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 |
|---|---|---|---|---|---|---|---|---|
| Video w/ Post Exam Immediately After Video | Parents will watch the video and then take the post test immediately after watching the video. Video: Watching a YouTube video containing post tonsillectomy discharge instructions. | 0 | None | 0 | 33 | 0 | 33 | View |
| Standard Discharge Teaching | Parents will receive standard discharge teaching from the nurse prior to discharge. Standard discharge teaching: Receiving standard post tonsillectomy discharge instructions from the nurse prior to discharge. | 0 | None | 0 | 33 | 0 | 33 | View |
| Video w/ Post Exam After Discharge Teaching | Parents will watch the video but wait to take the post exam until after the discharge instructions are given by the nurse prior to discharge. Video: Watching a YouTube video containing post tonsillectomy discharge instructions. Standard discharge teaching: Receiving standard post tonsillectomy discharge instructions from the nurse prior to discharge. | 0 | None | 0 | 33 | 0 | 33 | View |