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 |
|---|---|---|---|---|---|---|---|---|
| Usual Care | Patients will have access to an existing patient web portal (My Health at Vanderbilt) NOT embedded with the intervention (i.e., usual care). | 1 | None | 7 | 217 | 0 | 217 | View |
| Intervention | Patients have access to an existing patient web portal (My Health at Vanderbilt) embedded with the Diabetes Care Gaps Patient Portal Intervention. Diabetes Care Gaps Patient Portal Intervention: The Diabetes Care Gaps Patient Portal Intervention is embedded within an existing patient web portal (My Health at Vanderbilt). The intervention (a) notifies patients when selected, clinically meaningful, evidence-based diabetes preventative care (e.g., annual urine microalbumin) are due and (b) allows patients to initiate orders for the care. | 0 | None | 7 | 216 | 0 | 216 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Hospitalization | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| Hospitalization | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Hospitalization | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| Hospitalization | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Hospitalization | NON_SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |
| Death | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Hospitalization | NON_SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| Hospitalization | NON_SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | None | View |