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 |
|---|---|---|---|---|---|---|---|---|
| Low Weight Molecular Heparin | enoxaparin 0.4 ml subcutaneous per day Enoxaparin: enoxaparin 0.4 ml sc per day for 10 days started 72 hours after the stroke | 7 | None | 1 | 38 | 0 | 38 | View |
| Standard Therapy | Graduated compression stockings and/or intermittent pneumatic compression and/or early mobilization Graduated compression stockings and/or intermittent pneumatic compression and/or early mobilization: placebo standard therapy | 6 | None | 3 | 35 | 0 | 35 | View |