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 |
|---|---|---|---|---|---|---|---|---|
| Personalized Support for Progress (PSP) | In Personalized Support for Progress (PSP), patients meet with a navigator to prioritize their concerns using a decision aid, develop a plan based on their identified priorities, and execute the plan. Navigation: The navigator provides up to 4 months outreach and support to implement the personal care plan. Patients determine the preferred frequency and type of contact with the navigator. At the end of the four months, the patient and navigator will review the personal care plan, and the navigator will work with the patient as to how she can continue progress through accessing other supports and resources as needed. | 0 | None | 0 | 111 | 0 | 111 | View |
| Enhanced Screening and Referral (ESR) | Enhanced Screen and Referral (ESR)- participant will receive personal report of their current needs and list of resources available in the community. Enhanced Screening and Referral: Patients assigned to ESR will be provided with a print-out of their Promote-W comprehensive health screening results. More specifically, they will receive a list of concerns they endorsed plus a resource list of locations where they can obtain assistance with those issues, which are largely free. | 0 | None | 0 | 112 | 0 | 112 | View |