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 |
|---|---|---|---|---|---|---|---|---|
| Phone Call Group (Intervention Arm) | Follow-up phone call program: Patients will receive the first call attempt within 72 hours of hospital discharge with a maximum of 3 call attempts by the study nurse made up until post-discharge day 7. The semi-structured script embedded within the program specific electronic health record Discharge Phone Call Starform is used to guide a conversation to obtain information on potential causes of hospital readmission that can be identified and addressed to improve each patient's transition to outpatient care. | 68 | None | 0 | 1534 | 0 | 1534 | View |
| Usual Care Group (Control Arm) | Patients assigned to the Control Group receive standard discharge planning and follow-up per the usual care of their medical providers. | 75 | None | 0 | 1520 | 0 | 1520 | View |