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: 2025-12-24 @ 2:12 PM
Ignite Modification Date: 2025-12-25 @ 12:51 PM
NCT ID: NCT02692495
Description: Adverse effects were defined as any events, expected or not, that affected participant well being, regardless of whether there was a causal relationship with the diagnostic testing and discussion of the results. Serious adverse events were defined as those that prevented a participant from performing normal activities and required treatment.
Frequency Threshold: 0
Time Frame: All participants were followed up by email for at least one week after discussing their test results.
Study: NCT02692495
Study Brief: Evaluation of Potential Screening Tools for Metabolic Body Odor and Halitosis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Body Odor individuals self-reporting recurrent episodes of uncontrollable body odor with or without halitosis 0 None 0 12 0 12 View
Halitosis individuals self-reporting breath malodors but not body odors 0 None 0 4 0 4 View
Serious Events(If Any):
Other Events(If Any):