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 |
|---|---|---|---|---|---|---|---|---|
| Group 1 (Test Product) | Participants were instructed to apply test product (approximately 0.6-1 g) to full face topically twice daily (morning and evening) after cleansing for a total of 14 consecutive days. All participants were instructed to continue using the facial cleanser twice-daily during the morning and evening and to apply the sunscreen in the morning (after application of test product) and at lunchtime. | 0 | None | 0 | 37 | 1 | 37 | View |
| Group 2 (No Test Product) | Participants were instructed to use the facial cleanser twice-daily during the morning and evening, and to apply the sunscreen in the morning and at lunchtime for a total of 14 consecutive days. | 0 | None | 0 | 40 | 2 | 40 | View |