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 @ 1:32 AM
Ignite Modification Date: 2025-12-25 @ 11:45 PM
NCT ID: NCT03407794
Description: All study participants were healthy and no serious adverse events were expected.
Frequency Threshold: 5
Time Frame: 6 weeks
Study: NCT03407794
Study Brief: Effects of Fermented Vegetables on Gut Microflora and Inflammation in Women
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Control Participants randomized into the control group will be asked to follow their usual diet during the 6 weeks of the intervention. 0 None 0 10 3 10 View
Fermented Vegetable Participants randomized into the fermented vegetable group will receive 1/2 cup per day of fermented vegetables, including cabbage, carrots or pickles, for 6 weeks. Fermented vegetable: The intervention is to consume 1/2 cup fermented vegetables every day for 6 weeks 0 None 0 10 6 10 View
Non-fermented Vegetable Participants randomized into the non-fermented vegetable group will receive 1/2 cup per day of non-fermented vegetables, including cabbage, carrots or pickles, for 6 weeks. Non-fermented vegetable: The intervention is to consume 1/2 cup of non-fermented vegetables every day for 6 weeks 0 None 0 11 9 11 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Bloating SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea/Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Abdominal Pail SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Headache SYSTEMATIC_ASSESSMENT General disorders None View