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 |
|---|---|---|---|---|---|---|---|---|
| West Philadelphia Residents | For eligible residents of West Philadelphia, patients are contacted by Community Support Program Representative and offered free Lyft transportation to and from appointment. If patient has other questions about their upcoming appointment (location, time, etc.), Patient Navigator assists in answering questions Transportation: Eligible patients are contacted and offered free transportation to and from their upcoming appointment. | 0 | None | 0 | 0 | 0 | 0 | View |
| Non West Philadelphia Residents | For patients outside West Philadelphia, no contact is made and no free transportation is provided. Research coordinator logs their appointment attendance after the appointment date in question. | 0 | None | 0 | 0 | 0 | 0 | View |