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: NCT02968758
Description: Adverse event procedures were established at each site, but no adverse event was observed nor reported during the enrollment period.
Frequency Threshold: 0
Time Frame: Adverse event were assessed at the time of individual patient enrollment and participation, which lasts approximately 1-2 minutes at most.
Study: NCT02968758
Study Brief: Validation of the GenePOC CDiff Assay for the Detection of the Toxin B Gene From Toxigenic Clostridium Difficile Strains
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Accuracy Testing Comparison between GenePOC PCR and Reference Method Comparison between GenePOC PCR and Reference Method: Stool specimen will be tested with the GenePOC CDiff test on the GenePOC Instrument. The results will be compared to Reference Method defined as direct and enriched culture method for observation of a toxigenic Clostridium difficile strain. 0 None 0 2461 0 2461 View
Serious Events(If Any):
Other Events(If Any):