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 |
|---|---|---|---|---|---|---|---|---|
| Control | No treatment (healthy comparison participants with no history or presence of psychiatric disorder) | 0 | None | 2 | 67 | 3 | 67 | View |
| MDD (Escitalopram Tx) | Target dose 20mg for 12 weeks Escitalopram: 20 mg target dose for 12 weeks | 0 | None | 0 | 54 | 9 | 54 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Fall | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Fatigue + poor appetite | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Low libido + low mood | NON_SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| Skin - Hives/Itchiness | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | None | View |
| Elevated BP | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |