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 |
|---|---|---|---|---|---|---|---|---|
| Standard Care | resuscitation, blood and blood component transfusion per site standard care Standard Care: standard care including blood and blood component therapy | 13 | None | 4 | 98 | 0 | 98 | View |
| Cold-stored Platelet (CSP) | early infusion of one apheresis unit urgent release cold stored platelets (CSP) Cold Stored Platelets (CSP): early infusion of urgent release CSP | 12 | None | 9 | 102 | 0 | 102 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Thromboembolic events | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Coagulopathy | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |
| Pneumonia | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| Transfusion Associated Cardiac Overload | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |