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 |
|---|---|---|---|---|---|---|---|---|
| Gynoflor | Gynoflor vaginal tablet with lyophilised lactobacilli and 0.03 mg estriol:1 x 28 days, then 3x per week x 8 weeks | 0 | None | 0 | 16 | 14 | 16 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| cystitis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| Gastro-intestinal disorders | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Influenza-like ilness | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Ear and Labyrinth disorders | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | None | View |
| Vaginal discharge | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | None | View |