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 |
|---|---|---|---|---|---|---|---|---|
| Control | * 15 minute discharge planning session with health educator-This task was changed to a telephone session due to the COVID-19 Pandemic, which banned access to the recruitment sites. * Health education booklet containing SHE-Women intervention content in print form(N\~100) * access to health educator via text message | 0 | None | 0 | 0 | 0 | 0 | View |
| Intervention | Deliver text-Web intervention to (N \~100) women Researchers will deliver the integrated, multimedia electronic women's health literacy intervention arm of SHEWomen in text-Web format for individuals recently released from jail. Two health educators will be responsible for delivering content to participants, with an estimated contact time of \~10 hours pushed to participants over approximately a 5-day period. SHE-WOMEN: SHE-WOMEN is a text-Web intervention designed to increase jail-involved women's health literacy, reduce risk, and increase screening for prevention of cervical cancer, breast cancer, unintended pregnancy, and sexually transmitted infections. | 0 | None | 0 | 0 | 0 | 0 | View |
| Pilot | These participants will give feedback on the digital, booklet, and survey items of the intervention | 0 | None | 0 | 0 | 0 | 0 | View |