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 |
|---|---|---|---|---|---|---|---|---|
| Lidocaine Lubricant Then Placebo Lubricant | In this arm, subjects will use lidocaine lubricant in their normal bowel care routine on day one and placebo lubricant on day two. Lidocaine lubricant: Subjects using this intervention will receive 30 mL of Lidocaine hydrochloride jelly (2%) Placebo lubricant: Subjects using this intervention will receive 30 mL of placebo lubricant (no topical anesthetic) | 0 | None | 0 | 7 | 0 | 7 | View |
| Placebo Lubricant Then Lidocaine Lubricant. | In this arm, subjects will use regular lubricant (AMG MedPro lubricating gel) in their normal bowel care routine on day one and lidocaine lubricant on day two. Placebo lubricant: Subjects using this intervention will receive 30 mL of placebo lubricant (no topical anesthetic) Lidocaine lubricant: Subjects using this intervention will receive 30 mL of Lidocaine hydrochloride jelly (2%) | 0 | None | 0 | 6 | 0 | 6 | View |