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 |
|---|---|---|---|---|---|---|---|---|
| Partner-optimized Venue Placement Strategy | The Phase II intervention involves outreach from community partners to attend testing at existing events organized by community partners, such as the Mexican Consulate. At the event, it includes the on-site Promotores de Salud psychoeducation related to SARS-CoV-2 health related behaviors. Phase II Promotores de Salud: Community partners (e.g., Mexican Consulate) select events for testing and use their usual outreach methods to attract participants to the site and their event. Then, at the community partner's event, the research team holds COVID-19 testing events and the Promotores de Salud health behavior intervention is delivered by bilingual research staff. The health behavior intervention includes: 1) psychoeducation to promote hand-washing, social distancing, mask wearing if unvaccinated, and continued testing to mitigate the spread of COVID-19 and psychoeducation to address vaccine hesitancy; 2) information support and service navigation to address logistical challenges associated with testing and vaccination (e.g., scheduling health care visits, transportation, language barriers); 3) motivational interviewing to explore personal, social, and behavioral barriers to testing and vaccination, and to discuss available resources. | 0 | None | 0 | 1463 | 0 | 1463 | View |
| Active Comparator, Residential Density-located Venue Placement Strategy | This is the Phase I study (Clinical Trial ID: NCT04793464) and is comprised of the "Promotores", "Control", and "Unknown Treatment Status" Arms/Groups from the Phase I study. For all Phase I study activities, testing events re-occurred every two weeks at the same location and time, based on census density on Latinx individuals for site selection. Promotores de Salud intervention arm consists of outreach to promote testing and vaccination at re-occurring testing events that have been selected for sites that have a high residential density of Latinx persons. At the testing events, it includes the on-site Promotores de Salud psychoeducation related to SARS-CoV-2 health related behaviors. Outreach conducted by promotores occurs to increase attendance at the testing events. Outreach is culturally responsive (e.g., culturally tailored radio announcements, social media posts, community canvassing, referral by community leaders). Control treatment status sites consisted of sites with "business as usual" outreach methods. No additional outreach activities were completed and promotores were not on site to deliver the Promotores de Salud intervention. Unknown treatment status participants had data collected at an intervention or control site, but their exposure status is unknown. | 0 | None | 0 | 1623 | 0 | 1623 | View |