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 |
|---|---|---|---|---|---|---|---|---|
| Epiduo Gel | Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel. | None | None | 0 | 73 | 16 | 73 | View |
| Retin-A Micro Microsphere 0.1% | Tretinoin gel, 0.1% Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel. | None | None | 0 | 73 | 16 | 73 | View |
| Non-application Site | Adverse events occurring on non-application sites | None | None | 1 | 73 | 0 | 73 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Epilepsy | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 14.0 | View |