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 |
|---|---|---|---|---|---|---|---|---|
| Intervention Arm | The study coordinator would request medical records for study participants in the intervention arm in compliance with Texas state laws and aggregate pertinent information (ex: labs) into a prespecified case report form. The case report form was provided to the study pharmacist conducting MTM during study visits with study participants. | 1 | None | 8 | 64 | 0 | 0 | View |
| Control Arm | The study pharmacist conducted MTM with the study participants per standard of care (i.e. additional medical records information was not provided). | 1 | None | 9 | 65 | 0 | 0 | View |