active comparator 4: Low flavanol, low theobromine, high caffeine, single dose administration in hot water vehicle None None 0 23 0 23 View
Placebo No flavanol, no theobromine, no caffeine, single dose administration in hot water vehicle Inactive comparator: No flavanol, no theobromine, no caffeine, single dose administration in hot water vehicle None None 0 23 0 23 View
Serious Events(If Any):
Other Events(If Any):