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
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Vagal Symptoms With NS Flush | Number of subjects experiencing vasovagal symptoms (symptom complex including pallor, diaphoresis, dizziness, weakness, nausea, with or without syncope) with antegrade administration of NS flush solution | 0 | None | 0 | 5 | 0 | 5 | View |
| Vagal Symptoms With USP Glycerin Flush | Number of subjects experiencing vasovagal symptoms (symptom complex including pallor, diaphoresis, dizziness, weakness, nausea, with or without syncope) with antegrade administration of USP Glycerin flush solution | 0 | None | 0 | 5 | 1 | 5 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Vasovagal Response | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |