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 @ 2:12 AM
Ignite Modification Date: 2025-12-26 @ 12:40 AM
NCT ID: NCT00587860
Description: Patients will be evaluated on a bi-weekly basis by phone interview and paper questionnaire. During these queries, subjects will be asked to report study medication compliance and side effects or adverse events (AE). Adverse events will be categorized into Serious Adverse Events (SAE) and Non-serious Adverse Events (NAE).
Frequency Threshold: 5
Time Frame: Study duration
Study: NCT00587860
Study Brief: A Placebo-Controlled Trial of St. John's Wort for 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
Placebo Placebo, twice a day None None 0 35 0 35 View
St. John's Wort St. John's Wort, 450 mg twice a day None None 0 35 0 35 View
Serious Events(If Any):
Other Events(If Any):