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 |
|---|---|---|---|---|---|---|---|---|
| aMCI_62.5 | 62.5 mg levetiracetam twice daily for two weeks | 0 | None | 0 | 24 | 5 | 24 | View |
| aMCI_125 | 125 mg levetiracetam twice daily for two weeks | 0 | None | 0 | 23 | 3 | 23 | View |
| aMCI_125 Placebo | 125 mg placebo comparator (placebo capsule twice daily for two weeks) | 0 | None | 0 | 23 | 0 | 23 | View |
| aMCI_250 Placebo | 250 mg placebo comparator (placebo capsule twice daily for two weeks) | 0 | None | 0 | 22 | 7 | 22 | View |
| Age Matched Control | placebo capsule twice daily for two weeks | 0 | None | 0 | 27 | 3 | 27 | View |
| aMCI_62.5 Placebo | 62.5 mg placebo comparator (placebo capsule twice daily for two weeks) | 0 | None | 0 | 24 | 0 | 24 | View |
| aMCI_250 | 250 mg levetiracetam twice daily for two weeks | 0 | None | 0 | 22 | 5 | 22 | View |