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 |
|---|---|---|---|---|---|---|---|---|
| Sensoril | Sensoril(Ashwagandha) Sensoril: Sensoril® (or placebo) will be administered using random assignment at a dose of 250mg/day, increasing to a dose of 500mg/day by the second week. The dose of 500mg (or 250mg if tolerability is an issue) will be continued for a total of 8 weeks. | None | None | 0 | 30 | 5 | 30 | View |
| Placebo | Placebo Sensoril: Sensoril® (or placebo) will be administered using random assignment at a dose of 250mg/day, increasing to a dose of 500mg/day by the second week. The dose of 500mg (or 250mg if tolerability is an issue) will be continued for a total of 8 weeks. | None | None | 0 | 30 | 1 | 30 | View |
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |