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 |
|---|---|---|---|---|---|---|---|---|
| mPATH-Lung | Participants randomized to the mPATH arm will be shown a 5-minute animated LCS decision aid video, personalized risk/benefit information, and a values clarification exercise. The participants in this group will be given an option to request a screening appointment via the program. mPATH-Lung: A web-based program that determines patients eligibility for lung cancer screening (LCS), informs them of LCS, presents them with personalized risk-benefit information, helps them make a screening decision, and helps them schedule a LCS clinic appointment. | 0 | None | 0 | 669 | 0 | 669 | View |
| Usual Care (CONTROL) | Participants randomized to the control arm will be advised that they qualified for lung cancer screening and directed to speak with their provider if interested. The web app then displayed a 5-minute video about exercise for lung health before ending. They will not be offered the opportunity to estimate their predicted benefits and harms of screening or to request a lung cancer screening visit. Lung health video: Web-based video about guideline recommended exercise for lung health | 0 | None | 0 | 664 | 0 | 664 | View |