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 |
|---|---|---|---|---|---|---|---|---|
| Standard of Care | standard of care | 0 | None | 0 | 2702 | 0 | 2702 | View |
| IT Platform | Access to an IT platform for visit-based reminders about overdue abnormal cancer screening test results mFOCUS: To evaluate the effectiveness of the system, team and individual components of mFOCUS vs. standard care by conducting a 4-arm cluster randomized controlled trial (RCT) of individuals who are due for follow-up of an abnormal screen. | 0 | None | 0 | 3254 | 0 | 3254 | View |
| IT Platform and Patient Navigation | the IT platform available in Arm 3 and navigation to help with scheduling and to address social barriers to care. mFOCUS: To evaluate the effectiveness of the system, team and individual components of mFOCUS vs. standard care by conducting a 4-arm cluster randomized controlled trial (RCT) of individuals who are due for follow-up of an abnormal screen. | 0 | None | 0 | 3455 | 0 | 3455 | View |
| IT Platform With Reminders | Access to an IT platform that will deliver both visit based and between visit reminders about abnormal cancer screening test results. mFOCUS: To evaluate the effectiveness of the system, team and individual components of mFOCUS vs. standard care by conducting a 4-arm cluster randomized controlled trial (RCT) of individuals who are due for follow-up of an abnormal screen. | 0 | None | 0 | 2569 | 0 | 2569 | View |