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 |
|---|---|---|---|---|---|---|---|---|
| Navigation Bronchoscopy ALONE | This research study involves a screening period, a procedure and follow up visits * Procedure Visit Navigation Bronchoscopy Alone * Follow-Up Visits at Week 1, 4 and 12 Navigation Bronchoscopy: Navigation Bronchoscopy procedure will be performed per product instructions and the institution's standard practice. | 0 | None | 0 | 10 | 0 | 10 | View |
| CBCT-GUIDED Navigation Bronchoscopy | This research study involves a screening period, a procedure and follow up visits Procedure Visit- Cone Beam Computed Tomography - Guided Navigation Bronchoscopy for Peripheral Pulmonary Nodules -Follow-Up Visits at Week 1, 4 and 12 Navigation Bronchoscopy: Navigation Bronchoscopy procedure will be performed per product instructions and the institution's standard practice. Cone beam computed tomography (CBCT): Per Protocol | 0 | None | 0 | 10 | 0 | 10 | View |