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 |
|---|---|---|---|---|---|---|---|---|
| Video + MI for CR | This group receives the educational video and an MI session for CR participation. Video + Motivational interview for CR participation: Patients will be shown a 9 minute video that highlights actual CR patients discussing barriers they overcame to participate in CR, and introductions to the CR staff. The brief, phone-based motivational interview will focus on increasing motivation to participate in CR. | 0 | None | 0 | 0 | 0 | 0 | View |
| MI for Medication Adherence | This group receives an MI session for taking prescribed cardioprotective medications, Motivational interview for medication adherence: The brief, phone-based motivational interview will focus on increasing motivation to adhere to prescribed cardioprotective medications. | 0 | None | 0 | 0 | 0 | 0 | View |
| Control Group (Standard Care) | This group received standard care following a cardiac procedure. | 0 | None | 0 | 0 | 0 | 0 | View |