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 @ 12:14 AM
Ignite Modification Date: 2025-12-25 @ 10:16 PM
NCT ID: NCT02881658
Description: None
Frequency Threshold: 0
Time Frame: Participants were asked to complete a questionnaire related to adverse event that happened during the 3 weeks period of consuming soya beverage.
Study: NCT02881658
Study Brief: The Effect of 3-Week Consumption of Soya Beverage Enriched With Plant Sterols on Serum LDL-C
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Plant Sterols-enriched Soya Beverage Daily consumption of 2g of plant sterols as provided by one pack of 250 ml of plant sterols-enriched soya beverage for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner). Plant sterols-enriched soya beverage: the study product is a 2g plant sterols-enriched in 250ml soya beverage 0 None 0 100 5 100 View
Soya Beverage Daily consumption of one pack of 250 ml of soya beverage (without plant sterols) for consecutive 3 weeks, each pack consumed once with main meal (i.e breakfast, lunch or dinner). Soya beverage: the placebo product is a 250 ml soya beverage 0 None 0 101 1 101 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Stomach Bloating SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Slight hardening of stool during the three weeks period SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Flu SYSTEMATIC_ASSESSMENT Infections and infestations None View