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 |
|---|---|---|---|---|---|---|---|---|
| Reminder and Outreach Intervention | Participants randomized to this arm will receive the Reminder and Outreach intervention. Reminder and Outreach Intervention: This intervention includes (1) phone calls and text messages to remind participants that they are due for colorectal cancer (CRC) screening (2) mailed fecal occult blood test (FOBT) to participants so they can perform the test conveniently at home and mail them to the clinic, avoiding the need for a visit (3) plain language information and instructions to support understanding of CRC and FOBT use (4) a CRC screening coordinator to contact those still failing to complete testing by telephone or text (5) a feedback loop to patients regarding test results. | None | None | 0 | 225 | 0 | 225 | View |
| Usual Care Control Group | Patients assigned to this arm will receive usual care. | None | None | 0 | 225 | 0 | 225 | View |