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 @ 4:35 AM
Ignite Modification Date: 2025-12-26 @ 3:37 AM
NCT ID: NCT04542018
Description: Participants were encouraged to contact the study team if they experienced adverse events and were provided with contact information in the informed consent document. The study team did not specifically ask participants about adverse events or search medical records for potential AEs. Therefore, while all data collected is reported below, participants could have chosen not to report adverse events they experienced.
Frequency Threshold: 0
Time Frame: 4 weeks
Study: NCT04542018
Study Brief: Effects of Low FODMAP Diet on Colonic Epithelial Physiology in Diarrhea-predominant Irritable Bowel Syndrome
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Responders Patients with diarrhea-predominant IBS who will undergo a low FODMAP diet for 4 weeks a low FODMAP diet for 4 weeks: low FODMAP diet for 4 weeks Participants in this arm reported a change in IBS-SSS score between the baseline survey and the survey after 4 weeks of following the Low FODMAP diet of at least 100 points. 0 None 0 34 2 34 View
Non-Responders Patients with diarrhea-predominant IBS who will undergo a low FODMAP diet for 4 weeks a low FODMAP diet for 4 weeks: low FODMAP diet for 4 weeks Participants in this arm reported a change in IBS-SSS score between the baseline survey and the survey after 4 weeks of following the Low FODMAP diet of less-than 100 points. 0 None 0 8 0 8 View
Intervention Recipients Who Did Not Complete the Trial These participants began the 4 week Low FODMAP diet treatment, but did not complete the treatment or report data to study team. They were, therefore, not categorized into "responders" or "non-responders". 0 None 0 6 0 6 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Ankle fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
COVID-19 NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Post-Vaccination Stomach Pain and Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View