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 |
|---|---|---|---|---|---|---|---|---|
| Education Intervention | The intervention provides a personalized Meducation calendar to all patients enrolled in the study (identified in package as Example Calendar). The Meducation Calendar will include medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication. education intervention: Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study). The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development. | None | None | 14 | 23 | 0 | 23 | View |
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Infections | SYSTEMATIC_ASSESSMENT | Infections and infestations | None | View |
| ER visit | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | None | View |
| Vascular Event | SYSTEMATIC_ASSESSMENT | Vascular disorders | None | View |
| ER visit | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | None | View |
| ER visit | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | None | View |
| ER visit | SYSTEMATIC_ASSESSMENT | General disorders | None | View |
| ER visit | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | None | View |
| ER | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | None | View |
| Hospitalization | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | None | View |
| ER Visit | SYSTEMATIC_ASSESSMENT | Endocrine disorders | None | View |
| Hospitalization | SYSTEMATIC_ASSESSMENT | Nervous system disorders | None | View |
| Hospitalization | SYSTEMATIC_ASSESSMENT | Cardiac disorders | None | View |