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 Laryngoscope Group | For patients assigned to the video laryngoscope group, the operator will use a video laryngoscope on the first laryngoscopy attempt. A video laryngoscope will be defined as a laryngoscope with a camera and a video screen. Trial protocol will not dictate the brand of video laryngoscope. Video Laryngoscope: Laryngoscope with a camera and a video screen | 184 | None | 0 | 705 | 0 | 705 | View |
| Direct Laryngoscope Group | For patients assigned to the direct laryngoscope group, the operator will use a direct laryngoscope on the first laryngoscopy attempt. A direct laryngoscope will be defined as a laryngoscope without a camera or a video screen. Trial protocol will not dictate the brand of direct laryngoscope or the blade shape. Direct Laryngoscope: Laryngoscope without a camera or a video screen | 191 | None | 0 | 712 | 0 | 712 | View |