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 |
|---|---|---|---|---|---|---|---|---|
| Arm I Tailored and Interactive Digital Versatile Disc (DVD) (TIDVD) | TIDVD: In this arm of the intervention participants watch a tailored interactive DVD program and answer questions posed by the DVD program. | 0 | None | 0 | 382 | 0 | 382 | View |
| Arm II TIDVD and Patient Navigation (PN) (TIDVD, PN) | TIDVD,PN: In this arm of the educational intervention the participant receives a tailored interactive DVD to watch and telephone calls from a patient navigator | 0 | None | 0 | 388 | 0 | 388 | View |
| Arm III Usual Care (UC) | UC: In this arm of the intervention participants receive brochures that explain and provide information and encouragement for cancer screening. | 0 | None | 0 | 193 | 0 | 193 | View |